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

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ClinicalTrials.gov Identifier: NCT02370407
Recruitment Status : Completed
First Posted : February 24, 2015
Results First Posted : August 28, 2017
Last Update Posted : August 28, 2017
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Surgical Simulation Education Device: a laparoscopic simulator (Fundamentals of Laparoscopic Surgery (FLS), VT Medical Inc, Waltham, MA) Device: Mimic da Vinci robotic simulator Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Other
Official Title: Assessment of the Transferability of Skills From Robotic to Laparoscopic Simulation Platforms in Surgical Skill Naive Participants
Study Start Date : November 2014
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015
Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Time to Task Completion (Robotic Task) [ Time Frame: 1 day of practice ]
    Primary outcome will be time to task completion (seconds) on the robotic task

  2. Global Rating Scale Score on the Laparoscopic Task [ Time Frame: 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.

  3. Global Rating Scale Score on the Robotic Task [ Time Frame: 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.

  4. Time to Task Completion on the Laparoscopic Task [ Time Frame: 1 day of practice ]
    Time to task completion (seconds) on the laparoscopic task


Secondary Outcome Measures :
  1. Economy of Motion on the Robotic Task [ Time Frame: 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

  2. Instrument Out of View [ Time Frame: through study completion ]
    Automatically recorded data on the Mimic DV trainer, (sec). The longer out of view indicates decreased proficiency

  3. Instrument Collisions [ Time Frame: study duration ]
    Automatically recorded data on the Mimic DV trainer which records number of collisions

  4. Time Spent Using Excessive Force [ Time Frame: study duration ]
    Automatically recorded data on the Mimic DV trainer (seconds)

  5. Workspace Range [ Time Frame: 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


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02370407


Sponsors and Collaborators
Johns Hopkins University
Investigators
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Principal Investigator: Chi Chiung Grace Chen, MD Johns Hopkins University
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT02370407    
Other Study ID Numbers: IRB00031436
First Posted: February 24, 2015    Key Record Dates
Results First Posted: August 28, 2017
Last Update Posted: August 28, 2017
Last Verified: July 2017
Keywords provided by Johns Hopkins University:
surgical education
minimally invasive surgical procedures
laparoscopic simulation
robotic simulation
medical education