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
This trial is active, not recruiting.
|Conditions||colorectal cancer, perioperative/postoperative complications|
|Treatments||conventional surgery, management of therapy complications|
|Sponsor||Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)|
|Start date||June 2002|
|Trial size||100 participants|
|Trial identifier||NCT00070005, CDR0000328269, CKTO-2002-02-POCASTER, EU-20247|
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.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Amsterdam, Netherlands||Academisch Medisch Centrum at University of Amsterdam||no longer recruiting|
|Amsterdam, Netherlands||St. Lucas - Andreas Ziekenhuis||no longer recruiting|
|Amsterdam, Netherlands||Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital||no longer recruiting|
|Amsterdam, Netherlands||Onze Lieve Vrouwe Gasthuis||no longer recruiting|
|Apeldoorn, Netherlands||Gelre Ziekenhuizen - Lokatie Lukas||no longer recruiting|
|Delft, Netherlands||Reinier de Graaf Group - Delft||no longer recruiting|
|Dordrecht NM, Netherlands||Albert Schweitzerziekenhuis - Locatie Amstelwijck||no longer recruiting|
|Zwolle, Netherlands||Isala Klinieken - locatie Weezenlanden||no longer recruiting|
|Zwolle, Netherlands||Isala Klinieken - locatie Sophia||no longer recruiting|
|Primary purpose||supportive care|
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
Male or female participants at least 18 years old.
DISEASE CHARACTERISTICS: - Histologically confirmed adenocarcinoma of the rectum - T2 or T3 disease - Disease located in the mid- or distal rectum - No evidence of metastatic disease - No preexisting grade III or IV incontinence - Completed preoperative radiotherapy (5 x 5 Gy) before study entry PATIENT CHARACTERISTICS: Age - Over 18 Performance status - WHO 0-2 Life expectancy - Not specified Hematopoietic - Not specified Hepatic - Not specified Renal - Not specified Other - Working knowledge of the Dutch language PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - No prior chemotherapy Endocrine therapy - Not specified Radiotherapy - See Disease Characteristics - No prior radiotherapy to the pelvis Surgery - No prior colon resection - No prior anorectal surgery - No concurrent abdominoperineal resection
|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|
|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.|
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