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NCT06255080 Clinical Trial

Comparing Skills Acquisition on Different Laparoscopy Software

Laparoscopy Clinical Trial

Official title:
Re-defining Proficiency Levels Might be Necessary When Virtual Reality Simulator Software is Updated - a Randomized Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT06255080
Other study ID # Software changes on LAPSIM
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 1, 2022
Est. completion date January 20, 2023

Study information
Verified date February 2024
Source Copenhagen Academy for Medical Education and Simulation
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Simulation based training is a standard part of surgical training. Over the years virtual reality simulator have been more and more integrated into the surgical curriculum for surgical novices. Evidence shows that practicing using proficiency-based training programs significantly reduces the operation time and complication rates for during intial operations for young doctors. The aim of this trial is to examine if skills obtained on a newer software version is transferable to the original software.

Recruitment information / eligibility
Status Completed
Enrollment 20
Est. completion date January 20, 2023
Est. primary completion date January 15, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Medical students without any prior laparoscopy experience in both a clinical or simulated setting Exclusion Criteria: - Prior experience with simulation based laparoscopy or clinical experience with laparoscopy

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Training intervention
The intervention consists of making the intervention group practice till proficiency using the 2019-version. The control group practices till they have reached proficiency using the standard 2016-version. We wanted to compare time to completetion for the intervention. For the follow-up test we invited all participants to return after 4-6 weeks (where no training was allowed) and made them practice till proficiency again using the standard 2016-version. Time to reach proficiency for the follow-up test was compared.

Locations
Country Name City State
Denmark Copenhagen Academy for Medical Education and Simulation Copenhagen Capital Region

Sponsors (1)
Lead Sponsor Collaborator
Copenhagen Academy for Medical Education and Simulation

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary Time to reach proficiency (in minutes) To examine if there was any difference in the time to reach proficiency for the two software versions 1-2 months
Secondary Transferability of skills We made all 20 participants return for a follow-up test, where they had to practice till they reached proficiency again using the standard 2016-version. Time to complete was compared 2-3 weeks
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