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

Not Applicable

• Conditions: Colorectal Cancer; Gastrointestinal Complications; Perioperative/Postoperative Complications

• Registration Number: NCT01110798
• Lead Sponsor: Azienda Ospedaliera di Padova

Brief 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.

Study Timeline

• Study Start: 2009-10
• Study First Submitted: 2010-04-23
• Study First Submitted QC: 2010-04-23
• Study First Posted: 2010-04-27
• Status Verified: 2011-02
• Primary Completion: 2011-10
• Last Update Submitted: 2013-09-16
• Last Update Posted: 2013-09-17

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Major anastomotic leak rate

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (4)

Universita Degli Studi di Florence - Policlinico di Careggi; 🇮🇹 Florence, Italy

Fondazione Istituto Nazionale dei Tumori; 🇮🇹 Milan, Italy

Azienda Ospedaliera di Padova; 🇮🇹 Padova, Italy

Ospedale Civile Di San Vito Al Tagliamento; 🇮🇹 San Vito Al Talgliamento, Italy