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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Massarat Zutshi, The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT01182116
First received: May 25, 2010
Last updated: March 22, 2017
Last verified: March 2017
  Purpose
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: Intervention Model: Single Group Assignment
Masking: No masking
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

Further study details as provided by Massarat Zutshi, The Cleveland Clinic:

Primary Outcome Measures:
  • Improved function and capacity of the neorectum. [ Time Frame: 2 years from date of surgery ]

Estimated Enrollment: 400
Study Start Date: March 2009
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2018 (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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
The Cleveland Clinic
Investigators
Principal Investigator: Massarat Zutshi, MD The Cleveland Clinic
  More Information

Responsible Party: Massarat Zutshi, MD, 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: March 22, 2017
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Massarat Zutshi, 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 May 25, 2017