Surgical Simulation Education
Conditions
Keywords
surgical education, minimally invasive surgical procedures, laparoscopic simulation, robotic simulation, medical education
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.
Interventions
DEVICEa laparoscopic simulator (Fundamentals of Laparoscopic Surgery (FLS), VT Medical Inc, Waltham, MA)
10 repetitions of practice on laparoscopic simulator.
DEVICEMimic da Vinci robotic simulator
10 repetitions of practice on Mimic da Vinci robotic simulator.
Sponsors
Johns Hopkins University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 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. |
| 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
| Measure | Time frame | Description |
|---|---|---|
| Instrument Collisions | study duration | Automatically recorded data on the Mimic DV trainer which records number of collisions |
| 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 |
| 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 |
| Instrument Out of View | through study completion | Automatically recorded data on the Mimic DV trainer, (sec). The longer out of view indicates decreased proficiency |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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).
a laparoscopic simulator (Fundamentals of Laparoscopic Surgery (FLS), VT Medical Inc, Waltham, MA): 10 repetitions of practice on laparoscopic simulator. | 20 |
| 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).
Mimic da Vinci robotic simulator: 10 repetitions of practice on Mimic da Vinci robotic simulator. | 20 |
| Total | 40 |
Baseline characteristics
| Characteristic | Laparoscopic Simulator | Mimic da Vinci Robotic Simulator | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 20 Participants | 20 Participants | 40 Participants |
| Sex: Female, Male Female | 12 Participants | 9 Participants | 21 Participants |
| Sex: Female, Male Male | 8 Participants | 11 Participants | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 20 |
| other Total, other adverse events | 0 / 20 | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 |
Outcome results
Primary
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.
Time frame: Study duration
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Laparoscopic Group | Global Rating Scale Score on the Laparoscopic Task | 22.5 units on a scale | Standard Deviation 3.8 |
| Robotic Group | Global Rating Scale Score on the Laparoscopic Task | 16.3 units on a scale | Standard Deviation 4.1 |
Primary
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.
Time frame: Study duration
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Laparoscopic Group | Global Rating Scale Score on the Robotic Task | 16.9 units on a scale | Standard Deviation 5.4 |
| Robotic Group | Global Rating Scale Score on the Robotic Task | 23.5 units on a scale | Standard Deviation 6.7 |
Primary
Time to Task Completion on the Laparoscopic Task
Time to task completion (seconds) on the laparoscopic task
Time frame: 1 day of practice
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Laparoscopic Group | Time to Task Completion on the Laparoscopic Task | 100 seconds | Standard Deviation 29 |
| Robotic Group | Time to Task Completion on the Laparoscopic Task | 158 seconds | Standard Deviation 65 |
Primary
Time to Task Completion (Robotic Task)
Primary outcome will be time to task completion (seconds) on the robotic task
Time frame: 1 day of practice
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Laparoscopic Group | Time to Task Completion (Robotic Task) | 120 seconds | Standard Deviation 42 |
| Robotic Group | Time to Task Completion (Robotic Task) | 71 seconds | Standard Deviation 23 |
Secondary
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
Time frame: Study duration
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Laparoscopic Group | Economy of Motion on the Robotic Task | 241 cm | Standard Deviation 57 |
| Robotic Group | Economy of Motion on the Robotic Task | 161 cm | Standard Deviation 35 |
Secondary
Instrument Collisions
Automatically recorded data on the Mimic DV trainer which records number of collisions
Time frame: study duration
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Laparoscopic Group | Instrument Collisions | 2.8 number of events | Standard Deviation 4.3 |
| Robotic Group | Instrument Collisions | 1.1 number of events | Standard Deviation 1.8 |
Secondary
Instrument Out of View
Automatically recorded data on the Mimic DV trainer, (sec). The longer out of view indicates decreased proficiency
Time frame: through study completion
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Laparoscopic Group | Instrument Out of View | 3.06 seconds | Standard Deviation 3.3 |
| Robotic Group | Instrument Out of View | 0.91 seconds | Standard Deviation 2.3 |
Secondary
Time Spent Using Excessive Force
Automatically recorded data on the Mimic DV trainer (seconds)
Time frame: study duration
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Laparoscopic Group | Time Spent Using Excessive Force | 0.28 seconds | Standard Deviation 0.58 |
| Robotic Group | Time Spent Using Excessive Force | 0.24 seconds | Standard Deviation 1.1 |
Secondary
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
Time frame: study duration
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Laparoscopic Group | Workspace Range | 9.41 cm | Standard Deviation 2.3 |
| Robotic Group | Workspace Range | 9.34 cm | Standard Deviation 2.5 |