CClinicalTrials.gg
CompletedNCT04959630LiVeRTrainerUpdated Jul 13, 2021

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

An interventional study of Clinical decision making based on visualizing liver 3D models in Virtual Reality (VR) environment or via a Desktop Interface (DI) in Hepatobiliary Neoplasm, sponsored by University Hospital, Ghent. Completed at 2 sites in 2 countries. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-07-13.

Sponsored by University Hospital, Ghent · Not applicable, Interventional, and Other

From the registry’s dates

  • Registered 9 months after the study started (first participant enrolled Sep 2020, registered Jun 2021).
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study 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.

02

Conditions studied

  • Hepatobiliary Neoplasm

Keywords

  • surgical education
  • 3D reconstruction
  • virtual reality
  • surgical planning
  • cognitive knowledge training
  • decision making
03

In context

Lead sponsor

University Hospital, Ghent is the lead sponsor of 665 studies on the registry; 156 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 4 (80%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • General surgery residents irrespective of their postgraduate year

Exclusion criteria

Exclusion Criteria:

  • No inform consent
  • Residents of other specialties
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Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Investigator)
Enrollment
50 participants (actual)

Study arms

  • 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)

  • 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)

Interventions

  • BehavioralClinical 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

06

What researchers measure

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.

    Time frame: Immediately after completing the educational intervention

Secondary outcomes

  1. Cognitive knowledge retention

    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.

    Time frame: Baseline and immediately after completing the educational intervention

  2. Residents' scores in recognizing intrahepatic structures and liver segments

    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.

    Time frame: Immediately after completing the educational intervention

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

    Assessed by total time needed to make decision for 10 patient cases in minutes

    Time frame: Immediately after completing the educational intervention

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Study locations

2 sites
  • Ghent University Hospital
    Ghent, Belgium
  • Federico II University
    Naples, Italy
08

References and documents

Publications

  • 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. PubMed 35961933 ↗

Study documents

  • Protocol and statistical analysis plan · Jul 15, 2020

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — All collected IPD are to be shared

Supporting information: Study protocol, Sap, Csr

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 13, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04959630
Lead sponsor
University Hospital, Ghent
Responsible party
GIHeelkunde (Department of GI Surgery, University Hospital, Ghent) — Principal investigator
First posted
Jul 13, 2021
Start date
Sep 1, 2020
Primary completion
Apr 19, 2021
Completion
Jun 15, 2021
Last update
Jul 13, 2021

Study contacts

Wouter Willaert, MD, PhD
principal investigator · University Hospital, Ghent
Roberto Troisi, MD, PhD
principal investigator · Federico II University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.

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