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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 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

May 25, 2010
July 29, 2013
March 2009
December 2013   (final data collection date for primary outcome measure)
Improved function and capacity of the neorectum. [ Time Frame: 2 years from date of surgery ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01182116 on ClinicalTrials.gov Archive Site
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Quality of Life in Patients That Undergo J Pouch or Side to End Coloanal Anastomosis for Rectal Cancer
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

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.

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Interventional
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Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Rectal Cancer
Procedure: J Pouch
Comparing J pouch, side to end coloanal surgery
Experimental: J Pouch side to end
Colorectal surgery Function Quality of Life
Intervention: Procedure: J Pouch
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
400
December 2013
December 2013   (final data collection date for primary outcome measure)

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 -
Both
18 Years to 75 Years
No
United States
 
NCT01182116
IRB 08-178
Yes
The Cleveland Clinic
The Cleveland Clinic
Not Provided
Principal Investigator: Massarat Zutshi, MD The Cleveland Clinic
The Cleveland Clinic
July 2013

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