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

NCT ID: NCT05389241

Last Updated: 2022-08-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-01
• Study Completion Date: 2024-03-01

Brief 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.

Detailed Description

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.

Conditions

Laparoscopy; Augmented Reality; Orientation, Spatial; Liver

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Method A

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

Group Type: EXPERIMENTAL

Method A

Intervention Type: OTHER

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.

Method B

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

Group Type: EXPERIMENTAL

Method B

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Universitätsklinikum Köln

OTHER

Sponsor Role: lead

Responsible Party

Roger Wahba, MD, PhD

Priv.-Doz. Dr. med Roger Wahba

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Roger Wahba, MD, PHD

Role: PRINCIPAL_INVESTIGATOR

Universitätsklinikum Köln

Locations

University of Cologne, Department of General, Visceral and Cancer Surgery

Cologne, , Germany

Countries

Germany

Central Contacts

Roger Wahba, MD, PHD

Role: CONTACT

roger.wahba@uk-koeln.de

+492214784803

Rabi Datta, MD, PHD

Role: CONTACT

rabi.datta@uk-koeln.de

+492214785164

Other Identifiers

21-1406

Identifier Type: -

Identifier Source: org_study_id