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

Hepatobiliary Neoplasm Clinical Trial

— LiVeRTrainer  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04959630
• Other study ID #: B6702020000275
• Status: Completed
• Phase: N/A
• Start date: September 1, 2020
• Est. completion date: June 15, 2021

Study information

• Verified date: July 2021
• Source: University Hospital, Ghent
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: June 15, 2021
• Est. primary completion date: April 19, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• General surgery residents irrespective of their postgraduate year

Exclusion Criteria:

• No inform consent
• Residents of other specialties

Related Conditions & MeSH terms

• Hepatobiliary Neoplasm

Intervention

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

Locations

Country	Name	City	State
Belgium	Ghent University Hospital	Ghent
Italy	Federico II University	Naples

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Ghent

Countries where clinical trial is conducted

Belgium,  Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Baseline and immediately after completing the educational intervention
Secondary	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.	Immediately after completing the educational intervention
Secondary	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	Immediately after completing the educational intervention