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

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

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.

Study Overview

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

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 Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Laparoscopic simulator; 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); 10 repetitions of practice on laparoscopic simulator.
Experimental: 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).	Device: Mimic da Vinci robotic simulator; 10 repetitions of practice on Mimic da Vinci robotic simulator.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Investigators: Principal Investigator: Chi Chiung Grace Chen, MD, Johns Hopkins University

Publications and helpful links

General Publications

• Orlando MS, Thomaier L, Abernethy MG, Chen CCG. Retention of laparoscopic and robotic skills among medical students: a randomized controlled trial. Surg Endosc. 2017 Aug;31(8):3306-3312. doi: 10.1007/s00464-016-5363-2. Epub 2017 Jan 11.

Study record dates

Study Major Dates

• Study Start: November 1, 2014
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: November 25, 2014
• First Submitted That Met QC Criteria: February 23, 2015
• First Posted (Estimate): February 24, 2015

Study Record Updates

• Last Update Posted (Actual): August 28, 2017
• Last Update Submitted That Met QC Criteria: July 26, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: medical education; surgical education; minimally invasive surgical procedures; laparoscopic simulation; robotic simulation
• Other Study ID Numbers: IRB00031436