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临床试验/NCT05475470
NCT05475470已完成不适用

A Prospective Randomized Controlled Trial on Safe Laparoscopic Access and Ports Insertion Using the Blade-Finger Technique

Zagazig University1 个研究点 分布在 1 个国家目标入组 1,005 人开始时间: 2020年3月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
1,005
试验地点
1
主要终点
time needed to access the peritoneal cavity

研究概览

简要总结

blade-finger technique is a new technique for laparoscopic access which is safe

详细描述

after optaining irb approval and patients consented, they were divided into 3 groups to whom one of the techniques of laparoscopic entery was applied and there was a comparison between these groups

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, Investigator)

入排标准

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

入选标准

  • •Patients more than 18 year-old.
  • •underwent laparoscopic surgery in general surgery departments in both centers from March, 2020 to May, 2022.

排除标准

  • •Patients with one or more previous abdominal surgery (upper, lower or upper and lower midline scars).
  • •Patients with distended abdomen due to bowel obstruction.
  • •Patients with uncorrected coagulopathy.

研究组 & 干预措施

group a

Experimental

the group we used our new blade-finger technique

干预措施: finger-blade technique (Procedure)

group b

Experimental

the group we used Hasson's technique

干预措施: Hasson's technique (Procedure)

group c

Experimental

the group we used veress needle technique

干预措施: veress needle technique (Procedure)

结局指标

主要结局

time needed to access the peritoneal cavity

时间窗: the first 15 minutes of operation

the time of the procedure of access

numbers of trials till the good peritoneal access achieved

时间窗: the first 15 minutes of operation

number of trials till succeeded peritoneal access

次要结局

  • rate of complications(the first 15 minutes of operation)

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Mohamed lotfy

Dr

Zagazig University

研究点 (1)

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