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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
346
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.
The University of Texas Health Science Center at Houston
Houston, Texas, United States
RECRUITINGCost-effectiveness of PVI relative to usual care
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.
Time frame: 30 day follow up
Total patient-reported costs
Patient-reported costs will be assessed using a patient survey, which will be verbally administered by research personnel at each time point specified.
Time frame: 30 days, 90 days, 6 months, and 12 months
Health-related quality of life as assessed by the EQ-5D-5L questionnaire
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.
Time frame: 30 days, 90 days, 6 months, and 12 months
Index admission total hospital costs
Time frame: Index admission (variable duration)
90-day total hospital costs
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Time frame: 90 day follow up
Index admission total length of hospital stay
Time frame: Index admission (variable duration)
90-day total length of hospital stay
Time frame: 90 day follow up
Number of days of work missed by participant
Time frame: 12 months
Postoperative complications
Complications include IAA, clinically relevant IAA, superficial/deep surgical site infection, ED visit, readmission, reoperation, subsequent procedure, or mortality
Time frame: 90 days follow up