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      Clinical impact of the triple‐layered circular stapler for reducing the anastomotic leakage in rectal cancer surgery: Porcine model and multicenter retrospective cohort analysis

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          Abstract

          Aim

          To investigate the impact of the triple‐layered circular stapler compared with the double‐layered circular stapler on anastomotic leakage after rectal cancer surgery.

          Methods

          The bursting pressure was compared between porcine ileocolic anastomoses created using a double‐ or triple‐layered stapler. We also retrospectively analyzed the incidence of severe anastomotic leakage in 194 patients who underwent colorectal anastomosis using a double‐ or triple‐layered circular stapler during rectal cancer resection performed in two cancer centers between January 2015 and April 2021.

          Results

          In the porcine model, the bursting pressure was higher in anastomoses created using the triple‐layered stapler than the double‐layered stapler (end‐to‐end anastomosis: 26.4 ± 6.2 mm Hg vs 14.5 ± 4.3 mm Hg, P = .0031; side‐to‐side anastomosis: 27.7 ± 5.0 mm Hg vs 18.0 ± 2.9 mm Hg, P = .0275). Intersectional leakage occurred in 41% and 83% of anastomoses created using the triple‐ or double‐layered stapler, respectively ( P = .0821). In the clinical cohort, the double‐ and triple‐layered stapler was used in 153 and 41 patients, respectively. The incidence of anastomotic leakage was lower for anastomoses created using the triple‐layered stapler vs the double‐layered stapler (0.0% vs 5.8%, P = .0362). In multivariate analysis, the factors independently associated with a lower incidence of anastomotic leakage were female sex (odds ratio: 0.16, 95% confidence interval: 0.01‐0.90, P = .0354) and triple‐layered stapler usage (odds ratio: 0.00, 95% confidence interval: 0.00‐0.96, P = .0465).

          Conclusion

          Anastomoses created using a triple‐layered circular stapler had high bursting pressure, which might contribute to a lower incidence of anastomotic leakage after rectal cancer surgery.

          Abstract

          In the porcine model, anastomoses created using the triple‐layered circular stapler had higher bursting pressure than the double‐layered stapler. Furthermore, in the multicenter clinical cohort, the use of the triple‐layered circular stapler was independently associated with the absence of anastomotic leakage.

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          Most cited references34

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          Definition and grading of anastomotic leakage following anterior resection of the rectum: a proposal by the International Study Group of Rectal Cancer.

          Anastomotic leakage represents a major complication after anterior resection of the rectum. The incidence of anastomotic leakage varies considerably among clinical studies in part owing to the lack of a standardized definition of this complication. The aim of the present article was to propose a definition and severity grading of anastomotic leakage after anterior rectal resection. After a literature review a consensus definition and severity grading of anastomotic leakage was developed within the International Study Group of Rectal Cancer. Anastomotic leakage should be defined as a defect of the intestinal wall at the anastomotic site (including suture and staple lines of neorectal reservoirs) leading to a communication between the intra- and extraluminal compartments. Severity of anastomotic leakage should be graded according to the impact on clinical management. Grade A anastomotic leakage results in no change in patients' management, whereas grade B leakage requires active therapeutic intervention but is manageable without re-laparotomy. Grade C anastomotic leakage requires re-laparotomy. The proposed definition and clinical grading is applicable easily in the setting of clinical studies. It should be applied in future reports to facilitate valid comparison of the results of different studies. Copyright 2010 Mosby, Inc. All rights reserved.
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            Postoperative complications following surgery for rectal cancer.

            This systematic review was designed to determine postoperative complication rates of radical surgery for rectal cancer (abdominal perineal resection and anterior resection). Lack of accepted complication rates for rectal cancer surgery may hinder quality improvement efforts and may impede the conception of future studies because of uncertainty regarding the expected event rates. All prospective studies of rectal cancer receiving radical surgery published between 1990 and August 2008 were obtained by searching Ovid MEDLINE, EMBASE, as well as ASCO GI, CAGS, and ASCRS meeting abstracts between 2004 and 2008. There was no language restriction. The outcomes extracted were anastomotic leak, pelvic sepsis, postoperative death, wound infection, and fecal incontinence. Summary complication rates were obtained using a random effects model; the Z-test was used to test for study heterogeneity. Fifty-three prospective cohort studies and 45 randomized controlled studies with 36,315 patients (24,845 patients had an anastomosis) were eligible for inclusion. Most of the studies found were based in continental Europe (58%), followed by Asia (25%), United Kingdom (10%), North America (5%), and Australia/New Zealand. The anastomotic leak rate, reported in 84 studies, was 11% (95% CI: 10, 12); the pelvic sepsis rate, in 29 studies, was 12% (9, 16); the postoperative death rate, in 75 studies, was 2% (2, 3); and the wound infection rate, in 50 studies, was 7% (5, 8). Fecal incontinence rates were reported in too few studies and so heterogeneously that numerical summarization was inappropriate. Year of publication, use of preoperative radiation, use of laparoscopy, and use of protecting stoma were not significant variables, but average age, median tumor height, and method of detection (clinical vs. radiologic) showed significance to explain heterogeneity in anastomotic leak rates. Year of publication, study origin, average age, and use of laparoscopy were significant, but median tumor height and preoperative radiation use were not significant in explaining heterogeneity among observed postoperative death rates. With multivariable analysis, only average age for anastomotic leak and year of publication for postoperative death remained significant. Benchmark complication rates for radical rectal cancer surgery were obtained for use in sample size calculations in future studies and for quality control purposes. Postoperative death rates showed improvement in recent years.
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              Risk factors for anastomotic leakage after resection of rectal cancer.

              The most important surgical complication following rectal resection with anastomosis is symptomatic anastomotic leakage, which is associated with a 6-22 per cent mortality rate. The aim of this retrospective study was to evaluate the risk factors for clinical anastomotic leakage after anterior resection for cancer of the rectum. From 1980 to 1995, 272 consecutive anterior resections for rectal cancer were performed by the same surgical team; 131 anastomoses were situated 5 cm or less from the anal verge. The associations between clinical anastomotic leakage and 19 patient-, tumour-, surgical-, and treatment-related variables were studied by univariate and multivariate analysis. The rate of clinical anastomotic leakage was 12 per cent (32 of 272). Multivariate analysis of the overall population showed that only male sex and level of anastomosis were independent factors for development of anastomotic leakage. The risk of leakage was 6.5 times higher for anastomoses situated less than 5 cm from the anal verge than for those situated above 5 cm; it was 2.7 times higher for men than for women. In a second analysis of low anastomoses (5 cm or less from the anal verge; n = 131), obesity was statistically associated with leakage. A protective stoma is suitable after sphincter-saving resection for rectal cancer for anastomoses situated at or less than 5 cm from the anal verge, particularly for men and obese patients.
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                Author and article information

                Contributors
                nakanishi.ryota.415@m.kyushu-u.ac.jp
                Journal
                Ann Gastroenterol Surg
                Ann Gastroenterol Surg
                10.1002/(ISSN)2475-0328
                AGS3
                Annals of Gastroenterological Surgery
                John Wiley and Sons Inc. (Hoboken )
                2475-0328
                07 October 2021
                March 2022
                : 6
                : 2 ( doiID: 10.1002/ags3.v6.2 )
                : 256-264
                Affiliations
                [ 1 ] Department of Surgery and Science Graduate School of Medical Sciences Kyushu University Fukuoka Japan
                [ 2 ] Department of Gastroenterological Surgery National Hospital Organization Kyushu Cancer Center Fukuoka Japan
                Author notes
                [*] [* ] Correspondence

                Ryota Nakanishi, Department of Surgery and Science, Graduate School of Medical Sciences, Kyushu University, Maidashi 3‐1‐1, Higashi‐ku, Fukuoka, 812‐8582, Japan.

                Email: naka12030930@ 123456gmail.com

                Author information
                https://orcid.org/0000-0001-9526-9501
                https://orcid.org/0000-0002-4497-1816
                Article
                AGS312516
                10.1002/ags3.12516
                8889859
                35261951
                b5ede3f7-02ac-4e49-bbb9-ca3ff6098084
                © 2021 The Authors. Annals of Gastroenterological Surgery published by John Wiley & Sons Australia, Ltd on behalf of The Japanese Society of Gastroenterology

                This is an open access article under the terms of the http://creativecommons.org/licenses/by/4.0/ License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited.

                History
                : 13 September 2021
                : 26 July 2021
                : 26 September 2021
                Page count
                Figures: 2, Tables: 4, Pages: 9, Words: 6873
                Categories
                Original Article
                Original Articles
                Custom metadata
                2.0
                March 2022
                Converter:WILEY_ML3GV2_TO_JATSPMC version:6.1.2 mode:remove_FC converted:02.03.2022

                anastomotic leak,colorectal surgery,postoperative complications,rectal neoplasms,surgical instruments

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