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临床试验/NCT02407483
NCT02407483已完成不适用

Laparoscopic Simulator Training With or Without Laser Visual Guidance -A Randomized Trial

Rigshospitalet, Denmark1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2015年3月1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
32
试验地点
1
主要终点
Motor skills performance parameters (Cumulative Instrument movement-time)

研究概览

简要总结

"Laparoscopic simulation training with or without laser visual guidance -A randomised study" which investigates if the use of laser visual guidance can help the novices to learn the laparoscopic skills.

详细描述

Background: The loss of depth perception due to working in a three-dimensional space based on two-dimensional images is one of the challenging aspects of laparoscopy compared to conventional open surgery.

Objectives: To examine the effect of laser visual guidance on laparoscopic performance and cognitive load in a simulated setting for novices.

Methods: Randomised Clinical Trial- Laser visual guidance vs. normal 2 D vision.

Outcomes:

Primary outcome: Motor skills performance parameters-movement-time:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

性别
All
接受健康志愿者
是

入选标准

  • •Surgical novices / medical students enrolled at The Faculty of Health Science, University of Copenhagen.
  • •Participants are required to provide informed consent before inclusion.

排除标准

  • •Participation in prior studies involving laparoscopic training.
  • •Experience with laparoscopy surgery (having performed minimum one laparoscopic procedure as primary surgeon, including supervised procedures).
  • •No informed consent.
  • •Does not speak Danish on a conversational level.

研究组 & 干预措施

Laser Visual Guidance group

Experimental

Will be tested using simulated laparoscopic tasks with the use of laser visual guidance

干预措施: Laser Visual Guidance (Device)

Normal 2D vision group

Active Comparator

Will be tested using simulated laparoscopic tasks without the use of laser visual guidance

干预措施: 2 D vision (Device)

结局指标

主要结局

Motor skills performance parameters (Cumulative Instrument movement-time)

时间窗: 3 hours

Cumulative Instrument movement-time

次要结局

  • The composite performance score (errors)(3 hours)

研究者

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

Stine Maya Dreier Sørensen

Medical Student

Rigshospitalet, Denmark

研究点 (1)

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