Pilot Study of Preoperative Intestinal Training Using Antegrade Ileostomy Infusion

NCT ID: NCT06461559

Last Updated: 2025-12-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-01

Study Completion Date

2026-05-01

Brief Summary

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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.

Detailed Description

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Conditions

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Stoma Ileostomy Ileostomy; Complications

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Caregivers Investigators

Study Groups

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Control

Group Type NO_INTERVENTION

No interventions assigned to this group

Ileostomy infusion

perform infusion if ileostomy prior to takedown operation

Group Type ACTIVE_COMPARATOR

antegrade infusion of ileostomy content

Intervention Type DEVICE

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

Interventions

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antegrade infusion of ileostomy content

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* unable to perform consent
* unable to perform stoma infusion
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of California, San Diego

OTHER

Sponsor Role lead

Responsible Party

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Shanglei Liu

Assistant Professor of Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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UC San Diego

La Jolla, California, United States

Site Status RECRUITING

Countries

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United States

Facility Contacts

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Shanglei Liu

Role: primary

858-249-1837

Other Identifiers

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810144

Identifier Type: -

Identifier Source: org_study_id

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