The APPI-Cost Trial: Cost Assessment of Povidone-Iodine Irrigation for Prevention of Intra-abdominal Abscess in Perforated Appendicitis
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 346
- 试验地点
- 1
- 主要终点
- Cost-effectiveness of PVI relative to usual care
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Plan to undergo appendectomy for acute appendicitis
排除标准
- •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
研究组 & 干预措施
PVI
干预措施: PVI (Drug)
Usual Care
干预措施: Usual Care (Drug)
结局指标
主要结局
Cost-effectiveness of PVI relative to usual care
时间窗: 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.
次要结局
- Total patient-reported costs(30 days, 90 days, 6 months, and 12 months)
- Health-related quality of life as assessed by the EQ-5D-5L questionnaire(30 days, 90 days, 6 months, and 12 months)
- Index admission total hospital costs(Index admission (variable duration))
- 90-day total hospital costs(90 day follow up)
- Index admission total length of hospital stay(Index admission (variable duration))
- 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)
研究者
Dalya M Ferguson, MD, MS
Assistant Professor
The University of Texas Health Science Center, Houston