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临床试验/NCT05848726
NCT05848726已完成不适用

Low-Pressure Laparoscopy Using the Airseal System Versus Standard Insufflation in Cholecystectomy in Children: A Monocentric Retrospective Study

University of Lorraine1 个研究点 分布在 1 个国家目标入组 23 人开始时间: 2021年1月1日最近更新:
适应症

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
Other
时间视角
Retrospective

入排标准

年龄范围
— 至 17 Years(Child)
性别
All
接受健康志愿者

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

  • Histological results(between 2 weeks and 4 weeks after surgery)
  • Length of stay(From the day of hospitalization to the day of discharge home, up to 20 days)
  • Anesthetic time(Perioperatively)
  • Operating time(Perioperatively)

研究者

发起方
University of Lorraine
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr Christelle DESTINVAL

Principal Investigator

University of Lorraine

研究点 (1)

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