Pilot Study of Preoperative Intestinal Training Using Antegrade Ileostomy Infusion

NCT06461559 | Recruiting Phase 1

• 1 other identifier: 810144
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Stoma Ileostomy; Ileostomy; Complications

Outcome Measures

Primary Outcomes (1)

• timing to return of bowel function

  time to return of bowel function after stoma surgery

  1-5 days

Secondary Outcomes (2)

• ease of stoma infusion

  2 weeks prior to surgery to time of surgery

• complications

  2 weeks prior to surgery to 30 days post operatively

Study Arms (2)

Control

NO INTERVENTION

Ileostomy infusion

ACTIVE COMPARATOR

perform infusion if ileostomy prior to takedown operation

Device: antegrade infusion of ileostomy content

Interventions

antegrade infusion of ileostomy content DEVICE

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

Ileostomy infusion

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• unable to perform consent
• unable to perform stoma infusion

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

UC San Diego

La Jolla, California, 92093, United States

RECRUITING

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Surgery

Study Record Dates

• First Submitted: June 11, 2024
• First Posted: June 17, 2024
• Study Start: August 1, 2024
• Primary Completion: March 1, 2026
• Study Completion: May 1, 2026
• Last Updated: December 15, 2025

Record last verified: 2025-06

Locations

US (1)