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 because the information has not been verified recently.
Verified February 2011 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01110798
First received: April 23, 2010
Last updated: September 16, 2013
Last verified: February 2011
  Purpose

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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Major anastomotic leak rate [ Designated as safety issue: No ]

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 [ 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 ]

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01110798

Locations
Italy
Universita Degli Studi di Florence - Policlinico di Careggi Recruiting
Florence, Italy, 50134
Contact: Contact Person    39-55-794-7449    f.tonelli@dfc.unifi.it   
Fondazione Istituto Nazionale dei Tumori Recruiting
Milan, Italy, 20133
Contact: Contact Person    39-2-5501-8044    ermanno.leo@istitutotumori.mi.it   
Azienda Ospedaliera di Padova Recruiting
Padova, Italy, 35128
Contact: Contact Person    39-49-821-2055    donato.nitti@unipd.it   
Ospedale Civile Di San Vito Al Tagliamento Recruiting
San Vito Al Talgliamento, Italy
Contact: Contact Person    39-434-841-351    ainfantino@libero.it   
Sponsors and Collaborators
Azienda Ospedaliera di Padova
Investigators
Principal Investigator: Donato Nitti, MD Azienda Ospedaliera di Padova
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT01110798     History of Changes
Other Study ID Numbers: CDR0000671070, USP-1935P, EU-21032
Study First Received: April 23, 2010
Last Updated: September 16, 2013
Health Authority: Unspecified

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:
Postoperative Complications
Colorectal Neoplasms
Colonic Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasms
Neoplasms by Site
Pathologic Processes
Rectal Diseases

ClinicalTrials.gov processed this record on October 20, 2014