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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


N/A
18 Years
75 Years
Open (Enrolling)
Both
Rectal Cancer

Thank you

Trial Information

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


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 -

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Outcome Measure:

Improved function and capacity of the neorectum.

Outcome Time Frame:

2 years from date of surgery

Safety Issue:

No

Principal Investigator

Massarat Zutshi, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

The Cleveland Clinic

Authority:

United States: Institutional Review Board

Study ID:

IRB 08-178

NCT ID:

NCT01182116

Start Date:

March 2009

Completion Date:

Related Keywords:

  • Rectal Cancer
  • J pouch
  • colorectal
  • rectal cancer
  • coloplasty
  • Rectal Neoplasms

Name

Location
Cleveland Clinic Cleveland, Ohio  44195