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Is Diverting Ileostomy Necessary in Stapled Ileoanal Pouch?

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01173250
First Posted: August 2, 2010
Last Update Posted: August 16, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Mansoura University
  Purpose
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.

Condition Intervention
Ulcerative Colitis Familial Adenomatous Polyposis Procedure: adding diverting ileostomy Procedure: omitting diverting ileostomy

Study Type: Interventional

Resource links provided by NLM:


Further study details as provided by Mansoura University:

Arms Assigned Interventions
Active Comparator: stapled ileoanal pouch without diverting ileostomy Procedure: omitting diverting ileostomy
Placebo Comparator: stapled ileoanal pouch with diverting ileostomy Procedure: adding diverting ileostomy

  Eligibility

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Criteria

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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

ClinicalTrials.gov Identifier: NCT01173250     History of Changes
Other Study ID Numbers: 251068
First Submitted: July 30, 2010
First Posted: August 2, 2010
Last Update Posted: August 16, 2010
Last Verified: October 2010

Keywords provided by Mansoura University:
total proctocolectomy with ileal pouch anal anastomosis with and without ileostomy

Additional relevant MeSH terms:
Colitis, Ulcerative
Adenomatous Polyposis Coli
Colitis
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Inflammatory Bowel Diseases
Colonic Diseases
Intestinal Diseases
Adenomatous Polyps
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplastic Syndromes, Hereditary
Intestinal Polyposis
Genetic Diseases, Inborn