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

NCT ID: NCT04959630

Last Updated: 2021-07-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-01

Study Completion Date

2021-06-15

Brief Summary

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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.

Detailed Description

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Conditions

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Hepatobiliary Neoplasm

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Investigators

Study Groups

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Group A

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

Group Type OTHER

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

Intervention Type BEHAVIORAL

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

Group B

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

Group Type OTHER

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

Intervention Type BEHAVIORAL

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

Interventions

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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

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

• General surgery residents irrespective of their postgraduate year

Exclusion Criteria

* No inform consent
* Residents of other specialties
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital, Ghent

OTHER

Sponsor Role lead

Responsible Party

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GIHeelkunde

Department of GI Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Wouter Willaert, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Ghent

Roberto Troisi, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Federico II University

Locations

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Ghent University Hospital

Ghent, , Belgium

Site Status

Federico II University

Naples, , Italy

Site Status

Countries

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Belgium Italy

References

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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.

Reference Type DERIVED
PMID: 35961933 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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B6702020000275

Identifier Type: -

Identifier Source: org_study_id

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