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

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.

Study Overview

• Status: Completed
• Conditions: Hepatobiliary Neoplasm
• Intervention / Treatment: Other: Holograms; Other: PDF

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Gianluca Rompianesi, MD PhD FEBS; Phone Number: +39 0817464408; Email: gianlucarompianesi@gmail.com
• Study Contact Backup: Name: Roberto Montalti, MD PhD; Phone Number: +39 0817462732; Email: robertomontalti@yahoo.it

Study Locations

• Italy
  • Naples, Italy, 80131
    • Federico II University
    • Contact: Gianluca Rompianesi, MD PhD FEBS; Phone Number: +39 0817454408; Email: gianlucarompianesi@gmail.com
    • Principal Investigator: Gianluca Rompianesi, MD PhD FEBS
    • Sub-Investigator: Roberto Montalti, MD PhD
    • Principal Investigator: Luigi Gallo
    • Sub-Investigator: Giuseppe Caggianese
    • Sub-Investigator: Agnese Augello
    • Sub-Investigator: Pietro Neroni
    • Sub-Investigator: Luigi Casoria
    • Sub-Investigator: Giuseppe De Pietro

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

• No informed consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A; Group A analyses 15 patient cases 3D Hologram models (first stage) and after the washout period the same 15 patients cases (anonymised, renamed and shuffled) in liver 3D models on computer monitor visualisation (PDF) (second stage)	Other: Holograms; Clinical decision making based on visualising liver 3D holographic augmented reality liver models; Other: PDF; Clinical decision making based on visualisation of 3D liver rendering on computer monitors on a PDF file
Experimental: Group B; Group B analyses 15 patient cases liver 3D models on computer monitor visualisation (PDF) (first stage) and after the washout period the same 15 patients cases (anonymised, renamed and shuffled) on 3D Hologram models (second stage)	Other: Holograms; Clinical decision making based on visualising liver 3D holographic augmented reality liver models; Other: PDF; Clinical decision making based on visualisation of 3D liver rendering on computer monitors on a PDF file

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Federico II University
• Collaborators: ICAR (Istituto di Calcolo e Reti ad Alte Prestazioni) - CNR (Consiglio Nazionale delle Ricerche)
• Investigators: Principal Investigator: Roberto I Troisi, MD PhD FEBS, Federico II University

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2023
• Primary Completion (Actual): November 30, 2023
• Study Completion (Actual): February 1, 2024

Study Registration Dates

• First Submitted: September 8, 2023
• First Submitted That Met QC Criteria: September 21, 2023
• First Posted (Actual): September 22, 2023

Study Record Updates

• Last Update Posted (Actual): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 24, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Augmented reality; Liver surgery; Preoperative planning; 3D rendering; Holograms
• Other Study ID Numbers: FIICNRHoloLiver

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All collected IPD are to be shared
• IPD Sharing Time Frame: Starting 6 months after publication
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

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