Pilot Study of Preoperative Intestinal Training Using Antegrade Ileostomy Infusion

University of California San Diego

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Stoma Ileostomy; Ileostomy; Complications

Treatments: Device: antegrade infusion of ileostomy content

Study type: Interventional

Funder types: Other

Identifiers

NCT06461559

810144

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• unable to perform consent
• unable to perform stoma infusion

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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20 participants in 2 patient groups

Control

No Intervention group

Ileostomy infusion

Active Comparator group

Description:

perform infusion if ileostomy prior to takedown operation

Treatment:

Device: antegrade infusion of ileostomy content