J-Pouch Colorectal Anastomosis or Straight Colorectal Anastomosis in Treating Patients With Rectal Cancer Who Have Undergone Surgery to Remove the Tumor

Study Overview
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Brief Summary
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RATIONALE: It is not yet known whether a J-pouch colorectal anastomosis is more effective than a straight colorectal anastomosis in treating patients with rectal cancer who have undergone surgery to remove the tumor. PURPOSE: This randomized clinical trial is studying J-pouch colorectal anastomosis to see how well it works compared with straight colorectal anastomosis in treating patients with rectal cancer who have undergone surgery to remove the tumor.

Detailed Description
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OBJECTIVES: Primary To assess whether the incidence of major anastomotic leak after low anterior resection, in patients with rectal cancer, is reduced by using the J-pouch reconstruction vs straight colorectal anastomosis. Secondary To compare the global anastomotic leak (major and minor) rate, the incidence of other complications in addition to anastomotic leak, and the functional outcome and the quality of life in these patients. To describe, in the J-pouch reconstruction group, the feasibility of the colonic J-pouch. OUTLINE: Ths is a multicenter study. Patients are stratified according to clinical center, gender (male vs female), and neoadjuvant treatment types. Patients are randomized to 1 of 2 treatment arms. Arm I: Patients undergo a total mesorectal excision with a low anterior rectal resection followed by a mechanical straight stapled colorectal anastomosis. Arm II: Patients undergo a total mesorectal excision with a low anterior rectal resection followed by a mechanical J-pouch stapled anastomosis reconstruction. Quality of life is assessed periodically using EORTC Quality of Life Questionnaires (EORTC QLQ-C30 and -CR38), and the MSKCC Bowel Function Questionnaire. After completion of study treatment, patients are followed at 1, 6, 12, and 24 months.

Official Title
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Colonic J-Pouch Reconstruction Versus Straight Colorectal Anastomosis After Low Anterior Resection for Rectal Cancer: Impact on Anastomotic Leak, Bowel Function and Quality of Life

Conditions
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Colorectal Cancer, Gastrointestinal Complications, Perioperative/Postoperative Complications

Intervention / Treatment
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* Other: intraoperative complication management/prevention
* Procedure: assessment of therapy complications
* Procedure: gastrointestinal complications management/prevention
* Procedure: quality-of-life assessment
* Procedure: therapeutic conventional surgery


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically confirmed rectal adenocarcinoma meeting the following criteria: Mid and/or low rectal cancer Tumor site ≤ 11 cm from anal verge Must have a temporary stoma (ileostomy or colostomy) Must be scheduled for a total mesorectal excision with a low anterior rectal resection and mechanic colorectal anastomosis that is potentially curative or with a microscopic residual resection (R0-R1) No locally recurrent disease No distant metastasis PATIENT CHARACTERISTICS: Must be able to understand the study PRIOR CONCURRENT THERAPY: No prior handsewn coloanal anastomosis No prior colonic resection No prior surgery for local recurrence

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: intraoperative complication management/prevention|nan|
|Procedure: assessment of therapy complications|nan|
|Procedure: gastrointestinal complications management/prevention|nan|
|Procedure: quality-of-life assessment|nan|
|Procedure: therapeutic conventional surgery|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major anastomotic leak rate |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of the colonic J-pouch reconstruction performed with respect to the total number of patients selected for the J-pouch treatment arm |  |  | 
| Global anastomotic leak rate |  |  | 
| Anastomotic complications rate in addition to anastomotic leak |  |  | 
| Bowel function, fecal incontinence, and quality of life, evaluated with validated questionnaires |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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perioperative/postoperative complications, gastrointestinal complications, adenocarcinoma of the rectum, stage I rectal cancer, stage II rectal cancer, stage III rectal cancer