NCT04959630

Brief Summary

Investigators hypothesize that a virtual reality (VR) environment enhances general surgery residents' performance compared to Desktop Interface (DI)-based visualization of 3D models in decision making for patients with liver tumors. To determine this, a proficiency-based stepwise training curriculum for preoperative planning has been developed using both modalities. The overall objective of the curriculum is that by the end of the training program, residents would be able to formulate a treatment plan for patients with liver tumors.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2020

Shorter than P25 for not_applicable

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2020

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 19, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2021

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

June 21, 2021

Completed
22 days until next milestone

First Posted

Study publicly available on registry

July 13, 2021

Completed
Last Updated

July 13, 2021

Status Verified

July 1, 2021

Enrollment Period

8 months

First QC Date

June 21, 2021

Last Update Submit

July 1, 2021

Conditions

Hepatobiliary Neoplasm

Keywords

surgical education3D reconstructionvirtual realitysurgical planningcognitive knowledge trainingdecision making

Outcome Measures

Primary Outcomes (1)

  • Residents' decision-making accuracy

    Residents' decision-making accuracy when reviewing patient data and 3D liver models using DI or VR, measured by comparing their performance to experts' opinions. The measurement tool will be a questionnaire consisting of ten questions, rate of correct answers will be recorded (e.g. 8/10 correct answers) and higher scores mean a better outcome. Minimum score=0; Maximum score=10.

    Immediately after completing the educational intervention

Secondary Outcomes (3)

  • Cognitive knowledge retention

    Baseline and immediately after completing the educational intervention

  • Residents' scores in recognizing intrahepatic structures and liver segments

    Immediately after completing the educational intervention

  • Time needed to devise a surgical plan using the DI or VR platform

    Immediately after completing the educational intervention

Study Arms (2)

Group A

OTHER

Group A received first five patient cases and 3D models via DI and another five cases in the VR environment

Behavioral: Clinical decision making based on visualizing liver 3D models in Virtual Reality (VR) environment or via a Desktop Interface (DI)

Group B

OTHER

Group B received first five patient cases and 3D models via VR and another five cases in the DI.

Behavioral: Clinical decision making based on visualizing liver 3D models in Virtual Reality (VR) environment or via a Desktop Interface (DI)

Interventions

Clinical decision making based on visualizing liver 3D models in Virtual Reality (VR) environment or via a Desktop Interface (DI)BEHAVIORAL

Visualizing 3D models of livers for preoperative surgical planning via two different environment: DI and VR in sequential order

Group AGroup B

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • General surgery residents irrespective of their postgraduate year

You may not qualify if:

  • No inform consent
  • Residents of other specialties

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Ghent University Hospital

Ghent, Belgium

Location

Federico II University

Naples, Italy

Location

Related Publications (1)

  • Rashidian N, Giglio MC, Van Herzeele I, Smeets P, Morise Z, Alseidi A, Troisi RI, Willaert W. Effectiveness of an immersive virtual reality environment on curricular training for complex cognitive skills in liver surgery: a multicentric crossover randomized trial. HPB (Oxford). 2022 Dec;24(12):2086-2095. doi: 10.1016/j.hpb.2022.07.009. Epub 2022 Jul 21.

    PMID: 35961933DERIVED

MeSH Terms

Interventions

Environment

Intervention Hierarchy (Ancestors)

Ecological and Environmental PhenomenaBiological PhenomenaEnvironment and Public Health

Study Officials

  • Wouter Willaert, MD, PhD

    University Hospital, Ghent

    PRINCIPAL INVESTIGATOR

  • Roberto Troisi, MD, PhD

    Federico II University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Department of GI Surgery

Study Record Dates

First Submitted

June 21, 2021

First Posted

July 13, 2021

Study Start

September 1, 2020

Primary Completion

April 19, 2021

Study Completion

June 15, 2021

Last Updated

July 13, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will share

All collected IPD are to be shared

Shared Documents
STUDY PROTOCOL, SAP, CSR
Time Frame
Starting 6 months after publication

Locations

IT(1)BE(1)