The C-seal trial: colorectal anastomosis protected by a biodegradable drain fixed to the anastomosis by a circular stapler, a multi-center randomized controlled trialBakker, I. S., Morks, A. N., Hoedemaker, H. O. T. C., Burgerhof, J. G. M., Leuvenink, H. G., Ploeg, R. J. & Havenga, K., 15-Nov-2012, In : BMC Surgery. 12, 5 p., 23.
Research output: Contribution to journal › Article › Academic › peer-review
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
|Number of pages||5|
|Publication status||Published - 15-Nov-2012|
- LOW ANTERIOR RESECTION, RECTAL-CANCER, MESORECTAL EXCISION, DEFUNCTIONING STOMA, BLOOD-FLOW, LEAKAGE, SURGERY, DEVICE, RISK