Immersive Virtual Reality Environment for Complex Cognitive Skills Curricular Training in Liver Surgery (LiVeRTrainer)

July 1, 2021 updated by: GIHeelkunde, University Hospital, Ghent

Effectiveness of an Immersive Virtual Reality Environment on Curricular Training for Complex Cognitive Skills in Liver Surgery: A Multicentric Crossover Randomized Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Ghent, Belgium
        • Ghent University Hospital
  • Italy
      • Naples, Italy
        • Federico II University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

• General surgery residents irrespective of their postgraduate year

Exclusion Criteria:

  • No inform consent
  • Residents of other specialties

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Group A
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)
Visualizing 3D models of livers for preoperative surgical planning via two different environment: DI and VR in sequential order
Other: Group B
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)
Visualizing 3D models of livers for preoperative surgical planning via two different environment: DI and VR in sequential order

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Residents' decision-making accuracy
Time Frame: Immediately after completing the educational intervention

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cognitive knowledge retention
Time Frame: Baseline and immediately after completing the educational intervention

Retention of knowledge assessed by validated multiple choice questions. Questionnaire consisted of 15 questions will be used, rate of correct answers will be recorded (e.g. 8/15 correct answers), and higher scores mean a better outcome.

Minimum score=0; Maximum score=15.
Baseline and immediately after completing the educational intervention
Residents' scores in recognizing intrahepatic structures and liver segments
Time Frame: Immediately after completing the educational intervention

Assessed by recognizing intrahepatic structures and 8 liver segments. Questionnaire consisted of 22 questions will be used, rate of correct answers will be recorded (e.g. 8/22 correct answers), and higher scores mean a better outcome.

Minimum score=0; Maximum score=22.
Immediately after completing the educational intervention
Time needed to devise a surgical plan using the DI or VR platform
Time Frame: Immediately after completing the educational intervention
Assessed by total time needed to make decision for 10 patient cases in minutes
Immediately after completing the educational intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Ghent

Investigators

  • Principal Investigator: Wouter Willaert, MD, PhD, University Hospital, Ghent
  • Principal Investigator: Roberto Troisi, MD, PhD, Federico II University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2020

Primary Completion (Actual)

April 19, 2021

Study Completion (Actual)

June 15, 2021

Study Registration Dates

First Submitted

June 21, 2021

First Submitted That Met QC Criteria

July 1, 2021

First Posted (Actual)

July 13, 2021

Study Record Updates

Last Update Posted (Actual)

July 13, 2021

Last Update Submitted That Met QC Criteria

July 1, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • B6702020000275

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All collected IPD are to be shared

IPD Sharing Time Frame

Starting 6 months after publication

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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