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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

May 25, 2010
March 22, 2017
March 2009
December 2018   (Final data collection date for primary outcome measure)
Improved function and capacity of the neorectum. [ Time Frame: 2 years from date of surgery ]
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 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.

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.

Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: No masking
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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
400
December 2018
December 2018   (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 -
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01182116
IRB 08-178
Yes
Not Provided
No
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Massarat Zutshi, The Cleveland Clinic
The Cleveland Clinic
Not Provided
Principal Investigator: Massarat Zutshi, MD The Cleveland Clinic
The Cleveland Clinic
March 2017

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