Randomized clinical trial of biodegradeable intraluminal sheath to prevent anastomotic leak after stapled colorectal anastomosis

Background: Anastomotic leakage is a potential major complication after colorectal surgery. The C-seal was developed to help reduce the clinical leakage rate. It is an intraluminal sheath that is stapled proximal to a colorectal anastomosis, covering it intraluminally and thus preventing intestinal leakage in case of anastomotic dehiscence. The C-seal trial was initiated to evaluate the efficacy of the C-seal in reducing anastomotic leakage in stapled colorectal anastomoses. Methods: This RCT was performed in 41 hospitals in the Netherlands, Germany, France, Hungary and Spain. Patients undergoing elective surgery with a stapled colorectal anastomosis less than 15 cmfrom the anal verge were eligible. Included patients were randomized to the C-seal and control groups, stratified for centre, anastomotic height and intention to create a defunctioning stoma. Primary outcome was anastomotic leakage requiring invasive treatment. Results: Between December 2011 and December 2013, 402 patients were included in the trial, 202 in the C-seal group and 200 in the control group. Anastomotic leakage was diagnosed in 31 patients (7.7 per cent), with a 10.4 per cent leak rate in the C-seal group and 5.0 per cent in the control group (P = 0.060). Male sex showed a trend towards a higher leak rate (P = 0.055). Construction of a defunctioning stoma led to a lower leakage rate, although this was not significant (P = 0.095). Conclusion: C-seal application in stapled colorectal anastomoses does not reduce anastomotic leakage. Registration number: NTR3080 (http://www.trialregister.nl/trialreg/index.asp). *Other members of the Collaborative C-seal Study Group are co-authors of this study and can be found under the heading Collaborators Presented in part to Chirurgendagen 2015 (Dutch Congress of Surgery), Veldhoven, The Netherlands, May 2015, and to the 36th Congress of the European Society of Surgical Oncology (ESSO 2016), Krakow, Poland, September 201