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APPI-Cost Trial for Perforated Appendicitis
Sponsor: The University of Texas Health Science Center, Houston
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.
Official title: The APPI-Cost Trial: Cost Assessment of Povidone-Iodine Irrigation for Prevention of Intra-abdominal Abscess in Perforated Appendicitis
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
346
Start Date
2025-04-07
Completion Date
2027-03-31
Last Updated
2025-12-11
Healthy Volunteers
No
Conditions
Interventions
PVI
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
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)
The University of Texas Health Science Center at Houston
Houston, Texas, United States