Surgical Simulation EducationNCT02370407
Assessment of the Transferability of Skills From Robotic to Laparoscopic Simulation Platforms
A study testing a laparoscopic simulator (Fundamentals of Laparoscopic Surgery (FLS), VT Medical Inc, Waltham, MA) and Mimic da Vinci robotic simulator in people with Surgical Simulation Education, run by Johns Hopkins University.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Surgical Simulation Education
- What is being tested?
- a laparoscopic simulator (Fundamentals of Laparoscopic Surgery (FLS), VT Medical Inc, Waltham, MA) and Mimic da Vinci robotic simulator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Nov 2014to Dec 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Medical students with no prior laparoscopic or robotic experience in clinical or practice setting
Who cannot join
- Prior laparoscopic or robotic experience in clinical setting or in practice setting
About this study
Official title: 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.
Read the 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.
- Conditions
- Surgical Simulation Education
- Being tested
- a laparoscopic simulator (Fundamentals of Laparoscopic Surgery (FLS), VT Medical Inc, Waltham, MA), Mimic da Vinci robotic simulator
- Keywords
- surgical education, minimally invasive surgical procedures, laparoscopic simulation, robotic simulation, medical education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 simulatorDevice
10 repetitions of practice on Mimic da Vinci robotic simulator.
| Study group | Role | What they receive |
|---|---|---|
| Laparoscopic simulator | Experimental | 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). Receives: Device: a laparoscopic simulator (Fundamentals of Laparoscopic Surgery (FLS), VT Medical Inc, Waltham, MA) |
| Mimic da Vinci robotic simulator | Experimental | 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). Receives: Device: Mimic da Vinci robotic simulator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Task Completion (Robotic Task)
Primary outcome will be time to task completion (seconds) on the robotic task
Measured: 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.
Measured: 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.
Measured: Study duration
Time to Task Completion on the Laparoscopic Task
Time to task completion (seconds) on the laparoscopic task
Measured: 1 day of practice
Secondary outcomes (5)
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
Measured: Study duration
Instrument Out of View
Automatically recorded data on the Mimic DV trainer, (sec). The longer out of view indicates decreased proficiency
Measured: through study completion
Instrument Collisions
Automatically recorded data on the Mimic DV trainer which records number of collisions
Measured: study duration
Time Spent Using Excessive Force
Automatically recorded data on the Mimic DV trainer (seconds)
Measured: 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
Measured: study duration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2015 (estimated)
- Study startNov 2014
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Surgical Simulation EducationStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chi Chiung Grace Chen, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02370407
- Sponsor's protocol ID
- IRB00031436
- Status last verified
- Jul 2017
- First submitted
- 25 Nov 2014
- Last updated
- 28 Aug 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
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.
PubMed 28078455
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Transferability of Skills From Robotic to Laparoscopic Simulation Platforms in Surgical Skill Naive Participants
- ClinicalTrials.gov ID
- NCT02370407
- Acronym / sponsor ID
- IRB00031436
- Conditions
- Surgical Simulation Education
- Keywords
- surgical education, minimally invasive surgical procedures, laparoscopic simulation, robotic simulation, medical education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 24 Feb 2015 (estimated)
- Results
- Posted 28 Aug 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laparoscopic simulator | Experimental | Device: 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 | Experimental | Device: Mimic da Vinci robotic simulator20 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). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Medical students with no prior laparoscopic or robotic experience in clinical or practice setting
Key exclusion criteria (1 listed)
- Prior laparoscopic or robotic experience in clinical setting or in practice setting
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| a laparoscopic simulator (Fundamentals of Laparoscopic Surgery (FLS), VT Medical Inc, Waltham, MA)10 repetitions of practice on laparoscopic simulator. | Device | Laparoscopic simulator |
| Mimic da Vinci robotic simulator10 repetitions of practice on Mimic da Vinci robotic simulator. | Device | Mimic da Vinci robotic simulator |
Primary outcome
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
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.
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.
Time to Task Completion on the Laparoscopic Task
Time frame: 1 day of practice
Time to task completion (seconds) on the laparoscopic task
5 secondary outcomes
Economy of Motion on the Robotic Task
Time frame: Study duration
Instrument Out of View
Time frame: through study completion
Instrument Collisions
Time frame: study duration
Time Spent Using Excessive Force
Time frame: study duration
Workspace Range
Time frame: study duration
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 28078455Orlando 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chi Chiung Grace Chen, MD principal investigator
Johns Hopkins University
Questions about this trial
What is this clinical trial studying?
A study testing a laparoscopic simulator (Fundamentals of Laparoscopic Surgery (FLS), VT Medical Inc, Waltham, MA) and Mimic da Vinci robotic simulator in people with Surgical Simulation Education, run by Johns Hopkins University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Aug 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Task Completion (Robotic Task) (time frame: 1 day of practice). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02370407, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2017.