Pilot Study of Preoperative Intestinal Training Using Antegrade Ileostomy Infusion
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorUniversity of California, San Diego
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Has a diverting loop ileostomy
undergoing evaluation for stoma takedown
Disqualifiers
unable to perform consent
unable to perform stoma infusion
Trial design
Design model
Parallel
Treatments tested in this trial
antegrade infusion of ileostomy content
Deviceinfusing the contents of ileostomy output back into intestine of the patient
Treatment groups
20 Participants
are divided into 2 treatment groupsGroup A: ControlNo intervention 0 interventions
Group B: Ileostomy infusionActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
timing to return of bowel function
time to return of bowel function after stoma surgery
Time frame
1-5 daysSecondary outcomes
1
ease of stoma infusion
how easy was it for patients to infuse contents
Time frame
2 weeks prior to surgery to time of surgery2
complications
if there are any complications from using the stoma infusion
Time frame
2 weeks prior to surgery to 30 days post operativelySponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov