Randomized Controlled Clinical Trial on Lateral Invagination of the Colorectal Anastomosis by Double Stapling
Not Applicable
Recruiting
- Conditions
- Colorectal cancer
- Registration Number
- JPRN-UMIN000048220
- Lead Sponsor
- HOSPITAL CLINIC DE BARCELONA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 786
Inclusion Criteria
Not provided
Exclusion Criteria
- Patients <18 years - Pregnancy - ASA> III - Absolute contraindication for anesthesia - Patients who receive more than 1 gastrointestinal anastomosis during the same procedure - Planned multi-organ resection during the same procedure - Urgent / emergent surgery - Reinforced anastomosis after positive intraoperative leak test - Patients with simultaneous application of debulking and HIPEC - Crohn's disease or active ulcerative colitis
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Evaluate the rate of anastomotic dehiscence diagnosed in the first 30 postoperative days.
- Secondary Outcome Measures
Name Time Method 1. Duration of surgery (min) 2. Perioperative morbidity (TF: 30 and 90 days postoperative, or in hospital) using the Clavien- Dindo classification. 3. Perioperative mortality (TF: 30 and 90 days postoperative, or in hospital) 4. Hospital stay. 5. Hospital readmissions 6. Surgical reinterventions 7. Stoma-free survival 1 year after surgery