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 — DEVICE
    infusing 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 infusion
    perform infusion if ileostomy prior to takedown operation

Primary Outcome Measure

timing to return of bowel function [ Time Frame: 1-5 days ]

Locations (1)

FacilityCityStateZIPSite coordinators
UC San DiegoLa JollaCalifornia92093
Shanglei Liu
858-249-1837

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