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Open Access Study protocol

The C-seal trial: colorectal anastomosis protected by a biodegradable drain fixed to the anastomosis by a circular stapler, a multi-center randomized controlled trial

Ilsalien S Bakker1*, Annelien N Morks2, Henk O ten Cate Hoedemaker1, Johannes G M Burgerhof3, Henri G Leuvenink1, Rutger J Ploeg4 and Klaas Havenga1

Author Affiliations

1 Department of Surgery, University Medical Center Groningen, Groningen, the Netherlands

2 Department of Surgery, Medical Center Leeuwarden, Leeuwarden, the Netherlands

3 Department of Epidemiology, University Medical Center Groningen, Groningen, the Netherlands

4 Nuffield Department of Surgical Sciences, University of Oxford, Oxford, United Kingdom

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BMC Surgery 2012, 12:23  doi:10.1186/1471-2482-12-23

Published: 15 November 2012

Abstract

Background

Anastomotic leakage is a major complication in colorectal surgery and with an incidence of 11% the most common cause of morbidity and mortality. In order to reduce the incidence of anastomotic leakage the C-seal is developed. This intraluminal biodegradable drain is stapled to the anastomosis with a circular stapler and prevents extravasation of intracolonic content in case of an anastomotic dehiscence.

The aim of this study is to evaluate the efficacy of the C-seal in reducing anastomotic leakage in stapled colorectal anastomoses, as assessed by anastomotic leakage leading to invasive treatment within 30 days postoperative.

Methods

The C-seal trial is a prospective multi-center randomized controlled trial with primary endpoint, anastomotic leakage leading to re-intervention within 30 days after operation. In this trial 616 patients will be randomized to the C-seal or control group (1:1), stratified by center, anastomotic height (proximal or distal of peritoneal reflection) and the intention to create a temporary deviating ostomy. Interim analyses are planned after 50% and 75% of patient inclusion. Eligible patients are at least 18 years of age, have any colorectal disease requiring a colorectal anastomosis to be made with a circular stapler in an elective setting, with an ASA-classification < 4. Oral mechanical bowel preparation is mandatory and patients with signs of peritonitis are excluded. The C-seal student team will perform the randomization procedure, supports the operating surgeon during the C-seal application and achieves the monitoring of the trial. Patients are followed for one year after randomization en will be analyzed on an intention to treat basis.

Discussion

This Randomized Clinical trial is designed to evaluate the effectiveness of the C-seal in preventing clinical anastomotic leakage.

Trial registration

NTR3080