Is Diverting Ileostomy Necessary in Stapled Ileoanal Pouch?
1 other identifier
interventional
N/A
0 countries
N/A
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.
Trial Health
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 30, 2010
CompletedFirst Posted
Study publicly available on registry
August 2, 2010
CompletedAugust 16, 2010
October 1, 2010
July 30, 2010
August 13, 2010
Conditions
Keywords
Study Arms (2)
stapled ileoanal pouch without diverting ileostomy
ACTIVE COMPARATORstapled ileoanal pouch with diverting ileostomy
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- patients having total proctocolectomy with ileal pouch anal anastomosis.
You may not qualify if:
- hypoalbuminemia
- prolonged steroid use
- anemia
- anastomosis under tension
- leak with air test
- bleeding
- poor vascular supply of anastomosis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
July 30, 2010
First Posted
August 2, 2010
Last Updated
August 16, 2010
Record last verified: 2010-10