Laparoscopy Using the Airseal System Versus Standard Insufflation in Cholecystectomy in Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Amount of analgesics consumed
研究概览
简要总结
The goal of this observational study is to compare the use of Airseal versus a standard insufflation, in children who underwent laparoscopic cholecystectomy, between January 2021 and December 2022.
The main questions it aims to answer are:
- amount of analgesics consumed postoperatively
- mean digital pain scale
Data are directly extracted from patients medical files.
The investigators will compare the Airseal group (A group) to the Standard insufflation group (S group) to see if the A group consumes significatively less analgesics and are less painful than the S group.
详细描述
Choosing to enter the A or the S group depends on the surgeon's choice.
Only the surgeon, the anesthetic and the nurses in the operating room know which type of insufflation has been chosen.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 0 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged under 18 years old
- •Who underwent laparoscopic cholecystectomy
- •From January 2021 to December 2022
排除标准
- •Patients older than 18 years old
结局指标
主要结局
Amount of analgesics consumed
时间窗: From the end of surgery to the discharge home, up to 20 days
Number of takings postoperatively
Mean Digital Pain Scale
时间窗: From the end of surgery to the discharge home, , up to 20 days
Digital Pain Scale: minimum is 0 out of 10 (which means no pain) and maximum is 10 out of 10 (which means very painful). Higher scores mean worse outcomes.
次要结局
- Operating time(Perioperatively)
- Anesthetic time(Perioperatively)
- Length of stay(From the day of hospitalization to the day of discharge home, up to 20 days)
- Histological results(Between 2 weeks and 4 weeks after surgery)
研究者
Destinval Christelle
Dr.
University Hospital, Clermont-Ferrand