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. Bakker*, Annelien N. Morks, Henk O. ten Cate Hoedemaker, Johannes G. M. Burgerhof, Henri G. Leuvenink, Rutger J. Ploeg, Klaas Havenga

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review

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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 multicenter randomized controlled trial with primary endpoint, anastomotic leakage leading to reintervention 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

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

Trial registration: NTR3080

Original languageEnglish
Article number23
Number of pages5
JournalBMC Surgery
Volume12
DOIs
Publication statusPublished - 15-Nov-2012

Keywords

  • LOW ANTERIOR RESECTION
  • RECTAL-CANCER
  • MESORECTAL EXCISION
  • DEFUNCTIONING STOMA
  • BLOOD-FLOW
  • LEAKAGE
  • SURGERY
  • DEVICE
  • RISK

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