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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2011 by National Cancer Institute (NCI).
Recruitment status was:  Recruiting
Information provided by:
National Cancer Institute (NCI) Identifier:
First received: April 23, 2010
Last updated: September 16, 2013
Last verified: February 2011

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.

Condition Intervention
Colorectal Cancer
Gastrointestinal Complications
Perioperative/Postoperative Complications
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 Type: Interventional
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

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Major anastomotic leak rate

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 600
Study Start Date: October 2009
Estimated Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Detailed Description:



  • 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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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


  • Must be able to understand the study


  • No prior handsewn coloanal anastomosis
  • No prior colonic resection
  • No prior surgery for local recurrence
  Contacts and Locations
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Please refer to this study by its identifier: NCT01110798

Universita Degli Studi di Florence - Policlinico di Careggi Recruiting
Florence, Italy, 50134
Contact: Contact Person    39-55-794-7449   
Fondazione Istituto Nazionale dei Tumori Recruiting
Milan, Italy, 20133
Contact: Contact Person    39-2-5501-8044   
Azienda Ospedaliera di Padova Recruiting
Padova, Italy, 35128
Contact: Contact Person    39-49-821-2055   
Ospedale Civile Di San Vito Al Tagliamento Recruiting
San Vito Al Talgliamento, Italy
Contact: Contact Person    39-434-841-351   
Sponsors and Collaborators
Azienda Ospedaliera di Padova
Principal Investigator: Donato Nitti, MD Azienda Ospedaliera di Padova
  More Information Identifier: NCT01110798     History of Changes
Other Study ID Numbers: CDR0000671070
Study First Received: April 23, 2010
Last Updated: September 16, 2013

Keywords provided by National Cancer Institute (NCI):
perioperative/postoperative complications
gastrointestinal complications
adenocarcinoma of the rectum
stage I rectal cancer
stage II rectal cancer
stage III rectal cancer

Additional relevant MeSH terms:
Colorectal Neoplasms
Rectal Neoplasms
Postoperative Complications
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Pathologic Processes processed this record on May 22, 2017