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
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|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||600 participants|
|Masking:||None (Open Label)|
|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|
- Major anastomotic leak rate
- 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
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
|Universita Degli Studi di Florence - Policlinico di Careggi||Recruiting|
|Florence, Italy, 50134|
|Contact: Contact Person 39-55-794-7449 firstname.lastname@example.org|
|Fondazione Istituto Nazionale dei Tumori||Recruiting|
|Milan, Italy, 20133|
|Contact: Contact Person 39-2-5501-8044 email@example.com|
|Azienda Ospedaliera di Padova||Recruiting|
|Padova, Italy, 35128|
|Contact: Contact Person 39-49-821-2055 firstname.lastname@example.org|
|Ospedale Civile Di San Vito Al Tagliamento||Recruiting|
|San Vito Al Talgliamento, Italy|
|Contact: Contact Person 39-434-841-351 email@example.com|
|Principal Investigator:||Donato Nitti, MD||Azienda Ospedaliera di Padova|