Is Diverting Ileostomy Necessary in Stapled Ileoanal Pouch?

NCT ID: NCT01173250

Last Updated: 2010-08-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Brief Summary

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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.

Detailed Description

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Conditions

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Ulcerative Colitis Familial Adenomatous Polyposis

Study Groups

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stapled ileoanal pouch without diverting ileostomy

Group Type ACTIVE_COMPARATOR

omitting diverting ileostomy

Intervention Type PROCEDURE

stapled ileoanal pouch with diverting ileostomy

Group Type PLACEBO_COMPARATOR

adding diverting ileostomy

Intervention Type PROCEDURE

Interventions

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adding diverting ileostomy

Intervention Type PROCEDURE

omitting diverting ileostomy

Intervention Type PROCEDURE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mansoura University

OTHER

Sponsor Role lead

Other Identifiers

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251068

Identifier Type: -

Identifier Source: org_study_id

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