Comparing Skills Acquisition on Different Laparoscopy Software

NCT06255080 | Completed

• 1 other identifier: Software changes on LAPSIM
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Simulation Training; Laparoscopy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Transferability of skills

  2-3 weeks

Study Arms (2)

Intervention group

EXPERIMENTAL

This group practiced the proficiency-based program on the LAPSIM(R) simulator using the new 2019-version of the software

Other: Training intervention

Control Group

NO INTERVENTION

This group practiced the proficiency-based program on the LAPSIM(R) simulator using the original (and evidence based) 2016-version of the software

Interventions

Training intervention OTHER

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.

Intervention group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Medical students without any prior laparoscopy experience in both a clinical or simulated setting

You may not qualify if:

• Prior experience with simulation based laparoscopy or clinical experience with laparoscopy

Sponsors & Collaborators

• Copenhagen Academy for Medical Education and Simulation: lead

Study Sites (1)

Copenhagen Academy for Medical Education and Simulation

Copenhagen, Capital Region, 2100, Denmark

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Fellow

Study Record Dates

• First Submitted: February 2, 2024
• First Posted: February 12, 2024
• Study Start: September 1, 2022
• Primary Completion: January 15, 2023
• Study Completion: January 20, 2023
• Last Updated: February 12, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)