Pilot Study of Preoperative Intestinal Training Using Antegrade Ileostomy Infusion
Part of paid clinical trials in La Jolla, California.
- Sponsor
- University of California, San Diego
- Study ID
- NCT06461559
- Phase
- PHASE1/PHASE2
- Status
- Recruiting
Conditions
- Ileostomy; Complications
- Stoma Ileostomy
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 80 Years
- Healthy Volunteers
- Not accepted
Interventions
- antegrade infusion of ileostomy content — DEVICEinfusing the contents of ileostomy output back into intestine of the patient
Study Details
This research study is being conducted to study the effect of infusing your contents from your ostomy bag back into your intestine to re-train them prior to the ostomy takedown operation, which is a surgery to reverse your ostomy to put your intestine back together. Because your intestine past the ostomy hasn't seen any intestinal content for several weeks to months before the takedown operation, it is no longer used to handling the daily work of processing intestinal content and will take time to recover its normal function after surgery. We hope to speed up this process by training them before your planned surgery.
Key Dates
- Start date
- Aug 1, 2024
- Status verified
- Jun 2025
- Primary completion
- Mar 1, 2026
- Completion
- May 1, 2026
Study Design
- Enrollment
- 20 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- No Intervention: Control
- Active Comparator: Ileostomy infusionperform infusion if ileostomy prior to takedown operation
Primary Outcome Measure
timing to return of bowel function [ Time Frame: 1-5 days ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| UC San Diego | La Jolla | California | 92093 |
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