APPI-Cost Trial for Perforated Appendicitis
The APPI-Cost Trial: Cost Assessment of Povidone-Iodine Irrigation for Prevention of Intra-abdominal Abscess in Perforated Appendicitis
The University of Texas Health Science Center, Houston
346 participants
Apr 7, 2025
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria4
- Eligibility for Enrollment
- Plan to undergo appendectomy for acute appendicitis
- Enrolled in study preoperatively
- Intraoperative diagnosis of perforated appendicitis
Exclusion Criteria10
- 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
- Non-perforated appendicitis
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Interventions
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
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.
Locations(1)
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NCT06705842