Procedure-to-procedure Transfer Trial

Study Overview
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Brief Summary
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Surgical training programs using virtual reality simulators often only use basic skills training and the use of procedural training is very limited. Procedural training differs from basic skills training by requiring integration of isolated skills and decision making and planning components. However, it is unknown if it is necessary to practice all procedures before operating on actual patients or whether it is simply a matter of learning psychomotor skills and if these skills are transferable between different tasks. The main hypothesis is that practicing a laparoscopic procedure on a simulator makes it easier to reach proficiency on a different laparoscopic procedure on the simulator because participants have already practiced the integration of isolated skills.

Official Title
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A Randomised Educational Trial of Practicing One Versus Two Laparoscopic Procedural Modules in Simulator Training for Novices on Procedure-to-procedure Transferability

Conditions
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Surgery

Intervention / Treatment
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* Other: Practice a procedural module on a simulator


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Medical students enrolled at The Faculty of Health Science, University of Copenhagen. Obtained the bachelor degree in medicine. Signed informed consent. Exclusion Criteria: Previous participation in trials involving laparoscopic training. Experience with laparoscopy surgery (having performed minimum one laparoscopic procedure as primary surgeon, including supervised procedures). No informed consent. Does not speak Danish on a conversational level.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Practice two procedures on a simulator<br>All participants start by practicing a series of six basic skills modules until they reach a predefined proficiency level for each module. For all of the basic skills exercises proficiency is reached when the participants have passed the proficiency level for all exercises. Participants randomised to the intervention group will practice two procedures on a simulator. First a procedural module A (a laparoscopic appendectomy) to a predefined proficiency level. Upon reaching proficiency for procedural module A the participants will practice procedural module B (a laparoscopic salpingectomy) to a predefined proficiency level. | Other: Practice a procedural module on a simulator<br> <br> |
| No Intervention: Practice one procedure on a simulator<br>All participants start by practicing a series of six basic skills modules until they reach a predefined proficiency level for each module. For all of the basic skills exercises proficiency is reached when the participants have passed the proficiency level for all exercises. Each exercise has to be passed twice within five consecutive attempts. Participants randomised to the control group will practice procedural module B (a laparoscopic salpingectomy) to a predefined proficiency level. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of repetitions needed to reach a predefined proficiency level for a procedural module on a simulator | The number of repetitions needed to reach a predefined proficiency level for a procedural module (a laparoscopic salpingectomy) on the simulator. | Up to 26 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The effective training time on the simulator (minutes) needed to reach the predefined proficiency level for a procedural module. | The effective training time on the simulator (minutes) needed to reach a predefined proficiency level for a procedural module (a laparoscopic salpingectomy) on the simulator. | Up to 26 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Simulator, Laparoscopy, Training