APPI-Cost Trial for Perforated Appendicitis

Phase 4

Recruiting

• Conditions: Perforated Appendicitis
• Interventions: Drug: PVI; Drug: Usual Care

• Registration Number: NCT06705842
• Lead Sponsor: The University of Texas Health Science Center, Houston

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-11-19
• Study First Submitted QC: 2024-11-22
• Study First Posted: 2024-11-26
• Status Verified: 2025-04
• Study Start: 2025-04-07
• Last Update Submitted: 2025-04-28
• Last Update Posted: 2025-04-29
• Primary Completion: 2026-06-30
• Study Completion: 2027-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 346

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PVI	PVI	-
Usual Care	Usual Care	-

Primary Outcome Measures

Name	Time	Method
Cost-effectiveness of PVI relative to usual care	90 day follow up	Cost-effectiveness of PVI irrigation relative to usual care will be assessed as the incremental 90-day total societal costs per percent reduction in IAA rate. The Incremental Cost Effectiveness Ratio (ICER) will be calculated as: (societal costs with PVI irrigation minus societal costs with usual care) divided by (IAA rate with PVI minus IAA rate with usual care). IAA will be defined as an image-confirmed fluid collection deemed to be an IAA by an attending surgeon or radiologist, or an abscess confirmed during percutaneous intervention or reoperation. Societal costs will be defined as patient-reported costs plus medical costs for inpatient and outpatient care within 90 days from randomization. PVI will be deemed cost-effective by either 1) reducing 90-day IAA rate without increasing 90-day total societal costs, 2) reducing 90-day total societal costs without increasing 90-day IAA rate, or 3) reducing both 90-day societal costs and IAA rate.

Secondary Outcome Measures

Name	Time	Method
Total patient-reported costs	30 days, 90 days, 6 months, and 12 months	Patient-reported costs will be assessed using a patient survey, which will be verbally administered by research personnel at each time point specified.
Health-related quality of life as assessed by the EQ-5D-5L questionnaire	30 days, 90 days, 6 months, and 12 months	This is a 6 item questionnaire and the first 5 questions are each scored from 1 (no problem) - 5 (unable to), for a maximum score of 25, with a higher number indicating a worse outcome. The 6th question is scored on a Likert scale from 0 (worst health you can imagine) - 100 (best health you can imagine), with a higher score indicating a worse outcome.
Index admission total hospital costs	Index admission (variable duration)
90-day total hospital costs	90 day follow up
Index admission total length of hospital stay	Index admission (variable duration)
90-day total length of hospital stay	90 day follow up
Number of days of work missed by participant	12 months
Postoperative complications	90 days follow up	Complications include IAA, clinically relevant IAA, superficial/deep surgical site infection, ED visit, readmission, reoperation, subsequent procedure, or mortality

Trial Locations

Locations (1)

The University of Texas Health Science Center at Houston; 🇺🇸 Houston, Texas, United States