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OpenTrials
Completed

NCT Number: NCT06049836

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Federico II University

Naples, 80131, Italy

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • No informed consent

Treatment and study plan

Holograms

Other

Clinical decision making based on visualising liver 3D holographic augmented reality liver models

PDF

Other

Clinical decision making based on visualisation of 3D liver rendering on computer monitors on a PDF file

Primary outcomes

  1. Diagnostic and planning accuracy

    Time frame: 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 outcomes

  1. Time consumed

    Time frame: 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

  2. NASA Task Load Index

    Time frame: 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:

    • 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

Sponsors and collaborators

Lead sponsor

Federico II University

Other

Collaborators

  • ICAR (Istituto di Calcolo e Reti ad Alte Prestazioni) - CNR (Consiglio Nazionale delle Ricerche)

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Sep 22, 2023
Registry last updated
Feb 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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