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

Study Overview
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Brief Summary
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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.

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

Conditions
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Hepatobiliary Neoplasm

Intervention / Treatment
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* Other: Holograms
* Other: PDF


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: General Surgery Trainees with at least 6 months experience in HPB surgery Exclusion Criteria: No informed consent
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>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<br>* Clinical decision making based on visualising liver 3D holographic augmented reality liver models<br>Other: PDF<br>* Clinical decision making based on visualisation of 3D liver rendering on computer monitors on a PDF file<br>|
| Experimental: Group B<br>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<br>* Clinical decision making based on visualising liver 3D holographic augmented reality liver models<br>Other: PDF<br>* Clinical decision making based on visualisation of 3D liver rendering on computer monitors on a PDF file<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Liver surgery, Preoperative planning, 3D rendering, Augmented reality, Holograms