The C-Seal study: Colorectal anastomosis protected by a biodegradable drain fixed to the anastomosis by a circular stapler: a phase II study.
Phase 2
Completed
- Conditions
- rectal cancersigmoid cancer100179901001799110017998
- Registration Number
- NL-OMON33015
- Lead Sponsor
- niversitair Medisch Centrum Groningen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 35
Inclusion Criteria
Age > 18 years;
The patient requires an anastomosis, maximally 15 cm proximal from the anus
The patient will receive a colorectal anastomosis by means of stapling;
The patient is willing and able to comply with the specified follow-up evaluation;
The patient must provide written informed consent prior to the procedure.
Exclusion Criteria
Patient treatment is acute (not elective);
Patient is associated with infections at the time of intervention (peritonitis);
Major surgical or interventional procedures within 30 days prior to this study or planned surgical or interventional procedures within 30 days of entry into this study;
Patients with ASA classification >3;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary endpoint is recovery of the patient without clinical manifestation<br /><br>of anastomotic leakage. Anastomotic leakage is considered to be clinical<br /><br>manifest if any of the following occurs:<br /><br>* Relaparotomy with dismantling of the anastomosis and creation of an end<br /><br>colostomy<br /><br>* Relaparotomy with placement of drains in the pelvis<br /><br>* Relaparotomy with creation of a diverting ostomy<br /><br>* Radiologically guided drainage of any fluid in the pelvis </p><br>
- Secondary Outcome Measures
Name Time Method