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

Not Applicable

Completed

• Conditions: Hepatobiliary Neoplasm

• Registration Number: NCT06049836
• Lead Sponsor: Federico II University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-09-08
• Study First Submitted QC: 2023-09-21
• Study First Posted: 2023-09-22
• Study Start: 2023-10-15
• Primary Completion: 2023-11-30
• Status Verified: 2024-02
• Study Completion: 2024-02-01
• Last Update Submitted: 2024-02-24
• Last Update Posted: 2024-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

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

Exclusion Criteria

• No informed consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Diagnostic and planning accuracy	Immediately after completing the evaluation	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.

Secondary Outcome Measures

Name	Time	Method
Time consumed	Immediately after completing the evaluation	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
NASA Task Load Index	Immediately after completing the evaluation	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: 1. Mental demand - how much thinking, deciding, or calculating was required to perform the task.; 2. Physical demand - the amount and intensity of physical activity required to complete the task.; 3. Temporal demand - the amount of time pressure involved in completing the task.; 4. Effort - how hard does the participant have to work to maintain their level of performance?; 5. Performance - the level of success in completing the task.; 6. 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

Trial Locations

Locations (1)

Federico II University; 🇮🇹 Naples, Italy