Comparing Skills Acquisition on Different Laparoscopy Software

NCT06255080 — Not applicable, Completed, 20 participants, Copenhagen Academy for Medical Education and Simulation

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

Registry	NCT06255080
Status	Completed
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: single, other
Enrollment	20 (Actual)
Sponsor	Copenhagen Academy for Medical Education and Simulation (Other)
Conditions	Simulation Training, Laparoscopy
Interventions	Training intervention (Other)
Dates	start 2022-09-01, primary completion 2023-01-15, completion 2023-01-20, first posted 2024-02-12, last updated 2024-02-12
Locations	1 site in Denmark

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Intervention group	Experimental	Other: Training intervention	This group practiced the proficiency-based program on the LAPSIM(R) simulator using the new 2019-version of the software
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

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.

+Outcome measures

Primary outcomes

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

Secondary outcomes

Transferability of skills [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

+Eligibility

Sex: All, accepts healthy volunteers

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

+Locations (1)

Facility	City	Country	Status
Copenhagen Academy for Medical Education and Simulation	Copenhagen, Capital Region	Denmark