Colorectal Cancer, Perioperative/Postoperative Complications
Conditions
Keywords
perioperative/postoperative complications, stage I rectal cancer, stage II rectal cancer, stage III rectal cancer, adenocarcinoma of the rectum
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.
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.
Interventions
PROCEDUREconventional surgery
PROCEDUREmanagement of therapy complications
Sponsors
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Study design
Allocation
RANDOMIZED
Primary purpose
SUPPORTIVE_CARE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Functional outcome as measured by a validated questionnaire | — |
Secondary
| Measure | Time frame |
|---|---|
| Quality life as measured by a validated questionnaire | — |
| Anorectal function as assessed by anorectal manometry and barostat measurements | — |
Countries
Netherlands
Outcome results
None listed