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临床试验/NCT03445429
NCT03445429已完成不适用

3D- vs. 4K-display System - Influence of "State-of-the-art"-Display Technique on Surgical Performance

Universitätsklinikum Köln2 个研究点 分布在 1 个国家目标入组 133 人开始时间: 2018年2月28日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
133
试验地点
2
主要终点
Surgical Performance Time

研究概览

简要总结

Modern display technique seems to optimize visualization in minimal-invasive surgery. Many systems are available right now with a fundamental difference between the passive polarizing 3-dimensional (3D) and 2-dimensional (2D) technique. Data seems to show a benefit for the 3D technique in the visualization of the operative field. This could lead to more precision in minimal-invasive surgery. 2D-systems with high resolution of 4.096 x 2.180 pixels (4K) could be a promising alternative. This study wants to evaluate if 3D- or 4K- display technique could optimize surgeons´ view and improve the performance during minimal-invasive surgery. Therefore medical students and surgeons of different experience levels will perform surgical tasks on a minimal-invasive training system.They will be randomized to use first the 3D- or the 4K-display system in the training set-up. After completing the tasks with one system the minimal-invasive training set-up will be repeated with the other display system. NASA (National Aeronautics and Space Administration) task load index is evaluated after each round. The ability for stereoscopic vision is tested after finishing the complete training set-up with both systems. The primary outcome parameter surgical performance will be evaluated in this study defined as the performance time and the number of defined mistakes made during each task.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Single (Participant)

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

  • medical student
  • medical doctor
  • informed consent signed

排除标准

  • known deficit of stereoscopic view
  • experience with the tasks of the minimal-invasive training set-up
  • not able to use both hands for minimal-invasive training set-up

结局指标

主要结局

Surgical Performance Time

时间窗: immediately after tasks are performed, Day 1

The surgical performance time is defined as time needed to complete the tasks at the minimal-invasive trainer. the time is measured in seconds

Surgical Performance Errors

时间窗: immediately after tasks are performed, Day 1

it is measured once directly after completing the task with the 3D performance time and the number of errors: the surgical performance errors are defined as the number of defined errors made during the performance of the tasks at the minimal invasive trainer surgical performance errors = number of errors

次要结局

  • Stereoscopic view Cover(immediately after tasks with both systems (3D and 4K) are performed, Day 1)
  • Task Load(immediately after tasks are performed, Day 1)
  • Learning curve(immediately after tasks with both systems (3D and 4K) are performed, Day 1)
  • Stereoscopic view Bagolini(immediately after tasks with both systems (3D and 4K) are performed, Day 1)
  • Stereoscopic view Lang I/II(immediately after tasks with both systems (3D and 4K) are performed, Day 1)
  • Stereoscopic view Titmus(immediately after tasks with both systems (3D and 4K) are performed, Day 1)
  • Stereoscopic view TNO(immediately after tasks with both systems (3D and 4K) are performed, Day 1)

研究者

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

Roger Wahba, MD, PhD

Priv.-Doz. Dr. med. Roger Wahba

Universitätsklinikum Köln

研究点 (2)

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