Is Diverting Ileostomy Necessary in Stapled Ileoanal Pouch?

August 13, 2010 updated by: Mansoura University
Total proctocolectomy with ileal pouch anal anastomosis is the first choice surgical operation for management of ulcerative colitis and familial adenomatous polyposis. The addition of diverting ileostomy may reduce septic complications. In this randomized study the investigators compare two groups of patients with stapled ileoanal pouch one of them had diverting ileostomy and in the other this step is omitted.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients having total proctocolectomy with ileal pouch anal anastomosis.

Exclusion Criteria:

  • hypoalbuminemia
  • prolonged steroid use
  • anemia
  • anastomosis under tension
  • leak with air test
  • bleeding
  • poor vascular supply of anastomosis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: stapled ileoanal pouch without diverting ileostomy
Procedure: omitting diverting ileostomy
Placebo Comparator: stapled ileoanal pouch with diverting ileostomy
Procedure: adding diverting ileostomy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mansoura University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

July 30, 2010

First Submitted That Met QC Criteria

July 30, 2010

First Posted (Estimate)

August 2, 2010

Study Record Updates

Last Update Posted (Estimate)

August 16, 2010

Last Update Submitted That Met QC Criteria

August 13, 2010

Last Verified

October 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 251068

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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