Colorectal anastomosis protected by a biodegradable drain fixed to the anastomosis by a circular stapler: a randomised, controlled, multicenter trial.
Not Applicable
- Conditions
- Anastomotic Leakage after colorectal surgery
- Registration Number
- DRKS00005123
- Lead Sponsor
- niversity Medical Center GroningenDepartment of Abdominal Surgery
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting stopped after recruiting started
- Sex
- All
- Target Recruitment
- 542
Inclusion Criteria
The patient will receive a colorectal anastomosis by means of stapling
- Elective surgery
- Age: 18 or older
- American Society of Anesthesiologist (ASA) classification 1,2 or 3
- The patient did receive preoperative oral mechanical bowel preparation
Exclusion Criteria
- There are clinical signs of peritonitis
- The patient underwent major surgical or interventional procedures in the last 30 days prior to this study or surgical or interventional procedures are planned within 30 days of entry in this study
- There are psychological, familial, sociological conditions which could hampering compliance with the study protocol or follow-up schedule
- Patient is randomized in this trial before
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary outcome is the incidence of anastomotic leakage leading to invasive treatment within 30 days after the primary operation.
- Secondary Outcome Measures
Name Time Method Secondary Outcomes:<br>- Number of dismantled anastomoses<br>- Grade A, B or C Anastomotic Leakage<br>- Interval between the primary operation and the diagnosis of Anastomotic Leakage<br>- Pain Score at day 3 postoperatively on a visual analogue scale<br>- Number of ostomies created<br>- Late anastomotic leakage (diagnosed 30 days after the primary operation)<br>- Number of ostomies present after one year<br>- Total duration of hospital stay including readmissions for (serious) adverse events and/or stoma closure<br>- Interval between the primary operation and the excretion of the C-Seal through the anus<br>- Other complications