Laparoscopic Versus Open Appendectomy? Let the Patient Decide
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Choice Based on Cost
研究概览
简要总结
This protocol examines choice where it pertains to choosing between two standard methods for appendectomy, laparoscopic or open procedures, and the affect that "cost" of the appendectomy has upon choice.
Children admitted with a diagnosis of uncomplicated appendicitis will be consented to participate in a study in which the patient can choose between laparoscopic or open appendectomy procedures. Those that agree to review a consent form will be randomly placed into one of two groups. The two groups consist of one in which the consent form includes "cost information for each operative procedure" in the comparison between the procedures, and the other group receives a consent form that does not include "cost information for each operative procedure". Both groups also view a short, group specific, computerized presentation that describes each procedure.
The hypothesis is that those patients given a choice between two similar surgical procedures and are provided with "cost information" will more often choose the less expensive surgical procedure than those that do not have information related to the cost of the surgical procedures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 年龄范围
- — 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •acute appendicitis
排除标准
- •age 18 or older
- •imaging positive for perforation; ultrasound or CT scan
- •pain for greater than 2 days
- •children with a body mass index > 95% for age and sex
- •surgeon decision for non-equivalent procedure based on patient presentation
结局指标
主要结局
Choice Based on Cost
时间窗: Outcome assessed prior to surgical procedure with data presented within 1 year
The group given information related to the cost of each surgical procedure will more often choose the less expensive procedure as compared to those not given cost information
次要结局
- Hospital/Operative Dollars(Data will be collected within an expected average of 3 months post-discharge with data presented within 1 year)