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

NCT05389241 | Unknown

• 1 other identifier: 21-1406
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Laparoscopy; Augmented Reality; Orientation, Spatial; Liver

Keywords

Augmented reality; liver; minimally invasive surgery; laparoscopy; 3D; spatial orientation; digital health; artificial intelligence

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Task Load Index

  immediately after tasks are performed, Day 1

• Modification of procedure planning

  immediately after tasks are performed with both methods, Day 1

• Learning curve

  immediately after tasks are performed with both methods, Day 1

Study Arms (2)

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

Other: Method A

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

Other: Method B

Interventions

Method A 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 A

Method B 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.

Method B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Universitätsklinikum Köln: lead

Study Sites (1)

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

Cologne, 50931, Germany

Location

MeSH Terms

Conditions

Orientation, Spatial

Condition Hierarchy (Ancestors)

Spatial Behavior; Behavior

Study Officials

• Roger Wahba, MD, PHD

  Universitätsklinikum Köln

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Roger Wahba, MD, PHD

CONTACT

+492214784803; roger.wahba@uk-koeln.de

Rabi Datta, MD, PHD

CONTACT

+492214785164; rabi.datta@uk-koeln.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Priv.-Doz. Dr. med Roger Wahba

Study Record Dates

• First Submitted: May 19, 2022
• First Posted: May 25, 2022
• Study Start: September 1, 2022
• Primary Completion: December 1, 2023
• Study Completion: March 1, 2024
• Last Updated: August 16, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)