NCT01110798

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 600 (estimated)
• Sponsor: Azienda Ospedaliera di Padova · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Colorectal Cancer
• Gastrointestinal Complications
• Perioperative/Postoperative Complications

Interventions

Type	Name	Description
OTHER	intraoperative complication management/prevention
PROCEDURE	assessment of therapy complications
PROCEDURE	gastrointestinal complications management/prevention
PROCEDURE	quality-of-life assessment
PROCEDURE	therapeutic conventional surgery

Timeline

• Start date: 2009-10-01
• Primary completion: 2011-10-01
• First posted: 2010-04-27
• Last updated: 2013-09-17

Locations

4 sites across 1 country: Italy