NL-OMON39412
Completed
Phase 3
Colorectal anastomosis protected by a biodegradable drain fixed to the anastomosis by a circular stapler. A Multi-Center Randomized Controlled Trial (C-seal study) - C-seal
Overview
- Phase
- Phase 3
- Status
- Completed
- Enrollment
- 350
Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 99 (—)
Inclusion Criteria
- •Any colorectal disease requiring a colorectal anastomosis to be made by a circular stapler/cutter;
- •Elective surgery;
- •Age \> 18 years;
- •American Society of Anesthesiologists (ASA) classification 1, 2 or 3;
- •No clinical signs of peritonitis;
- •No 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.
Exclusion Criteria
- •Incapacitated patients.
Investigators
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