Actively Recruiting
Pilot Study of Preoperative Intestinal Training Using Antegrade Ileostomy Infusion
Led by University of California, San Diego · Updated on 2025-12-15
20
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research study focuses on people with a diverting loop ileostomy who are preparing for a stoma takedown operation, which reconnects the intestine after a period of diversion. Because the part of the intestine past the ileostomy has not processed intestinal content for weeks to months, it may take time to regain normal function after surgery. The study aims to see if infusing the contents from the ostomy bag back into the intestine before surgery can help retrain it and speed up bowel recovery. Participants will be randomly assigned to one of two groups: one group will receive antegrade infusion of ileostomy contents back into their intestine before surgery, while the other group will not receive this intervention. The infusion is planned to be performed prior to the stoma takedown operation to simulate normal intestinal activity. The study is designed as a double-blind, randomized trial and includes phases 1 and 2. During the study, researchers will monitor how quickly bowel function returns after surgery, measuring the timing within 1 to 5 days. They will also track how easy it is to perform the stoma infusion from two weeks before surgery until the time of surgery, and monitor any complications from two weeks before surgery through 30 days after the operation. Participants will be followed throughout this period to assess safety and effectiveness of the intervention.
CONDITIONS
Brief Title
Pilot Study of Preoperative Intestinal Training Using Antegrade Ileostomy Infusion
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Has a diverting loop ileostomy
- Undergoing evaluation for stoma takedown
You will not qualify if you...
- Unable to provide informed consent
- Unable to perform stoma infusion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2 weeks prior to surgery
Participants undergo antegrade infusion of ileostomy content prior to their stoma takedown operation.
Weekly visits for up to 2 weeks
Duration - 1 to 5 days
Participants undergo stoma takedown surgery and immediate recovery.
1 visit (in-person) for surgery and hospital stay
Duration - 30 days post operatively
Participants are monitored for complications and recovery following surgery.
Approximately 4 follow-up visits
Trial Site Locations
Total: 1 location
1
UC San Diego
La Jolla, California, United States, 92093
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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