Comparing Skills Acquisition on Different Laparoscopy Software

February 9, 2024 updated by: Anishan Vamadevan, Copenhagen Academy for Medical Education and Simulation

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Capital Region
      • Copenhagen, Capital Region, Denmark, 2100
        • Copenhagen Academy for Medical Education and Simulation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention group
This group practiced the proficiency-based program on the LAPSIM(R) simulator using the new 2019-version of the software
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.
No Intervention: Control Group
This group practiced the proficiency-based program on the LAPSIM(R) simulator using the original (and evidence based) 2016-version of the software

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to reach proficiency (in minutes)
Time Frame: 1-2 months
To examine if there was any difference in the time to reach proficiency for the two software versions
1-2 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Transferability of skills
Time Frame: 2-3 weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Copenhagen Academy for Medical Education and Simulation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2022

Primary Completion (Actual)

January 15, 2023

Study Completion (Actual)

January 20, 2023

Study Registration Dates

First Submitted

February 2, 2024

First Submitted That Met QC Criteria

February 9, 2024

First Posted (Actual)

February 12, 2024

Study Record Updates

Last Update Posted (Actual)

February 12, 2024

Last Update Submitted That Met QC Criteria

February 9, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • Software changes on LAPSIM

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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