Hepatobiliary NeoplasmLiVeRTrainerNCT04959630
Immersive Virtual Reality Environment for Complex Cognitive Skills Curricular Training in Liver Surgery
A study testing Clinical decision making based on visualizing liver 3D models in Virtual Reality (VR) environment or via a Desktop Interface (DI) in people with Hepatobiliary Neoplasm, run by University Hospital, Ghent at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hepatobiliary Neoplasm
- What is being tested?
- Clinical decision making based on visualizing liver 3D models in Virtual Reality (VR) environment or via a Desktop Interface (DI)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 Sep 2020to 15 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- General surgery residents irrespective of their postgraduate year
Who cannot join
- No inform consent
- Residents of other specialties
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: 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.
- Conditions
- Hepatobiliary Neoplasm
- Being tested
- Clinical decision making based on visualizing liver 3D models in Virtual Reality (VR) environment or via a Desktop Interface (DI)
- Keywords
- surgical education, 3D reconstruction, virtual reality, surgical planning, cognitive knowledge training, decision making
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical decision making based on visualizing liver 3D models in Virtual Reality (VR) environment or via a Desktop Interface (DI)Behavioural
Visualizing 3D models of livers for preoperative surgical planning via two different environment: DI and VR in sequential order
| Study group | Role | What they receive |
|---|---|---|
| Group A | Other | Group A received first five patient cases and 3D models via DI and another five cases in the VR environment Receives: 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. Receives: Behavioral: Clinical decision making based on visualizing liver 3D models in Virtual Reality (VR) environment or via a Desktop Interface (DI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Immediately after completing the educational intervention
Secondary outcomes (3)
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.
Measured: Baseline and immediately after completing the educational intervention
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.
Measured: Immediately after completing the educational intervention
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
Measured: Immediately after completing the educational intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2021
- Study start1 Sep 2020
- Primary completion19 Apr 2021
- Study completion15 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepatobiliary NeoplasmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, GIHeelkunde, University Hospital, Ghent
- Investigators
- Wouter Willaert, MD, PhD, Principal investigator, University Hospital, GhentRoberto Troisi, MD, PhD, Principal investigator, Federico II University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04959630
- Sponsor's protocol ID
- B6702020000275
- Acronym
- LiVeRTrainer
- Status last verified
- Jul 2021
- First submitted
- 21 Jun 2021
- Last updated
- 13 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected IPD are to be shared
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 at a glance
From the registry record, last updated by the sponsor on 13 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of an Immersive Virtual Reality Environment on Curricular Training for Complex Cognitive Skills in Liver Surgery: A Multicentric Crossover Randomized Trial
- ClinicalTrials.gov ID
- NCT04959630
- Acronym / sponsor ID
- LiVeRTrainer / B6702020000275
- Conditions
- Hepatobiliary Neoplasm
- Keywords
- surgical education, 3D reconstruction, virtual reality, surgical planning, cognitive knowledge training, decision making
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 19 Apr 2021 (actual)
- Study completion
- 15 Jun 2021 (actual)
- First posted
- 13 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Other | Behavioral: Clinical decision making based on visualizing liver 3D models in Virtual Reality (VR) environment or via a Desktop Interface (DI)Group A received first five patient cases and 3D models via DI and another five cases in the VR environment |
| Group B | Other | Behavioral: Clinical decision making based on visualizing liver 3D models in Virtual Reality (VR) environment or via a Desktop Interface (DI)Group B received first five patient cases and 3D models via VR and another five cases in the DI. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- General surgery residents irrespective of their postgraduate year
Key exclusion criteria (2 listed)
- No inform consent
- Residents of other specialties
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Behavioural | Group A, Group B |
Primary outcome
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.
3 secondary outcomes
Cognitive knowledge retention
Time frame: 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
Time needed to devise a surgical plan using the DI or VR platform
Time frame: Immediately after completing the educational intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2021.
- Derived from this study: PubMed 35961933Rashidian 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.
- Individual participant dataSharing planned: Yes. All collected IPD are to be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wouter Willaert, MD, PhD principal investigator
University Hospital, Ghent
Roberto Troisi, MD, PhD principal investigator
Federico II University
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clinical decision making based on visualizing liver 3D models in Virtual Reality (VR) environment or via a Desktop Interface (DI) in people with Hepatobiliary Neoplasm, run by University Hospital, Ghent at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Residents' decision-making accuracy (time frame: Immediately after completing the educational intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04959630, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2021.