J-Pouch Colorectal Anastomosis or Straight Colorectal Anastomosis in Treating Patients With Rectal Cancer Who Have Undergone Surgery to Remove the Tumor
Recruitment status was: Recruiting
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.
Other: intraoperative complication management/prevention
Procedure: assessment of therapy complications
Procedure: gastrointestinal complications management/prevention
Procedure: quality-of-life assessment
Procedure: therapeutic conventional surgery
|Study Design:||Allocation: Randomized
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- Major anastomotic leak rate [ Designated as safety issue: No ]
- Percentage of the colonic J-pouch reconstruction performed with respect to the total number of patients selected for the J-pouch treatment arm [ Designated as safety issue: No ]
- Global anastomotic leak rate [ Designated as safety issue: No ]
- Anastomotic complications rate in addition to anastomotic leak [ Designated as safety issue: No ]
- Bowel function, fecal incontinence, and quality of life, evaluated with validated questionnaires [ Designated as safety issue: No ]
|Study Start Date:||October 2009|
|Estimated Primary Completion Date:||October 2011 (Final data collection date for primary outcome measure)|
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01110798
|Universita Degli Studi di Florence - Policlinico di Careggi|
|Florence, Italy, 50134|
|Fondazione Istituto Nazionale dei Tumori|
|Milan, Italy, 20133|
|Azienda Ospedaliera di Padova|
|Padova, Italy, 35128|
|Ospedale Civile Di San Vito Al Tagliamento|
|San Vito Al Talgliamento, Italy|
|Principal Investigator:||Donato Nitti, MD||Azienda Ospedaliera di Padova|