Short Versus Long Interval to Ileostomy Reversal After Ileal Pouch Surgery for Ulcerative Colitis

Who is this study for? Patients with ulcerative colitis
Status: Terminated
Location: See all (8) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

In patients with ulcerative or indeterminate colitis who undergo ileal pouch anal anastomosis and diverting loop ileostomy (IPAA) surgery* a short interval to loop ileostomy reversal will result in differences in complications and quality of life compared to a long interval to loop ileostomy reversal.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 64
Healthy Volunteers: No
View:

• Signed informed consents.

• Man or woman between 18 and 64 years of age.

• Ulcerative colitis (UC) or indeterminate colitis (IC) diagnosed by routine clinical, radiographic, endoscopic, and pathological criteria.

• Patient will be scheduled for non-emergent proctocolectomy or completion proctectomy with ileal j-pouch anal anastomosis (IPAA) and loop ileostomy (IPAA).

• Clinical assessment of patient after IPAA surgery indicates that patient is suitable for early ileostomy reversal

Locations
United States
California
Cedars Sinai
Los Angeles
Colorado
University of Colorado Denver
Aurora
Illinois
Northwestern University Medical Center
Chicago
University of Chicago
Chicago
Massachusetts
Beth Israel
Boston
Michigan
University of Michigan
Ann Arbor
Missouri
Washington University
Saint Louis
Ohio
Cleveland Clinic
Cleveland
Time Frame
Start Date: November 6, 2018
Completion Date: March 31, 2021
Participants
Target number of participants: 36
Treatments
Experimental: Early ileostomy closure
Early ileostomy closure will be performed 7 to 12 days after with ileal j-pouch anal anastomosis (IPAA) and loop ileostomy (IPAA).
Active Comparator: Late ileostomy closure
Late ileostomy closure will be performed 8 - 12 weeks after IPAA.
Authors
Jon Vogel, Mark Koruda, Liliana Bordeianou, Steven Mills, Neil Hyman, Walter Peters, Matthew Mutch, Luca Stocchi, Walter Koltun, Feza Remzi, Philip Fleshner, Emily Steinhagen, Giovanna DaSilva, David Stewart, Vitaily Polylin, David Bargas
Sponsors
Leads: University of Colorado, Denver

This content was sourced from clinicaltrials.gov

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