Perforated Appendicitis
Conditions
Keywords
Perforated Appendicitis, Povidone Iodine, Cost effectiveness, Intra-abdominal abscess, Appendectomy, Implementation science
Brief 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.
Interventions
DRUGPVI
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
DRUGUsual 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.
Sponsors
National Center for Advancing Translational Sciences (NCATS)
The University of Texas Health Science Center, Houston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cost-effectiveness of PVI relative to usual care | 30 day follow up | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Health-related quality of life as assessed by the EQ-5D-5L questionnaire | 30 days, 90 days, 6 months, and 12 months | 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. |
| Index admission total hospital costs | Index admission (variable duration) | — |
| 90-day total hospital costs | 90 day follow up | — |
| Total patient-reported costs | 30 days, 90 days, 6 months, and 12 months | Patient-reported costs will be assessed using a patient survey, which will be verbally administered by research personnel at each time point specified. |
| 90-day total length of hospital stay | 90 day follow up | — |
| Number of days of work missed by participant | 12 months | — |
| Postoperative complications | 90 days follow up | Complications include IAA, clinically relevant IAA, superficial/deep surgical site infection, ED visit, readmission, reoperation, subsequent procedure, or mortality |
| Index admission total length of hospital stay | Index admission (variable duration) | — |
Countries
United States
Contacts
Primary ContactDalya M Ferguson, MD, MS
Backup ContactDebbie Nguyen
Outcome results
None listed