Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

April 23, 2010
September 16, 2013
October 2009
October 2011   (final data collection date for primary outcome measure)
Major anastomotic leak rate [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01110798 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
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

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.

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.

Interventional
Not Provided
Allocation: Randomized
Masking: Open Label
Primary Purpose: Treatment
  • 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 Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
600
Not Provided
October 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Italy
 
NCT01110798
CDR0000671070, USP-1935P, EU-21032
Not Provided
Not Provided
Azienda Ospedaliera di Padova
Not Provided
Principal Investigator: Donato Nitti, MD Azienda Ospedaliera di Padova
National Cancer Institute (NCI)
February 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP