Assessment of the Transferability of Skills From Robotic to Laparoscopic Simulation Platforms

Study Overview
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Brief Summary
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This is a randomized controlled trial that will randomize 40 surgical skill naive medical students to practice on a robotic simulator or laparoscopic simulator after first completing a baseline evaluation on both surgical simulation platforms. Medical students will be evaluated again after 10 practice sessions on the laparoscopic or robotic platforms to assess transferability of skills between the surgical simulation platforms.

Detailed Description
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This is a randomized controlled trial that will randomize medical students to practice on a robotic simulator or a laparoscopic simulator. The investigators will first obtain baseline data by having the study participants perform one task (peg transfer exercise) on a laparoscopic simulator (Fundamentals of Laparoscopic Surgery (FLS), VT Medical Inc, Waltham, MA), and a similar task on a robotic trainer (Mimic da Vinci Simulator, Intuitive Surgical, Sunnyvale, CA). Participants will then be randomized to practice on the robotic simulator or practice on the laparoscopic trainer for at least 10 repetitions. After the participants complete 10 repetitions, they will be evaluated again on both the laparoscopic and robotic simulator using time to task completion and Mimi DV trainer motion metrics. Two expert laparoscopic and robotic surgeons will also evaluate participant performance using previously validated global rating scales for robotic and laparoscopic surgery.

Official Title
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Assessment of the Transferability of Skills From Robotic to Laparoscopic Simulation Platforms in Surgical Skill Naive Participants

Conditions
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Surgical Simulation Education

Intervention / Treatment
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* Device: a laparoscopic simulator (Fundamentals of Laparoscopic Surgery (FLS), VT Medical Inc, Waltham, MA)
* Device: Mimic da Vinci robotic simulator


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Medical students with no prior laparoscopic or robotic experience in clinical or practice setting Exclusion Criteria: Prior laparoscopic or robotic experience in clinical setting or in practice setting
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: Laparoscopic simulator<br>20 study participants will be randomized to perform peg transfer task on a laparoscopic simulator 10 times (Fundamentals of Laparoscopic Surgery (FLS), VT Medical Inc, Waltham, MA). | Device: a laparoscopic simulator (Fundamentals of Laparoscopic Surgery (FLS), VT Medical Inc, Waltham, MA)<br>* 10 repetitions of practice on laparoscopic simulator.<br>|
| Experimental: Mimic da Vinci robotic simulator<br>20 study participants will be randomized to perform peg board 1 exercise 10 times on a Mimic da Vinci robotic simulator (Mimic da Vinci Simulator, Intuitive Surgical, Sunnyvale, CA). | Device: Mimic da Vinci robotic simulator<br>* 10 repetitions of practice on Mimic da Vinci robotic simulator.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Task Completion (Robotic Task) | Primary outcome will be time to task completion (seconds) on the robotic task | 1 day of practice | 
| Global Rating Scale Score on the Laparoscopic Task | Global rating scale score on the laparoscopic task. A composite score of (1) depth perception, (2) bimanual dexterity, (3) efficiency, (4) tissue handling, (5) time and motion, (6) instrument handling, and (7) flow of operation, each scored 1 through 5 on an anchored Likert scale where higher scores indicated improved proficiency. Point range 7 - 35. | Study duration | 
| Global Rating Scale Score on the Robotic Task | A composite score of (1) depth perception, (2) bimanual dexterity, (3) efficiency, (4) tissue handling, (5) time and motion, (6) instrument handling, and (7) flow of operation, each scored 1 through 5 on an anchored Likert scale where higher scores indicated improved proficiency. Point range 7 - 35. | Study duration | 
| Time to Task Completion on the Laparoscopic Task | Time to task completion (seconds) on the laparoscopic task | 1 day of practice | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Economy of Motion on the Robotic Task | (cm, where lower measurements represent improved economy of motion). This measures how many cm the instruments traveled in order to accomplish the task | Study duration | 
| Instrument Out of View | Automatically recorded data on the Mimic DV trainer, (sec). The longer out of view indicates decreased proficiency | through study completion | 
| Instrument Collisions | Automatically recorded data on the Mimic DV trainer which records number of collisions | study duration | 
| Time Spent Using Excessive Force | Automatically recorded data on the Mimic DV trainer (seconds) | study duration | 
| Workspace Range | Automatically recorded data on the Mimic DV trainer consisting of workspace range (cm, this is the widest range traveled by the 2 instruments, one in each hand), and number of peg drops | study duration | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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surgical education, minimally invasive surgical procedures, laparoscopic simulation, robotic simulation, medical education