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

NeuroTherapia, Inc.

Status: Completed

Conditions: Rectal Cancer

Treatments: Procedure: J Pouch

Study type: Interventional

Funder types: Other

Identifiers

NCT01182116

IRB 08-178

Details and patient eligibility

About

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.

Full 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.

Enrollment: 46 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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 -

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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46 participants in 1 patient group

J Pouch side to end

Experimental group

Description:

Colorectal surgery Function Quality of Life

Treatment:

Procedure: J Pouch