Colorectal anastomosis protected by a biodegradable drain fixed to the anastomosis by a circular stapler. A Multi-Center Randomized Controlled Trial (C-seal study)
Phase 3
Completed
- Conditions
- anastomotic leakage10017998
- Registration Number
- NL-OMON39412
- Lead Sponsor
- niversitair Medisch Centrum Groningen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 350
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Anastomotic leakage, necessitating an invasive intervention, in the 1st 30 days<br /><br>post-surgery.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Number of dismantled anastomoses; AL within 30 days according to the ISGRC<br /><br>classification; interval between the operation and AL; The pain score at<br /><br>postoperative day 3; number of ostomies (also after 1 year); late AL (diagnosed<br /><br>>=30 days and <1 year); total duration of hospital stay for adverse events<br /><br>and/or stoma closure; Interval between C-seal application and C-seal loss.</p><br>