Is Diverting Ileostomy Necessary in Stapled Ileoanal Pouch?

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. Identifier: NCT01173250
Recruitment Status : Completed
First Posted : August 2, 2010
Last Update Posted : August 16, 2010
Information provided by:
Mansoura University

Brief Summary:
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 or disease Intervention/treatment Phase
Ulcerative Colitis Familial Adenomatous Polyposis Procedure: adding diverting ileostomy Procedure: omitting diverting ileostomy Not Applicable

Study Type : Interventional  (Clinical Trial)

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

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All

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 Identifier: NCT01173250     History of Changes
Other Study ID Numbers: 251068
First Posted: August 2, 2010    Key Record Dates
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
Gastrointestinal Diseases
Digestive System Diseases
Inflammatory Bowel Diseases
Colonic Diseases
Intestinal Diseases
Adenomatous Polyps
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplastic Syndromes, Hereditary
Intestinal Polyposis
Genetic Diseases, Inborn