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
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.
Procedure: conventional surgery
Procedure: management of therapy complications
|Study Design:||Allocation: Randomized
Primary Purpose: Supportive Care
|Official Title:||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|
- Functional outcome as measured by a validated questionnaire
- Quality life as measured by a validated questionnaire
- Anorectal function as assessed by anorectal manometry and barostat measurements
|Study Start Date:||June 2002|
- 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 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00070005
|Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital|
|Amsterdam, Netherlands, 1066 CX|
|St. Lucas - Andreas Ziekenhuis|
|Amsterdam, Netherlands, 1091 AE|
|Onze Lieve Vrouwe Gasthuis|
|Amsterdam, Netherlands, 1091 HA|
|Academisch Medisch Centrum at University of Amsterdam|
|Amsterdam, Netherlands, 1105 AZ|
|Gelre Ziekenhuizen - Lokatie Lukas|
|Apeldoorn, Netherlands, 7300 DS|
|Reinier de Graaf Group - Delft|
|Delft, Netherlands, 2625 AD|
|Albert Schweitzerziekenhuis - Locatie Amstelwijck|
|Dordrecht NM, Netherlands, NL-3317|
|Isala Klinieken - locatie Sophia|
|Zwolle, Netherlands, 8000 GK|
|Isala Klinieken - locatie Weezenlanden|
|Zwolle, Netherlands, 8000 GK|
|Study Chair:||Roel Bakx, MD||Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)|