The C-seal study.
Recruiting
- Conditions
- ow anterior resection, anastomotic leakage, anastomotic dehiscence, rectal cancer, surgeryIn Dutch: naadlekkage, rectumcarcinoom, laag anterior resectie, chirurgie
- Registration Number
- NL-OMON28405
- Lead Sponsor
- niversity Medical Center Groningen, The Netherlands
- Brief Summary
Protection of stapled colorectal anastomoses with a biodegradable device: the C-seal feasibility study Kolkert JL, Havenga K, ten Cate Hoedemaker HO, Zuidema J, Ploeg RJ. Accepted for publication in American Journal of Surgery.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 35
Inclusion Criteria
1. Age > 18 years;
2. The patient requires an anastomosis, maximally 15 cm proximal from the anus;
Exclusion Criteria
1. Patient treatment is acute (not elective);
2. Patient is associated with infections at the time of intervention (peritonitis);
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To estimate the occurrence of anastomotic leakage when the C-seal is used.
- Secondary Outcome Measures
Name Time Method 1. The assessment of technical feasibility defined as technical success, determined by a gastrografin enema X-ray of the rectum one week after the operation;<br /><br>2. The successful clearance of the C-seal at 6 weeks without the occurrence of a serious adverse event;<br /><br>3. Estimation of patient friendliness of the drain, at one week and 6 weeks;<br /><br>4. Technical success: The Technical success is defined as the successful application of the C-seal;<br /><br>5. Acute procedural success: Acute procedural success is defined as the successful application of the C-seal without the occurrence of a Serious Adverse Effects (SAE) caused by the drain/protector during or directly after the procedure;<br /><br>6. Procedural success: The successful placement of the C-seal and the successful clearance of the C-seal with absence of any serious adverse events up to 30 days.