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

NCT06049836 | Completed

• 1 other identifier: FIICNRHoloLiver
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatobiliary Neoplasm

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Time consumed

  Immediately after completing the evaluation

• NASA Task Load Index

  Immediately after completing the evaluation

Study Arms (2)

Group A

EXPERIMENTAL

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; Other: PDF

Group B

EXPERIMENTAL

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; Other: PDF

Interventions

Holograms OTHER

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

Group A; Group B

PDF OTHER

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

Group A; Group B

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• No informed consent

Sponsors & Collaborators

• Federico II University: lead
• ICAR (Istituto di Calcolo e Reti ad Alte Prestazioni) - CNR (Consiglio Nazionale delle Ricerche): collaborator

Study Sites (1)

Federico II University

Naples, 80131, Italy

Location

Study Officials

• Roberto I Troisi, MD PhD FEBS

  Federico II University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Surgery - MD, PhD, FEBS (HPB, Transplantation)

Study Record Dates

• First Submitted: September 8, 2023
• First Posted: September 22, 2023
• Study Start: October 15, 2023
• Primary Completion: November 30, 2023
• Study Completion: February 1, 2024
• Last Updated: February 28, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Starting 6 months after publication

Locations

IT (1)