Ignite Creation Date:
2024-05-05 @ 11:34 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00070005
Status:
UNKNOWN
Last Update Posted:
2013-08-07
First Post:
2003-10-03
Brief Title:
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
Sponsor:
Academisch Medisch Centrum - Universiteit van Amsterdam AMC-UvA
Organization:
National Cancer Institute NCI
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2007-04
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
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
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EU-20247 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000328269 | REGISTRY | None | None |