Randomized, Prospective, Single Blinded Trial of Laparoscopic Versus Open Appendectomy in Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 400
- 试验地点
- 3
- 主要终点
- Surgical complications, length of stay, pain medication requirements
研究概览
简要总结
The study intends to compare the results of two surgical methods to remove the appendix in children with appendicitis. Specifically, up to 500 children over 3 years will be placed in two groups where the only difference in treatment is open or laparoscopic (scope) operation. Each group will be tracked for their baseline characteristics, events during operation and recovery, pain medication requirements, duration of hospital stay, and patient/family satisfaction.
The investigators hypothesize that their will be no difference in the parameters measured between the techniques of appendix removal.
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
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All children under the age of 18 years with diagnosed appendicitis
排除标准
- •Refusal of consent
- •Primary language other than English or Spanish.
研究组 & 干预措施
1
children randomized to open appendectomy
干预措施: open appendectomy (Procedure)
2
children randomized to laparoscopic appendectomy
干预措施: laparoscopic appendectomy (Procedure)
结局指标
主要结局
Surgical complications, length of stay, pain medication requirements
时间窗: within 30 days of intervention
次要结局
- Patient/family satisfaction(within 7 days of intervention)
研究者
David Bliss
MD
Oregon Health and Science University