Comparison of da Vinci Simulator vs LapSim Simulator

Study Overview
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Brief Summary
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Virtual reality surgical simulators (VRSS) are gaining popularity for general surgery training, both for conventional laparoscopic and robotically-assisted surgery. Although numerous studies have analysed the impact of VRSS training on surgical skills, there is a lack of data regarding the comparison of robotic VRSS (RVRSS) and laparoscopic VRSS (LVRSS) training on conventional laparoscopic skills among subjects with no prior surgical experience. The hypothesis of the present study is that RVRSS could improve conventional laparoscopic skills as much as laparoscopic LVRSS among naïve subjects

Official Title
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Comparison of the da Vinci Skills Simulator and the LapSim Laparoscopy Simulator for Conventional Laparoscopic Skills Improvement: a Prospective, Randomized Trial

Conditions
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Robotic Surgery Training, Laparoscopy Training

Intervention / Treatment
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* Other: da Vinci Skills Simulator®
* Other: LapSim®
* Other: Dry lab box laparoscopic training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy medical students aged 20 to 30 years old Exclusion Criteria: No prior surgical, laparoscopic or robotic experience No previously known severe learning disability or mental deficiency No handicap limiting the usage of one or both upper limb(s)

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 30 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

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Da Vinci Skills Simulator®<br>Participants in this group will undergo robotic virtual reality surgical simulator training (Da Vinci Mimics) and will subsequently be evaluated on a dry lab laparoscopic box | Other: da Vinci Skills Simulator®<br>* Initial robotic virtual reality surgical simulator Training (da Vinci Skills Simulator ® System), then laparoscopic dry box evaluation<br>|
| Active Comparator: LapSim®<br>Participants in this group will undergo laparoscopic virtual reality surgical simulator Training (LapSim) and will subsequently be evaluated on a dry lab laparoscopic box | Other: LapSim®<br>* Initial laparoscopic virtual reality surgical simulator training (LapSim ® System), then laparoscopic dry box evaluation<br>|
| Placebo Comparator: Dry lab box laparoscopic training<br>Participants in this group will undergo dry lab box laparoscopic training only | Other: Dry lab box laparoscopic training<br>* No initial simulator training. Dry lab box laparoscopic Training only.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Exercises times | Time to realize each training exercise as well as the final evaluation exercise | Within 1 day after randomization / data will be presented after completion of the study (an average of 9 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objects drops | Number of time objects were unwillingly dropped during each training exercise as well as the final evaluation exercise | Within 1 day after randomization / data will be presented after completion of the study (an average of 9 months) | 
| Objects out of view | Number of times one or both instruments or objects used for the exercises were out of the viewing field during each training exercise as well as the final evaluation exercise | Within 1 day after randomization / data will be presented after completion of the study (an average of 9 months) | 
| Instruments collisions | Number of collisions between the different instruments used to perform each training exercise as well as the final evaluation exercise | Within 1 day after randomization / data will be presented after completion of the study (an average of 9 months) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Laparoscopy, Surgery, Training, Virtual reality, Simulation, Robotic Surgery, Da Vinci