Laparoscopic Augmented Reality for Identification of Liver Lesions - a Pre-clinical Randomized Cross-over Trial

Summary

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.

Conditions

• Laparoscopy
• Augmented Reality
• Orientation, Spatial
• Liver

Interventions

OTHER

Method A

The subjects will perform tasks on the liver phantom (identification of target lesions). They will perform the tasks with Method A (2D-CT) or Method B (2D-CT + 3D augmented reality model). the intervention type Method A means that the trainings set up is performed first with Method A an after that with Method B.

OTHER

Method B

The subjects will perform tasks on the liver phantom (identifikation of target lesions). They will perform the tasks with Method A (2D-CT) or Method B (2D-CT + 3D augmented reality model). the intervention type Method B means that the trainings set up is performed first with Method B an after that with Method A.

Sponsors & Collaborators

• Universitätsklinikum Köln

  lead OTHER

Principal Investigators

• Roger Wahba, MD, PHD · Universitätsklinikum Köln

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

SINGLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2022-09-01

Primary Completion

2023-12-01

Completion

2024-03-01

Countries

• Germany

Study Locations