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

Not Applicable

Completed

• Conditions: Surgical Simulation Education
• Interventions: Device: a laparoscopic simulator (Fundamentals of Laparoscopic Surgery (FLS), VT Medical Inc, Waltham, MA); Device: Mimic da Vinci robotic simulator

• Registration Number: NCT02370407
• Lead Sponsor: Johns Hopkins University

Brief Summary

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

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.

Study Timeline

• Study Start: 2014-11
• Study First Submitted: 2014-11-25
• Study First Submitted QC: 2015-02-23
• Study First Posted: 2015-02-24
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Results First Submitted: 2017-05-23
• Status Verified: 2017-07
• Results First Submitted QC: 2017-07-26
• Last Update Submitted: 2017-07-26
• Results First Posted: 2017-08-28
• Last Update Posted: 2017-08-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Laparoscopic simulator	a laparoscopic simulator (Fundamentals of Laparoscopic Surgery (FLS), VT Medical Inc, Waltham, MA)	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).
Mimic da Vinci robotic simulator	Mimic da Vinci robotic simulator	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).

Primary Outcome Measures

Name	Time	Method
Global Rating Scale Score on the Laparoscopic Task	Study duration	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.
Time to Task Completion (Robotic Task)	1 day of practice	Primary outcome will be time to task completion (seconds) on the robotic task
Global Rating Scale Score on the Robotic Task	Study duration	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.
Time to Task Completion on the Laparoscopic Task	1 day of practice	Time to task completion (seconds) on the laparoscopic task

Secondary Outcome Measures

Name	Time	Method
Instrument Collisions	study duration	Automatically recorded data on the Mimic DV trainer which records number of collisions
Instrument Out of View	through study completion	Automatically recorded data on the Mimic DV trainer, (sec). The longer out of view indicates decreased proficiency
Time Spent Using Excessive Force	study duration	Automatically recorded data on the Mimic DV trainer (seconds)
Economy of Motion on the Robotic Task	Study duration	(cm, where lower measurements represent improved economy of motion). This measures how many cm the instruments traveled in order to accomplish the task
Workspace Range	study duration	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