From 40550646fede5e02430d661bef106b8010e128d6 Mon Sep 17 00:00:00 2001 From: Moritz Dueck Date: Tue, 12 Dec 2023 15:02:47 +0100 Subject: [PATCH] mobile version 1.2 --- aian/.DS_Store | Bin 6148 -> 6148 bytes aian/app/.DS_Store | Bin 6148 -> 0 bytes aian/app/immutable/.DS_Store | Bin 6148 -> 0 bytes .../assets/{2.9d710b48.css => 2.9809fe71.css} | 2 +- ...{_page.1da4dbcd.css => _page.2f75f52e.css} | 2 +- ...ons.d694f9e4.js => singletons.dd4b5ee8.js} | 2 +- .../{app.f8151b23.js => app.7815ffc6.js} | 2 +- .../{start.fae2758e.js => start.7003fcc4.js} | 2 +- .../nodes/{1.7dba2c34.js => 1.f55c3549.js} | 2 +- aian/app/immutable/nodes/2.60dbd6a3.js | 1 - aian/app/immutable/nodes/2.6503796f.js | 1 + aian/app/version.json | 2 +- aian/favicon.png | Bin 1571 -> 0 bytes aian/favicon.svg | 13 ++++++++++ aian/index.html | 23 +++++++++--------- 15 files changed, 33 insertions(+), 19 deletions(-) delete mode 100644 aian/app/.DS_Store delete mode 100644 aian/app/immutable/.DS_Store rename 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:where(.join-item:last-child:not(:first-child)),.join :where(*:last-child:not(:first-child) .join-item){border-start-end-radius:inherit;border-end-end-radius:inherit}@supports not selector(:has(*)){:where(.join *){border-radius:inherit}}@supports selector(:has(*)){:where(.join *:has(.join-item)){border-radius:inherit}}.link{cursor:pointer;text-decoration-line:underline}.range{height:1.5rem;width:100%;cursor:pointer;-moz-appearance:none;appearance:none;-webkit-appearance:none;--range-shdw: var(--fallback-bc,oklch(var(--bc)/1));overflow:hidden;border-radius:var(--rounded-box, 1rem);background-color:transparent}.range:focus{outline:none}.select{display:inline-flex;cursor:pointer;-webkit-user-select:none;-moz-user-select:none;user-select:none;-webkit-appearance:none;-moz-appearance:none;appearance:none;height:3rem;min-height:3rem;padding-left:1rem;padding-right:2.5rem;font-size:.875rem;line-height:1.25rem;line-height:2;border-radius:var(--rounded-btn, .5rem);border-width:1px;border-color:transparent;--tw-bg-opacity: 1;background-color:var(--fallback-b1,oklch(var(--b1)/var(--tw-bg-opacity)));background-image:linear-gradient(45deg,transparent 50%,currentColor 50%),linear-gradient(135deg,currentColor 50%,transparent 50%);background-position:calc(100% - 20px) calc(1px + 50%),calc(100% - 16.1px) calc(1px + 50%);background-size:4px 4px,4px 4px;background-repeat:no-repeat}.select[multiple]{height:auto}.table{position:relative;width:100%;border-radius:var(--rounded-box, 1rem);text-align:left;font-size:.875rem;line-height:1.25rem}.table :where(.table-pin-rows thead tr){position:sticky;top:0;z-index:1;--tw-bg-opacity: 1;background-color:var(--fallback-b1,oklch(var(--b1)/var(--tw-bg-opacity)))}.table :where(.table-pin-rows tfoot tr){position:sticky;bottom:0;z-index:1;--tw-bg-opacity: 1;background-color:var(--fallback-b1,oklch(var(--b1)/var(--tw-bg-opacity)))}.table :where(.table-pin-cols tr th){position:sticky;left:0;right:0;--tw-bg-opacity: 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.camera:after{content:"";position:absolute;top:20%;left:70%;width:8px;height:8px;border-radius:5px;background-color:#0f0b25}.mockup-phone .display{overflow:hidden;border-radius:40px;margin-top:-25px}.mockup-browser .mockup-browser-toolbar .input{position:relative;margin-left:auto;margin-right:auto;display:block;height:1.75rem;width:24rem;overflow:hidden;text-overflow:ellipsis;white-space:nowrap;--tw-bg-opacity: 1;background-color:var(--fallback-b2,oklch(var(--b2)/var(--tw-bg-opacity)));padding-left:2rem;direction:ltr}.mockup-browser .mockup-browser-toolbar .input:before{content:"";position:absolute;left:.5rem;top:50%;aspect-ratio:1 / 1;height:.75rem;--tw-translate-y: -50%;transform:translate(var(--tw-translate-x),var(--tw-translate-y)) rotate(var(--tw-rotate)) skew(var(--tw-skew-x)) skewY(var(--tw-skew-y)) scaleX(var(--tw-scale-x)) scaleY(var(--tw-scale-y));border-radius:9999px;border-width:2px;border-color:currentColor;opacity:.6}.mockup-browser .mockup-browser-toolbar .input:after{content:"";position:absolute;left:1.25rem;top:50%;height:.5rem;--tw-translate-y: 25%;--tw-rotate: -45deg;transform:translate(var(--tw-translate-x),var(--tw-translate-y)) rotate(var(--tw-rotate)) skew(var(--tw-skew-x)) skewY(var(--tw-skew-y)) scaleX(var(--tw-scale-x)) scaleY(var(--tw-scale-y));border-radius:9999px;border-width:1px;border-color:currentColor;opacity:.6}@keyframes modal-pop{0%{opacity:0}}@keyframes progress-loading{50%{background-position-x:-115%}}@keyframes radiomark{0%{box-shadow:0 0 0 12px var(--fallback-b1,oklch(var(--b1)/1)) inset,0 0 0 12px var(--fallback-b1,oklch(var(--b1)/1)) inset}50%{box-shadow:0 0 0 3px var(--fallback-b1,oklch(var(--b1)/1)) inset,0 0 0 3px var(--fallback-b1,oklch(var(--b1)/1)) inset}to{box-shadow:0 0 0 4px var(--fallback-b1,oklch(var(--b1)/1)) inset,0 0 0 4px var(--fallback-b1,oklch(var(--b1)/1)) inset}}.range:focus-visible::-webkit-slider-thumb{--focus-shadow: 0 0 0 6px var(--fallback-b1,oklch(var(--b1)/1)) inset, 0 0 0 2rem var(--range-shdw) inset}.range:focus-visible::-moz-range-thumb{--focus-shadow: 0 0 0 6px var(--fallback-b1,oklch(var(--b1)/1)) inset, 0 0 0 2rem var(--range-shdw) inset}.range::-webkit-slider-runnable-track{height:.5rem;width:100%;border-radius:var(--rounded-box, 1rem);background-color:var(--fallback-bc,oklch(var(--bc)/.1))}.range::-moz-range-track{height:.5rem;width:100%;border-radius:var(--rounded-box, 1rem);background-color:var(--fallback-bc,oklch(var(--bc)/.1))}.range::-webkit-slider-thumb{position:relative;height:1.5rem;width:1.5rem;border-radius:var(--rounded-box, 1rem);border-style:none;--tw-bg-opacity: 1;background-color:var(--fallback-b1,oklch(var(--b1)/var(--tw-bg-opacity)));-moz-appearance:none;appearance:none;-webkit-appearance:none;top:50%;color:var(--range-shdw);transform:translateY(-50%);--filler-size: 100rem;--filler-offset: .6rem;box-shadow:0 0 0 3px var(--range-shdw) inset,var(--focus-shadow, 0 0),calc(var(--filler-size) * -1 - var(--filler-offset)) 0 0 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var(--range-shdw) inset}.range:focus-visible::-moz-range-thumb{--focus-shadow: 0 0 0 6px var(--fallback-b1,oklch(var(--b1)/1)) inset, 0 0 0 2rem var(--range-shdw) inset}.range::-webkit-slider-runnable-track{height:.5rem;width:100%;border-radius:var(--rounded-box, 1rem);background-color:var(--fallback-bc,oklch(var(--bc)/.1))}.range::-moz-range-track{height:.5rem;width:100%;border-radius:var(--rounded-box, 1rem);background-color:var(--fallback-bc,oklch(var(--bc)/.1))}.range::-webkit-slider-thumb{position:relative;height:1.5rem;width:1.5rem;border-radius:var(--rounded-box, 1rem);border-style:none;--tw-bg-opacity: 1;background-color:var(--fallback-b1,oklch(var(--b1)/var(--tw-bg-opacity)));-moz-appearance:none;appearance:none;-webkit-appearance:none;top:50%;color:var(--range-shdw);transform:translateY(-50%);--filler-size: 100rem;--filler-offset: .6rem;box-shadow:0 0 0 3px var(--range-shdw) inset,var(--focus-shadow, 0 0),calc(var(--filler-size) * -1 - var(--filler-offset)) 0 0 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:where(.join-item){border-start-end-radius:0;border-end-end-radius:0;border-end-start-radius:0;border-start-start-radius:0}.join .join-item:not(:first-child):not(:last-child),.join *:not(:first-child):not(:last-child) .join-item{border-start-end-radius:0;border-end-end-radius:0;border-end-start-radius:0;border-start-start-radius:0}.join .join-item:first-child:not(:last-child),.join *:first-child:not(:last-child) .join-item{border-start-end-radius:0;border-end-end-radius:0}.join .dropdown .join-item:first-child:not(:last-child),.join *:first-child:not(:last-child) .dropdown .join-item{border-start-end-radius:inherit;border-end-end-radius:inherit}.join :where(.join-item:first-child:not(:last-child)),.join :where(*:first-child:not(:last-child) .join-item){border-end-start-radius:inherit;border-start-start-radius:inherit}.join .join-item:last-child:not(:first-child),.join *:last-child:not(:first-child) .join-item{border-end-start-radius:0;border-start-start-radius:0}.join 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.5rem);border-width:1px;border-color:transparent;--tw-bg-opacity: 1;background-color:var(--fallback-b1,oklch(var(--b1)/var(--tw-bg-opacity)));background-image:linear-gradient(45deg,transparent 50%,currentColor 50%),linear-gradient(135deg,currentColor 50%,transparent 50%);background-position:calc(100% - 20px) calc(1px + 50%),calc(100% - 16.1px) calc(1px + 50%);background-size:4px 4px,4px 4px;background-repeat:no-repeat}.select[multiple]{height:auto}.table{position:relative;width:100%;border-radius:var(--rounded-box, 1rem);text-align:left;font-size:.875rem;line-height:1.25rem}.table :where(.table-pin-rows thead tr){position:sticky;top:0;z-index:1;--tw-bg-opacity: 1;background-color:var(--fallback-b1,oklch(var(--b1)/var(--tw-bg-opacity)))}.table :where(.table-pin-rows tfoot tr){position:sticky;bottom:0;z-index:1;--tw-bg-opacity: 1;background-color:var(--fallback-b1,oklch(var(--b1)/var(--tw-bg-opacity)))}.table :where(.table-pin-cols tr th){position:sticky;left:0;right:0;--tw-bg-opacity: 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Intraoperative use of indocyanine green fluorescence angiography (ICGFA) can help prevent anastomotic leakage, but its use is controversial. We conducted a systematic review and meta-analysis to determine the efficacy of ICGFA in reducing anastomotic leakage.",id:4,pmid:"PMC10213353",text:"Anastomotic leakage is a serious complication after rectal cancer resection. Intraoperative use of indocyanine green fluorescence angiography (ICGFA) can help prevent anastomotic leakage, but its use is controversial. We conducted a systematic review and meta-analysis to determine the efficacy of ICGFA in reducing anastomotic leakage. Rectal cancer morbidity and mortality are increasing. With the advancement in pathophysiology, current individualized treatments for rectal cancer include endoscopic, local surgical resection, systemic treatment, preoperative radiotherapy, local ablation treatment for metastatic tumors, extensive surgery for local and metastatic diseases, targeted therapy, palliative chemotherapy, and immunotherapy, whereas surgery is the cornerstone of curative intent treatment. However, rectal cancer patients may face many complications after resection, one of which is anastomotic leakage.Despite significant advances in surgical techniques and perioperative management in recent years, the incidence of anastomotic leakage after rectal cancer surgery remains between 5 and 19%. The occurrence of anastomotic leakage will result in prolonged hospitalization, increased hospitalization costs, increased local recurrence rate, and shortened survival time. Studies have shown that the risk factors for anastomotic leakage have been determined by age, male gender, smoking, diabetes, previous radiotherapy and chemotherapy, intraoperative complications, anastomotic tension, and low perfusion. Among these, insufficient blood perfusion at the anastomosis plays an important role in the pathogenesis of anastomotic leakage.Indocyanine green fluorescent angiography (ICGFA) is widely used in many surgical fields, including gastrointestinal surgery. The ICGFA allows the surgeon to visualize the blood supply of the intestinal canal and avoid inadequate perfusion of the anastomosis during colorectal surgery. The doctor injected diluted indocyanine green (ICG) into the venous system and monitored the development signal with a fluorescent laparoscope. When the ICG enters the anastomosis area to be observed, the doctor can dynamically observe the blood supply of the colorectal anastomosis with the fluorescent display. Therefore, intraoperative ICG use for intestinal anastomosis blood supply imaging could theoretically become a predictive test to evaluate anastomotic perfusion, reducing the risk of anastomotic leakage. Some meta-analyses have recently revealed that ICGFA can help reduce the incidence of anastomotic leakage after rectal cancer surgery. However, most of them are not convincing due to the limited number of good qualities RCT studies included and the small number of patients.According to recently published research, we updated this meta-analysis to evaluate whether this technique can reduce the anastomotic leakage rate of rectal cancer patients after resection.This systematic review and meta-analysis is based on the Preferred Reporting Items for Systematic Reviews and Meta-Analysis statements (PRISMA). Because this study is a meta-analysis, neither institutional review committee approval nor patient-informed consent was required.We conducted a comprehensive and systematic search of electronic databases, including PubMed, Embase, and the Cochrane Library; retrieved relevant research published until September 30, 2022; and identified potential articles using the following keyword combinations: (indocyanine green OR fluorescein angiography OR fluorescence imaging OR indocyanine green-sulfo-OSu OR ICG) AND (Rectal Neoplasm OR Rectal Tumor OR Rectal Cancer OR Rectum Cancer). Simultaneously, we searched the reference list and previous comments in these studies for more comprehensive studies that could be included. Two authors (SJ-X and WJ-W) worked independently on this study.Anastomotic leakage was defined as a defect in the anastomotic region where there is communication between the intraluminal and extraluminal chambers. Anastomotic leakage was graded by the International Research Group on Rectal Cancer based on its clinical symptoms. Type A had the mildest clinical symptoms, and type C had the most severe clinical symptoms. Type A anastomotic leakage is referred to as subclinical leakage or imaging leakage, whereas type B and C anastomotic leakages are referred to as clinical leakage or significant leakage.The inclusion criteria of this study were as follows: (a) patients undergoing rectal cancer surgery; (b) the report result compares the incidence of anastomotic leakage between the ICGFA group and the control group; and (c) the study design was a randomized controlled trial (RCT), prospective trial, or retrospective trial.The exclusion criteria were as follows: (a) the study was published in the form of comments, case reports, and letters; (b) the data were insufficient or could not be obtained from the author for meta-analysis; and (c) all inconsistent articles that were ruled by the third examiner (Y-L).The two authors (SJ-X and LD-L) conducted independent research and were selected to extract data at the same time based on the inclusion and exclusion criteria. Each included article provided the following information: first author, publication year, research country, research design, and the number of anastomotic leakages.After reading the full text of each included study, the two authors (LJ-M and LC-Y) independently evaluated the quality of the study using the Newcastle Ottawa Scale (NOS). The NOS includes the following four areas: patient selection quality, exposure determination, group comparability, and patient results. The total NOS score ranges from 0 to 9, with a score 6 indicating high quality.The purpose of this study was to compare the incidence of anastomotic leakages in patients undergoing rectal cancer surgery with and without ICG. The secondary analysis was a subgroup analysis, which included the difference in the incidence of anastomotic leakages between regions and grades.This study is primarily based on binary data. The risk ratio (RR) is used as the effect measure, with a 95% confidence interval. All statistical tests had a significance level of p < 0.05 (double-tailed). I2 statistics was used to determine heterogeneity, with results ranging from 0 to 100%. When I2 = 0%, heterogeneity was assumed as not observed; I2 = 25%, heterogeneity was low; I2 = 50%, heterogeneity was medium; and I2 = 75%, heterogeneity was high. When I2 < 50%, a fixed model effect was used. The random model effect was used for all other cases. This study was conducted using the Review Manager software version 5.3 (Nordic Cochrane Center, Cochrane Collaboration, London, UK).The detailed process of literature retrieval and screening is shown in Figure 1. A total of 1,007 papers were retrieved. After reading the title and abstract, we excluded 531 studies because they did not meet our inclusion criteria. A total of 22 studies met the inclusion criteria among the remaining 94 potential included studies. From 2013 to 2021, 22 studies involving 4,738 patients from 10 countries were published. The sample size of the study ranged from 38 to 657 people. Three RCTs, three prospective studies, and sixteen retrospective studies were conducted. We scored 22 studies from 5 to 9 on the NOS, with 19 (86.4%) rated as high quality. Table 1 shows the basic information included in the study.The combined results of 22 studies revealed that the total anastomotic leakage rates of the ICG and non-ICG groups were 3.7 and 7.6%, respectively (RR = 0.46; 95% CI, 0.390.56; p < 0.001; Figure 2).As in the summary analysis, a similar relationship was observed for grade A anastomotic leakages but not for grades B and C. Grade A anastomotic leakage rate was 2.4% in the ICG group and 7.9% in the non-ICG group (RR = 0.25; 95% CI, 0.140.44; p < 0.00001); grade B: 2.9 and 3.9%, respectively (RR = 0.70; 95% CI, 0.381.31; p = 0.27); and grade C: 2.5 and 2.8%, respectively (RR = 0.97; 95% CI, 0.511.97; p = 0.93; Figure 3).The subgroup analysis of 22 studies from different regions revealed that the rate of anastomotic leakage in the ICG group was 3.2% in Asia compared with 11.4% in the non-ICG group (RR = 0.33; 95% CI, 0.230.48; p < 0.00001), 6.5 and 14.1% in Europe (RR = 0.38; 95% CI, 0.270.53; p < 0.00001), and 6.0 and 9.4% in North America (RR = 0.72; 95% CI, 0.401.29; p = 0.27; Figure 4).Funnel plots were used to assess potential publication bias in a meta-analysis of the relationship between ICG use and anastomotic leakages. The funnel plot is symmetrical, as shown in Figure 5, indicating that the risk of deviation published in this study is low.The largest meta-analysis on the impact of ICGFA on anastomotic leakage in patients with rectal cancer surgery included 22 articles and 4,738 patients. The results of a pooled analysis of these patients revealed that the use of ICGFA during surgery was associated with a lower incidence of anastomotic leakage after rectal cancer resection. The results of a subgroup analysis of these patients revealed that the use of ICGFA during surgery in Asia and Europe was associated with a lower incidence of anastomotic leakage after rectal cancer resection and the use of ICGFA during surgery was associated with a lower incidence of grade A anastomotic leakage after rectal cancer resection.The negative impact of anastomotic leakage after rectal cancer surgery cannot be ignored. Anastomotic leakage will result in prolonged hospitalization, increased hospitalization costs, increased local recurrence rate, and shortened survival time. Many studies have determined that anastomotic leakage is an independent risk factor for low long-term survival rate of patients with rectal cancer. The study shows that anastomotic leakage risk factors have been determined in many situations, such as age, male gender, smoking, diabetes, previous radiotherapy and chemotherapy, intraoperative complications, anastomotic tension, and low perfusion. These risk factors are partly related to patients, tumors, and surgery. Some risk factors are objective and cannot be changed, whereas other risk factors can be changed. Anastomotic perfusion is one of the few variables that can be changed.ICG is a biocompatible near-infrared contrast agent that can be excited by external light with a wavelength of 750800 nm and emit near-infrared light with a longer wavelength, allowing tissues and organs to develop. Because Nagata first used ICG in colorectal surgery in 2006, this technology has demonstrated significant research value and promising application prospects in the auxiliary diagnosis and treatment of colorectal cancer. It has been reported in the literature that ICG near-infrared imaging technology can improve the visualization of tumor lesions, improve the detection rate of lymph nodes, and reduce the incidence of anastomotic leakage in laparoscopic colorectal cancer surgery.The ICG near-infrared imaging technique is used to evaluate the intestinal blood supply at the anastomotic site during colorectal cancer surgery. Before the proximal intestinal wall is disconnected, the operator can use clinical judgment to select the resection line under white light or visible light and mark the pre-resection line on the intestinal wall without damage. However, it should be noted that unipolar or bipolar electrical equipment should be used to burn the mark to avoid damaging the local blood supply of the intestinal wall and ultimately affecting the accuracy of the assessment. After the location of intestinal resection was determined, ICG was injected intravenously for the first time, and vascular perfusion was monitored using a near-infrared camera system. If the ICG vascular perfusion imaging is good within 60 s, the intestinal blood supply is likely to be adequate. ICG has a median development time of 35 (2944) s and a duration of 3 min. Record the boundary between perfusion and non-perfusion tissues of the intestinal tube and compare it with the previously marked pre-resection line of the intestinal tube before cutting the intestinal wall along the ischemic line. If the blood perfusion at the pre-resection line of the intestinal tube is deemed insufficient, the pre-resection line at the proximal end of the intestinal tube should be moved to a position with adequate blood perfusion. ICG was injected intravenously again after intestinal anastomosis. The perfusion after anastomosis was evaluated using a fluorescence system, and the blood supply and appearance of the intestinal wall were observed to determine whether the surgical strategy should be changed and intestinal anastomosis performed again.The use of ICGFA in assessing anastomotic perfusion has been concerned in recent years due to its relative ease of use, low cost, and satisfactory safety. Recently published meta-analyses showed that the risk of anastomotic leakage after rectal surgery in patients with ICGFA was significantly reduced, which was consistent with our results. However, due to the limited number of articles included, the majority of the studies are inconclusive. In comparison to these studies, the advantage of our meta-analysis lies in the inclusion of all relevant RCT, prospective, and retrospective studies, allowing us to analyze a larger sample size than previous meta-analyses and produce more convincing research results. Simultaneously, our research object is more specific and singular, which is patients with rectal cancer undergoing surgical treatment. In patients undergoing rectal cancer resection, the incidence of anastomotic leakage is higher than in patients undergoing colon cancer surgery. Therefore, this group is most likely to benefit from this intervention.According to a summary analysis of all patients, the use of ICGFA during surgery is associated with a reduction of anastomotic leakage after rectal cancer resection (RR = 0.25; 95% CI, 0.140.44; p < 0.00001). We found that using ICGFA during surgery was associated with a reduction in the incidence of anastomotic leakage after rectal cancer resection in Asia and Europe (RR = 0.33; 95% CI, 0.230.48; p < 0.00001 and RR = 0.38; 95% CI, 0.270.53; p < 0.00001) but not in North America (RR = 0.72; 95% CI, 0.401.29; p = 0.27). We believe that this is due to fewer studies and a smaller sample size, which causes heterogeneity in the analysis of results. The use of ICGFA during surgery is associated with a reduction in the incidence of grade A anastomotic leakage after rectal cancer resection (RR = 0.25; 95% CI, 0.140.44; p < 0.00001), but there is no difference in the incidence of grades B and C anastomotic leakages (RR = 0.70; 95% CI, 0.381.31; p = 0.27 and RR = 0.97; 95% CI, 0.511.97; p = 0.93). Therefore, we can conclude that ICGFA cannot reduce the occurrence of type B and C anastomotic leakages after rectal cancer resection. Because both the ICGFA intervention and control groups had a low incidence of types B and C anastomotic leakage, ICGFA could not reduce the incidence of types B and C anastomotic leakage after rectal cancer resection.At the same time, we recognize that this study has some limitations. First, the diagnosis of anastomotic leakage varied across the studies. Some studies were diagnosed solely through radiology, whereas others were diagnosed through physical examination and endoscopy as well. Second, the dose of ICG administered and timing of the included studies were inconsistent. Third, restricted by the articles included, this study cannot be analyzed according to the level of rectal cancer. Finally, the number of RCTs in the study is insufficient, which may increase the risk of deviation. These limitations may result in heterogeneity in the analysis of research findings.In conclusion, the results of this systematic review and meta-analysis show that using ICGFA during rectal cancer surgery is associated with a significant reduction in AL. However, given the limitations mentioned above, more multicenter RCT studies with a large sample size are required in the future to demonstrate our research findings.The datasets presented in this study can be found in online repositories. The names of the repository/repositories and accession number(s) can be found below: https://pubmed.ncbi.nlm.nih.gov/.SX: analysis, interpretation of data, and drafting the article or revising it critically for important intellectual content. WW: conception and design and final approval of the version to be published. LL, LM, LY, and YL: acquisition of data. All authors contributed to the article and approved the submitted version.The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article, or claim that may be made by its manufacturer, is not guaranteed or endorsed by the publisher.",title:"Indocyanine green fluorescence angiography decreases the risk of anastomotic leakage after rectal cancer surgery: a systematic review and 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leakage is a feared complication after esophagectomy and associated with increased post-operative morbidity and mrotality. The aim of this study was to evaluate the management of leakage after robot-assisted minimally invasive esophagectomy (RAMIE) with intrathoracic anastomosis. From a single center prospectively maintained database, all patients with anastomotic leakages defined by the Esophageal Complications Consensus Group between 2016 and 2021 were included. Contained leakage was defined as presence of air or fluid at level of the anastomosis without the involvement of the mediastinum or thorax. Non-contained leakage was defined as mediastinitis and/or mediastinal/pleural fluid collections. The primary outcome was 90-day mortality and the secondary outcome was successful recovery. In this study, 40 patients with anastomotic leakage were included. The 90-day mortality rate was 3% (n=1). Leakage was considered contained in 29 patients (73%) and non-contained in 11 patients (27%). In the contained group, the majority of the patients were treated non-surgically (n=27, 93%) and management was successful in 22 patients (76%). In the non-contained group, all patients required a reoperation with thoracic drainage and management was successful in seven patients (64%). Management failed in 11 patients (28%) of whom 7 developed an esophagobronchial fistula, 3 had a disconnection of the anastomosis and 1 died of a septic bleeding. In conclusion, this study demonstrates that the management anastomotic leakage in patients who underwent RAMIE with an intrathoracic anastomosis was successful in 73% of the patients with a 90-day mortality rate of 3%. A differentiated approach for the management of intrathoracic anastomotic leakage is proposed.",id:5,pmid:"PMC10226267",text:"Anastomotic leakage is a feared complication after esophagectomy and associated with increased post-operative morbidity and mrotality. The aim of this study was to evaluate the management of leakage after robot-assisted minimally invasive esophagectomy (RAMIE) with intrathoracic anastomosis. From a single center prospectively maintained database, all patients with anastomotic leakages defined by the Esophageal Complications Consensus Group between 2016 and 2021 were included. Contained leakage was defined as presence of air or fluid at level of the anastomosis without the involvement of the mediastinum or thorax. Non-contained leakage was defined as mediastinitis and/or mediastinal/pleural fluid collections. The primary outcome was 90-day mortality and the secondary outcome was successful recovery. In this study, 40 patients with anastomotic leakage were included. The 90-day mortality rate was 3% (n=1). Leakage was considered contained in 29 patients (73%) and non-contained in 11 patients (27%). In the contained group, the majority of the patients were treated non-surgically (n=27, 93%) and management was successful in 22 patients (76%). In the non-contained group, all patients required a reoperation with thoracic drainage and management was successful in seven patients (64%). Management failed in 11 patients (28%) of whom 7 developed an esophagobronchial fistula, 3 had a disconnection of the anastomosis and 1 died of a septic bleeding. In conclusion, this study demonstrates that the management anastomotic leakage in patients who underwent RAMIE with an intrathoracic anastomosis was successful in 73% of the patients with a 90-day mortality rate of 3%. A differentiated approach for the management of intrathoracic anastomotic leakage is proposed. Esophagectomy is the cornerstone of treatment for patients with locally advanced esophageal cancer. Recently, there has been a vast increase in the use of minimally invasive techniques for esophagectomy as they have been associated with less post-operative complications and comparable oncological outcomes compared to open esophagectomy. Despite technical improvements, esophageal surgery remains a highly complex procedure associated with significant post-operative morbidity.Anastomotic leakage after esophagectomy is one of the most feared post-operative complication and associated with significant morbidity, prolonged hospital stay, increased healthcare expenditure and reduced (long-term) survival. Treatment of anastomotic leakage is challenging and standardized treatment protocols are lacking. The manifestation and primary treatment strategy of leakage largely depends on the location of the anastomosis. Although the reported incidence of anastomotic leakage is higher for a cervical anastomosis compared to an intrathoracic anastomosis, leakage of an intrathoracic anastomosis has been associated with more severe intrathoracic manifestations requiring a different treatment strategy.In our center, a robot-assisted hand-sewn intrathoracic anastomosis was first implemented in 2016 and the anastomotic technique was further improved during the following years. During this period, different manifestations of anastomotic leakage were observed requiring different treatment strategies. The aim of this study was to evaluate the treatment of patients with anastomotic leakage after robot-assisted minimally invasive esophagectomy (RAMIE) with an intrathoracic anastomosis and to present a differentiated approach to manage intrathoracic anastomotic leakage.Patients were selected from a prospectively maintained institutional database. In the database, patient characteristics, details of the surgical procedure and complications were prospectively registered during a weekly multidisciplinary meeting. Patients who underwent RAMIE with intrathoracic anastomosis in the University Medical Center Utrecht (UMC Utrecht) and developed anastomotic leakage were extracted from the database and included in the study. All esophagectomies with intrathoracic anastomosis are performed robotically in the UMC Utrecht. As the intrathoracic robot-assisted hand-sewn anastomosis was introduced in February 2016, patients were included from February 2016 to December 2021. There were no exclusion criteria. The institutional review board approved this study and the need for written informed consent was waived.RAMIE consisted of a field-field lymphadenectomy and creation of a gastric conduit followed by a hand-sewn intrathoracic anastomosis. A detailed description of the procedure was published previously. In summary, the anastomoses were created as follows: indocyanine green was used to assess the perfusion of the gastric conduit and determine the most optimal location for the anastomosis. In case of mal perfusion of the conduit tip, this part was stapled off. The anastomoses were created by a hand-sewn, end-to-side, technique with a barbed 4/0 running V-Loc (Medtronic/Covidien; Minneapolis, MN, USA). From April 2018 onwards, three to four tension releasing stiches with Vicryl 3/0 (Ethicon, Somerville, NJ) were added to the technique to reduce the traction on the anastomosis. An omental wrap concluded the anastomosis. All patients who underwent RAMIE were treated according to our local enhanced recovery after esophagectomy (EROES) protocol. Components of the EROES protocol included preoperative optimization by a dietician and physiotherapist, epidural or paravertebral analgesia, direct extubation in the operation room and early mobilization. During the study period several adjustment to the EROES protocol were made. Initially, all patients resumed oral intake immediately after surgery. From January 2019 onwards, all patients received a feeding jejunostomy whilst being kept on a nil by mouth diet. On the fourth post-operative day a contrast swallow was performed. The primary aim of the contrast swallow was to asses for delayed conduit emptying. If there were no signs of delayed gastric emptying, patients were allowed to start oral water intake. In the absence of post-operative complications, solid food was allowed from the 14th post-operative day and onwards.Anastomotic leakage was defined according to the Esophageal Complications Consensus Group (ECCG). Anastomotic leakage was suspected when a patient had a combination of signs including fever, tachycardia, elevated serum levels of C-reactive protein (CRP) and/or elevated leucocytes. When anastomotic leakage was suspected, patients underwent a computed tomography (CT) scan and an additional endoscopy if needed. A contrast swallow examination was not used to detect anastomotic leakage as its predictive value is too low. In addition, it does not provide information on mediastinal or pleural involvement. At the day of diagnosis, anastomotic leakage was considered contained or non-contained based on a CT-scan. Leakage was defined as contained in case of local presence air or fluid at level of the anastomosis, without the involvement of the mediastinum or thoracic cavity. Non-contained leakage was defined as presence of mediastinitis and/or mediastinal/pleural fluid collections. All CT-scans performed at the day of diagnosis were retrospectively reviewed and scored and scored in a consensus as contained or non-contained leak (EdG, SB, JB, SH and RvH). Observers were blinded for the patients outcome. For the current analysis, the score was not adjusted in case a leak developed from a contained leak into a non-contained leak after the day of diagnosis.When anastomotic leakage was suspected, all patients were immediately treated with a nil by mouth regimen, endoscopic placement of a nasogastric tube in the gastric conduit and intravenous antibiotics. Additionally, depending on the severity of anastomotic leakage, patients were treated endoscopically and/or surgically. Endoscopic treatment consisted of placement of a suction-drain placed through the anastomotic defect into the mediastinum or placement of a stent. Surgical treatment consisted of drainage and washing of the thoracic cavity by a video-assisted thoracoscopy or thoracotomy. When the anastomosis was completely dehiscent during the reoperation, or when there was severe gastric conduit necrosis, the anastomosis had to be disconnected. Gastric conduit necrosis was diagnosed intraoperatively based on macroscopic appearance of the conduit combined with the endoscopically observed appearance of the mucosa and transmural defect.After hospital discharge, all patients with anastomotic leakage visited the outpatient clinic and underwent a contrast swallow investigation to evaluate anastomotic integrity. In some cases, a CT-scan or endoscopy was performed to evaluate anastomotic integrity. If the anastomosis was deemed sufficient, patients restarted their oral intake. Hereafter, patients were routinely followed at the outpatient clinic every 3months in the first year, every 6months during the second year and yearly until 5years after RAMIE.The primary outcome was 90-day mortality. The secondary outcome was successful recovery after treatment for anastomotic leakage. Recovery was defined to be successful when the following criteria were met:The defect in the anastomosis healed, confirmed by radiology (CT-scan/contrast swallow) or endoscopy leading to restart oral intake.The patient did not develop an esophagobronchial/esophagopleural fistula during the follow-up.No disconnection of the anastomosis was performed.Other outcomes were as follows: days between RAMIE and diagnosis of anastomotic leakage, diet at moment of diagnosis, serum levels of CRP and leucocytes measured at the day of diagnosis, pneumonia defined by the Uniform Pneumonia Score, in-hospital mortality, duration of hospital stay, duration of intensive care unit (ICU) stay and readmissions to the ICU. In addition, complications, such as esophagobronchial fistula and anastomotic strictures defined by the need of endoscopic dilation were reported.For the purpose of this study, only descriptive analyses were performed. Categorical variables were demonstrated as count with percentage. Continuous variables were demonstrated as mean (with standard deviation) or median (with range), depending on the type of data. All statistical analyses were performed by using SPSS 25.0 (IBM).Between February 2016 and December 2021, 152 patients underwent RAMIE with an intrathoracic anastomosis after which 40 patients developed anastomotic leakage (26%) whom were included in this study. There were no differences in patient characteristics of both patients with and without anastomotic leakage (Table 1). Of the 40 patients with anastomotic leakage, 29 (73%) were classified as contained and 11 (27%) as non-contained leaks at the day of diagnosis. Anastomotic leakage was diagnosed after a median of 8days (range 122) post-operatively. At diagnosis, 22 (55%) patients were on a liquid diet, 17 (43%) patients on a nil by mouth policy and 1 (3%) patient had intake for solid food. On the day of diagnosis, the median serum level of CRP was 188 (range 38404) and of median leucocytes was 13.8 (range 5.126.4).One patient in the non-contained group died after discharge within 90days after RAMIE due to a septic bleeding. The septic bleeding was most likely caused by an ongoing anastomotic leakage that led to an abscess that damaged the aortic wall, resulting in a rupture.The majority of patients had a contained anastomotic leak (n=29, 73%). Management of anastomotic leakage in these patients is summarized in Figure 1.In 28 of the 29 patients, an endoscopy was performed to evaluate the integrity of the anastomosis. In one patient, no endoscopy was performed and anastomotic leakage was diagnosed based on radiological findings. This patient was treated with antibiotics and a nil by mouth diet after which the patient recovered successfully.A visible anastomotic defect was present in 20 of the 28 patients who underwent endoscopy. The eight patients without a visible defect were kept on a nil by mouth diet and received intravenous antibiotics. They all recovered successfully.Of the 20 patients with a visible anastomotic defect, 10 patients were treated with a drain through the defect into the mediastinum combined with antibiotics and a nil by mouth diet, 8 patients with antibiotics and a nil by mouth diet only and 2 patients with an endoscopically placed stent. Of the 10 patients that were treated with a drain through the anastomotic defect, 8 recovered successfully, 1 developed an esophagobronchial fistula and the anastomosis had to be disconnected due to complete dehiscence in 1 patient. Of the eighy patients who were only treated with antibiotics and a nil by mouth diet, five developed an esophagobronchial fistula and three patients recovered successfully. The two patients treated with an endoscopically placed stent recovered successfully.In summary, 22 out of 29 patients (76%) with a contained leak recovered successfully. A healed anastomosis was observed after a median of 30days (range 1678) after the diagnosis of leakage. Treatment failed in seven (24%) patients; in one patient, the anastomosis was disconnected due to complete dehiscence, and six patients developed an esophagobronchial fistula. Of the six patients who developed an esophagobronchial fistula, five patients had a visible anastomotic defect during endoscopy and were initially treated with antibiotics and a nil by mouth diet only for their anastomotic leakage.Of the 40 patients, 11 (27%) were classified as having non-contained anastomotic leakage. Management of these patients is summarized in Figure 2. Treatment consisted of surgical thoracic drainage in all patients (n=11) of which three patients received an endoscopic stent simultaneously. Treatment was successful in seven patients, the anastomosis had to be disconnected due to severe leakage in two patients, one patient developed an esophagobronchial fistula and one patient died after discharge due to a septic bleeding, as mentioned previously.In summary, 7 out of 11 patients with a non-contained leak (64%) recovered successfully with a healed anastomosis after a median of 51days (range 2588) from the day of diagnosis.Clinical outcomes are presented in Table 2. The median hospital stay was 22days (range 5139) and the median stay on the ICU was 1day (range 072) with a readmission rate to the ICU of 38% (n=15). There was no in-hospital mortality. The median follow-up was 41months (range 160). An esophagobronchial fistula occurred in 7 (18%) patients, median 58days after RAMIE (range 15698). These fistulas were treated endoscopically in four patients and surgically in three patients. Endoscopic treatment consisted of stent placement in three patients and an endoscopic clip in one patient. Surgical treatment consisted of bronchial repair with a bovine patch followed by interposition of healthy tissue in all three patients. Strictures were diagnosed in 19 (48%) patients after a median of 94days following RAMIE (range 41383). Strictures were treated with endoscopic dilatations in all patients with a median of 5 dilatations (range 120). The stricture rate for patients without anastomotic leakage was 47% (n=53). Strictures were treated with endoscopic dilatations in all patients with a median of four dilatations (range 167).This study evaluated the treatment strategy of anastomotic leakage in 40 patients who underwent RAMIE with an intrathoracic anastomosis. Anastomotic leakage was considered contained in 29 patients of which the majority was treated non-surgically (n=27, 93%). In this group, treatment was successful in 22 patients (76%). The other 11 patients had a non-contained leak with thoracic manifestation who all required a reoperation. Treatment was successful in seven patients (64%). No in-hospital mortality occurred and the 90-day mortality rate was 3% (n=1). Failures were mainly due to inadequately drained leaks in the contained group, resulting in an esophagobronchial fistula in five patients.Previously reported success rates in literature of different treatment strategies for anastomotic leakage range between 50 and 100%. However, it is hard to compare success rates between studies as the limited number of studies on this topic have a small sample size (range 528) and used different definitions for successful treatment of anastomotic leakage. As proxy for the success of treatment of the anastomotic leakage, 90-day mortality rates are often used. In this context, a recent international multicenter study that included 319 patients with anastomotic leakage reported a 90-day mortality rate of 12%. Other studies have reported similar 90-mortality rates after anastomotic leakage ranging between 10% and 35%. The 3% 90-day mortality after anastomotic leakage in the current study is considerably lower and therewith supports the proposed treatment strategy for anastomotic leakage.Despite the low mortality rate, management of leakage failed in 11 patients (28%) of which the majority developed an esophagobronchial fistula. In this study, five of eight patients with a visible anastomotic defect during endoscopy treated with antibiotics only developed an esophagobronchial fistula. The high rate of esophagobronchial fistula in these patients is likely caused by inadequately drained anastomotic leakage after which the persistent abscess between the esophagus and bronchus developed into an esophagobronchial fistula. Based on these results, a differentiated approach for the management of anastomotic leakage was developed and is presented in Figure 3. Essential in this strategy is the importance of drain placement in case of a visible anastomotic defect during endoscopy. Therefore, we recommend that all patients with anastomotic leakage, even if considered contained, should undergo an endoscopy to evaluate the integrity of the anastomosis. If a defect is visible, a nasogastric drain is placed through the defect into the mediastinum. Following this strategy, no more esophagobronchial fistulas were diagnosed from January 2019 onwards. Furthermore, management of a non-contained leaks should always consist of a reoperation with thoracic drainage. In addition, an endoscopy should be performed in order to create source control with a stent or additional drainage through the anastomotic defect.The role of a stent in the management of anastomotic leakage is still under debate in literature. In our opinion, a stent could be used in non-contained leaks to provide source control combined with pleural or mediastinal drainage. On the other hand, stents are associated with failure and complications such as migration of the stent, which occurs in 20% of the patients. An alternative might be the use of an endoscopic vacuum-assisted closure (Endovac (B. Braun, Melsungen, Germany)) device with reported success rates of 60%80%. Higher negative pressure could be achieved with an Endovac compared with a drain through the anastomotic defect into the mediastinum. However, whether the Endovac achieves better results over a drain through the mediastinum is still unclear as high quality studies are scarce. In addition, serious disadvantages are reported as well, including Endovac migration, bleeding, trachea damage and the need for multiple endoscopies to change the Endovac device, which is burdensome for patients and logistically difficult.The incidence of anastomotic leakage was relatively high in this cohort. This is most likely caused by a learning curve effect for the hand-sewn robot-assisted intrathoracic anastomosis, that has been published previously. In the most recent 1.5years, our leak rate decreased to 6%, indicating that proficiency is being reached.The severity grade of anastomotic leakage according to the ECCG is currently based on the type of treatment (conservative, endoscopic, surgical). Although the current definition allows for an objective classification, a definition to classify severity based on leakage characteristics might be more helpful for applying and providing recommendations for the right treatment. In addition, if a center would treat leakages more frequently endoscopically, the severity grade of anastomotic leakage of that center will decrease while the nature of the leakage is in fact not changing. Therefore, we recommend a new classification that is based on radiological and endoscopic findings to define the severity of anastomotic leakage. Based on radiology, anastomotic leakage should be defined as contained (grade I or II) or non-contained (grade III) according to the definition used in this study. Based on endoscopy, a contained leak could be classified as grade I when no defect is visible or grade II in case of a visible anastomotic defect.A strength of this study is the large cohort of patients treated with a uniform RAMIE technique and an unique level of detail regarding treatment strategies for anastomotic leakage. In addition, the anastomotic leakage was scored prospectively. A limitation of this study is that developments in perioperative care might have caused a heterogeneous cohort. However, bias caused by a heterogeneous cohort should be minimal as the aim of this study was to evaluate the treatment strategy of leakage.In conclusion, this study demonstrated that the management of anastomotic leakage in patients who underwent RAMIE with intrathoracic anastomosis was successful in more than 70% of the patients with an in-hospital mortality of 0% and a 90-day mortality of 3%. A visible anastomotic defect during endoscopy always requires drainage by endoscopic drain placement through the defect or surgical thoracic drainage. Based on these findings, a differentiated approach for the management of intrathoracic anastomotic leakage is proposed.There was no funding received for this work.Richard van Hillegersberg and Jelle Ruurda are proctors for Intuitive Surgical Inc and consultants for Medtronic. Eline de Groot, Sebastiaan Bronzwaer, Lucas Goense, Feike Kingma, Sylvia van der Horst and Jan Willem van den Berg have no conflicts of interest to declare.",title:"Management of anastomotic leakage after robot-assisted minimally invasive esophagectomy with an intrathoracic 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of Interest",cui:"C0079152",end:22093,id:97124,score:-898,semtype:"idcn",start:22072,text_id:5},{candidate:"TO",cui:"C0040363",end:22096,id:97125,score:-1e3,semtype:"geoa",start:22094,text_id:5},{candidate:"TO",cui:"C0041260",end:22096,id:97126,score:-1e3,semtype:"aapp",start:22094,text_id:5},{candidate:"To",cui:"C1883351",end:22096,id:97127,score:-1e3,semtype:"qlco",start:22094,text_id:5}],Xt={abstract:"Colorectal cancer (CRC) is one of the most common malignancies in the world. Despite significant improvements in surgical technique, postoperative complications still occur in a fair percentage of patients undergoing colorectal surgery. The most feared complication is anastomotic leakage. It negatively affects short-term prognosis, with increased post-operative morbidity and mortality, higher hospitalization time and costs. Moreover, it may require further surgery with the creation of a permanent or temporary stoma. While there is no doubt about the negative impact of anastomotic dehiscence on the short-term prognosis of patients operated on for CRC, still under discussion is its impact on the long-term prognosis. Some authors have described an association between leakage and reduced overall survival, disease-free survival, and increased recurrence, while other Authors have found no real impact of dehiscence on long term prognosis. The purpose of this paper is to review all the literature about the impact of anastomotic dehiscence on long-term prognosis after CRC surgery. The main risk factors of leakage and early detection markers are also summarized.",id:7,pmid:"PMC10277951",text:`Colorectal cancer (CRC) is one of the most common malignancies in the world. Despite significant improvements in surgical technique, postoperative complications still occur in a fair percentage of patients undergoing colorectal surgery. The most feared complication is anastomotic leakage. It negatively affects short-term prognosis, with increased post-operative morbidity and mortality, higher hospitalization time and costs. Moreover, it may require further surgery with the creation of a permanent or temporary stoma. While there is no doubt about the negative impact of anastomotic dehiscence on the short-term prognosis of patients operated on for CRC, still under discussion is its impact on the long-term prognosis. Some authors have described an association between leakage and reduced overall survival, disease-free survival, and increased recurrence, while other Authors have found no real impact of dehiscence on long term prognosis. The purpose of this paper is to review all the literature about the impact of anastomotic dehiscence on long-term prognosis after CRC surgery. The main risk factors of leakage and early detection markers are also summarized. Core Tip: Colorectal cancer (CRC) is one of the most common malignancies in the world. Despite significant improvements in surgical technique, postoperative complications still occur in a fair percentage of patients undergoing colorectal surgery. The most feared complication is anastomotic leakage. It negatively affects short-term prognosis, with increased post-operative morbidity and mortality, higher hospitalization time and costs. Moreover, it may require further surgery with the creation of a permanent or temporary stoma. While there is no doubt about the negative impact of anastomotic dehiscence on the short-term prognosis of patients operated on for CRC, still under discussion is its impact on the long-term prognosis. Some authors have described an association between leakage and reduced overall survival, disease-free survival, and increased recurrence, while other authors have found no real impact of dehiscence on long term prognosis. The purpose of this paper is to review all the literature about the impact of anastomotic dehiscence on long-term prognosis after CRC surgery. The main risk factors of leakage and early detection markers are also summarized.Anastomotic leakage (AL) is a major cause of postoperative morbidity and mortality after colorectal cancer (CRC) surgery. AL is a defect of the intestinal wall integrity at the colorectal or colo-anal anastomosis site (including suture and staple lines of neorectal reservoirs) leading to a communication between the intra- and extraluminal compartments. However, there are several definitions of AL in literature and most studies define it using clinical signs (pain, fever, tachycardia, peritonitis, purulent or fecal drainage), radiographic findings (fluid and/or gas-containing collections), and/or intraoperative features (peritoneal effusion and ruptured anastomosis). The use of different definitions in clinical studies can partly explain the considerable variations in AL reported rates. The incidence of AL reported in different studies is highly variable (2%-19%) and certainly influenced first of all by the surgeon's experience and the emergency or elective surgical setting. It is also influenced by the site of the anastomosis: It is lowest for ileocolic anastomoses (1%-3%) and highest for coloanal anastomoses (10%-20%).AL has been divided into "early" and "late" depending on whether AL is diagnosed within or after 30 d after surgery. In general, early AL manifests with severe peritonitis and it is mainly related to a technical error in performing the anastomosis, usually due to mal vascularization of the intestinal stumps or tension at the anastomotic site. In contrast, late AL is often associated with long-standing pelvic abscess and is due to preexisting conditions in patients, such as local sepsis, poor nutrition, immunosuppression, morbid obesity, and radiation exposure.AL is also classified according to severity into grade A, B and C. Grade A is represented by AL that does not require active therapeutic intervention, grade B by AL that requires active therapeutic intervention but manageable without re-laparotomy, and grade C by AL that requires re-laparotomy.Several risk factors for anastomotic dehiscence following colorectal surgery have been identified over the years. They can be classified for convenience into preoperative, intraoperative, and postoperative.Preoperative risk factors commonly reported in the literature include male sex, obesity, tobacco habit, alcohol consumption, an American Society of Anaesthesiologistscore of 3 or higher, and prolonged corticosteroid intake. Tumor location, size and stage must be considered among the risk factors. Akiyoshi et al reported that tumor localization in the rectum, rather than the colon, was independently predictive of AL development on multivariate analysis.The AL rate was 10 times higher (20.6% vs 2.3%) when the anastomotic region was located within 5 cm of the anal verge.Low anterior resection (LAR) involves surgery in an anatomically confined space and when tumor size and/or stage increases, intrapelvic manipulation becomes limited and rectal dissection more challenging. In a series of 154 patients with rectal carcinoma, tumor size 5 cm in diameter was associated with a 4-fold increased risk of leakage. Zhu et al found that tumors greater than 3 cm in diameter, as well as TNM stage, were independently associated with leakage.Intraoperative risk factors include: The surgeon experience (and hospital size), the number of linear stapler firings, left colic artery ligation, emergency surgery (patients with peritonitis and/or bowel obstruction are at higher risk of postoperative adverse events), operative time and blood loss during surgery. Intra-operatively, it is also important to ensure good vascularization of the anastomosed bowel segments. Indocyanine green (ICG) fluorescence angiography may help in this evaluation. In a recent meta-analysis, an incidence of anastomotic dehiscence was observed in 3.8% of cases in the ICG group and 7.8% in the control group in which ICG was not used.Postoperative risk factors are anemia, hypoalbuminemia, and late initiation of enteral nutrition.Early detection of AL is crucial to treat patients limiting negative effects. Baeza-Murcia et al analyzed the accuracy of C-reactive protein (CRP) and procalcitonin (PCT) for early detection of AL and have found that CRP is more accurate than PCT on both postoperative day (POD) 3 and 5. According to this study CRP measured on POD 5 is the most useful test for early diagnosis of AL and that values above 9.1 mg/dL are indicative of anastomotic dehiscence.In a recent meta-analysis by Yeung et al a CRP cutoff level of 14.8 mg/dL at POD 3 had a sensitivity and specificity of 95%, while CRP cut-off levels of 12.3 mg/dL at day 4, 11.5 mg/dL at day 5, 10.5 mg/dL at day 6, and 9.6 mg/dL at day 7 had a sensitivity and specificity of 100% for anastomotic dehiscence.According to Garcia-Granero et al and El Zaher et al, PCT is also a very good predictor of anastomotic dehiscence, particularly from POD 5 or higher. The predictive power of PCT may also be enhanced in combination with CRP or white blood cell, or both (area under the curve 0.92, 0.92, 0.93, respectively). A recent meta-analysis by Xu et al shows that PCT at POD 3 has potential clinical value in the early diagnosis of AL and has better diagnostic accuracy in patients undergoing laparoscopic surgery. Cut-off values are recommended in the range of 0.7-1.3 ng/mL to ensure accurate diagnosis and safe discharge. However, PCT is a valid predictor only for patients with major clinical losses confirmed by radiology and presenting with severe clinical signs and symptoms that require a change in therapeutic management and in most cases a reintervention. Cousin et al conducted a meta-analysis and concluded that PCT does not add value to CRP in the diagnosis of AL.It can be said that CRP and PCT at POD 5 have a high negative predictive value, which would allow early and safe discharge.Tavernier et al considered 5 criteria for safe early discharge after laparoscopic colorectal surgery: A CRP level of less than 15 mg/dL, absence of fever during the entire hospital stay (temperature < 38 C), return of bowel function (flatus with or without stool), adequate pain control with oral analgesics (pain less than 5 out of 10 on a 10-point visual analog scale) and tolerance of a solid diet. The negative predictive value in ruling out an anastomotic leak was 98.4% for all 5 criteria combined. The false-negative rate was 13.3%.AL affects the outcome of surgery, worsening the short-term outcomes and increasing the time and cost of hospitalization. The mortality related was reported to be between 0.8% and 27%. Mortality was higher after leak from a colonic anastomosis than after leak from a rectal anastomosis (43.8% vs 7.1%). Bertelsen et al found in a multicenter study a 4-fold increase in 30-d mortality in patients with AL. According to a Cochrane review, AL is associated with a perioperative mortality rate of 2% to 24% and high morbidity, with the risk of a definitive ostomy exceeding 25%. Warps et al found an overall AL rate of 4.8%, ranging from 4.0% (right hemicolectomy) to 15.4% (subtotal colectomy). AL was predominantly managed with reintervention, ranging from 81.2% of cases after transversectomy to 92.4% after sigmoid resection. After reintervention, the highest mortality rates were observed for transversectomy (15.4%) and right hemicolectomy (14.4%) and the lowest for sigmoid resection (5.6%) and subtotal colectomy (5.9%). The intensive care unit admission rate was 62.6% overall (range 56.7%-69.2%) and the stoma rate ranged from 65.5% (right hemicolectomy) to 93.0% (sigmoid resection).While the short-term consequences of AL are well known, its impact on long-term prognosis in CRC patients is still debated.In the literature, the first authors to concern themselves with outcomes related to anastomotic dehiscence after resective surgery for CRC were Phillips et al and Sauven et al. In both cases, the parameter evaluated was local recurrence (LR). In the first study, AL did not appear among the significant risk factors for recurrence, while in the second, anastomotic dehiscence was associated with an increased rate of LR. In the same years, Amato et al evaluated the association between CRC and AL by focusing exclusively on patients with rectal tumors operated with an anterior resection. In this study, AL did not influence the recurrence rate.In 1991, Akyol et al performed a study on patients operated for left colon or rectal cancer and demonstrated an important influence of AL on recurrence and cancer-specific survival (CSS) at 24 mo. The independence of the impact of dehiscence on outcomes from tumor stage was highlighted. This was the first study that analyzed local and distant recurrence separately and used multivariate Cox regression.Two years later, a study published by Fujita et al showed the impact of AL on LR and disease-free survival (DFS). DFS is significantly lower in the AL group for patients with Duke stage A and B cancers but not for C and D. The importance of this work also lies in the separate evaluation of subjects with colon and rectal cancer.Petersen et al studied the influence of leakage on LR, CSS, overall survival (OS) and postoperative mortality. AL influence only LR and CSS, confirming the previous findings of Akyol et al. Branagan et al reached similar conclusions in 2005. Further studies showed a correlation between AL and higher 30-d mortality, lower OS and CSS.Law et al in 2007 found a significant association between AL and 5-year CSS, 30-d mortality and recurrence (local and systemic).According to the study by Eberhardt et al, AL does not change the risk of recurrence and mortality for colon cancer, whereas it does for rectal cancer. The article also offers an assessment of OS, CSS, LR and overall recurrence for each stage, as well as an analysis of these outcomes at both 1 and 5 years after surgery.According to Marra et al, AL significantly reduces OS without affecting the risk of recurrence, while other studies have found an impact of leakage on OS, recurrence, and DFS. However, Katoh et al evaluated only patients with stage II CRC and Breugom et al only patients with stage I-III colon cancer. To be precise, Park et al in 2016 found an effect of AL on OS and DFS only for patients with rectal cancer. Nachiappan et al found a reduction in OS in patients with AL who required reoperation compared with subjects without AL. Ramphal et al demonstrated that LR develops with the same frequency in symptomatic and asymptomatic dehiscence.Krarup et al identified in patients with AL an increase in distant recurrence (DR) and in mortality. However, there was no significant association with LR. Nordholm-Carstensen et al and Ng et al evaluated the impact of AL in patients with stage IV CRC. The 3-year survival rate is affected by dehiscence for both colon (18.7% vs 44.6%) and rectum (53.7% vs 73.3%).The first meta-analysis on this topic was performed by Mirnezami et al on 22 studies. It reported an association between AL and LR, DR and cancer-specific mortality.The subsequent meta-analysis by Ha et al evaluated 34 studies and divided the results into two categories. In the first group rectal anastomosis data were analyzed, and AL was associated with increased LR and reduced OS, CSS, and DFS. There were no significant effect on distant recurrence. In the second group colic anastomoses were analyzed and AL was associated with reduced OS and DFS and there was no correlation with local or distant recurrence.The studies by Sammour et al and Goto et al also analyzed CSS. They showed a significant reduction in 5-year OS for patients with AL, without finding differences in LR, CSS and postoperative mortality (in rectal carcinoma, leakage affects only the latter). The second one documented instead a reduction in OS (80. 8% vs 90.3%) and CSS (89.6% vs 95.1%), an increase in LR and no correlation with distant recurrence.A subsequent meta-analysis conducted in 2020 by Bashir Mohamed et al demonstrated a lack of significant effect of AL on recurrences, however it reduced OS, DFS and CSS.Recent articles on this topic were written by Stormark et al and Kryzauskas et al. The former concluded that leakage only after surgery for stage III CRC is able to reduce survival, whereas the latter demonstrated that AL impaired disease-free and OS in patients undergoing sigmoid and rectal surgery.Regarding rectal cancer alone, the first data of the new millennium showed an increase in LR and a decrease in CSS. Subsequent studies can be divided into 3 categories. In the first group, there are studies that supported the absence of an impact of AL on cancer outcomes such as OS, CSS, DFS, LR and DR. The second group covers studies defining AL as an independent prognostic factor for reduced OS, CSS, DFS and increased recurrence. In the third group, we can place studies midway between the first two categories, as the study of Noh et al, demonstrating that AL is associated with increased LR and reduced DFS, whereas its relationship with OS and distant recurrence is not significant. These findings were confirmed in a recent study by Peltrini et al.To the above groups, we must also add studies evaluating also perioperative mortality. Ptok et al and Hain et al found an impact of dehiscence on 30-d mortality, DFS, and LR, whereas Eriksen et al and Bertelsen et al found an increase in 30-d mortality, but without a significant increase in LR. Bertelsen et al also noted the lack of reduction in OS and impact on distant recurrence.Lim et al in 2015 classified ALs into 3 categories based on the consequences: (1) Generalized peritonitis; (2) Localized peritonitis with or without abscess; and (3) Fistula. Oncologic outcomes were evaluated separately for each type and reduced OS and LRFS (LR-free survival) were identified. According to Bostrm et al, leaks only impact OS if they require intervention.In 2022, Dulskas et al evaluated AL in patients undergoing right colectomy for CRC and concluded that AL is a factor that negatively affects long term prognosis. In contrast, a Dutch retrospective study found that disease recurrence is not associated with AL after CRC resection.Koedam et al, analyzing data from the COLOR and COLOR II studies, show that ALs after rectal cancer surgery are associated with an increased rate of LR and a decreased DFS at 5-year follow-up. DR and OS are not significantly affected. Regarding colon cancer surgery, no significant effect of AL on long-term oncologic outcomes was observed, presumably because of a relatively low leakage rate. Strengths of this study include the randomized, multicenter design of the two included studies and uniform study protocol for perioperative care and follow-up to limit practice variability.All studies on this topic are summarized in Table 1.AL appears to be an independent risk factor influencing long-term oncologic outcomes after rectal cancer surgery. On the other hand, regarding colon cancer, the results are still extremely heterogeneous and unclear. Further studies on patients undergoing resection for CRC are needed to confirm the oncological impact of AL.Based on these data, we would recommend more frequent follow-up for patients with AL after CRC cancer surgery.`,title:"Impact of anastomotic leakage on long-term prognosis after colorectal cancer 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surgery",cui:"C2608114",end:17578,id:120578,score:-600,semtype:"topp",start:17575,text_id:7}],Kt={abstract:"Serum C-reactive protein (CRP) is commonly used by surgeons to raise suspicion of anastomotic leakage and other infectious complications, but most studies on optimal cut-off values are retrospective with a small sample of patients. The aim of this study was to determine the accuracy and optimal cut-off value of CRP for anastomotic leakage in patients following esophagectomy for cancer.",id:8,pmid:"PMC10310558",text:"Serum C-reactive protein (CRP) is commonly used by surgeons to raise suspicion of anastomotic leakage and other infectious complications, but most studies on optimal cut-off values are retrospective with a small sample of patients. The aim of this study was to determine the accuracy and optimal cut-off value of CRP for anastomotic leakage in patients following esophagectomy for cancer. Anastomotic leakage following esophagectomy for cancer is a severe complication, generally leading to additional postoperative morbidity or even death. C-reactive protein (CRP) is a serum acute-phase reactant produced by the liver in response to pro-inflammatory cytokines that play a role in activating the complement system. CRP can be tested easily at low cost and is, therefore, often used to detect infectious complications after surgery. In colorectal surgery, it has been validated as a useful negative predictor test for septic complications, and cut-off values have been determined as guidance for additional diagnostic tests. CRP is used by most surgeons to detect postoperative complications after esophagectomy, but the literature on optimal cut-off values are retrospective with a small sample of patients. Identifying an optimal cut-off value for CRP for anastomotic leakage may contribute to earlier detection of a complicated postoperative course and can be used in ERAS protocols to guide the indication for additional investigations such as a CT scan or endoscopy.The primary aim of this study was to determine the accuracy and optimal cut-off values of CRP with regard to anastomotic leakage in esophageal cancer patients following minimally invasive esophagectomy. The secondary aims were to determine if there is an association between the level of CRP and the severity of anastomotic leakage and the correlation between the level of CRP and incidence of other complications.This prospective observational study was conducted in the Amsterdam UMC, location AMC, the Netherlands. According to national guidelines, this study was exempted from official institutional review board (IRB) approval. The IRB assessed the study design and protocol, and a waiver was obtained. Informed consent was obtained from all patients. The Standards for Reporting Diagnostic accuracy studies (STARD) guidelines were used to ensure the correct reporting of this diagnostic study.Consecutive patients with a histologically proven, resectable (cT0-4aN0-3M0) esophageal or gastroesophageal junction carcinoma in whom a minimally invasive esophagectomy with gastric conduit reconstruction was performed between April 2016 and October 2018 were included. Patients were excluded if a salvage esophagectomy was performed.Esophagectomy was performed by means of a minimally invasive, formation of a gastric conduit, and construction of an intrathoracic or cervical anastomosis. The indication for a cervical anastomosis depended on the location of the primary tumor ( mid-esophageal), the clinical presence of paratracheal lymph node metastases, and the proximal extension of the radiation field (with the aim of creating the anastomosis outside the radiation field). A two-field lymphadenectomy was performed (Stations 2 on indication, 4, 5, 7, 8, 9, and 1519 according to the AJCC 8th edition and lymph nodes in the hepatoduodenal ligament). Levels of CRP were measured on postoperative days 3, 5, and 7, according to local protocol. There may be reasons for deviating from this protocol, such as for clinical deterioration warranting determining of CRP on an earlier day or admittance to the ICU, where CRP was not routinely measured.The diagnosis of anastomotic leakage was made when a defect or leakage of oral contrast was seen on a CT scan or by endoscopy or if saliva was draining from the neck incision. Final confirmation of diagnosis was made with consensus by all upper GI surgeons (SSG, MvBH, and WJE). The day of diagnosis is defined as the day anastomotic leakage was confirmed on a CT scan, by endoscopy of saliva was draining from the neck incision. Definitions and grading of anastomotic leakage and other complications were done according to the EsophagealComplicationsConsensus Group(ECCG) classification. A type 1 leak was defined as a local defect requiring no change in therapy or treated medically or with dietary modification, a type 2 leak includes a localized defect requiring interventional but not surgical therapy, for example, interventional radiology drain, stent or bedside opening, and packing of incision,and a type 3 leak was defined as a localized defect requiring surgical therapy.Primary outcomes were the accuracy of CRP as a marker for anastomotic leakage and the optimal cut-off value of CRP to detect anastomotic leakage. Secondary study outcomes included the association between the severity (grade) of anastomotic leakage and the level of CRP, and the correlation between CRP and other complications.The aim was to include a minimal number of events (patients who develop anastomotic leakage after surgery) of 20 in this study, since this is a generally accepted number of events for the calculation of the diagnostic accuracy of a test. The incidence of anastomotic leakage in the literature varies from 3 to 25%. An incidence of 10% was used because the incidence of anastomotic leakage is around 10% in the study center. Based on these numbers, it was determined that at least 200 patients needed to be included in this study.Continuous variables with normal distributions are presented as means with standard deviations and were compared using independent t-test. Medians and interquartile ranges (IQR) were used as central tendency for continuous variables with non-normal distributions, these data were compared using the MannWhitney U-test. Categorical data were expressed with percentage frequencies and were compared using a Chi-square or Fishers exact test where appropriate. Difference in CRP levels between patients with and without complications was analyzed using the independent t-test. The diagnostic accuracy of CRP was assessed by receiver operator curve (ROC) analysis for CRP on postoperative days 3, 5, and 7. The area under the ROC (AUC) is a direct measure of the diagnostic accuracy of a test. An AUC value>0.50 indicates the ability of a test to significantly discriminate between positive and negative cases with regard to the classification variable (e.g., presence or absence of disease). Youdens index was adopted to determine the cut-off value in ROC analysis with highest sensitivity and specificity. Sensitivity, specificity, positive predictive value, and negative predictive value were calculated for these CRP cut-off values on postoperative days 3, 5, and 7. KruskalWallis test was used to compare CRP levels in patients with different types of severity of anastomotic leakage. A P-value<0.05 (two-sided tests) was considered significant. Missing data were handled with complete case analysis. Statistical analysis was performed with SPSS, version 24.0 for Windows (SPSS Inc., Chicago, IL).There were 200 patients included in this study. In 13 patients (6.5%), an open esophagectomy was performed, these patients were excluded from analyses. Baseline characteristics are shown in Table 1. With 20 patients developing anastomotic leakage, the incidence was 11%. More patients in the anastomotic leakage group had diabetes. Twenty-six percent of the patients (6 out of 23) with a cervical anastomosis developed anastomotic leakage, significantly higher than the 8.5% of the patients (14 out of 164) with anastomotic leakage with an intrathoracic anastomosis (p=0.011). Patients with anastomotic leakage were more often readmitted within 30days (p<0.001) and had a higher rate of in-hospital mortality (0 patients without anastomotic leakage died in-hospital and 2 out of 20 patients with anastomotic leakage died in-hospital, p=0.011). The postoperative day of diagnosis of anastomotic leakage ranged from 1 to 15days, with a median of 8days.CRP was measured in 174 patients on day 3, in 158 patients on day 5, and in 128 patients on day 7. The mean level of CRP for patients with and without anastomotic leakage was 206 and 141mg/L, respectively, on day 3 (p<0.001), 174 and 91mg/L on day 5 (p<0.001), and 166 and 86mg/L on day 7 (p<0.001). Figure1a shows the levels of CRP on postoperative days 3, 5, and 7 for patients with and without anastomotic leakage.Table 2 shows different cut-off values for CRP on postoperative days 3, 5, and 7, and corresponding AUC, sensitivity, specificity, positive predicting value, and negative predicting value. The level of CRP on postoperative day 5 has the highest accuracy to detect anastomotic leakage, with a sensitivity of 75%, specificity of 82%, negative predicting value of 97%, and positive predicting value of 32%. The optimal cut-off value for day 5 was 120mg/L.Although the median level of CRP in patients with a more severe grade of anastomotic leakage was higher, the severity of anastomotic leakage did not significantly correlate with the level of CRP (Table 3). There was also no significant difference between the level of CRP and grade of anastomotic leakage when comparing type 1 leakages with types 2 and 3 leakages together (the median levels of CRP for patients with a type 1 or type 2/3 leak were 144 and 204mg/L, p=0.159 on day 3; 72 and 160mg/L, p=0.101 on day 5; and 73 and 200mg/L, p=0.122 on day 7). Figure1b shows the level of CRP for the different types of anastomotic leakage.One hundred and nineteen patients (64%) had at least one postoperative complication, and 36 of these patients (30%) had a complication of ClavienDindo grade IIIB or higher. Fifty patients (27%) had a pulmonary complication, 56 (30%) had a cardiac complication, 23 patients (12%) had chyle leakage, 6 (3%) of the patients had a urologic complication, 5 patients (3%) had vocal cord paresis, and 31 patients (17%) had another complication.The mean level of CRP for patients with and without any complication was 164 and 121mg/L, respectively, on day 3 (p<0.001), 118and 71mg/L on day 5 (p<0.001), and 114 and 59mg/L on day 7 (p<0.001). Figure1c shows the mean level of CRP for patients with any complication or no complication. Table 2 shows the optimal cut-off values for CRP on postoperative days 3, 5, and 7, and corresponding AUC, sensitivity, specificity, positive predicting value, and negative predicting value for predicting any postoperative complication. The level of CRP on postoperative day 7 had the highest AUC (0.696), with an optimal cut-off value of 72mg/L.The primary aim of this prospective observational study was to determine the accuracy and optimal cut-off values of CRP to predict anastomotic leakage. We found that the optimal postoperative day to predict anastomotic leakage was day 5, with a cut-off value of 120mg/L. This resulted in an AUC of 0.825, sensitivity of 75%, specificity of 82%, and a positive predictive value and negative predictive value of 32 and 97%, respectively. This is one of the few studies reporting about the correlation between CRP and anastomotic leakage after minimally invasive esophageal surgery and determining an optimal cut-off value for CRP as guidance for further diagnostic tests.The level of CRP on postoperative day 5 had the highest accuracy to detect anastomotic leakage with an optimal cut-off value of 120mg/L. Most other studies also found postoperative day 5 the most accurate day to measure the level of CRP. Nonetheless, the cut-off value of 120mg/L is lower than in other studies where the cut-off levels range from 154 to 189mg/L. Authors of these studies used similar statistical techniques to determine the optimal cut-off value. Most of these studies, however, were retrospective in design and contained a small sample of patients, with a wider variety of surgical approaches. Only one study, by Asti et al., found a lower optimal cut-off value than the present study, this was a CRP level of 83mg/L. A reason for the low cut-off value of CRP in both cohorts could be that all patients were operated by minimally invasive approach. More invasive esophageal surgery, such as an open esophagectomy, is correlated with a higher level of CRP posteroperatively.The diagnostic accuracy of CRP on postoperative day 5 was high, with an AUC of 0.825. With a cut-off value of 120mg/L, specificity and negative predicting value were 82 and 97%, respectively, while sensitivity and positive predicting value were lower (75 and 32%). Other studies also found higher specificity and negative predicting values compared to sensitivity and positive predicting values. This indicates that CRP is a feasible marker to guide the use of additional investigations such as CT scanning to detect anastomotic leakage. In case of a low CRP, anastomotic leakage becomes very unlikely, and clinical observation can be continued.Although the CRP level was directly proportional with the severity of anastomotic leakage, this was not statistically significant. Due to the small number of patients in the different severity groups, there might have been insufficient power to reach significance. Another possibility could be that not the level of CRP itself, but the rapidity of rise in CRP could be an indicator for the severity of the leakage. An indicator to predict the severity of anastomotic leakage can be of clinical importance, as it could contribute to decision making in the management of leakage. Unfortunately, the number of patients was too small to look at the influence of difference of CRP level between days 3 and 5 on the severity on the leakage. Moreover, there is no available evidence to compare our results with.CRP is a marker of inflammation, and elevated levels of CRP can be caused by other inflammatory conditions, for example, pneumonia. CRP is not specific for anastomotic leakage, and other clinical symptoms should, therefore, be considered when evaluating CRP. This makes interpretation of accuracy parameters difficult to interpret. However, CRP can be used as a guide for the conditional use of postoperative CT scanning or endoscopy. In the present study, 40 patients had a CRP of 120mg/L or higher on day 5, but only 12 of these patients (30%) had anastomotic leakage. This suggests that 69% of the patients would have received unnecessary additional diagnostics. However, the majority of these patients had another complication that would have been likely to find on a CT scan. CRP is an unspecific marker, feasible to detect postoperative complications, including anastomotic leakage.Four out of 16 patients with anastomotic leakage (and measurement of CRP available on day 5) did not have a CRP higher than 120mg/L on day 5. It should be noted that in all of these patients, anastomotic leakage was detected on day 7 or later. It is possible that anastomotic leakage in these patients occurred later on than usual, and therefore, they did not have a CRP higher than 120mg/L on day 5. Despite the high NPV of 96% in patients with a CRP<120, additional CT scan should be performed in patients with (late) clinically suspected anastomotic leakage.A limitation of the present study was that only CRP levels of days 3, 5, and 7 were routinely measured. Levels on more postoperative days could have resulted in a cut-off value with higher diagnostic accuracy. Also, not in every patient CRP levels were available for days 3, 5, and 7 which might have caused bias. Moreover, determining only on days 357 may be insufficient for early detection of anastomotic leakage, as this may occur on the in-between days. Moreover, it would have been valuable to stratify our results for cervical and intrathoracic anastomosis, since cut-off levels might be different. Though there were only 14 patients in the group of patients with an intrathoracic anastomosis and six patients in the group of patients with a cervical anastomosis. Unfortunately, these numbers of events are too low to perform a reliable analysis on these subgroups.CRP can be a useful tool, but other symptoms such as fever can also indicate that there is an anastomotic leakage. Future studies should attempt to identify predictors for different types of anastomotic leakage and possibly stratify results for a cervical and intrathoracic anastomosis. Predicting anastomotic leakage might improve when other markers such as white blood cell count, temperature, or amylase level in drain fluid are also considered. A combination of different markers could contribute to a useful algorithm in the diagnosis and management of anastomotic leakage.CRP on postoperative day 5 can be used as a marker to raise suspicion of anastomotic leakage in patients following an esophagectomy for esophageal cancer, but can especially be used as a negative predictor. With a cut-off value of 120mg/L, a negative predicting value of 97% and specificity of 82% were found. When CRP exceeds 120mg/L on postoperative day 5, additional investigations should be considered.None.Van Berge Henegouwen reports to be a consultant for Johnson and Johnson, Medtronic, Stryker, and Mylan, in addition to institutional grants from Stryker and Olympus. The remaining have no conflict of interest to report. 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which was developed with the aim of providing reliable and reproducible anastomosis, provides complete anastomosis, resulting in a reduced risk of anastomotic leakage. The aim of this study was to compare the incidence of anastomotic leakage between a conventional manual circular stapler (MCS) and the ECHELON CIRCULAR Powered Stapler (ECPS) in patients with left-sided colorectal cancer who underwent anastomosis with the double stapling technique.",id:9,pmid:"PMC10354928",text:"The powered circular stapler, which was developed with the aim of providing reliable and reproducible anastomosis, provides complete anastomosis, resulting in a reduced risk of anastomotic leakage. The aim of this study was to compare the incidence of anastomotic leakage between a conventional manual circular stapler (MCS) and the ECHELON CIRCULAR Powered Stapler (ECPS) in patients with left-sided colorectal cancer who underwent anastomosis with the double stapling technique. Due to advances in surgical techniques and improvements in surgical devices, postoperative complications in digestive surgery have decreased. However, anastomotic leakage remains a serious complication in colorectal surgery and continues to be a concern for colorectal surgeons. Anastomotic leakage can worsen not only short-term outcomes, such as the rate of reoperation and duration of hospitalization but also oncological outcomes, such as the rate of recurrence and survival time. Furthermore, anastomotic leakage has a negative impact on economic outcomes.Intraoperative factors, such as intestinal perfusion, tension and incomplete anastomosis, have been reported to affect the incidence of anastomotic leakage, in addition to patient background factors, such as sex, body mass index (BMI), diabetes, tumor diameter, distance from anal verge, American Society of Anesthesiologists (ASA) physical status and neoadjuvant chemoradiotherapy. In addition to the reinforcement of anastomosis, such as additional sutures and the use of a polyglycolic acid (PGA) sheet, we focused on a powered circular stapler, the ECHELON CIRCULAR Powered Stapler (ECPS) (Ethicon, Somerville, NJ, USA), which was launched in Japan in 2020, as a measure against incomplete anastomosis. This powered circular stapler was developed with the aim of providing reliable and reproducible anastomosis. The use of this new device provides complete anastomosis, resulting in a reduced risk of anastomotic leakage.The aim of this study was to compare the incidence of anastomotic leakage between a conventional manual circular stapler (MCS) and the ECPS in patients with left-sided colorectal cancer who underwent anastomosis with the double stapling technique (DST).A total of 187 patients with left-sided colorectal cancer who underwent DST anastomosis with a conventional MCS, the ENDOPATH ENDOSCOPIC INTRALUMINAL STAPLER (Ethicon, Somerville, NJ, USA) or the ECPS during surgery at Osaka City University Hospital between January 2016 and July 2022 were enrolled in this study. An expert in colorectal surgery participated in all surgeries. There was no operator bias in the use of circular staplers. High ligation of the inferior mesenteric artery was performed in all cases. Indocyanine green fluorescence imaging was performed to evaluate blood perfusion in patients who underwent surgery after June 2017. Mobilization of the splenic flexure was performed when tension at the anastomotic site was noted. Reinforcement of anastomosis, such as additional sutures and/or a PGA sheet, was added according to the judgment of the surgeon.Anastomotic leakage was defined as the extravasation observed on radiologic examinations. Upon clinical symptoms that suggested anastomotic leakage, such as abdominal pain, high fever, pus or fecal discharge from the pelvic drain, or leukocytosis, computed tomography (CT) was performed to confirm the presence of anastomotic leakage. The following CT findings were considered suggestive of anastomotic leakage: abscess, fluid collection, or air bubbles surrounding the anastomotic site. Water-soluble contrast enema was also performed as needed to confirm the presence of communication between the intra- and extraluminal compartments.This retrospective study was approved by the Ethics Committee of Osaka City University (approval number: 4182) and was conducted in accordance with the Declaration of Helsinki. Written informed consent was obtained from all patients.All statistical analyses were performed using the SPSS software package for Windows (IBM, Chicago, IL, USA). The significance of differences according to the circular stapler that was used and the patients background/operative outcomes were analyzed using the chi-squared test, Fishers exact test, and the MannWhitney U test. A logistic regression model was used to evaluate the factors associated with anastomotic leakage. P values<0.05 were considered to indicate a statistically significant difference. To reduce the impact of selection bias and potential confounding, we performed propensity score matching. The propensity scores were estimated using multivariate logistic regression models, with the groups as the dependent variable and patient characteristics and operative outcomes as covariates. Matching was performed with a one-to-one greedy nearest neighbor algorithm with a caliper of 0.2 without replacement.The MCS was used in 119 cases (MCS group), and the ECPS was used in 68 cases (ECPS group). Associations between the type of circular stapler and the patients characteristics/operative outcomes are summarized in Table1. The ECPS was significantly associated with nonsmokers, lower BMI, a higher proportion of robot-associated surgery and smaller circular staplers and tended to be associated with lower rectal cancer. Associations between the type of circular stapler and postoperative complications are summarized in Table2. The incidence of anastomotic leakage in the ECPS group was significantly lower than that in the MCS group (4.4% versus 14.3%, p=0.048). The reoperation rate in the ECPS group was lower than that in the MCS group (1.5% versus 2.5%, p>0.999); however, the difference did not reach statistical significance due to the extremely small number of events. No patients with anastomotic bleeding were observed in the ECPS or MCS group. The associations between anastomotic leakage and various factors are shown in Table3. According to a univariate analysis, anastomotic leakage showed significant associations with male sex, large tumor, absence of diverting ileostomy, long operation time, and manual circular stapler. Furthermore, even after propensity score matching using the three covariates of BMI, tumor location, and smoking, which have been reported to affect anastomotic leakage and which showed significant differences in patient backgrounds, the ECPS remained associated with a reduced incidence of anastomotic leakage.This study demonstrated that the use of the ECPS reduces the rate of anastomotic leakage in left-sided colorectal surgery, as demonstrated in previous reports. To our knowledge, this is the first report from Asia to evaluate the usefulness of the ECPS for the prevention of anastomotic leakage in colorectal surgery. In this study, the ECPS group had some adverse conditions (e.g., lower anastomosis) in comparison to the MCS group. Nevertheless, the outcomes in the ECPS group were better than those in the MCS group. Furthermore, even after propensity score matching, an association was found between the use of the ECPS and a reduced incidence of anastomotic leakage. These results strongly support the usefulness of the ECPS.The introduction of the circular stapler in colorectal surgery has greatly contributed not only to shortening the operation time but also to the establishment of stable procedures that are not affected by the skill of the surgeon and to the improvement of clinical outcomes. In addition to various past improvements in circular stapler technology, the ECPS was developed based on the concept of increased strength at the anastomotic site, a gentler approach to the tissue, minimization of variation in usage and standardization of performance across users. The details of the improvements are as follows.First, the powered stapling system, which is operated by electricity, was introduced. Since MCS requires a strong force to fire, movement at the distal tip becomes large when using MCS, especially when performed by a surgeon with small hands or insufficient grip strength. Therefore, MCS may cause suboptimal tension on the tissue at the anastomotic site, which may cause microtissue damage, leading to anastomotic trouble. On the other hand, the ECPS requires less force to fire. Therefore, movement at the distal tip can be reduced, resulting in a reduction in suboptimal tissue tension at the anastomotic site and providing more stable stapler positioning and staple line formation.Second, 3D stapling technology has been newly introduced. Although the staple array of the ECPS is 2 rows, the same as the MCS, the area covered by one staple of the ECPS is increased in comparison to the MCS due to the use of a 3D staple shape that compresses the tissue widely and sterically. As a result, the physical pressure resistance increases in comparison to the MCS. Although it is unclear whether there is a direct correlation between physical pressure resistance and the rate of anastomotic leakage, it is an undeniable fact that the use of the ECPS dramatically reduced the rate of anastomotic leakage in several previous reports. Furthermore, it has been reported that improved staple formation contributes to the prevention of bleeding at the anastomotic site as well as anastomotic leakage.Third, Gripping Surface Technology (GST), which provides gentler handling with precise compression only where it is needed, has also been introduced. This improvement minimizes tissue damage, resulting in a 33% reduction in compressive force on tissue.As described above, the ECPS has been improved in various points in comparison to the MCS. Nevertheless, the increase in selling price is set to be mild. Thus, the ECPS may account for most of the circular stapler market share in the near future.In this study, small-diameter circular staplers were more frequently used in the ECPS group than in the MCS group. The reason for this is the recent increase in the use of smaller-sized circular staplers, based on the hypothesis that the use of circular staplers of smaller diameter may reduce the overstretching of tissue, resulting in less anastomotic trouble. However, the size of the circular stapler was not associated with the incidence of anastomotic leakage, as documented in a previous report.In the current study, anastomotic leakage was observed in three patients in the ECPS group. All three patients had lower anastomosis and required a long operation time of 9h. In addition, the tumor diameter was 7cm in 2 of these 3 cases. Given these facts, there may have been invisible damage to the intestinal tract in these three patients who developed anastomotic leakage.The present study is associated with several limitations. First, this was a retrospective study with a small cohort in a single center. Based on previous reports on medical statistics, we abandoned the multivariate analysis with a Cox proportional hazards model for anastomotic leakage due to an insufficient total number of events. Instead, propensity score matching was performed to reduce the impact of selection bias and potential confounding factors. However, due to the small number of cases, the relationship between the reduced incidence of anastomotic leakage and the use of the ECPS showed a trend but did not reach statistical significance. Large prospective studies should be performed to confirm our findings. Second, additional reinforcement may have the potential to have some impact on the rate of anastomotic leakage, although there was no statistically significant correlation in this study because additional reinforcement tended to be omitted in patients with a low risk of anastomotic leakage. Third, the ECPS, which was launched in recent years, was more frequently used in robot-assisted surgery in comparison to the MCS due to historical backdrop. However, it has been reported that robot-assisted surgery and laparoscopic surgery are comparable in terms of postoperative complications.In conclusion, the ECPS has the potential to help reduce the rate of anastomotic leakage in left-sided colorectal surgery.MS designed the study, performed the statistical analysis and draft the manuscript. TF, YI, HK and KK collected the clinical data and revised the manuscript critically. KM designed the study and critically reviewed the manuscript. All authors read and approved the final manuscript.No funding was acquired for this study.The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request.This research conformed to the provisions of the Declaration of Helsinki. Written informed consent was obtained from all participants. This retrospective study was approved by the Ethics Committee of Osaka City University (approval number: 4182).Not applicable.The authors declare that they have no competing interests.BMIbody mass indexASAAmerican Society of AnesthesiologistsPGApolyglycolic acidECPSECHELON CIRCULAR Powered StaplerMCSmanual circular staplerDSTdouble-stapling techniqueCTcomputed tomographyN/Anot applicable",title:"Impact of a circular powered stapler on preventing anastomotic leakage in patients with left-sided colorectal cancer: a retrospective 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Intraoperative use of indocyanine green fluorescence angiography (ICGFA) can help prevent anastomotic leakage, but its use is controversial. We conducted a systematic review and meta-analysis to determine the efficacy of ICGFA in reducing anastomotic leakage.",id:4,pmid:"PMC10213353",text:"Anastomotic leakage is a serious complication after rectal cancer resection. Intraoperative use of indocyanine green fluorescence angiography (ICGFA) can help prevent anastomotic leakage, but its use is controversial. We conducted a systematic review and meta-analysis to determine the efficacy of ICGFA in reducing anastomotic leakage. Rectal cancer morbidity and mortality are increasing. With the advancement in pathophysiology, current individualized treatments for rectal cancer include endoscopic, local surgical resection, systemic treatment, preoperative radiotherapy, local ablation treatment for metastatic tumors, extensive surgery for local and metastatic diseases, targeted therapy, palliative chemotherapy, and immunotherapy, whereas surgery is the cornerstone of curative intent treatment. However, rectal cancer patients may face many complications after resection, one of which is anastomotic leakage.Despite significant advances in surgical techniques and perioperative management in recent years, the incidence of anastomotic leakage after rectal cancer surgery remains between 5 and 19%. The occurrence of anastomotic leakage will result in prolonged hospitalization, increased hospitalization costs, increased local recurrence rate, and shortened survival time. Studies have shown that the risk factors for anastomotic leakage have been determined by age, male gender, smoking, diabetes, previous radiotherapy and chemotherapy, intraoperative complications, anastomotic tension, and low perfusion. Among these, insufficient blood perfusion at the anastomosis plays an important role in the pathogenesis of anastomotic leakage.Indocyanine green fluorescent angiography (ICGFA) is widely used in many surgical fields, including gastrointestinal surgery. The ICGFA allows the surgeon to visualize the blood supply of the intestinal canal and avoid inadequate perfusion of the anastomosis during colorectal surgery. The doctor injected diluted indocyanine green (ICG) into the venous system and monitored the development signal with a fluorescent laparoscope. When the ICG enters the anastomosis area to be observed, the doctor can dynamically observe the blood supply of the colorectal anastomosis with the fluorescent display. Therefore, intraoperative ICG use for intestinal anastomosis blood supply imaging could theoretically become a predictive test to evaluate anastomotic perfusion, reducing the risk of anastomotic leakage. Some meta-analyses have recently revealed that ICGFA can help reduce the incidence of anastomotic leakage after rectal cancer surgery. However, most of them are not convincing due to the limited number of good qualities RCT studies included and the small number of patients.According to recently published research, we updated this meta-analysis to evaluate whether this technique can reduce the anastomotic leakage rate of rectal cancer patients after resection.This systematic review and meta-analysis is based on the Preferred Reporting Items for Systematic Reviews and Meta-Analysis statements (PRISMA). Because this study is a meta-analysis, neither institutional review committee approval nor patient-informed consent was required.We conducted a comprehensive and systematic search of electronic databases, including PubMed, Embase, and the Cochrane Library; retrieved relevant research published until September 30, 2022; and identified potential articles using the following keyword combinations: (indocyanine green OR fluorescein angiography OR fluorescence imaging OR indocyanine green-sulfo-OSu OR ICG) AND (Rectal Neoplasm OR Rectal Tumor OR Rectal Cancer OR Rectum Cancer). Simultaneously, we searched the reference list and previous comments in these studies for more comprehensive studies that could be included. Two authors (SJ-X and WJ-W) worked independently on this study.Anastomotic leakage was defined as a defect in the anastomotic region where there is communication between the intraluminal and extraluminal chambers. Anastomotic leakage was graded by the International Research Group on Rectal Cancer based on its clinical symptoms. Type A had the mildest clinical symptoms, and type C had the most severe clinical symptoms. Type A anastomotic leakage is referred to as subclinical leakage or imaging leakage, whereas type B and C anastomotic leakages are referred to as clinical leakage or significant leakage.The inclusion criteria of this study were as follows: (a) patients undergoing rectal cancer surgery; (b) the report result compares the incidence of anastomotic leakage between the ICGFA group and the control group; and (c) the study design was a randomized controlled trial (RCT), prospective trial, or retrospective trial.The exclusion criteria were as follows: (a) the study was published in the form of comments, case reports, and letters; (b) the data were insufficient or could not be obtained from the author for meta-analysis; and (c) all inconsistent articles that were ruled by the third examiner (Y-L).The two authors (SJ-X and LD-L) conducted independent research and were selected to extract data at the same time based on the inclusion and exclusion criteria. Each included article provided the following information: first author, publication year, research country, research design, and the number of anastomotic leakages.After reading the full text of each included study, the two authors (LJ-M and LC-Y) independently evaluated the quality of the study using the Newcastle Ottawa Scale (NOS). The NOS includes the following four areas: patient selection quality, exposure determination, group comparability, and patient results. The total NOS score ranges from 0 to 9, with a score 6 indicating high quality.The purpose of this study was to compare the incidence of anastomotic leakages in patients undergoing rectal cancer surgery with and without ICG. The secondary analysis was a subgroup analysis, which included the difference in the incidence of anastomotic leakages between regions and grades.This study is primarily based on binary data. The risk ratio (RR) is used as the effect measure, with a 95% confidence interval. All statistical tests had a significance level of p < 0.05 (double-tailed). I2 statistics was used to determine heterogeneity, with results ranging from 0 to 100%. When I2 = 0%, heterogeneity was assumed as not observed; I2 = 25%, heterogeneity was low; I2 = 50%, heterogeneity was medium; and I2 = 75%, heterogeneity was high. When I2 < 50%, a fixed model effect was used. The random model effect was used for all other cases. This study was conducted using the Review Manager software version 5.3 (Nordic Cochrane Center, Cochrane Collaboration, London, UK).The detailed process of literature retrieval and screening is shown in Figure 1. A total of 1,007 papers were retrieved. After reading the title and abstract, we excluded 531 studies because they did not meet our inclusion criteria. A total of 22 studies met the inclusion criteria among the remaining 94 potential included studies. From 2013 to 2021, 22 studies involving 4,738 patients from 10 countries were published. The sample size of the study ranged from 38 to 657 people. Three RCTs, three prospective studies, and sixteen retrospective studies were conducted. We scored 22 studies from 5 to 9 on the NOS, with 19 (86.4%) rated as high quality. Table 1 shows the basic information included in the study.The combined results of 22 studies revealed that the total anastomotic leakage rates of the ICG and non-ICG groups were 3.7 and 7.6%, respectively (RR = 0.46; 95% CI, 0.390.56; p < 0.001; Figure 2).As in the summary analysis, a similar relationship was observed for grade A anastomotic leakages but not for grades B and C. Grade A anastomotic leakage rate was 2.4% in the ICG group and 7.9% in the non-ICG group (RR = 0.25; 95% CI, 0.140.44; p < 0.00001); grade B: 2.9 and 3.9%, respectively (RR = 0.70; 95% CI, 0.381.31; p = 0.27); and grade C: 2.5 and 2.8%, respectively (RR = 0.97; 95% CI, 0.511.97; p = 0.93; Figure 3).The subgroup analysis of 22 studies from different regions revealed that the rate of anastomotic leakage in the ICG group was 3.2% in Asia compared with 11.4% in the non-ICG group (RR = 0.33; 95% CI, 0.230.48; p < 0.00001), 6.5 and 14.1% in Europe (RR = 0.38; 95% CI, 0.270.53; p < 0.00001), and 6.0 and 9.4% in North America (RR = 0.72; 95% CI, 0.401.29; p = 0.27; Figure 4).Funnel plots were used to assess potential publication bias in a meta-analysis of the relationship between ICG use and anastomotic leakages. The funnel plot is symmetrical, as shown in Figure 5, indicating that the risk of deviation published in this study is low.The largest meta-analysis on the impact of ICGFA on anastomotic leakage in patients with rectal cancer surgery included 22 articles and 4,738 patients. The results of a pooled analysis of these patients revealed that the use of ICGFA during surgery was associated with a lower incidence of anastomotic leakage after rectal cancer resection. The results of a subgroup analysis of these patients revealed that the use of ICGFA during surgery in Asia and Europe was associated with a lower incidence of anastomotic leakage after rectal cancer resection and the use of ICGFA during surgery was associated with a lower incidence of grade A anastomotic leakage after rectal cancer resection.The negative impact of anastomotic leakage after rectal cancer surgery cannot be ignored. Anastomotic leakage will result in prolonged hospitalization, increased hospitalization costs, increased local recurrence rate, and shortened survival time. Many studies have determined that anastomotic leakage is an independent risk factor for low long-term survival rate of patients with rectal cancer. The study shows that anastomotic leakage risk factors have been determined in many situations, such as age, male gender, smoking, diabetes, previous radiotherapy and chemotherapy, intraoperative complications, anastomotic tension, and low perfusion. These risk factors are partly related to patients, tumors, and surgery. Some risk factors are objective and cannot be changed, whereas other risk factors can be changed. Anastomotic perfusion is one of the few variables that can be changed.ICG is a biocompatible near-infrared contrast agent that can be excited by external light with a wavelength of 750800 nm and emit near-infrared light with a longer wavelength, allowing tissues and organs to develop. Because Nagata first used ICG in colorectal surgery in 2006, this technology has demonstrated significant research value and promising application prospects in the auxiliary diagnosis and treatment of colorectal cancer. It has been reported in the literature that ICG near-infrared imaging technology can improve the visualization of tumor lesions, improve the detection rate of lymph nodes, and reduce the incidence of anastomotic leakage in laparoscopic colorectal cancer surgery.The ICG near-infrared imaging technique is used to evaluate the intestinal blood supply at the anastomotic site during colorectal cancer surgery. Before the proximal intestinal wall is disconnected, the operator can use clinical judgment to select the resection line under white light or visible light and mark the pre-resection line on the intestinal wall without damage. However, it should be noted that unipolar or bipolar electrical equipment should be used to burn the mark to avoid damaging the local blood supply of the intestinal wall and ultimately affecting the accuracy of the assessment. After the location of intestinal resection was determined, ICG was injected intravenously for the first time, and vascular perfusion was monitored using a near-infrared camera system. If the ICG vascular perfusion imaging is good within 60 s, the intestinal blood supply is likely to be adequate. ICG has a median development time of 35 (2944) s and a duration of 3 min. Record the boundary between perfusion and non-perfusion tissues of the intestinal tube and compare it with the previously marked pre-resection line of the intestinal tube before cutting the intestinal wall along the ischemic line. If the blood perfusion at the pre-resection line of the intestinal tube is deemed insufficient, the pre-resection line at the proximal end of the intestinal tube should be moved to a position with adequate blood perfusion. ICG was injected intravenously again after intestinal anastomosis. The perfusion after anastomosis was evaluated using a fluorescence system, and the blood supply and appearance of the intestinal wall were observed to determine whether the surgical strategy should be changed and intestinal anastomosis performed again.The use of ICGFA in assessing anastomotic perfusion has been concerned in recent years due to its relative ease of use, low cost, and satisfactory safety. Recently published meta-analyses showed that the risk of anastomotic leakage after rectal surgery in patients with ICGFA was significantly reduced, which was consistent with our results. However, due to the limited number of articles included, the majority of the studies are inconclusive. In comparison to these studies, the advantage of our meta-analysis lies in the inclusion of all relevant RCT, prospective, and retrospective studies, allowing us to analyze a larger sample size than previous meta-analyses and produce more convincing research results. Simultaneously, our research object is more specific and singular, which is patients with rectal cancer undergoing surgical treatment. In patients undergoing rectal cancer resection, the incidence of anastomotic leakage is higher than in patients undergoing colon cancer surgery. Therefore, this group is most likely to benefit from this intervention.According to a summary analysis of all patients, the use of ICGFA during surgery is associated with a reduction of anastomotic leakage after rectal cancer resection (RR = 0.25; 95% CI, 0.140.44; p < 0.00001). We found that using ICGFA during surgery was associated with a reduction in the incidence of anastomotic leakage after rectal cancer resection in Asia and Europe (RR = 0.33; 95% CI, 0.230.48; p < 0.00001 and RR = 0.38; 95% CI, 0.270.53; p < 0.00001) but not in North America (RR = 0.72; 95% CI, 0.401.29; p = 0.27). We believe that this is due to fewer studies and a smaller sample size, which causes heterogeneity in the analysis of results. The use of ICGFA during surgery is associated with a reduction in the incidence of grade A anastomotic leakage after rectal cancer resection (RR = 0.25; 95% CI, 0.140.44; p < 0.00001), but there is no difference in the incidence of grades B and C anastomotic leakages (RR = 0.70; 95% CI, 0.381.31; p = 0.27 and RR = 0.97; 95% CI, 0.511.97; p = 0.93). Therefore, we can conclude that ICGFA cannot reduce the occurrence of type B and C anastomotic leakages after rectal cancer resection. Because both the ICGFA intervention and control groups had a low incidence of types B and C anastomotic leakage, ICGFA could not reduce the incidence of types B and C anastomotic leakage after rectal cancer resection.At the same time, we recognize that this study has some limitations. First, the diagnosis of anastomotic leakage varied across the studies. Some studies were diagnosed solely through radiology, whereas others were diagnosed through physical examination and endoscopy as well. Second, the dose of ICG administered and timing of the included studies were inconsistent. Third, restricted by the articles included, this study cannot be analyzed according to the level of rectal cancer. Finally, the number of RCTs in the study is insufficient, which may increase the risk of deviation. These limitations may result in heterogeneity in the analysis of research findings.In conclusion, the results of this systematic review and meta-analysis show that using ICGFA during rectal cancer surgery is associated with a significant reduction in AL. However, given the limitations mentioned above, more multicenter RCT studies with a large sample size are required in the future to demonstrate our research findings.The datasets presented in this study can be found in online repositories. The names of the repository/repositories and accession number(s) can be found below: https://pubmed.ncbi.nlm.nih.gov/.SX: analysis, interpretation of data, and drafting the article or revising it critically for important intellectual content. WW: conception and design and final approval of the version to be published. LL, LM, LY, and YL: acquisition of data. All authors contributed to the article and approved the submitted version.The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. 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leakage is a feared complication after esophagectomy and associated with increased post-operative morbidity and mrotality. The aim of this study was to evaluate the management of leakage after robot-assisted minimally invasive esophagectomy (RAMIE) with intrathoracic anastomosis. From a single center prospectively maintained database, all patients with anastomotic leakages defined by the Esophageal Complications Consensus Group between 2016 and 2021 were included. Contained leakage was defined as presence of air or fluid at level of the anastomosis without the involvement of the mediastinum or thorax. Non-contained leakage was defined as mediastinitis and/or mediastinal/pleural fluid collections. The primary outcome was 90-day mortality and the secondary outcome was successful recovery. In this study, 40 patients with anastomotic leakage were included. The 90-day mortality rate was 3% (n=1). Leakage was considered contained in 29 patients (73%) and non-contained in 11 patients (27%). In the contained group, the majority of the patients were treated non-surgically (n=27, 93%) and management was successful in 22 patients (76%). In the non-contained group, all patients required a reoperation with thoracic drainage and management was successful in seven patients (64%). Management failed in 11 patients (28%) of whom 7 developed an esophagobronchial fistula, 3 had a disconnection of the anastomosis and 1 died of a septic bleeding. In conclusion, this study demonstrates that the management anastomotic leakage in patients who underwent RAMIE with an intrathoracic anastomosis was successful in 73% of the patients with a 90-day mortality rate of 3%. A differentiated approach for the management of intrathoracic anastomotic leakage is proposed.",id:5,pmid:"PMC10226267",text:"Anastomotic leakage is a feared complication after esophagectomy and associated with increased post-operative morbidity and mrotality. The aim of this study was to evaluate the management of leakage after robot-assisted minimally invasive esophagectomy (RAMIE) with intrathoracic anastomosis. From a single center prospectively maintained database, all patients with anastomotic leakages defined by the Esophageal Complications Consensus Group between 2016 and 2021 were included. Contained leakage was defined as presence of air or fluid at level of the anastomosis without the involvement of the mediastinum or thorax. Non-contained leakage was defined as mediastinitis and/or mediastinal/pleural fluid collections. The primary outcome was 90-day mortality and the secondary outcome was successful recovery. In this study, 40 patients with anastomotic leakage were included. The 90-day mortality rate was 3% (n=1). Leakage was considered contained in 29 patients (73%) and non-contained in 11 patients (27%). In the contained group, the majority of the patients were treated non-surgically (n=27, 93%) and management was successful in 22 patients (76%). In the non-contained group, all patients required a reoperation with thoracic drainage and management was successful in seven patients (64%). Management failed in 11 patients (28%) of whom 7 developed an esophagobronchial fistula, 3 had a disconnection of the anastomosis and 1 died of a septic bleeding. In conclusion, this study demonstrates that the management anastomotic leakage in patients who underwent RAMIE with an intrathoracic anastomosis was successful in 73% of the patients with a 90-day mortality rate of 3%. A differentiated approach for the management of intrathoracic anastomotic leakage is proposed. Esophagectomy is the cornerstone of treatment for patients with locally advanced esophageal cancer. Recently, there has been a vast increase in the use of minimally invasive techniques for esophagectomy as they have been associated with less post-operative complications and comparable oncological outcomes compared to open esophagectomy. Despite technical improvements, esophageal surgery remains a highly complex procedure associated with significant post-operative morbidity.Anastomotic leakage after esophagectomy is one of the most feared post-operative complication and associated with significant morbidity, prolonged hospital stay, increased healthcare expenditure and reduced (long-term) survival. Treatment of anastomotic leakage is challenging and standardized treatment protocols are lacking. The manifestation and primary treatment strategy of leakage largely depends on the location of the anastomosis. Although the reported incidence of anastomotic leakage is higher for a cervical anastomosis compared to an intrathoracic anastomosis, leakage of an intrathoracic anastomosis has been associated with more severe intrathoracic manifestations requiring a different treatment strategy.In our center, a robot-assisted hand-sewn intrathoracic anastomosis was first implemented in 2016 and the anastomotic technique was further improved during the following years. During this period, different manifestations of anastomotic leakage were observed requiring different treatment strategies. The aim of this study was to evaluate the treatment of patients with anastomotic leakage after robot-assisted minimally invasive esophagectomy (RAMIE) with an intrathoracic anastomosis and to present a differentiated approach to manage intrathoracic anastomotic leakage.Patients were selected from a prospectively maintained institutional database. In the database, patient characteristics, details of the surgical procedure and complications were prospectively registered during a weekly multidisciplinary meeting. Patients who underwent RAMIE with intrathoracic anastomosis in the University Medical Center Utrecht (UMC Utrecht) and developed anastomotic leakage were extracted from the database and included in the study. All esophagectomies with intrathoracic anastomosis are performed robotically in the UMC Utrecht. As the intrathoracic robot-assisted hand-sewn anastomosis was introduced in February 2016, patients were included from February 2016 to December 2021. There were no exclusion criteria. The institutional review board approved this study and the need for written informed consent was waived.RAMIE consisted of a field-field lymphadenectomy and creation of a gastric conduit followed by a hand-sewn intrathoracic anastomosis. A detailed description of the procedure was published previously. In summary, the anastomoses were created as follows: indocyanine green was used to assess the perfusion of the gastric conduit and determine the most optimal location for the anastomosis. In case of mal perfusion of the conduit tip, this part was stapled off. The anastomoses were created by a hand-sewn, end-to-side, technique with a barbed 4/0 running V-Loc (Medtronic/Covidien; Minneapolis, MN, USA). From April 2018 onwards, three to four tension releasing stiches with Vicryl 3/0 (Ethicon, Somerville, NJ) were added to the technique to reduce the traction on the anastomosis. An omental wrap concluded the anastomosis. All patients who underwent RAMIE were treated according to our local enhanced recovery after esophagectomy (EROES) protocol. Components of the EROES protocol included preoperative optimization by a dietician and physiotherapist, epidural or paravertebral analgesia, direct extubation in the operation room and early mobilization. During the study period several adjustment to the EROES protocol were made. Initially, all patients resumed oral intake immediately after surgery. From January 2019 onwards, all patients received a feeding jejunostomy whilst being kept on a nil by mouth diet. On the fourth post-operative day a contrast swallow was performed. The primary aim of the contrast swallow was to asses for delayed conduit emptying. If there were no signs of delayed gastric emptying, patients were allowed to start oral water intake. In the absence of post-operative complications, solid food was allowed from the 14th post-operative day and onwards.Anastomotic leakage was defined according to the Esophageal Complications Consensus Group (ECCG). Anastomotic leakage was suspected when a patient had a combination of signs including fever, tachycardia, elevated serum levels of C-reactive protein (CRP) and/or elevated leucocytes. When anastomotic leakage was suspected, patients underwent a computed tomography (CT) scan and an additional endoscopy if needed. A contrast swallow examination was not used to detect anastomotic leakage as its predictive value is too low. In addition, it does not provide information on mediastinal or pleural involvement. At the day of diagnosis, anastomotic leakage was considered contained or non-contained based on a CT-scan. Leakage was defined as contained in case of local presence air or fluid at level of the anastomosis, without the involvement of the mediastinum or thoracic cavity. Non-contained leakage was defined as presence of mediastinitis and/or mediastinal/pleural fluid collections. All CT-scans performed at the day of diagnosis were retrospectively reviewed and scored and scored in a consensus as contained or non-contained leak (EdG, SB, JB, SH and RvH). Observers were blinded for the patients outcome. For the current analysis, the score was not adjusted in case a leak developed from a contained leak into a non-contained leak after the day of diagnosis.When anastomotic leakage was suspected, all patients were immediately treated with a nil by mouth regimen, endoscopic placement of a nasogastric tube in the gastric conduit and intravenous antibiotics. Additionally, depending on the severity of anastomotic leakage, patients were treated endoscopically and/or surgically. Endoscopic treatment consisted of placement of a suction-drain placed through the anastomotic defect into the mediastinum or placement of a stent. Surgical treatment consisted of drainage and washing of the thoracic cavity by a video-assisted thoracoscopy or thoracotomy. When the anastomosis was completely dehiscent during the reoperation, or when there was severe gastric conduit necrosis, the anastomosis had to be disconnected. Gastric conduit necrosis was diagnosed intraoperatively based on macroscopic appearance of the conduit combined with the endoscopically observed appearance of the mucosa and transmural defect.After hospital discharge, all patients with anastomotic leakage visited the outpatient clinic and underwent a contrast swallow investigation to evaluate anastomotic integrity. In some cases, a CT-scan or endoscopy was performed to evaluate anastomotic integrity. If the anastomosis was deemed sufficient, patients restarted their oral intake. Hereafter, patients were routinely followed at the outpatient clinic every 3months in the first year, every 6months during the second year and yearly until 5years after RAMIE.The primary outcome was 90-day mortality. The secondary outcome was successful recovery after treatment for anastomotic leakage. Recovery was defined to be successful when the following criteria were met:The defect in the anastomosis healed, confirmed by radiology (CT-scan/contrast swallow) or endoscopy leading to restart oral intake.The patient did not develop an esophagobronchial/esophagopleural fistula during the follow-up.No disconnection of the anastomosis was performed.Other outcomes were as follows: days between RAMIE and diagnosis of anastomotic leakage, diet at moment of diagnosis, serum levels of CRP and leucocytes measured at the day of diagnosis, pneumonia defined by the Uniform Pneumonia Score, in-hospital mortality, duration of hospital stay, duration of intensive care unit (ICU) stay and readmissions to the ICU. In addition, complications, such as esophagobronchial fistula and anastomotic strictures defined by the need of endoscopic dilation were reported.For the purpose of this study, only descriptive analyses were performed. Categorical variables were demonstrated as count with percentage. Continuous variables were demonstrated as mean (with standard deviation) or median (with range), depending on the type of data. All statistical analyses were performed by using SPSS 25.0 (IBM).Between February 2016 and December 2021, 152 patients underwent RAMIE with an intrathoracic anastomosis after which 40 patients developed anastomotic leakage (26%) whom were included in this study. There were no differences in patient characteristics of both patients with and without anastomotic leakage (Table 1). Of the 40 patients with anastomotic leakage, 29 (73%) were classified as contained and 11 (27%) as non-contained leaks at the day of diagnosis. Anastomotic leakage was diagnosed after a median of 8days (range 122) post-operatively. At diagnosis, 22 (55%) patients were on a liquid diet, 17 (43%) patients on a nil by mouth policy and 1 (3%) patient had intake for solid food. On the day of diagnosis, the median serum level of CRP was 188 (range 38404) and of median leucocytes was 13.8 (range 5.126.4).One patient in the non-contained group died after discharge within 90days after RAMIE due to a septic bleeding. The septic bleeding was most likely caused by an ongoing anastomotic leakage that led to an abscess that damaged the aortic wall, resulting in a rupture.The majority of patients had a contained anastomotic leak (n=29, 73%). Management of anastomotic leakage in these patients is summarized in Figure 1.In 28 of the 29 patients, an endoscopy was performed to evaluate the integrity of the anastomosis. In one patient, no endoscopy was performed and anastomotic leakage was diagnosed based on radiological findings. This patient was treated with antibiotics and a nil by mouth diet after which the patient recovered successfully.A visible anastomotic defect was present in 20 of the 28 patients who underwent endoscopy. The eight patients without a visible defect were kept on a nil by mouth diet and received intravenous antibiotics. They all recovered successfully.Of the 20 patients with a visible anastomotic defect, 10 patients were treated with a drain through the defect into the mediastinum combined with antibiotics and a nil by mouth diet, 8 patients with antibiotics and a nil by mouth diet only and 2 patients with an endoscopically placed stent. Of the 10 patients that were treated with a drain through the anastomotic defect, 8 recovered successfully, 1 developed an esophagobronchial fistula and the anastomosis had to be disconnected due to complete dehiscence in 1 patient. Of the eighy patients who were only treated with antibiotics and a nil by mouth diet, five developed an esophagobronchial fistula and three patients recovered successfully. The two patients treated with an endoscopically placed stent recovered successfully.In summary, 22 out of 29 patients (76%) with a contained leak recovered successfully. A healed anastomosis was observed after a median of 30days (range 1678) after the diagnosis of leakage. Treatment failed in seven (24%) patients; in one patient, the anastomosis was disconnected due to complete dehiscence, and six patients developed an esophagobronchial fistula. Of the six patients who developed an esophagobronchial fistula, five patients had a visible anastomotic defect during endoscopy and were initially treated with antibiotics and a nil by mouth diet only for their anastomotic leakage.Of the 40 patients, 11 (27%) were classified as having non-contained anastomotic leakage. Management of these patients is summarized in Figure 2. Treatment consisted of surgical thoracic drainage in all patients (n=11) of which three patients received an endoscopic stent simultaneously. Treatment was successful in seven patients, the anastomosis had to be disconnected due to severe leakage in two patients, one patient developed an esophagobronchial fistula and one patient died after discharge due to a septic bleeding, as mentioned previously.In summary, 7 out of 11 patients with a non-contained leak (64%) recovered successfully with a healed anastomosis after a median of 51days (range 2588) from the day of diagnosis.Clinical outcomes are presented in Table 2. The median hospital stay was 22days (range 5139) and the median stay on the ICU was 1day (range 072) with a readmission rate to the ICU of 38% (n=15). There was no in-hospital mortality. The median follow-up was 41months (range 160). An esophagobronchial fistula occurred in 7 (18%) patients, median 58days after RAMIE (range 15698). These fistulas were treated endoscopically in four patients and surgically in three patients. Endoscopic treatment consisted of stent placement in three patients and an endoscopic clip in one patient. Surgical treatment consisted of bronchial repair with a bovine patch followed by interposition of healthy tissue in all three patients. Strictures were diagnosed in 19 (48%) patients after a median of 94days following RAMIE (range 41383). Strictures were treated with endoscopic dilatations in all patients with a median of 5 dilatations (range 120). The stricture rate for patients without anastomotic leakage was 47% (n=53). Strictures were treated with endoscopic dilatations in all patients with a median of four dilatations (range 167).This study evaluated the treatment strategy of anastomotic leakage in 40 patients who underwent RAMIE with an intrathoracic anastomosis. Anastomotic leakage was considered contained in 29 patients of which the majority was treated non-surgically (n=27, 93%). In this group, treatment was successful in 22 patients (76%). The other 11 patients had a non-contained leak with thoracic manifestation who all required a reoperation. Treatment was successful in seven patients (64%). No in-hospital mortality occurred and the 90-day mortality rate was 3% (n=1). Failures were mainly due to inadequately drained leaks in the contained group, resulting in an esophagobronchial fistula in five patients.Previously reported success rates in literature of different treatment strategies for anastomotic leakage range between 50 and 100%. However, it is hard to compare success rates between studies as the limited number of studies on this topic have a small sample size (range 528) and used different definitions for successful treatment of anastomotic leakage. As proxy for the success of treatment of the anastomotic leakage, 90-day mortality rates are often used. In this context, a recent international multicenter study that included 319 patients with anastomotic leakage reported a 90-day mortality rate of 12%. Other studies have reported similar 90-mortality rates after anastomotic leakage ranging between 10% and 35%. The 3% 90-day mortality after anastomotic leakage in the current study is considerably lower and therewith supports the proposed treatment strategy for anastomotic leakage.Despite the low mortality rate, management of leakage failed in 11 patients (28%) of which the majority developed an esophagobronchial fistula. In this study, five of eight patients with a visible anastomotic defect during endoscopy treated with antibiotics only developed an esophagobronchial fistula. The high rate of esophagobronchial fistula in these patients is likely caused by inadequately drained anastomotic leakage after which the persistent abscess between the esophagus and bronchus developed into an esophagobronchial fistula. Based on these results, a differentiated approach for the management of anastomotic leakage was developed and is presented in Figure 3. Essential in this strategy is the importance of drain placement in case of a visible anastomotic defect during endoscopy. Therefore, we recommend that all patients with anastomotic leakage, even if considered contained, should undergo an endoscopy to evaluate the integrity of the anastomosis. If a defect is visible, a nasogastric drain is placed through the defect into the mediastinum. Following this strategy, no more esophagobronchial fistulas were diagnosed from January 2019 onwards. Furthermore, management of a non-contained leaks should always consist of a reoperation with thoracic drainage. In addition, an endoscopy should be performed in order to create source control with a stent or additional drainage through the anastomotic defect.The role of a stent in the management of anastomotic leakage is still under debate in literature. In our opinion, a stent could be used in non-contained leaks to provide source control combined with pleural or mediastinal drainage. On the other hand, stents are associated with failure and complications such as migration of the stent, which occurs in 20% of the patients. An alternative might be the use of an endoscopic vacuum-assisted closure (Endovac (B. Braun, Melsungen, Germany)) device with reported success rates of 60%80%. Higher negative pressure could be achieved with an Endovac compared with a drain through the anastomotic defect into the mediastinum. However, whether the Endovac achieves better results over a drain through the mediastinum is still unclear as high quality studies are scarce. In addition, serious disadvantages are reported as well, including Endovac migration, bleeding, trachea damage and the need for multiple endoscopies to change the Endovac device, which is burdensome for patients and logistically difficult.The incidence of anastomotic leakage was relatively high in this cohort. This is most likely caused by a learning curve effect for the hand-sewn robot-assisted intrathoracic anastomosis, that has been published previously. In the most recent 1.5years, our leak rate decreased to 6%, indicating that proficiency is being reached.The severity grade of anastomotic leakage according to the ECCG is currently based on the type of treatment (conservative, endoscopic, surgical). Although the current definition allows for an objective classification, a definition to classify severity based on leakage characteristics might be more helpful for applying and providing recommendations for the right treatment. In addition, if a center would treat leakages more frequently endoscopically, the severity grade of anastomotic leakage of that center will decrease while the nature of the leakage is in fact not changing. Therefore, we recommend a new classification that is based on radiological and endoscopic findings to define the severity of anastomotic leakage. Based on radiology, anastomotic leakage should be defined as contained (grade I or II) or non-contained (grade III) according to the definition used in this study. Based on endoscopy, a contained leak could be classified as grade I when no defect is visible or grade II in case of a visible anastomotic defect.A strength of this study is the large cohort of patients treated with a uniform RAMIE technique and an unique level of detail regarding treatment strategies for anastomotic leakage. In addition, the anastomotic leakage was scored prospectively. A limitation of this study is that developments in perioperative care might have caused a heterogeneous cohort. However, bias caused by a heterogeneous cohort should be minimal as the aim of this study was to evaluate the treatment strategy of leakage.In conclusion, this study demonstrated that the management of anastomotic leakage in patients who underwent RAMIE with intrathoracic anastomosis was successful in more than 70% of the patients with an in-hospital mortality of 0% and a 90-day mortality of 3%. A visible anastomotic defect during endoscopy always requires drainage by endoscopic drain placement through the defect or surgical thoracic drainage. Based on these findings, a differentiated approach for the management of intrathoracic anastomotic leakage is proposed.There was no funding received for this work.Richard van Hillegersberg and Jelle Ruurda are proctors for Intuitive Surgical Inc and consultants for Medtronic. Eline de Groot, Sebastiaan Bronzwaer, Lucas Goense, Feike Kingma, Sylvia van der Horst and Jan Willem van den Berg have no conflicts of interest to declare.",title:"Management of anastomotic leakage after robot-assisted minimally invasive esophagectomy with an intrathoracic 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of Interest",cui:"C0079152",end:22093,id:97124,score:-898,semtype:"idcn",start:22072,text_id:5},{candidate:"TO",cui:"C0040363",end:22096,id:97125,score:-1e3,semtype:"geoa",start:22094,text_id:5},{candidate:"TO",cui:"C0041260",end:22096,id:97126,score:-1e3,semtype:"aapp",start:22094,text_id:5},{candidate:"To",cui:"C1883351",end:22096,id:97127,score:-1e3,semtype:"qlco",start:22094,text_id:5}],$t={abstract:"Colorectal cancer (CRC) is one of the most common malignancies in the world. Despite significant improvements in surgical technique, postoperative complications still occur in a fair percentage of patients undergoing colorectal surgery. The most feared complication is anastomotic leakage. It negatively affects short-term prognosis, with increased post-operative morbidity and mortality, higher hospitalization time and costs. Moreover, it may require further surgery with the creation of a permanent or temporary stoma. While there is no doubt about the negative impact of anastomotic dehiscence on the short-term prognosis of patients operated on for CRC, still under discussion is its impact on the long-term prognosis. Some authors have described an association between leakage and reduced overall survival, disease-free survival, and increased recurrence, while other Authors have found no real impact of dehiscence on long term prognosis. The purpose of this paper is to review all the literature about the impact of anastomotic dehiscence on long-term prognosis after CRC surgery. The main risk factors of leakage and early detection markers are also summarized.",id:7,pmid:"PMC10277951",text:`Colorectal cancer (CRC) is one of the most common malignancies in the world. Despite significant improvements in surgical technique, postoperative complications still occur in a fair percentage of patients undergoing colorectal surgery. The most feared complication is anastomotic leakage. It negatively affects short-term prognosis, with increased post-operative morbidity and mortality, higher hospitalization time and costs. Moreover, it may require further surgery with the creation of a permanent or temporary stoma. While there is no doubt about the negative impact of anastomotic dehiscence on the short-term prognosis of patients operated on for CRC, still under discussion is its impact on the long-term prognosis. Some authors have described an association between leakage and reduced overall survival, disease-free survival, and increased recurrence, while other Authors have found no real impact of dehiscence on long term prognosis. The purpose of this paper is to review all the literature about the impact of anastomotic dehiscence on long-term prognosis after CRC surgery. The main risk factors of leakage and early detection markers are also summarized. Core Tip: Colorectal cancer (CRC) is one of the most common malignancies in the world. Despite significant improvements in surgical technique, postoperative complications still occur in a fair percentage of patients undergoing colorectal surgery. The most feared complication is anastomotic leakage. It negatively affects short-term prognosis, with increased post-operative morbidity and mortality, higher hospitalization time and costs. Moreover, it may require further surgery with the creation of a permanent or temporary stoma. While there is no doubt about the negative impact of anastomotic dehiscence on the short-term prognosis of patients operated on for CRC, still under discussion is its impact on the long-term prognosis. Some authors have described an association between leakage and reduced overall survival, disease-free survival, and increased recurrence, while other authors have found no real impact of dehiscence on long term prognosis. The purpose of this paper is to review all the literature about the impact of anastomotic dehiscence on long-term prognosis after CRC surgery. The main risk factors of leakage and early detection markers are also summarized.Anastomotic leakage (AL) is a major cause of postoperative morbidity and mortality after colorectal cancer (CRC) surgery. AL is a defect of the intestinal wall integrity at the colorectal or colo-anal anastomosis site (including suture and staple lines of neorectal reservoirs) leading to a communication between the intra- and extraluminal compartments. However, there are several definitions of AL in literature and most studies define it using clinical signs (pain, fever, tachycardia, peritonitis, purulent or fecal drainage), radiographic findings (fluid and/or gas-containing collections), and/or intraoperative features (peritoneal effusion and ruptured anastomosis). The use of different definitions in clinical studies can partly explain the considerable variations in AL reported rates. The incidence of AL reported in different studies is highly variable (2%-19%) and certainly influenced first of all by the surgeon's experience and the emergency or elective surgical setting. It is also influenced by the site of the anastomosis: It is lowest for ileocolic anastomoses (1%-3%) and highest for coloanal anastomoses (10%-20%).AL has been divided into "early" and "late" depending on whether AL is diagnosed within or after 30 d after surgery. In general, early AL manifests with severe peritonitis and it is mainly related to a technical error in performing the anastomosis, usually due to mal vascularization of the intestinal stumps or tension at the anastomotic site. In contrast, late AL is often associated with long-standing pelvic abscess and is due to preexisting conditions in patients, such as local sepsis, poor nutrition, immunosuppression, morbid obesity, and radiation exposure.AL is also classified according to severity into grade A, B and C. Grade A is represented by AL that does not require active therapeutic intervention, grade B by AL that requires active therapeutic intervention but manageable without re-laparotomy, and grade C by AL that requires re-laparotomy.Several risk factors for anastomotic dehiscence following colorectal surgery have been identified over the years. They can be classified for convenience into preoperative, intraoperative, and postoperative.Preoperative risk factors commonly reported in the literature include male sex, obesity, tobacco habit, alcohol consumption, an American Society of Anaesthesiologistscore of 3 or higher, and prolonged corticosteroid intake. Tumor location, size and stage must be considered among the risk factors. Akiyoshi et al reported that tumor localization in the rectum, rather than the colon, was independently predictive of AL development on multivariate analysis.The AL rate was 10 times higher (20.6% vs 2.3%) when the anastomotic region was located within 5 cm of the anal verge.Low anterior resection (LAR) involves surgery in an anatomically confined space and when tumor size and/or stage increases, intrapelvic manipulation becomes limited and rectal dissection more challenging. In a series of 154 patients with rectal carcinoma, tumor size 5 cm in diameter was associated with a 4-fold increased risk of leakage. Zhu et al found that tumors greater than 3 cm in diameter, as well as TNM stage, were independently associated with leakage.Intraoperative risk factors include: The surgeon experience (and hospital size), the number of linear stapler firings, left colic artery ligation, emergency surgery (patients with peritonitis and/or bowel obstruction are at higher risk of postoperative adverse events), operative time and blood loss during surgery. Intra-operatively, it is also important to ensure good vascularization of the anastomosed bowel segments. Indocyanine green (ICG) fluorescence angiography may help in this evaluation. In a recent meta-analysis, an incidence of anastomotic dehiscence was observed in 3.8% of cases in the ICG group and 7.8% in the control group in which ICG was not used.Postoperative risk factors are anemia, hypoalbuminemia, and late initiation of enteral nutrition.Early detection of AL is crucial to treat patients limiting negative effects. Baeza-Murcia et al analyzed the accuracy of C-reactive protein (CRP) and procalcitonin (PCT) for early detection of AL and have found that CRP is more accurate than PCT on both postoperative day (POD) 3 and 5. According to this study CRP measured on POD 5 is the most useful test for early diagnosis of AL and that values above 9.1 mg/dL are indicative of anastomotic dehiscence.In a recent meta-analysis by Yeung et al a CRP cutoff level of 14.8 mg/dL at POD 3 had a sensitivity and specificity of 95%, while CRP cut-off levels of 12.3 mg/dL at day 4, 11.5 mg/dL at day 5, 10.5 mg/dL at day 6, and 9.6 mg/dL at day 7 had a sensitivity and specificity of 100% for anastomotic dehiscence.According to Garcia-Granero et al and El Zaher et al, PCT is also a very good predictor of anastomotic dehiscence, particularly from POD 5 or higher. The predictive power of PCT may also be enhanced in combination with CRP or white blood cell, or both (area under the curve 0.92, 0.92, 0.93, respectively). A recent meta-analysis by Xu et al shows that PCT at POD 3 has potential clinical value in the early diagnosis of AL and has better diagnostic accuracy in patients undergoing laparoscopic surgery. Cut-off values are recommended in the range of 0.7-1.3 ng/mL to ensure accurate diagnosis and safe discharge. However, PCT is a valid predictor only for patients with major clinical losses confirmed by radiology and presenting with severe clinical signs and symptoms that require a change in therapeutic management and in most cases a reintervention. Cousin et al conducted a meta-analysis and concluded that PCT does not add value to CRP in the diagnosis of AL.It can be said that CRP and PCT at POD 5 have a high negative predictive value, which would allow early and safe discharge.Tavernier et al considered 5 criteria for safe early discharge after laparoscopic colorectal surgery: A CRP level of less than 15 mg/dL, absence of fever during the entire hospital stay (temperature < 38 C), return of bowel function (flatus with or without stool), adequate pain control with oral analgesics (pain less than 5 out of 10 on a 10-point visual analog scale) and tolerance of a solid diet. The negative predictive value in ruling out an anastomotic leak was 98.4% for all 5 criteria combined. The false-negative rate was 13.3%.AL affects the outcome of surgery, worsening the short-term outcomes and increasing the time and cost of hospitalization. The mortality related was reported to be between 0.8% and 27%. Mortality was higher after leak from a colonic anastomosis than after leak from a rectal anastomosis (43.8% vs 7.1%). Bertelsen et al found in a multicenter study a 4-fold increase in 30-d mortality in patients with AL. According to a Cochrane review, AL is associated with a perioperative mortality rate of 2% to 24% and high morbidity, with the risk of a definitive ostomy exceeding 25%. Warps et al found an overall AL rate of 4.8%, ranging from 4.0% (right hemicolectomy) to 15.4% (subtotal colectomy). AL was predominantly managed with reintervention, ranging from 81.2% of cases after transversectomy to 92.4% after sigmoid resection. After reintervention, the highest mortality rates were observed for transversectomy (15.4%) and right hemicolectomy (14.4%) and the lowest for sigmoid resection (5.6%) and subtotal colectomy (5.9%). The intensive care unit admission rate was 62.6% overall (range 56.7%-69.2%) and the stoma rate ranged from 65.5% (right hemicolectomy) to 93.0% (sigmoid resection).While the short-term consequences of AL are well known, its impact on long-term prognosis in CRC patients is still debated.In the literature, the first authors to concern themselves with outcomes related to anastomotic dehiscence after resective surgery for CRC were Phillips et al and Sauven et al. In both cases, the parameter evaluated was local recurrence (LR). In the first study, AL did not appear among the significant risk factors for recurrence, while in the second, anastomotic dehiscence was associated with an increased rate of LR. In the same years, Amato et al evaluated the association between CRC and AL by focusing exclusively on patients with rectal tumors operated with an anterior resection. In this study, AL did not influence the recurrence rate.In 1991, Akyol et al performed a study on patients operated for left colon or rectal cancer and demonstrated an important influence of AL on recurrence and cancer-specific survival (CSS) at 24 mo. The independence of the impact of dehiscence on outcomes from tumor stage was highlighted. This was the first study that analyzed local and distant recurrence separately and used multivariate Cox regression.Two years later, a study published by Fujita et al showed the impact of AL on LR and disease-free survival (DFS). DFS is significantly lower in the AL group for patients with Duke stage A and B cancers but not for C and D. The importance of this work also lies in the separate evaluation of subjects with colon and rectal cancer.Petersen et al studied the influence of leakage on LR, CSS, overall survival (OS) and postoperative mortality. AL influence only LR and CSS, confirming the previous findings of Akyol et al. Branagan et al reached similar conclusions in 2005. Further studies showed a correlation between AL and higher 30-d mortality, lower OS and CSS.Law et al in 2007 found a significant association between AL and 5-year CSS, 30-d mortality and recurrence (local and systemic).According to the study by Eberhardt et al, AL does not change the risk of recurrence and mortality for colon cancer, whereas it does for rectal cancer. The article also offers an assessment of OS, CSS, LR and overall recurrence for each stage, as well as an analysis of these outcomes at both 1 and 5 years after surgery.According to Marra et al, AL significantly reduces OS without affecting the risk of recurrence, while other studies have found an impact of leakage on OS, recurrence, and DFS. However, Katoh et al evaluated only patients with stage II CRC and Breugom et al only patients with stage I-III colon cancer. To be precise, Park et al in 2016 found an effect of AL on OS and DFS only for patients with rectal cancer. Nachiappan et al found a reduction in OS in patients with AL who required reoperation compared with subjects without AL. Ramphal et al demonstrated that LR develops with the same frequency in symptomatic and asymptomatic dehiscence.Krarup et al identified in patients with AL an increase in distant recurrence (DR) and in mortality. However, there was no significant association with LR. Nordholm-Carstensen et al and Ng et al evaluated the impact of AL in patients with stage IV CRC. The 3-year survival rate is affected by dehiscence for both colon (18.7% vs 44.6%) and rectum (53.7% vs 73.3%).The first meta-analysis on this topic was performed by Mirnezami et al on 22 studies. It reported an association between AL and LR, DR and cancer-specific mortality.The subsequent meta-analysis by Ha et al evaluated 34 studies and divided the results into two categories. In the first group rectal anastomosis data were analyzed, and AL was associated with increased LR and reduced OS, CSS, and DFS. There were no significant effect on distant recurrence. In the second group colic anastomoses were analyzed and AL was associated with reduced OS and DFS and there was no correlation with local or distant recurrence.The studies by Sammour et al and Goto et al also analyzed CSS. They showed a significant reduction in 5-year OS for patients with AL, without finding differences in LR, CSS and postoperative mortality (in rectal carcinoma, leakage affects only the latter). The second one documented instead a reduction in OS (80. 8% vs 90.3%) and CSS (89.6% vs 95.1%), an increase in LR and no correlation with distant recurrence.A subsequent meta-analysis conducted in 2020 by Bashir Mohamed et al demonstrated a lack of significant effect of AL on recurrences, however it reduced OS, DFS and CSS.Recent articles on this topic were written by Stormark et al and Kryzauskas et al. The former concluded that leakage only after surgery for stage III CRC is able to reduce survival, whereas the latter demonstrated that AL impaired disease-free and OS in patients undergoing sigmoid and rectal surgery.Regarding rectal cancer alone, the first data of the new millennium showed an increase in LR and a decrease in CSS. Subsequent studies can be divided into 3 categories. In the first group, there are studies that supported the absence of an impact of AL on cancer outcomes such as OS, CSS, DFS, LR and DR. The second group covers studies defining AL as an independent prognostic factor for reduced OS, CSS, DFS and increased recurrence. In the third group, we can place studies midway between the first two categories, as the study of Noh et al, demonstrating that AL is associated with increased LR and reduced DFS, whereas its relationship with OS and distant recurrence is not significant. These findings were confirmed in a recent study by Peltrini et al.To the above groups, we must also add studies evaluating also perioperative mortality. Ptok et al and Hain et al found an impact of dehiscence on 30-d mortality, DFS, and LR, whereas Eriksen et al and Bertelsen et al found an increase in 30-d mortality, but without a significant increase in LR. Bertelsen et al also noted the lack of reduction in OS and impact on distant recurrence.Lim et al in 2015 classified ALs into 3 categories based on the consequences: (1) Generalized peritonitis; (2) Localized peritonitis with or without abscess; and (3) Fistula. Oncologic outcomes were evaluated separately for each type and reduced OS and LRFS (LR-free survival) were identified. According to Bostrm et al, leaks only impact OS if they require intervention.In 2022, Dulskas et al evaluated AL in patients undergoing right colectomy for CRC and concluded that AL is a factor that negatively affects long term prognosis. In contrast, a Dutch retrospective study found that disease recurrence is not associated with AL after CRC resection.Koedam et al, analyzing data from the COLOR and COLOR II studies, show that ALs after rectal cancer surgery are associated with an increased rate of LR and a decreased DFS at 5-year follow-up. DR and OS are not significantly affected. Regarding colon cancer surgery, no significant effect of AL on long-term oncologic outcomes was observed, presumably because of a relatively low leakage rate. Strengths of this study include the randomized, multicenter design of the two included studies and uniform study protocol for perioperative care and follow-up to limit practice variability.All studies on this topic are summarized in Table 1.AL appears to be an independent risk factor influencing long-term oncologic outcomes after rectal cancer surgery. On the other hand, regarding colon cancer, the results are still extremely heterogeneous and unclear. Further studies on patients undergoing resection for CRC are needed to confirm the oncological impact of AL.Based on these data, we would recommend more frequent follow-up for patients with AL after CRC cancer surgery.`,title:"Impact of anastomotic leakage on long-term prognosis after colorectal cancer 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Leakage",cui:"C0919691",end:17568,id:120570,score:-770,semtype:"patf",start:17566,text_id:7},{candidate:"Cancer",cui:"C0998265",end:17578,id:120571,score:-578,semtype:"euka",start:17575,text_id:7},{candidate:"colorectal surgery",cui:"C2608114",end:17578,id:120572,score:-600,semtype:"topp",start:17575,text_id:7},{candidate:"Anastomotic Leakage",cui:"C0919691",end:17568,id:120573,score:-770,semtype:"patf",start:17566,text_id:7},{candidate:"Cancer",cui:"C1306459",end:17578,id:120574,score:-578,semtype:"neop",start:17575,text_id:7},{candidate:"Surgery.colorectal",cui:"C0009369",end:17578,id:120575,score:-600,semtype:"bmod",start:17575,text_id:7},{candidate:"Anastomotic Leakage",cui:"C0919691",end:17568,id:120576,score:-770,semtype:"patf",start:17566,text_id:7},{candidate:"Cancer",cui:"C1306459",end:17578,id:120577,score:-578,semtype:"neop",start:17575,text_id:7},{candidate:"colorectal surgery",cui:"C2608114",end:17578,id:120578,score:-600,semtype:"topp",start:17575,text_id:7}],td={abstract:"Serum C-reactive protein (CRP) is commonly used by surgeons to raise suspicion of anastomotic leakage and other infectious complications, but most studies on optimal cut-off values are retrospective with a small sample of patients. The aim of this study was to determine the accuracy and optimal cut-off value of CRP for anastomotic leakage in patients following esophagectomy for cancer.",id:8,pmid:"PMC10310558",text:"Serum C-reactive protein (CRP) is commonly used by surgeons to raise suspicion of anastomotic leakage and other infectious complications, but most studies on optimal cut-off values are retrospective with a small sample of patients. The aim of this study was to determine the accuracy and optimal cut-off value of CRP for anastomotic leakage in patients following esophagectomy for cancer. Anastomotic leakage following esophagectomy for cancer is a severe complication, generally leading to additional postoperative morbidity or even death. C-reactive protein (CRP) is a serum acute-phase reactant produced by the liver in response to pro-inflammatory cytokines that play a role in activating the complement system. CRP can be tested easily at low cost and is, therefore, often used to detect infectious complications after surgery. In colorectal surgery, it has been validated as a useful negative predictor test for septic complications, and cut-off values have been determined as guidance for additional diagnostic tests. CRP is used by most surgeons to detect postoperative complications after esophagectomy, but the literature on optimal cut-off values are retrospective with a small sample of patients. Identifying an optimal cut-off value for CRP for anastomotic leakage may contribute to earlier detection of a complicated postoperative course and can be used in ERAS protocols to guide the indication for additional investigations such as a CT scan or endoscopy.The primary aim of this study was to determine the accuracy and optimal cut-off values of CRP with regard to anastomotic leakage in esophageal cancer patients following minimally invasive esophagectomy. The secondary aims were to determine if there is an association between the level of CRP and the severity of anastomotic leakage and the correlation between the level of CRP and incidence of other complications.This prospective observational study was conducted in the Amsterdam UMC, location AMC, the Netherlands. According to national guidelines, this study was exempted from official institutional review board (IRB) approval. The IRB assessed the study design and protocol, and a waiver was obtained. Informed consent was obtained from all patients. The Standards for Reporting Diagnostic accuracy studies (STARD) guidelines were used to ensure the correct reporting of this diagnostic study.Consecutive patients with a histologically proven, resectable (cT0-4aN0-3M0) esophageal or gastroesophageal junction carcinoma in whom a minimally invasive esophagectomy with gastric conduit reconstruction was performed between April 2016 and October 2018 were included. Patients were excluded if a salvage esophagectomy was performed.Esophagectomy was performed by means of a minimally invasive, formation of a gastric conduit, and construction of an intrathoracic or cervical anastomosis. The indication for a cervical anastomosis depended on the location of the primary tumor ( mid-esophageal), the clinical presence of paratracheal lymph node metastases, and the proximal extension of the radiation field (with the aim of creating the anastomosis outside the radiation field). A two-field lymphadenectomy was performed (Stations 2 on indication, 4, 5, 7, 8, 9, and 1519 according to the AJCC 8th edition and lymph nodes in the hepatoduodenal ligament). Levels of CRP were measured on postoperative days 3, 5, and 7, according to local protocol. There may be reasons for deviating from this protocol, such as for clinical deterioration warranting determining of CRP on an earlier day or admittance to the ICU, where CRP was not routinely measured.The diagnosis of anastomotic leakage was made when a defect or leakage of oral contrast was seen on a CT scan or by endoscopy or if saliva was draining from the neck incision. Final confirmation of diagnosis was made with consensus by all upper GI surgeons (SSG, MvBH, and WJE). The day of diagnosis is defined as the day anastomotic leakage was confirmed on a CT scan, by endoscopy of saliva was draining from the neck incision. Definitions and grading of anastomotic leakage and other complications were done according to the EsophagealComplicationsConsensus Group(ECCG) classification. A type 1 leak was defined as a local defect requiring no change in therapy or treated medically or with dietary modification, a type 2 leak includes a localized defect requiring interventional but not surgical therapy, for example, interventional radiology drain, stent or bedside opening, and packing of incision,and a type 3 leak was defined as a localized defect requiring surgical therapy.Primary outcomes were the accuracy of CRP as a marker for anastomotic leakage and the optimal cut-off value of CRP to detect anastomotic leakage. Secondary study outcomes included the association between the severity (grade) of anastomotic leakage and the level of CRP, and the correlation between CRP and other complications.The aim was to include a minimal number of events (patients who develop anastomotic leakage after surgery) of 20 in this study, since this is a generally accepted number of events for the calculation of the diagnostic accuracy of a test. The incidence of anastomotic leakage in the literature varies from 3 to 25%. An incidence of 10% was used because the incidence of anastomotic leakage is around 10% in the study center. Based on these numbers, it was determined that at least 200 patients needed to be included in this study.Continuous variables with normal distributions are presented as means with standard deviations and were compared using independent t-test. Medians and interquartile ranges (IQR) were used as central tendency for continuous variables with non-normal distributions, these data were compared using the MannWhitney U-test. Categorical data were expressed with percentage frequencies and were compared using a Chi-square or Fishers exact test where appropriate. Difference in CRP levels between patients with and without complications was analyzed using the independent t-test. The diagnostic accuracy of CRP was assessed by receiver operator curve (ROC) analysis for CRP on postoperative days 3, 5, and 7. The area under the ROC (AUC) is a direct measure of the diagnostic accuracy of a test. An AUC value>0.50 indicates the ability of a test to significantly discriminate between positive and negative cases with regard to the classification variable (e.g., presence or absence of disease). Youdens index was adopted to determine the cut-off value in ROC analysis with highest sensitivity and specificity. Sensitivity, specificity, positive predictive value, and negative predictive value were calculated for these CRP cut-off values on postoperative days 3, 5, and 7. KruskalWallis test was used to compare CRP levels in patients with different types of severity of anastomotic leakage. A P-value<0.05 (two-sided tests) was considered significant. Missing data were handled with complete case analysis. Statistical analysis was performed with SPSS, version 24.0 for Windows (SPSS Inc., Chicago, IL).There were 200 patients included in this study. In 13 patients (6.5%), an open esophagectomy was performed, these patients were excluded from analyses. Baseline characteristics are shown in Table 1. With 20 patients developing anastomotic leakage, the incidence was 11%. More patients in the anastomotic leakage group had diabetes. Twenty-six percent of the patients (6 out of 23) with a cervical anastomosis developed anastomotic leakage, significantly higher than the 8.5% of the patients (14 out of 164) with anastomotic leakage with an intrathoracic anastomosis (p=0.011). Patients with anastomotic leakage were more often readmitted within 30days (p<0.001) and had a higher rate of in-hospital mortality (0 patients without anastomotic leakage died in-hospital and 2 out of 20 patients with anastomotic leakage died in-hospital, p=0.011). The postoperative day of diagnosis of anastomotic leakage ranged from 1 to 15days, with a median of 8days.CRP was measured in 174 patients on day 3, in 158 patients on day 5, and in 128 patients on day 7. The mean level of CRP for patients with and without anastomotic leakage was 206 and 141mg/L, respectively, on day 3 (p<0.001), 174 and 91mg/L on day 5 (p<0.001), and 166 and 86mg/L on day 7 (p<0.001). Figure1a shows the levels of CRP on postoperative days 3, 5, and 7 for patients with and without anastomotic leakage.Table 2 shows different cut-off values for CRP on postoperative days 3, 5, and 7, and corresponding AUC, sensitivity, specificity, positive predicting value, and negative predicting value. The level of CRP on postoperative day 5 has the highest accuracy to detect anastomotic leakage, with a sensitivity of 75%, specificity of 82%, negative predicting value of 97%, and positive predicting value of 32%. The optimal cut-off value for day 5 was 120mg/L.Although the median level of CRP in patients with a more severe grade of anastomotic leakage was higher, the severity of anastomotic leakage did not significantly correlate with the level of CRP (Table 3). There was also no significant difference between the level of CRP and grade of anastomotic leakage when comparing type 1 leakages with types 2 and 3 leakages together (the median levels of CRP for patients with a type 1 or type 2/3 leak were 144 and 204mg/L, p=0.159 on day 3; 72 and 160mg/L, p=0.101 on day 5; and 73 and 200mg/L, p=0.122 on day 7). Figure1b shows the level of CRP for the different types of anastomotic leakage.One hundred and nineteen patients (64%) had at least one postoperative complication, and 36 of these patients (30%) had a complication of ClavienDindo grade IIIB or higher. Fifty patients (27%) had a pulmonary complication, 56 (30%) had a cardiac complication, 23 patients (12%) had chyle leakage, 6 (3%) of the patients had a urologic complication, 5 patients (3%) had vocal cord paresis, and 31 patients (17%) had another complication.The mean level of CRP for patients with and without any complication was 164 and 121mg/L, respectively, on day 3 (p<0.001), 118and 71mg/L on day 5 (p<0.001), and 114 and 59mg/L on day 7 (p<0.001). Figure1c shows the mean level of CRP for patients with any complication or no complication. Table 2 shows the optimal cut-off values for CRP on postoperative days 3, 5, and 7, and corresponding AUC, sensitivity, specificity, positive predicting value, and negative predicting value for predicting any postoperative complication. The level of CRP on postoperative day 7 had the highest AUC (0.696), with an optimal cut-off value of 72mg/L.The primary aim of this prospective observational study was to determine the accuracy and optimal cut-off values of CRP to predict anastomotic leakage. We found that the optimal postoperative day to predict anastomotic leakage was day 5, with a cut-off value of 120mg/L. This resulted in an AUC of 0.825, sensitivity of 75%, specificity of 82%, and a positive predictive value and negative predictive value of 32 and 97%, respectively. This is one of the few studies reporting about the correlation between CRP and anastomotic leakage after minimally invasive esophageal surgery and determining an optimal cut-off value for CRP as guidance for further diagnostic tests.The level of CRP on postoperative day 5 had the highest accuracy to detect anastomotic leakage with an optimal cut-off value of 120mg/L. Most other studies also found postoperative day 5 the most accurate day to measure the level of CRP. Nonetheless, the cut-off value of 120mg/L is lower than in other studies where the cut-off levels range from 154 to 189mg/L. Authors of these studies used similar statistical techniques to determine the optimal cut-off value. Most of these studies, however, were retrospective in design and contained a small sample of patients, with a wider variety of surgical approaches. Only one study, by Asti et al., found a lower optimal cut-off value than the present study, this was a CRP level of 83mg/L. A reason for the low cut-off value of CRP in both cohorts could be that all patients were operated by minimally invasive approach. More invasive esophageal surgery, such as an open esophagectomy, is correlated with a higher level of CRP posteroperatively.The diagnostic accuracy of CRP on postoperative day 5 was high, with an AUC of 0.825. With a cut-off value of 120mg/L, specificity and negative predicting value were 82 and 97%, respectively, while sensitivity and positive predicting value were lower (75 and 32%). Other studies also found higher specificity and negative predicting values compared to sensitivity and positive predicting values. This indicates that CRP is a feasible marker to guide the use of additional investigations such as CT scanning to detect anastomotic leakage. In case of a low CRP, anastomotic leakage becomes very unlikely, and clinical observation can be continued.Although the CRP level was directly proportional with the severity of anastomotic leakage, this was not statistically significant. Due to the small number of patients in the different severity groups, there might have been insufficient power to reach significance. Another possibility could be that not the level of CRP itself, but the rapidity of rise in CRP could be an indicator for the severity of the leakage. An indicator to predict the severity of anastomotic leakage can be of clinical importance, as it could contribute to decision making in the management of leakage. Unfortunately, the number of patients was too small to look at the influence of difference of CRP level between days 3 and 5 on the severity on the leakage. Moreover, there is no available evidence to compare our results with.CRP is a marker of inflammation, and elevated levels of CRP can be caused by other inflammatory conditions, for example, pneumonia. CRP is not specific for anastomotic leakage, and other clinical symptoms should, therefore, be considered when evaluating CRP. This makes interpretation of accuracy parameters difficult to interpret. However, CRP can be used as a guide for the conditional use of postoperative CT scanning or endoscopy. In the present study, 40 patients had a CRP of 120mg/L or higher on day 5, but only 12 of these patients (30%) had anastomotic leakage. This suggests that 69% of the patients would have received unnecessary additional diagnostics. However, the majority of these patients had another complication that would have been likely to find on a CT scan. CRP is an unspecific marker, feasible to detect postoperative complications, including anastomotic leakage.Four out of 16 patients with anastomotic leakage (and measurement of CRP available on day 5) did not have a CRP higher than 120mg/L on day 5. It should be noted that in all of these patients, anastomotic leakage was detected on day 7 or later. It is possible that anastomotic leakage in these patients occurred later on than usual, and therefore, they did not have a CRP higher than 120mg/L on day 5. Despite the high NPV of 96% in patients with a CRP<120, additional CT scan should be performed in patients with (late) clinically suspected anastomotic leakage.A limitation of the present study was that only CRP levels of days 3, 5, and 7 were routinely measured. Levels on more postoperative days could have resulted in a cut-off value with higher diagnostic accuracy. Also, not in every patient CRP levels were available for days 3, 5, and 7 which might have caused bias. Moreover, determining only on days 357 may be insufficient for early detection of anastomotic leakage, as this may occur on the in-between days. Moreover, it would have been valuable to stratify our results for cervical and intrathoracic anastomosis, since cut-off levels might be different. Though there were only 14 patients in the group of patients with an intrathoracic anastomosis and six patients in the group of patients with a cervical anastomosis. Unfortunately, these numbers of events are too low to perform a reliable analysis on these subgroups.CRP can be a useful tool, but other symptoms such as fever can also indicate that there is an anastomotic leakage. Future studies should attempt to identify predictors for different types of anastomotic leakage and possibly stratify results for a cervical and intrathoracic anastomosis. Predicting anastomotic leakage might improve when other markers such as white blood cell count, temperature, or amylase level in drain fluid are also considered. A combination of different markers could contribute to a useful algorithm in the diagnosis and management of anastomotic leakage.CRP on postoperative day 5 can be used as a marker to raise suspicion of anastomotic leakage in patients following an esophagectomy for esophageal cancer, but can especially be used as a negative predictor. With a cut-off value of 120mg/L, a negative predicting value of 97% and specificity of 82% were found. When CRP exceeds 120mg/L on postoperative day 5, additional investigations should be considered.None.Van Berge Henegouwen reports to be a consultant for Johnson and Johnson, Medtronic, Stryker, and Mylan, in addition to institutional grants from Stryker and Olympus. The remaining have no conflict of interest to report. 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which was developed with the aim of providing reliable and reproducible anastomosis, provides complete anastomosis, resulting in a reduced risk of anastomotic leakage. The aim of this study was to compare the incidence of anastomotic leakage between a conventional manual circular stapler (MCS) and the ECHELON CIRCULAR Powered Stapler (ECPS) in patients with left-sided colorectal cancer who underwent anastomosis with the double stapling technique.",id:9,pmid:"PMC10354928",text:"The powered circular stapler, which was developed with the aim of providing reliable and reproducible anastomosis, provides complete anastomosis, resulting in a reduced risk of anastomotic leakage. The aim of this study was to compare the incidence of anastomotic leakage between a conventional manual circular stapler (MCS) and the ECHELON CIRCULAR Powered Stapler (ECPS) in patients with left-sided colorectal cancer who underwent anastomosis with the double stapling technique. Due to advances in surgical techniques and improvements in surgical devices, postoperative complications in digestive surgery have decreased. However, anastomotic leakage remains a serious complication in colorectal surgery and continues to be a concern for colorectal surgeons. Anastomotic leakage can worsen not only short-term outcomes, such as the rate of reoperation and duration of hospitalization but also oncological outcomes, such as the rate of recurrence and survival time. Furthermore, anastomotic leakage has a negative impact on economic outcomes.Intraoperative factors, such as intestinal perfusion, tension and incomplete anastomosis, have been reported to affect the incidence of anastomotic leakage, in addition to patient background factors, such as sex, body mass index (BMI), diabetes, tumor diameter, distance from anal verge, American Society of Anesthesiologists (ASA) physical status and neoadjuvant chemoradiotherapy. In addition to the reinforcement of anastomosis, such as additional sutures and the use of a polyglycolic acid (PGA) sheet, we focused on a powered circular stapler, the ECHELON CIRCULAR Powered Stapler (ECPS) (Ethicon, Somerville, NJ, USA), which was launched in Japan in 2020, as a measure against incomplete anastomosis. This powered circular stapler was developed with the aim of providing reliable and reproducible anastomosis. The use of this new device provides complete anastomosis, resulting in a reduced risk of anastomotic leakage.The aim of this study was to compare the incidence of anastomotic leakage between a conventional manual circular stapler (MCS) and the ECPS in patients with left-sided colorectal cancer who underwent anastomosis with the double stapling technique (DST).A total of 187 patients with left-sided colorectal cancer who underwent DST anastomosis with a conventional MCS, the ENDOPATH ENDOSCOPIC INTRALUMINAL STAPLER (Ethicon, Somerville, NJ, USA) or the ECPS during surgery at Osaka City University Hospital between January 2016 and July 2022 were enrolled in this study. An expert in colorectal surgery participated in all surgeries. There was no operator bias in the use of circular staplers. High ligation of the inferior mesenteric artery was performed in all cases. Indocyanine green fluorescence imaging was performed to evaluate blood perfusion in patients who underwent surgery after June 2017. Mobilization of the splenic flexure was performed when tension at the anastomotic site was noted. Reinforcement of anastomosis, such as additional sutures and/or a PGA sheet, was added according to the judgment of the surgeon.Anastomotic leakage was defined as the extravasation observed on radiologic examinations. Upon clinical symptoms that suggested anastomotic leakage, such as abdominal pain, high fever, pus or fecal discharge from the pelvic drain, or leukocytosis, computed tomography (CT) was performed to confirm the presence of anastomotic leakage. The following CT findings were considered suggestive of anastomotic leakage: abscess, fluid collection, or air bubbles surrounding the anastomotic site. Water-soluble contrast enema was also performed as needed to confirm the presence of communication between the intra- and extraluminal compartments.This retrospective study was approved by the Ethics Committee of Osaka City University (approval number: 4182) and was conducted in accordance with the Declaration of Helsinki. Written informed consent was obtained from all patients.All statistical analyses were performed using the SPSS software package for Windows (IBM, Chicago, IL, USA). The significance of differences according to the circular stapler that was used and the patients background/operative outcomes were analyzed using the chi-squared test, Fishers exact test, and the MannWhitney U test. A logistic regression model was used to evaluate the factors associated with anastomotic leakage. P values<0.05 were considered to indicate a statistically significant difference. To reduce the impact of selection bias and potential confounding, we performed propensity score matching. The propensity scores were estimated using multivariate logistic regression models, with the groups as the dependent variable and patient characteristics and operative outcomes as covariates. Matching was performed with a one-to-one greedy nearest neighbor algorithm with a caliper of 0.2 without replacement.The MCS was used in 119 cases (MCS group), and the ECPS was used in 68 cases (ECPS group). Associations between the type of circular stapler and the patients characteristics/operative outcomes are summarized in Table1. The ECPS was significantly associated with nonsmokers, lower BMI, a higher proportion of robot-associated surgery and smaller circular staplers and tended to be associated with lower rectal cancer. Associations between the type of circular stapler and postoperative complications are summarized in Table2. The incidence of anastomotic leakage in the ECPS group was significantly lower than that in the MCS group (4.4% versus 14.3%, p=0.048). The reoperation rate in the ECPS group was lower than that in the MCS group (1.5% versus 2.5%, p>0.999); however, the difference did not reach statistical significance due to the extremely small number of events. No patients with anastomotic bleeding were observed in the ECPS or MCS group. The associations between anastomotic leakage and various factors are shown in Table3. According to a univariate analysis, anastomotic leakage showed significant associations with male sex, large tumor, absence of diverting ileostomy, long operation time, and manual circular stapler. Furthermore, even after propensity score matching using the three covariates of BMI, tumor location, and smoking, which have been reported to affect anastomotic leakage and which showed significant differences in patient backgrounds, the ECPS remained associated with a reduced incidence of anastomotic leakage.This study demonstrated that the use of the ECPS reduces the rate of anastomotic leakage in left-sided colorectal surgery, as demonstrated in previous reports. To our knowledge, this is the first report from Asia to evaluate the usefulness of the ECPS for the prevention of anastomotic leakage in colorectal surgery. In this study, the ECPS group had some adverse conditions (e.g., lower anastomosis) in comparison to the MCS group. Nevertheless, the outcomes in the ECPS group were better than those in the MCS group. Furthermore, even after propensity score matching, an association was found between the use of the ECPS and a reduced incidence of anastomotic leakage. These results strongly support the usefulness of the ECPS.The introduction of the circular stapler in colorectal surgery has greatly contributed not only to shortening the operation time but also to the establishment of stable procedures that are not affected by the skill of the surgeon and to the improvement of clinical outcomes. In addition to various past improvements in circular stapler technology, the ECPS was developed based on the concept of increased strength at the anastomotic site, a gentler approach to the tissue, minimization of variation in usage and standardization of performance across users. The details of the improvements are as follows.First, the powered stapling system, which is operated by electricity, was introduced. Since MCS requires a strong force to fire, movement at the distal tip becomes large when using MCS, especially when performed by a surgeon with small hands or insufficient grip strength. Therefore, MCS may cause suboptimal tension on the tissue at the anastomotic site, which may cause microtissue damage, leading to anastomotic trouble. On the other hand, the ECPS requires less force to fire. Therefore, movement at the distal tip can be reduced, resulting in a reduction in suboptimal tissue tension at the anastomotic site and providing more stable stapler positioning and staple line formation.Second, 3D stapling technology has been newly introduced. Although the staple array of the ECPS is 2 rows, the same as the MCS, the area covered by one staple of the ECPS is increased in comparison to the MCS due to the use of a 3D staple shape that compresses the tissue widely and sterically. As a result, the physical pressure resistance increases in comparison to the MCS. Although it is unclear whether there is a direct correlation between physical pressure resistance and the rate of anastomotic leakage, it is an undeniable fact that the use of the ECPS dramatically reduced the rate of anastomotic leakage in several previous reports. Furthermore, it has been reported that improved staple formation contributes to the prevention of bleeding at the anastomotic site as well as anastomotic leakage.Third, Gripping Surface Technology (GST), which provides gentler handling with precise compression only where it is needed, has also been introduced. This improvement minimizes tissue damage, resulting in a 33% reduction in compressive force on tissue.As described above, the ECPS has been improved in various points in comparison to the MCS. Nevertheless, the increase in selling price is set to be mild. Thus, the ECPS may account for most of the circular stapler market share in the near future.In this study, small-diameter circular staplers were more frequently used in the ECPS group than in the MCS group. The reason for this is the recent increase in the use of smaller-sized circular staplers, based on the hypothesis that the use of circular staplers of smaller diameter may reduce the overstretching of tissue, resulting in less anastomotic trouble. However, the size of the circular stapler was not associated with the incidence of anastomotic leakage, as documented in a previous report.In the current study, anastomotic leakage was observed in three patients in the ECPS group. All three patients had lower anastomosis and required a long operation time of 9h. In addition, the tumor diameter was 7cm in 2 of these 3 cases. Given these facts, there may have been invisible damage to the intestinal tract in these three patients who developed anastomotic leakage.The present study is associated with several limitations. First, this was a retrospective study with a small cohort in a single center. Based on previous reports on medical statistics, we abandoned the multivariate analysis with a Cox proportional hazards model for anastomotic leakage due to an insufficient total number of events. Instead, propensity score matching was performed to reduce the impact of selection bias and potential confounding factors. However, due to the small number of cases, the relationship between the reduced incidence of anastomotic leakage and the use of the ECPS showed a trend but did not reach statistical significance. Large prospective studies should be performed to confirm our findings. Second, additional reinforcement may have the potential to have some impact on the rate of anastomotic leakage, although there was no statistically significant correlation in this study because additional reinforcement tended to be omitted in patients with a low risk of anastomotic leakage. Third, the ECPS, which was launched in recent years, was more frequently used in robot-assisted surgery in comparison to the MCS due to historical backdrop. However, it has been reported that robot-assisted surgery and laparoscopic surgery are comparable in terms of postoperative complications.In conclusion, the ECPS has the potential to help reduce the rate of anastomotic leakage in left-sided colorectal surgery.MS designed the study, performed the statistical analysis and draft the manuscript. TF, YI, HK and KK collected the clinical data and revised the manuscript critically. KM designed the study and critically reviewed the manuscript. All authors read and approved the final manuscript.No funding was acquired for this study.The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request.This research conformed to the provisions of the Declaration of Helsinki. Written informed consent was obtained from all participants. This retrospective study was approved by the Ethics Committee of Osaka City University (approval number: 4182).Not applicable.The authors declare that they have no competing interests.BMIbody mass indexASAAmerican Society of AnesthesiologistsPGApolyglycolic acidECPSECHELON CIRCULAR Powered StaplerMCSmanual circular staplerDSTdouble-stapling techniqueCTcomputed tomographyN/Anot applicable",title:"Impact of a circular powered stapler on preventing anastomotic leakage in patients with left-sided colorectal cancer: a retrospective 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