Holographic Augmented Reality Versus Screen Visualisation of 3D Rendering Models for the Pre-operative Evaluation and Planning of Liver Resections

Hepatobiliary Neoplasm Clinical Trial

Official title:

Holographic Augmented Reality Versus Screen Visualisation of 3D Rendering Models for the Pre-operative Evaluation and Planning of Liver Resections

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06049836
• Other study ID #: FIICNRHoloLiver
• Status: Completed
• Phase: N/A
• Start date: October 15, 2023
• Est. completion date: February 1, 2024

Study information

• Verified date: February 2024
• Source: Federico II University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this trial is to compare the evaluation of 3D liver models visualised as holograms with HoloLens 2 and on digital PDF files in HPB surgical trainees.

The main questions it aims to answer are:

• Do the holographic models allow a superior accuracy in terms of anatomical evaluation and surgical planning?

• Is there any difference in terms of time consumed and Task Load Index? Participants will analyse cases through both modalities and answer a questionnaire.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: February 1, 2024
• Est. primary completion date: November 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• General Surgery Trainees with at least 6 months experience in HPB surgery

Exclusion Criteria:

• No informed consent

Related Conditions & MeSH terms

• Hepatobiliary Neoplasm

Intervention

Other:
• Holograms
Clinical decision making based on visualising liver 3D holographic augmented reality liver models
• PDF
Clinical decision making based on visualisation of 3D liver rendering on computer monitors on a PDF file

Locations

Country	Name	City	State
Italy	Federico II University	Naples

Sponsors (2)

Lead Sponsor	Collaborator
Federico II University	ICAR (Istituto di Calcolo e Reti ad Alte Prestazioni) - CNR (Consiglio Nazionale delle Ricerche)

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic and planning accuracy	Correctly identify anatomy and appropriate surgical planning Residents' decision-making accuracy when reviewing patient data and 3D liver models using Holograms or on PDF, measured by comparing their performance.; The measurement tool will be a questionnaire consisting of 11 questions, rate of correct answers will be recorded (e.g. 8/10 correct answers) and higher scores mean a better outcome.	Immediately after completing the evaluation
Secondary	Time consumed	Analyse the time spent for the evaluation of the cases and complete the questionnaire Assessed by total time needed to make decision for 15 patient cases in minutes	Immediately after completing the evaluation
Secondary	NASA Task Load Index	Analyse the NASA TLI score for each participant to evaluate the cases by conducting a subjective mental workload assessment rating performance across six dimensions to determine an overall workload rating: Mental demand - how much thinking, deciding, or calculating was required to perform the task.; Physical demand - the amount and intensity of physical activity required to complete the task.; Temporal demand - the amount of time pressure involved in completing the task.; Effort - how hard does the participant have to work to maintain their level of performance?; Performance - the level of success in completing the task.; Frustration level - how insecure, discouraged, or secure or content the participant felt during the task.; Each participant gives a rating for each subscale from 1 (low) to 20 (high) and the TLX will calculate the overall worklaod score between 0 and 100	Immediately after completing the evaluation