APPI-Cost Trial for Perforated Appendicitis

Browse trials for

• Appendicitis 419
• Abdominal Abscess 31

Keywords

• Perforated Appendicitis
• Povidone Iodine
• Cost effectiveness
• Intra-abdominal abscess
• Appendectomy
• Implementation science

Appendicitis

419 studies on the registry are indexed under Appendicitis; 67 are open to participants now.

This study's planned enrollment of 346 is above the median of 111 across 252 interventional studies indexed under Appendicitis.

Lead sponsor

The University of Texas Health Science Center, Houston is the lead sponsor of 897 studies on the registry; 214 are open to participants now.

Of its 173 completed or terminated interventional studies of FDA-regulated products, 142 (82%) have results posted.

Eligibility criteria

Study arms

• Active comparator
  PVI

  Drug: PVI

• Active comparator
  Usual Care

  Drug: Usual Care

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.

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 up

Secondary 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 months

2. 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

3. Index admission total hospital costs

   Time frame: Index admission (variable duration)

4. 90-day total hospital costs

   Time frame: 90 day follow up

5. Index admission total length of hospital stay

   Time frame: Index admission (variable duration)

6. 90-day total length of hospital stay

   Time frame: 90 day follow up

7. Number of days of work missed by participant

   Time frame: 12 months

8. 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

Individual participant data

Plan to share: Undecided — Starting 6 months after study publication, de-identified data and study materials may be made available to researchers on a case-by-case basis.