Randomized clinical trial of biodegradeable intraluminal sheath to prevent anastomotic leak after stapled colorectal anastomosis. BJS 2017; 104: 1010-1019.
Published: 10th May 2017
Authors: I. S. Bakker, A. N. Morks, H. O. ten Cate Hoedemaker, J. G. M. Burgerhof, H. G. Leuvenink, J. B. van Praagh et al.
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.
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 (
C‐seal application in stapled colorectal anastomoses does not reduce anastomotic leakage. Registration number:
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