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OpenTrials
Completed

NCT Number: NCT02370407

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

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.

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Key information

Conditions

Surgical Simulation Education

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

a laparoscopic simulator (Fundamentals of Laparoscopic Surgery (FLS), VT Medical Inc, Waltham, MA)

Device

10 repetitions of practice on laparoscopic simulator.

Mimic da Vinci robotic simulator

Device

10 repetitions of practice on Mimic da Vinci robotic simulator.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Feb 24, 2015
Registry last updated
Aug 28, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.