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

Rectal Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01182116
• Other study ID #: IRB 08-178
• Status: Completed
• Phase: N/A
• Start date: March 2009
• Est. completion date: December 2016

Study information

• Verified date: May 2018
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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 -

Related Conditions & MeSH terms

• Rectal Cancer
• Rectal Neoplasms

Intervention

Procedure:
• J Pouch
Comparing J pouch, side to end coloanal surgery

Locations

Country	Name	City	State
United States	Cleveland Clinic	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improved function and capacity of the neorectum.		2 years from date of surgery