Pilot Study of Preoperative Intestinal Training Using Antegrade Ileostomy Infusion
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: antegrade infusion of ileostomy content.
- Who it may be relevant to
- Registry conditions: Stoma Ileostomy, Ileostomy; Complications. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Device antegrade infusion of ileostomy content
infusing the contents of ileostomy output back into intestine of the patient
Primary outcome measures
- timing to return of bowel function [Time frame: 1-5 days]
Secondary outcome measures (2)
- ease of stoma infusion [Time frame: 2 weeks prior to surgery to time of surgery]
- complications [Time frame: 2 weeks prior to surgery to 30 days post operatively]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- UC San Diego — La Jolla
Identifiers
NCT: NCT06461559 · 810144