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临床试验/NCT05389241
NCT05389241Unknown不适用

Monocentric Prospective Randomized Study on the Influence of On-screen Use of a Virtual 3-dimensional Liver Model Reconstructed From CT Data on Spatial Perception During Laparoscopy on the Liver Phantom.

Universitätsklinikum Köln1 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2022年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
72
试验地点
1
主要终点
Number of correctly identified targets

研究概览

简要总结

Procedure preparation and accurate knowledge of the specific anatomy is an integral part of performing minimally invasive procedures. Due to the complexity with high variability and the non-visibility of the vascular structures, the liver poses a particular challenge.

Therefore medical students and experienced surgeons will receive standardized, structured training on liver anatomy, the use of laparoscopic ultrasound and the application and use of CT data sets and the virtual 3D liver model. This training will be evaluated by questionnaires. Both groups then carry out a series of localization exercises on an artificial liver phantom: tumor imitations, which are displayed in the image(3D virtaul mdoel or 2D-CT-Data-Set), have to be found in the liver phantom laparoscopically using ultrasound.

In each round, different scenarios are worked on, once without and then with the support of the virtual 3D liver model. The virtual 3D model can be displayed directly on the laparoscopic monitor using a display software specially developed for the trial and can be manipulated by the subjects.

The aim of the study is to provide evidence that the availability and use of a virtual 3D model (augmented reality) leads to a significantly improved spatial perception of the subjects during laparoscopy of the liver. In addition, the subjectively perceived cognitive load of the subjects during the test run with and without the support of the virtual 3D model is surveyed and the learning success is evaluated.

详细描述

Procedure preparation and accurate knowledge of the specific anatomy is an integral part of performing a minimally invasive procedure. Due to the complexity with high variability and the non-visibility of the vascular structures due to the location in the parenchyma, the liver poses a particular challenge. The spatial perception and cognitive processing of the anatomical target structures is of particular importance.

The aim of this study is to test the hypothesis that the use of a 3-dimensional (3D) virtual liver model (virtual 3D model crating augmented reality) presenedt on teh laparoscopic screeen reconstructed from CT data exerts an influence on the spatial perception of subjects during laparoscopy on the liver phantom.

After informed consent and consent to the study, a pseudonymised subject population consisting of surgeons with experience in laparoscopy (n=36) and an equal number of medical students without experience in laparoscopy (n=36) will be included in the study included. The subjects will be randomized and divided into two groups of equal size, stratified according to experience in laparoscopy. The randomization is carried out by a data trustee. All subjects then receive standardized, structured training on liver anatomy, the use of laparoscopic ultrasound, and the application and use of CT data sets and the virtual 3D liver model. This is evaluated by means of a questionnaire. Both groups then sequentially carry out a defined series of localization exercises on an artificial liver phantom: tumor imitations, which are displayed in the image, have to be found in the liver phantom laparoscopically using ultrasound. In each round, different scenarios are worked on once without and then with the support of the virtual 3D liver model. The virtual 3D model can be displayed directly on the laparoscopic monitor using display software specially made for the study and can be manipulated by the subjects. The aim of the study is to provide evidence that the availability and use of a virtual 3D model leads to a significantly improved spatial perception of the subjects during laparoscopy of the liver. In addition, the subjectively perceived cognitive load of the subjects during the test run with and without the support of the virtual 3D model is surveyed by NASA Task Load Index and the learning success is evaluated.

The primary endpoints of the study are the number of correctly spatially identified target structures and the time required to localize the given target structures.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Other
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
是

入选标准

  • •medical student of University of Cologne OR medical doctor in a surgical specialty
  • •informed consent signed

排除标准

  • •known and not correctable deficit of stereoscopic view
  • •for medical students: experience with laparoscopy or laparoscopy simulators

研究组 & 干预措施

Method A

Experimental

Subjects in this arm will perform the task on the liver phantom with Method A (2D-CT). Then they will do the NASA task load index questionnaire. After that they will perform the tasks with Method B (2D-CT + 3D augmented reality model). After that again a NASA Task load index questionnaire is performed

干预措施: Method A (Other)

Method B

Experimental

Subjects in this arm will perform the task on the liver phantom with method B (2D-CT + 3D augmented reality model). Then they will do the NASA task load index questionnaire. After that they will perform the tasks with Method A (2D-CT). After that again a NASA Task load index questionnaire is performed

干预措施: Method B (Other)

结局指标

主要结局

Number of correctly identified targets

时间窗: immediately after tasks are performed, Day 1

The number of correctly spatially identified targets (tumors in the liver phantom)

Time required

时间窗: immediately after tasks are performed, Day 1

The time required to localize the specified target structures (tumors in the live phantom)

次要结局

  • Learning curve(immediately after tasks are performed with both methods, Day 1)
  • Task Load Index(immediately after tasks are performed, Day 1)
  • Modification of procedure planning(immediately after tasks are performed with both methods, 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 (1)

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