Quality of Life in Patients That Undergo J Pouch or Side to End Coloanal Anastomosis for Rectal Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by The Cleveland Clinic
Sponsor:
Information provided by (Responsible Party):
The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT01182116
First received: May 25, 2010
Last updated: July 29, 2013
Last verified: July 2013
  Purpose

The side to end anastomosis has become popular in recent years as it is technically simple to construct. The difference between the Baker type(side to end) of anastomosis and the J pouch, is that no formal pouch is constructed in the side to end. It has one staple line and the anastomosis.

The investigators hypothesis is that the patients who receive a side to end anastomosis have bowel outcome and quality of life that is equivalent to those who receive a J pouch.


Condition Intervention
Rectal Cancer
Procedure: J Pouch

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: A Randomized, Controlled Trial to Compare the Functional Outcome and Quality of Life in Patients With Low Rectal Cancer Who Undergo a J Pouch or a Side to End Coloanal Anastomosis

Resource links provided by NLM:


Further study details as provided by The Cleveland Clinic:

Primary Outcome Measures:
  • Improved function and capacity of the neorectum. [ Time Frame: 2 years from date of surgery ] [ Designated as safety issue: No ]

Estimated Enrollment: 400
Study Start Date: March 2009
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: J Pouch side to end
Colorectal surgery Function Quality of Life
Procedure: J Pouch
Comparing J pouch, side to end coloanal surgery

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients with distal rectal cancers who will be having an abdominal proctocolectomy with a low colorectal anastomosis within 4 cm of the dentate line or a coloanal anastomosis will be candidates for this study.
  2. No evidence of distant metastatsis -

Exclusion Criteria: Stage IV rectal cancer

  1. History of radiation to the pelvis ( eg. for uterine or prostatic cancer)
  2. Evidence of synchronus or metachronus disease
  3. H/o dementia
  4. Prisoners
  5. Women who are pregnant
  6. History of previous Right Colectomy
  7. History of inflammatory bowel disease -
  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: NCT01182116

Locations
United States, Ohio
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Contact: Massarat Zutshi, MD    216-445-9456    zutshim@ccf.org   
Contact: Elizabeth Corrao, BA    216-445-3321    coarraoe@ccf.org   
Sponsors and Collaborators
The Cleveland Clinic
Investigators
Principal Investigator: Massarat Zutshi, MD The Cleveland Clinic
  More Information

No publications provided

Responsible Party: The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT01182116     History of Changes
Other Study ID Numbers: IRB 08-178
Study First Received: May 25, 2010
Last Updated: July 29, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by The Cleveland Clinic:
J pouch
colorectal
rectal cancer
coloplasty

Additional relevant MeSH terms:
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on July 20, 2014