APPI-Cost Trial for Perforated Appendicitis
ConditionPerforated Appendicitis
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe University of Texas Health Science Center, Houston
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Plan to undergo appendectomy for acute appendicitis
Disqualifiers
Preoperative hemodynamic instability requiring ongoing infusion of vasopressors
Allergy to iodine
Uncontrolled hyper- or hypothyroidism
Renal dysfunction
Trial design
Design model
Parallel
Treatments tested in this trial
PVI
DrugAfter 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
DrugSurgeons 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.
Treatment groups
346 Participants
are divided into 2 treatment groupsGroup A: PVIActive comparator 1 intervention
Group B: Usual CareActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Cost-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 upSecondary outcomes
1
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 months2
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 months3
Index admission total hospital costs
Time frame
Index admission (variable duration)4
90-day total hospital costs
Time frame
90 day follow upSponsors and contacts
Click on the lead sponsor to view all of their trials.
The University of Texas Health Science Center, Houston
Lead sponsor
National Center for Advancing Translational Sciences (NCATS)
Collaborator
Source ClinicalTrials.gov