Pilot Study of Preoperative Intestinal Training Using Ant... | NCT06461559

Studies
Pilot Study of Preoperative Intestinal Training Using Antegrade Ileostomy Infusion

NCT06461559

Sponsor

University of California, San Diego

Status

Recruiting

Last Update Posted

Dec 15, 2025Actual

Enrollment

20Estimated

Phase

Phase 1Phase 2

Conditions

Stoma Ileostomy
Ileostomy; Complications

Interventions

antegrade infusion of ileostomy content

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 1, 2024Actual

Primary Completion Date

Mar 1, 2026Estimated

Completion Date

May 1, 2026Estimated

First Submitted Date

Jun 11, 2024

First Submission Date that Met QC Criteria

Jun 11, 2024

First Posted Date

Jun 17, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 11, 2025

Last Update Posted Date

Dec 15, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Shanglei Liu, Assistant Professor of Surgery, University of California, San DiegoPrincipal Investigator

Lead Sponsor

University of California, San DiegoOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Control	No Intervention
Ileostomy infusion	Active Comparator	perform infusion if ileostomy prior to takedown operation	Device: antegrade infusion of ileostomy content

Interventions

Name	Type	Description	Arm Group Labels	Other Names
antegrade infusion of ileostomy content	Device	infusing the contents of ileostomy output back into intestine of the patient	Ileostomy infusion

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
timing to return of bowel function	time to return of bowel function after stoma surgery	1-5 days

Secondary Outcomes

Measure	Description	Time Frame
ease of stoma infusion	how easy was it for patients to infuse contents	2 weeks prior to surgery to time of surgery
complications	if there are any complications from using the stoma infusion

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Has a diverting loop ileostomy
undergoing evaluation for stoma takedown

Exclusion Criteria:

unable to perform consent
unable to perform stoma infusion

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
UC San Diego	Recruiting	La Jolla	California	92093	United States

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided