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- Title
Randomized clinical trial of biodegradeable intraluminal sheath to prevent anastomotic leak after stapled colorectal anastomosis.
- Authors
Bakker, I. S.; Morks, A. N.; ten Cate Hoedemaker, H. O.; Burgerhof, J. G. M.; Leuvenink, H. G.; van Praagh, J. B.; Ploeg, R. J.; Havenga, K.; van Etten, B.; Lange, J. F. M.; Hemmer, P. H. J.; Sonneveld, D. J. A.; Tanis, P. J.; Wegdam, J. A.; Jonk, A.; Lutke Holzik, M. F.; Bosker, R. J. I.; Lamme, B.; Spillenaar Bilgen, E. J.; Bremers, A. J.
- Abstract
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 cm from 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 ().
- Subjects
INTRAVASCULAR ultrasonography; SURGICAL anastomosis; PROCTOLOGY; SURGICAL wound dehiscence; ELECTIVE surgery
- Publication
British Journal of Surgery, 2017, Vol 104, Issue 8, p1010
- ISSN
0007-1323
- Publication type
Article
- DOI
10.1002/bjs.10534