The C-Seal Trial
Research type
Research Study
Full title
Colorectal anastamosis protected by a biodegradable drain fixed to the anastomosis by a circular stapler
IRAS ID
123159
Contact name
Andrew Mark Gudgeon
Contact email
Sponsor organisation
University Medical Center Groningen, Netherlands
Research summary
Approximately one in ten patients undergoing colorectal resection of the bowel (surgical removal of diseased section and re-joining the remaining ends) may suffer serious and potentially fatal complications of infection as a result of leakage of faecal contents from the newly sutured (stitched) or stapled join before it has time to heal properly. This joint is called the anastomosis.
A new device has been developed by the Department of Surgery at the University Medical Centre, Groningen in the Netherlands, which is aimed at protecting the colorectal anastomosis and lowering the incidence of leakage. The ' C-SEAL®' is a thin, soft biofragmentable polyurethane tube, which lines the inside of the rectum and covers the anastomosis. It allows faecal contents to pass through the tube like a ‘drain’ and prevents leakage of faeces through any gaps into the peritoneal cavity before it breaks down as is passed out with the faeces 2 – 4 weeks postoperatively.
Two small studies in the Netherlands have shown that the C-SEAL® can be successfully applied in colorectal surgery, being easily attached with the same instrument used to cut and join the two ends. Clinical outcome seen in these trial patients suggests that it may also be effective in reducing the number of complications from leakage. It has already been ‘CE-marked’ for use throughout the EU but its true effectiveness needs to be established, statistically, in a large number of patients.
This international trial will evaluate the efficacy and safety of the C-SEAL® in reducing leakage from the anastomosis by comparing outcome in 616 patients with and without the C-Seal, principally in terms of numbers of patients requiring further intervention and invasive treatment because of leakage and infection during the usual post-operative care over one year.
REC name
London - Dulwich Research Ethics Committee
REC reference
13/LO/0471
Date of REC Opinion
21 May 2013
REC opinion
Further Information Favourable Opinion