NL-OMON33015
Completed
Phase 2
The C-Seal study: Colorectal anastomosis protected by a biodegradable drain fixed to the anastomosis by a circular stapler: a phase II study. - The C-Seal study
Overview
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 35
Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 99 (—)
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;
Investigators
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