Randomized Controlled Clinical Trial on Lateral Invagination of the Colorectal Anastomosis by Double Stapling

UMIN ID: UMIN000048220

Registered date:01/07/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Colorectal cancer
• Date of first enrollment: 2020/12/01
• Target sample size: 786
• Countries of recruitment: Japan,Europe
• Study type: Interventional

Intervention(s)

Anastomosis with double stapling technique
Anastomosis with lateral invagination technique

Outcome(s)

• Primary Outcome: Evaluate the rate of anastomotic dehiscence diagnosed in the first 30 postoperative days.
• Secondary Outcome: 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

Key inclusion & exclusion criteria

• Age minimum: 18years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude 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

Related Information

• Primary Sponsor: HOSPITAL CLINIC DE BARCELONA
• Source(s) of Monetary Support: HOSPITAL CLINIC DE BARCELONA