NCT03587519

Short Versus Long Interval to Ileostomy Reversal After Ileal Pouch Surgery

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: University of Colorado, Denver · Academic / Other
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Aim #1: To compare the Comprehensive Complication Index (CCI), the incidence of postoperative complications, including total number of complications per patient, percent of patients with complications, and total number of ostomy-related complications per patient among IPAA patients who have their ileostomy reversed after a short interval compared to a long interval. Aim #2: To compare the short vs. long interval groups on measures of health-related quality of life (PROMIS) and IPAA functional outcomes

Conditions

• Ulcerative Colitis
• Ileal Pouch
• Ileostomy - Stoma

Interventions

Type	Name	Description
PROCEDURE	Early	Early ileostomy closure
PROCEDURE	Late	Late ileostomy closure

Timeline

• Start date: 2018-11-06
• Primary completion: 2021-02-16
• Completion: 2021-03-31
• First posted: 2018-07-16
• Last updated: 2022-03-04

Locations

8 sites across 1 country: United States