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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06049836
Enrollment
16
Registered
2023-09-22
Start date
2023-10-15
Completion date
2024-02-01
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatobiliary Neoplasm

Keywords

Liver surgery, Preoperative planning, 3D rendering, Augmented reality, Holograms

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.

Interventions

OTHERHolograms

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

OTHERPDF

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

Sponsors

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

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

* No informed consent

Design outcomes

Primary

MeasureTime frameDescription
Diagnostic and planning accuracyImmediately after completing the evaluationCorrectly 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

MeasureTime frameDescription
Time consumedImmediately after completing the evaluationAnalyse 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 IndexImmediately after completing the evaluationAnalyse 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

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026