Immediate versus MOdified DElayed coloanal anastomosis after Total Mesorectal Excision: A Randomized Controlled Trial

Not Applicable

Recruiting

• Conditions: Cancer; Digestive System

• Registration Number: PACTR202209500145137
• Lead Sponsor: Debussy Clinic

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-08-24
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

Age = 18 years
- Histologically proven cancer of the mid or lower rectum (lower pole of the tumor located within 10 cm of the anal margin) eligible for R0 surgery.
- Patients with or without resectable or non-resectable distant metastases.

Exclusion Criteria

- ycT4 tumors invading the external sphincter or levator ani requiring Abdominoperineal resection.
- Anal incontinence (Wexner score = 6)
- Altered mental status preventing adherence to the study.
- Refusal.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Anastomotic fistula rate.<br>The International Study Group of Rectal Cancer (ISREC) definition will be adopted: any dehiscence of the coloanal anastomosis leading to communication between the intra- and extraluminal compartment.