APPI-Cost Trial for Perforated Appendicitis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: PVI, Usual Care.
- Who it may be relevant to
- Registry conditions: Perforated Appendicitis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The APPI-Cost Trial: Cost Assessment of Povidone-Iodine Irrigation for Prevention of Intra-abdominal Abscess in Perforated Appendicitis
Overview
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.
Interventions
- Drug 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 - Drug 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.
Primary outcome measures
- Cost-effectiveness of PVI relative to usual care [Time frame: 30 day follow up]
Secondary outcome measures (8)
- Total patient-reported costs [Time frame: 30 days, 90 days, 6 months, and 12 months]
- Health-related quality of life as assessed by the EQ-5D-5L questionnaire [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 [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 [Time frame: 90 days follow up]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- The University of Texas Health Science Center at Houston — Houston
Identifiers
NCT: NCT06705842 · HSC-MS-24-0772 · 1K12TR004908-01