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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
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| 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| a laparoscopic simulator (Fundamentals of Laparoscopic Surgery (FLS), VT Medical Inc, Waltham, MA) | Device | 10 repetitions of practice on laparoscopic simulator. |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chi Chiung Grace Chen, MD | Johns Hopkins University | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28078455 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Mimic da Vinci robotic simulator | Device | 10 repetitions of practice on Mimic da Vinci robotic simulator. |
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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 |
| FG001 |
| 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. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Time to Task Completion (Robotic Task) | Primary outcome will be time to task completion (seconds) on the robotic task | Posted | Mean | Standard Deviation | seconds | 1 day of practice |
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| 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. | Posted | Mean | Standard Deviation | units on a scale | Study duration |
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| 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. | Posted | Mean | Standard Deviation | units on a scale | Study duration |
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| Primary | Time to Task Completion on the Laparoscopic Task | Time to task completion (seconds) on the laparoscopic task | Posted | Mean | Standard Deviation | seconds | 1 day of practice |
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| 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 | Posted | Mean | Standard Deviation | cm | Study duration |
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| Secondary | Instrument Out of View | Automatically recorded data on the Mimic DV trainer, (sec). The longer out of view indicates decreased proficiency | Posted | Mean | Standard Deviation | seconds | through study completion |
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| Secondary | Instrument Collisions | Automatically recorded data on the Mimic DV trainer which records number of collisions | Posted | Mean | Standard Deviation | number of events | study duration |
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| Secondary | Time Spent Using Excessive Force | Automatically recorded data on the Mimic DV trainer (seconds) | Posted | Mean | Standard Deviation | seconds | study duration |
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| 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 | Posted | Mean | Standard Deviation | cm | study duration |
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40 surgical skill naive medical students practiced techniques on simulators. They were randomized to either practice on a robotic simulator or laparoscopic simulator. No participants were at risk for health outcomes, as they were assessed only on time to completion of a task compared to the two different interventions. However, this was done only in a simulated setting, and not on a patient.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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). Laparoscopic simulator (Fundamentals of Laparoscopic Surgery (FLS), VT Medical Inc, Waltham, MA): 10 repetitions of practice on laparoscopic simulator. | 0 | 20 | 0 | 20 | 0 | 20 |
| EG001 | 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. | 0 | 20 | 0 | 20 | 0 | 20 |
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We modified three previously validated scales to create a 35-point scale to evaluate participants; therefore, the validity of these scales may have been impacted.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Lauren Thomaier | Johns Hopkins University | 410-955-6710 | lthomai1@jhmi.edu |
| >=65 years |
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| Male |
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