Randomized clinical trial of biodegradeable intraluminal sheath to prevent anastomotic leak after stapled colorectal anastomosis (original) (raw)
Related papers
2013
Purpose The present study was performed to get a better insight in the incidence of anastomotic leakage leading to reintervention when using the C-seal: a biodegradable sheath that protects the stapled colorectal anastomosis from leakage. Methods The C-seal is a thin walled tube-like sheath that forms a protective sheath within the bowel lumen. Thirtyseven patients undergoing surgery with creation of a stapled colorectal anastomosis with C-seal were analyzed. Followup was completed until 3 months after surgery. Results One patient (3 %) developed anastomotic leakage leading to reintervention. None of the 37 anastomoses was dismantled. One patient was diagnosed with a rectovaginal fistula. In three patients (8 %), a perianastomotic abscess spontaneously drained. Conclusion The incidence of anastomotic leakage leading to reintervention when using the C-seal (3 %) is lower than expected based on the literature (11 %). We have currently set-up a multicenter randomized trial to confirm the efficiency of the C-seal (www.csealtrial.nl).
How to Prevent Anastomotic Leak in Colorectal Surgery? A Systematic Review
Annals of Coloproctology
Anastomosis leakage (AL) after colorectal surgery is an embarrassing problem. It is associated with poor consequence. This review aims to summarize published evidence on prevention of AL after colorectal surgery and provide recommendations according to the Oxford Centre for Evidence-Based Medicine. We conducted bibliographic research on January 15, 2020, of PubMed, Cochrane Library, Embase, Scopus, and Google Scholar. We retained meta-analysis, reviews, and randomized clinical trials. We concluded that mechanical bowel preparation did not reduce AL. It seems that oral antibiotic or oral antibiotic with mechanical bowel preparation could reduce the risk of AL. The surgical approach did not affect the AL rate. The low ligation of the inferior mesenteric artery could reduce the AL rate. The mechanical anastomosis is superior to handsewn anastomosis only in case of right colectomies, with similar results in rectal surgery between the 2 anastomosis techniques. In the case of right colect...
Can intraluminal devices prevent or reduce colorectal anastomotic leakage: A review
World Journal of Gastroenterology, 2011
Colorectal anastomotic leakage is a serious complication of colorectal surgery, leading to high morbidity and mortality rates. In recent decades, many strategies aimed at lowering the incidence of anastomotic leakage have been examined. The focus of this review will be on mechanical aids protecting the colonic anastomosis against leakage. A literature search was performed using MEDLINE, EMBASE, and The Cochrane Collaborative library for all papers related to prevention of anastomotic leakage by placement of a device in the colon. Devices were categorised as decompression devices, intracolonic devices, and biodegradable devices. A decompression device functions by keeping the anal sphincter open, thereby lowering the intraluminal pressure and lowering the pressure on the anastomosis. Intracolonic devices do not prevent the formation of dehiscence. However, they prevent the faecal load from contacting the anastomotic site, thereby preventing leakage of faeces into the peritoneal cavity. Many attempts have been made to find a device that decreases the incidence of AL; however, to date, none of the devices have been widely accepted.
Journal of the American College of Surgeons, 2009
BACKGROUND: Laparoscopic rectal transection carries the risk of anastomotic leakage because of its technical difficulty and long staple line with an inadequate cutting angle. Our objective was to investigate the risk factors affecting anastomotic leakage after laparoscopic intracorporeal colorectal anastomosis with a double stapling technique. STUDY DESIGN: Between November 2006 and September 2008, 270 consecutive patients underwent laparoscopic sigmoidectomy and anterior resection with double stapling technique for distal sigmoid and rectal cancer. Data were collected prospectively. Univariate and multivariate analyses were performed to determine risk factors for anastomotic leakage. Additionally, we evaluated the relationship between the number of stapler firings and clinical parameters. RESULTS: Anastomotic leakage was noted in 17 (6.3%) of 270 patients. In univariate analyses, tumor location (p ϭ 0.021), operation time (p ϭ 0.025), number of stapler firings (p ϭ 0.040), and diameter of the circular stapler (p ϭ 0.022) were significant risk factors for anastomotic leakage. Multivariate analyses showed that middle or lower rectal cancer was an independent factor affecting anastomotic leakage (p ϭ 0.013). The number of stapler firings increased significantly in men (p ϭ 0.023), in patients with a tumor at a lower level (p ϭ 0.034), and in those with longer operation times (p Ͻ 0.001). CONCLUSIONS: A reduction in the number of linear stapler firings is necessary to avoid anastomotic leakage after laparoscopic colorectal anastomosis with a double stapling technique. We recommend that a diverting ileostomy is mandatory in patients with middle and lower rectal cancer where multiple linear staplers were used.
Colorectal disease : the official journal of the Association of Coloproctology of Great Britain and Ireland, 2014
Preclinical studies have suggested that the Nitinol-based compression anastomosis might be a viable solution. A prospective multicentre open label study was designed to evaluate the performance of the ColonRing(™) in (low) colorectal anastomosis. The primary outcome measure was anastomotic leakage. Patients were recruited at 13 different colorectal surgical units in Europe, the United States and Israel. Institutional review board (IRB) approval was obtained. Between March 21 2010 and August 3 2011, 266 patients completed the study protocol,. The overall anastomotic leakage rate was 5.3% for all anastomoses, including a rate of 3.1% for low anastomoses. Overall septic anastomotic complications occurred in 8.3% and 8.2%. The Nitinol compression anastomosis is safe, effective, and easy to use and may offer an advantage for low colorectal anastomosis. A prospective randomized trial comparing ColonRing(™) with conventional stapling is needed. This article is protected by copyright. All r...
Surgical Endoscopy, 2009
Background Anastomotic leakage is a feared complication following colorectal surgery and is associated with early and long-term morbidity and mortality. The presacral cavity as the result of leakage can be treated with an endosponge (B-Braun Medical). The aim of this study was to assess the effectiveness of endo-sponge treatment of the presacral cavity as the result of anastomotic leakage in the Netherlands. Methods Between July 2006 and April 2008, 16 patients (M/F = 9:7) with median age 64 years (range 19-78 years) who underwent surgery for rectal cancer (n = 13) or ulcerative colitis (n = 3) were treated with the endo-sponge treatment after anastomotic leakage.
How to reduce anastomotic leakage in colorectal surgery—report from German expert meeting
Langenbeck's Archives of Surgery, 2020
Aims Anastomotic leakage is one of the most worrisome complications in colorectal surgery. An expert meeting was organized to discuss and find a consensus on various aspects of the surgical management of colorectal disease with a possible impact on anastomotic leakage. Methods A three-step Delphi-method was used to find consensus recommendations. Results Strong consensus was achieved for the use of mechanical bowel preparation and oral antibiotics prior to colorectal resections, the abundance of non-selective NSAIDs, the preoperative treatment of severe iron deficiency anemia, and for attempting to improve the patients' general performance in the case of frailty. Concerning technical aspects of rectal resection, there was a strong consensus in regard to routinely mobilizing the splenic flexure, to dividing the inferior mesenteric vein, and to using air leak tests to check anastomotic integrity. There was also a strong consensus on not to oversew the stapled anastomoses routinely, to use protective ileostomies for low rectal and intersphincteric, but not for high-rectal anastomoses. Furthermore, a consensus was reached in regard to using CT-scans with rectal contrast enema to evaluate suspected anastomotic leakage as well as measuring C-reactive protein routinely to monitor the postoperative course after colorectal resections. No consensus was found concerning the indication and technique for testing bowel perfusion, the routine use of endoscopy to check the integrity of the anastomosis, the placement of transanal drains for rectal anastomoses and the management of anastomotic leakage with peritonitis. Conclusion Consensus could be found for several practice details in the perioperative management in colorectal surgery that might have an influence on anastomotic leakage. Keywords Delphi method. Consensus conference. Anastomotic failure. Leak rate Anastomotic leakage (AL) is still one of the most worrisome complications in colorectal surgery with an incidence of up to