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

Not Applicable

Completed

• Conditions: Rectal Cancer
• Interventions: Procedure: J Pouch

• Registration Number: NCT01182116
• Lead Sponsor: The Cleveland Clinic

Brief Summary

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.

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.

Study Timeline

• Study Start: 2009-03
• Study First Submitted: 2010-05-25
• Study First Submitted QC: 2010-08-13
• Study First Posted: 2010-08-16
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-08
• Last Update Posted: 2018-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

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 -

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
J Pouch side to end	J Pouch	Colorectal surgery Function Quality of Life

Primary Outcome Measures

Name	Time	Method
Improved function and capacity of the neorectum.	2 years from date of surgery

Trial Locations

Locations (1)

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States