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Is Diverting Ileostomy Necessary in Stapled Ileoanal Pouch?

This study has been completed.
Sponsor:
Information provided by:
Mansoura University
ClinicalTrials.gov Identifier:
NCT01173250
First received: July 30, 2010
Last updated: August 13, 2010
Last verified: October 2010
  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

Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT01173250     History of Changes
Other Study ID Numbers: 251068
Study First Received: July 30, 2010
Last Updated: August 13, 2010
Health Authority: Egypt: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on November 24, 2014