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

Laparoscopy Clinical Trial

— LARA  

Official title:

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05389241
• Other study ID #: 21-1406
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2022
• Est. completion date: March 1, 2024

Study information

• Verified date: August 2022
• Source: Universitätsklinikum Köln
• Contact: Roger Wahba, MD, PHD
• Phone: +492214784803
• Email: roger.wahba[@]uk-koeln.de
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 72
• Est. completion date: March 1, 2024
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Augmented Reality
• Laparoscopy
• Liver

Intervention

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.
• 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.

Locations

Country	Name	City	State
Germany	University of Cologne, Department of General, Visceral and Cancer Surgery	Cologne

Sponsors (1)

Lead Sponsor	Collaborator
Universitätsklinikum Köln

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of correctly identified targets	The number of correctly spatially identified targets (tumors in the liver phantom)	immediately after tasks are performed, Day 1
Primary	Time required	The time required to localize the specified target structures (tumors in the live phantom)	immediately after tasks are performed, Day 1
Secondary	Task Load Index	The specific cognitive effort of the subject (measured using the NASA Task Load Index)	immediately after tasks are performed, Day 1
Secondary	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
Secondary	Learning curve	Qualitative evaluation of the learning curve and success of the subjects	immediately after tasks are performed with both methods, Day 1