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Is Diverting Ileostomy Necessary in Stapled Ileoanal Pouch?

Primary Purpose

Ulcerative Colitis, Familial Adenomatous Polyposis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
adding diverting ileostomy
omitting diverting ileostomy
Sponsored by
Mansoura University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional trial for Ulcerative Colitis focused on measuring total proctocolectomy with ileal pouch anal anastomosis with and without ileostomy

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All Sexes

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    stapled ileoanal pouch without diverting ileostomy

    stapled ileoanal pouch with diverting ileostomy

    Arm Description

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    July 30, 2010
    Last Updated
    August 13, 2010
    Sponsor
    Mansoura University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01173250
    Brief Title
    Is Diverting Ileostomy Necessary in Stapled Ileoanal Pouch?
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2010
    Overall Recruitment Status
    Completed
    Study Start Date
    undefined (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Mansoura University

    4. Oversight

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Ulcerative Colitis, Familial Adenomatous Polyposis
    Keywords
    total proctocolectomy with ileal pouch anal anastomosis with and without ileostomy

    7. Study Design

    Study Phase
    Not Applicable

    8. Arms, Groups, and Interventions

    Arm Title
    stapled ileoanal pouch without diverting ileostomy
    Arm Type
    Active Comparator
    Arm Title
    stapled ileoanal pouch with diverting ileostomy
    Arm Type
    Placebo Comparator
    Intervention Type
    Procedure
    Intervention Name(s)
    adding diverting ileostomy
    Intervention Type
    Procedure
    Intervention Name(s)
    omitting diverting ileostomy

    10. Eligibility

    Sex
    All
    Eligibility 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

    12. IPD Sharing Statement

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    Is Diverting Ileostomy Necessary in Stapled Ileoanal Pouch?

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