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Recruiting

NCT Number: NCT06461559

Pilot Study of Preoperative Intestinal Training Using Antegrade Ileostomy Infusion

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.

Recruiting

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Key information

Conditions

Stoma Ileostomy Ileostomy; Complications

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

UC San Diego

La Jolla, California, 92093, United States

Location status: Recruiting

Location contact

Shanglei Liu

CONTACT

[email protected]

858-249-1837

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • unable to perform consent
  • unable to perform stoma infusion

Treatment and study plan

antegrade infusion of ileostomy content

Device

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

Primary outcomes

  1. timing to return of bowel function

    Time frame: 1-5 days

    time to return of bowel function after stoma surgery

Secondary outcomes

  1. ease of stoma infusion

    Time frame: 2 weeks prior to surgery to time of surgery

    how easy was it for patients to infuse contents

  2. complications

    Time frame: 2 weeks prior to surgery to 30 days post operatively

    if there are any complications from using the stoma infusion

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jun 17, 2024
Registry last updated
Dec 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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