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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

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ClinicalTrials.gov Identifier: NCT01110798
Recruitment Status : Unknown
Verified February 2011 by National Cancer Institute (NCI).
Recruitment status was:  Recruiting
First Posted : April 27, 2010
Last Update Posted : September 17, 2013
Sponsor:
Information provided by:
National Cancer Institute (NCI)

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.


Condition or disease Intervention/treatment Phase
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 Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Masking: None (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
Study Start Date : October 2009
Estimated Primary Completion Date : October 2011



Primary Outcome Measures :
  1. Major anastomotic leak rate

Secondary Outcome Measures :
  1. Percentage of the colonic J-pouch reconstruction performed with respect to the total number of patients selected for the J-pouch treatment arm
  2. Global anastomotic leak rate
  3. Anastomotic complications rate in addition to anastomotic leak
  4. Bowel function, fecal incontinence, and quality of life, evaluated with validated questionnaires


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT01110798     History of Changes
Other Study ID Numbers: CDR0000671070
USP-1935P
EU-21032
First Posted: April 27, 2010    Key Record Dates
Last Update Posted: September 17, 2013
Last Verified: February 2011

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
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Pathologic Processes