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
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
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
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
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Primary Completion Date
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Study Completion Date
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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
Learn more about this trial
Is Diverting Ileostomy Necessary in Stapled Ileoanal Pouch?
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