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Pilot Study of Preoperative Intestinal Training Using Antegrade Ileostomy Infusion

Pilot Study of Preoperative Intestinal Training Using Antegrade Ileostomy Infusion

Status
Recruiting
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06461559
Enrollment
20
Registered
2024-06-17
Start date
2024-08-01
Completion date
2026-05-01
Last updated
2025-12-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ileostomy; Complications, Stoma Ileostomy

Brief summary

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.

Interventions

DEVICEantegrade infusion of ileostomy content

infusing the contents of ileostomy output back into intestine of the patient

Sponsors

University of California, San Diego
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* Has a diverting loop ileostomy * undergoing evaluation for stoma takedown

Exclusion criteria

* unable to perform consent * unable to perform stoma infusion

Design outcomes

Primary

MeasureTime frameDescription
timing to return of bowel function1-5 daystime to return of bowel function after stoma surgery

Secondary

MeasureTime frameDescription
ease of stoma infusion2 weeks prior to surgery to time of surgeryhow easy was it for patients to infuse contents
complications2 weeks prior to surgery to 30 days post operativelyif there are any complications from using the stoma infusion

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026