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
- 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.
- 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
- Arm II: Patients undergo total mesorectal excision followed by a side-to-end coloanal
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
Allocation: Randomized, Primary Purpose: Supportive Care
Functional outcome as measured by a validated questionnaire
Roel Bakx, MD
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
United States: Federal Government