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临床试验/NCT06734494
NCT06734494已完成不适用

Laparoscopic Appendectomy Using Airseal or a Standard Insufflator for Peritonitis in Children

Destinval Christelle1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2022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
100
试验地点
1
主要终点
Consumption of analgesics

研究概览

简要总结

The AirSeal System Valve-less Trocar is known to decrease postoperative pain, consumption of analgesics, operating time, and length of stay in adults during robotic and laparoscopic procedures. The investigators would like to know if these allegations also apply to children.

详细描述

From January the 1st 2022 to December the 31st 2022, 100 children aged under 18 years old had an appendicular peritonitis treated by laparoscopic appendectomy. The pediatric surgeons either used the AirSeal System Valve-less Trocar or the standard insufflation. On one hand, only the surgeon, the anesthetist and the nurses of the operating room knew which type of insufflation was used. On the other hand, the patient, his parents and the nurses in the pediatric department did not know which type of insufflation was used. The participants were divided in two groups: the Airseal group (A) and the standard group (S). In each group, the investigators studied and compared the postoperative pain, the consumption of analgesics, the operating time, and the length of stay for each participant.

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
4 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children aged between 4 and 17 years old
  • Who underwent laparoscopic appendectomy for appendicular peritonitis
  • Between 2022/06/1st and 2022/12/31st

排除标准

  • Children younger than 4 years old or older than 18 years old
  • Who did not have appendicular peritonitis
  • Between 2022/01/1st and 2022/12/31st

结局指标

主要结局

Consumption of analgesics

时间窗: From the end of surgery to the discharge home, up to 20 days

Number of medications taken during hospitalization

次要结局

  • Length of stay(From the admission to the discharge home, up to 20 days)
  • Operating Time(From beginning to end of surgery)
  • Mean Digital Pain Scale(Immediately after surgery until discharge home, up to 20 days)

研究者

发起方
Destinval Christelle
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Destinval Christelle

Dr.

University Hospital, Clermont-Ferrand

研究点 (1)

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