NCT00070005

J-Pouch Coloanal Anastomosis Compared With Side-to-End Coloanal Anastomosis After Radiation Therapy and Surgery to Remove the Rectum in Treating Patients With Rectal Adenocarcinoma

A Phase III Randomised Study Of J-Pouch Coloanal Anastomosis Versus Side-To-End Coloanal Anastomosis After Preoperative Radiotherapy And Total Mesorectal Excision In Patients With Mid And Distal Rectal Cancer

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: A coloanal anastomosis may be effective in restoring bowel function after radiation therapy and surgery to remove the rectum. It is not yet known whether a J-pouch coloanal anastomosis is more effective than a side-to-end coloanal anastomosis in restoring bowel function in patients with rectal adenocarcinoma who have undergone radiation therapy and surgery to remove the rectum. PURPOSE: This randomized phase III trial is studying how well J-pouch coloanal anastomosis works compared to side-to-end coloanal anastomosis in treating patients with rectal adenocarcinoma who have undergone radiation therapy and surgery to remove the rectum.

Detailed description

OBJECTIVES: Primary * Compare functional outcome in patients with mid- or distal rectal adenocarcinoma when treated with J-pouch coloanal anastomosis vs side-to-end coloanal anastomosis after preoperative radiotherapy and total mesorectal excision. Secondary * Compare the quality of life of patients treated with these procedures. * Compare anorectal function in patients treated with these procedures. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center and gender. Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients undergo total mesorectal excision followed by a J-pouch coloanal anastomosis. * Arm II: Patients undergo total mesorectal excision followed by a side-to-end coloanal anastomosis. In both arms, patients receive a temporary ileostomy. The ileostomy is closed after 1 week provided recovery is uneventful and no radiological signs of anastomotic leakage are detected. If early closure is not possible, the ileostomy is closed after 6-8 weeks. Functional outcome, quality of life, and anorectal function are assessed before surgery and at 4 and 12 months after surgery. PROJECTED ACCRUAL: A minimum of 100 patients (50 per treatment arm) will be accrued for this study.

Conditions

• Colorectal Cancer
• Perioperative/Postoperative Complications

Interventions

Type	Name	Description
PROCEDURE	conventional surgery
PROCEDURE	management of therapy complications

Timeline

• Start date: 2002-06-01
• First posted: 2003-10-07
• Last updated: 2013-08-07

Locations

9 sites across 1 country: Netherlands