RecruitingPhase 4

APPI-Cost Trial for Perforated Appendicitis

United States346 participantsStarted 2025-04-07

Plain-language summary

The purpose of this study to assess the clinical effectiveness and cost-effectiveness of povidone-iodine (PVI) irrigation in perforated appendicitis, to investigate barriers and facilitators to future implementation of PVI irrigation, and to collect costs and clinical and patient-reported outcomes among patients with non-perforated appendicitis.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Eligibility for Enrollment Inclusion Criteria: * Plan to undergo appendectomy for acute appendicitis Exclusion Criteria: * Preoperative hemodynamic instability requiring ongoing infusion of vasopressors * Allergy to iodine * Uncontrolled hyper- or hypothyroidism * Renal dysfunction * Pregnant or breastfeeding * Primary language neither English nor Spanish * Lack of functioning telephone or email account * Incarcerated or in police custody Eligibility for Randomization Inclusion Criteria: * Enrolled in study preoperatively * Intraoperative diagnosis of perforated appendicitis Exclusion Criteria: * Non-perforated appendicitis

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Cost-effectiveness of PVI relative to usual care

Timeframe: 30 day follow up

Trial details

NCT IDNCT06705842

SponsorThe University of Texas Health Science Center, Houston

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-06-30

Contact for this trial

Dalya M Ferguson, MD, MS

(713) 566-5098 Dalya.M.Ferguson@uth.tmc.edu

View on ClinicalTrials.gov More Perforated Appendicitis trials