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NCT06461559 Clinical Trial

Pilot Study of Preoperative Intestinal Training Using Antegrade Ileostomy Infusion

Stoma Ileostomy Clinical Trial

Official title:
Pilot Study of Preoperative Intestinal Training Using Antegrade Ileostomy Infusion

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06461559
Other study ID # 810144
Secondary ID
Status Not yet recruiting
Phase Phase 1/Phase 2
First received
Last updated
Start date August 1, 2024
Est. completion date November 1, 2025

Study information
Verified date June 2024
Source University of California, San Diego
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 20
Est. completion date November 1, 2025
Est. primary completion date August 1, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: - Has a diverting loop ileostomy - undergoing evaluation for stoma takedown Exclusion Criteria: - unable to perform consent - unable to perform stoma infusion

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• ileostomy infusion
infusing patient's own ileostomy content into the diverted intestine

Locations
Country Name City State
United States UC San Diego La Jolla California

Sponsors (1)
Lead Sponsor Collaborator
University of California, San Diego

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary timing to return of bowel function time to return of bowel function after stoma surgery 1-5 days
Secondary ease of stoma infusion how easy was it for patients to infuse contents 2 weeks prior to surgery to time of surgery
Secondary complications if there are any complications from using the stoma infusion 2 weeks prior to surgery to 30 days post operatively
See also
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Completed NCT03619226 - Evaluation of the Ability of Newly Developed Adhesives to Absorb Moisture N/A
Completed NCT06237686 - Clinical Investigation Exploring Two Ostomy Product Prototypes N/A