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

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.

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Laparoscopy; Liver; Augmented Reality; Orientation, Spatial
• Intervention / Treatment: Other: Method A; Other: Method B

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.

• Study Type: Interventional
• Enrollment (Anticipated): 72
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rabi Datta, MD, PHD; Phone Number: +492214785164; Email: rabi.datta@uk-koeln.de

Study Locations

• Germany
  • Cologne, Germany, 50931
    • University of Cologne, Department of General, Visceral and Cancer Surgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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	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.
EXPERIMENTAL: 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	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of correctly identified targets	The number of correctly spatially identified targets (tumors in the liver phantom)	immediately after tasks are performed, Day 1
Time required	The time required to localize the specified target structures (tumors in the live phantom)	immediately after tasks are performed, Day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Task Load Index	The specific cognitive effort of the subject (measured using the NASA Task Load Index)	immediately after tasks are performed, Day 1
Modification of procedure planning	The modification of the initially prepared procedure planning when the virtual 3D model is available	immediately after tasks are performed with both methods, Day 1
Learning curve	Qualitative evaluation of the learning curve and success of the subjects	immediately after tasks are performed with both methods, Day 1

Collaborators and Investigators

• Sponsor: Universitätsklinikum Köln
• Investigators: Principal Investigator: Roger Wahba, MD, PHD, Universitatsklinikum Koln

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): September 1, 2022
• Primary Completion (ANTICIPATED): December 1, 2023
• Study Completion (ANTICIPATED): March 1, 2024

Study Registration Dates

• First Submitted: May 19, 2022
• First Submitted That Met QC Criteria: May 19, 2022
• First Posted (ACTUAL): May 25, 2022

Study Record Updates

• Last Update Posted (ACTUAL): August 16, 2022
• Last Update Submitted That Met QC Criteria: August 14, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: laparoscopy; artificial intelligence; digital health; liver; minimally invasive surgery; Augmented reality; 3D; spatial orientation
• Other Study ID Numbers: 21-1406

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No