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NCT Number: NCT06705842

APPI-Cost Trial for Perforated Appendicitis

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.

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Key information

Conditions

Perforated Appendicitis Abdominal Abscess Abscess Appendicitis Cecal Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Infections Intestinal Diseases Intraabdominal Infections Suppuration

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PVI

Drug

After removal of the appendix from the patient's abdomen and attainment of hemostasis, 10 mL/kg of 1% PVI (up to a maximum of 1,000 mL) will be used to irrigate the pelvis and right upper and lower quadrants. The solution will be left to dwell for 1 minute and then suctioned out

Usual Care

Drug

Surgeons may utilize local irrigation with saline if deemed necessary, defined as instillation of a small volume (<100 mL) of liquid followed by aspiration, for the purpose of confirming hemostasis or suctioning thick fluid. Some surgeons may utilize large volume irrigation with saline solution, if that is consistent with their usual practice. Patients in the usual care arm will not receive PVI irrigation.

Primary outcomes

  1. Cost-effectiveness of PVI relative to usual care

    Time frame: 30 day follow up

    Cost-effectiveness of PVI irrigation relative to usual care will be assessed as the incremental 30-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 30 days from randomization. PVI will be deemed cost-effective by either 1) reducing 30-day IAA rate without increasing 30-day total societal costs, 2) reducing 30-day total societal costs without increasing 30-day IAA rate, or 3) reducing both 30-day societal costs and IAA rate.

Secondary outcomes

  1. Total patient-reported costs

    Time frame: 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.

  2. Health-related quality of life as assessed by the EQ-5D-5L questionnaire

    Time frame: 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.

  3. Index admission total hospital costs

    Time frame: Index admission (variable duration)

  4. 90-day total hospital costs

    Time frame: 90 day follow up

  5. Index admission total length of hospital stay

    Time frame: Index admission (variable duration)

  6. 90-day total length of hospital stay

    Time frame: 90 day follow up

  7. Number of days of work missed by participant

    Time frame: 12 months

  8. Postoperative complications

    Time frame: 90 days follow up

    Complications include IAA, clinically relevant IAA, superficial/deep surgical site infection, ED visit, readmission, reoperation, subsequent procedure, or mortality

Study contacts

Contact information is provided by the study sponsor or research team.

Dalya M Ferguson, MD, MS

CONTACT

[email protected]

(713) 566-5098

Debbie Nguyen

CONTACT

[email protected]

(713) 566-5098

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Collaborators

  • National Center for Advancing Translational Sciences (NCATS)

Registry information

Official study title

The APPI-Cost Trial: Cost Assessment of Povidone-Iodine Irrigation for Prevention of Intra-abdominal Abscess in Perforated Appendicitis

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Nov 26, 2024
Registry last updated
Dec 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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