跳至主要内容
临床试验/NCT06045546
NCT06045546进行中(未招募)不适用

A (5-5-5-8) Technique for Laparoscopic Cholecystectomy

ClinAmygate1 个研究点 分布在 1 个国家目标入组 524 人开始时间: 2023年9月20日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
524
试验地点
1
主要终点
Duration of the operation

研究概览

简要总结

The aim of this current study is to investigate the effectiveness and safety of a novel technique which is the 5-5-5-8 where the camera port is 5 mm.

详细描述

More than 50 different LC procedures are described in the literature, mostly as a result of changes made by surgeons to enhance cosmetic and postoperative results. Some adjustments include port size and/or number reductions relative to conventional LC usage. Each of these methods has benefits and drawbacks, and each one is appropriate for usage in particular circumstances.

The aim of this current study is to investigate the effectiveness and safety of a novel technique which is the 5-5-5-8 where the camera port is 5 mm.

The study has two analyses:

  1. at 6 month follow up
  2. at 24 months follow up

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
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Aged > 18 years
  • Patients eligible for LC during the study period

排除标准

  • refused to participate

结局指标

主要结局

Duration of the operation

时间窗: 1 hour

Duration of the operation in minutes

Number of participants with Conversion to open surgery

时间窗: 1 hour

Number of participants with Failure of the technique and conversion to open surgery

Incidence of intra operative visceral injury

时间窗: 2 hours

Incidence of intra operative visceral injury

intra operative amount of blood loss

时间窗: 2 hours

intra operative amount of blood loss in ml

incidence of intra operative complications

时间窗: 2 hours

incidence of intra operative complications

次要结局

  • post operative stay(1 week)
  • incidence of port site infection(1 month)
  • Incidence of port site hernia(24 months)

研究者

发起方
ClinAmygate
申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验