Randomized clinical trial of biodegradeable intraluminal sheath to prevent anastomotic leak after stapled colorectal anastomosis. Issue 8 (10th May 2017)

• Record Type: Journal Article
• 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; Bakker, I S; Morks, A N; ten Cate Hoedemaker, H O; Leuvenink, H G; Ploeg, R J; Havenga, K; van Etten, B; Lange, J F M; Hemmer, P H J; Burgerhof, J G M; 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; van der Mijle, H C; Hoff, C; de Vries, D P; Logeman, F; Sietses, C; Lesanka Versluijs-Ossewaarde, F N; Leijtens, J W; Tobon Morales, R E; Neijenhuis, P A; Kloppenberg, F W; Schasfoort, R; Bleeker, W A; Hess, D; Rosman, C; Wit, F; Ton van Engelenburg, K C; Pronk, A; Bonsing, B A; Dekker, J W; Consten, E C; Patijn, G A; Bogdan Rajcs, S; Csapó, Z; Bálint, A; Harsányi, L; István, G; Horisberger, K; Bader, F; Kutup, A; Mariette, C; Cebrián, F;
• Is Part Of: British journal of surgery. Volume 104:Issue 8(2017)
• Page Start: 1010
• Page End: 1019
• Publication Date: 2017-05-10
• Subjects: Surgery -- Periodicals; 617.005
• DOI: 10.1002/bjs.10534
• Languages: English
• ISSNs: 0007-1323

Abstract

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 (http://www.trialregister.nl/trialreg/index.asp ). Abstract : Not effective