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
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00070005|
Recruitment Status : Unknown
Verified April 2007 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : October 7, 2003
Last Update Posted : August 7, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer Perioperative/Postoperative Complications||Procedure: conventional surgery Procedure: management of therapy complications||Phase 3|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|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|
|Study Start Date :||June 2002|
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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)|