Medical Students Naive to Surgical Robotics
Conditions
Brief summary
The goal of the project is to define the optimal learning environment and protocol for dvSS® simulation activities using medical students as robotic-naïve research participants.
Detailed description
The goal of the project is to define the optimal learning environment and protocol for dvSS® simulation activities using medical students as robotic-naïve research participants. The investigators propose to accomplish this goal through the following aims: Specific Aim #1: to investigate the total training time and the total number of repetitions required for participants to achieve proficiency (as defined on the dvSS® as 91%) for each of the selected exercises in selected dVSS activities. Specific Aim #2: to measure the transferability of skills acquired through a robotic simulation to live porcine models compared to nonintervention controls. The study will compare the effect of training with the dVSS to similar nonintervention controls by grading a suturing procedure on a live porcine model. Findings generated from this study will provide new insight into the efficacy of the dVSS as a simulation- based training tool for medical practitioners. Collectively, this work will build upon the narrow knowledge base on how to develop a nationally accredited simulation-based robotics curriculum. This study undoubtedly furthers the GWU SMHS mission of education, research, and healing. The study seeks to understand the learning curve students can achieve by simulation-based training and then to directly apply that training to a safe in vivo model in order to determine training interventions that can inform a robotic curriculum both locally at GWU and throughout the country. Additionally, this study is innovative in that it is the first of its kind to correlate skills acquired on a robotic-simulation gynecology based tool to a live porcine model. It seeks to enhance the current GWU GYN robotics- curriculum and assist with the development of a specific curriculum within the next year. Although the immediate goal is for planning toward a gynecology robotic curriculum, results of this study could also inform development of robotic programs in other disciplines such as general surgery and urology. Considering, the limited development of simulation-based robotics curriculum, further refining the curriculum would allow GWU to continue to be globally recognized as a medical center that embraces the challenge of…transforming health care, and expanding research to enrich and improve the lives of those \[served\]. It also serves to leverage the SMHS brand to enhance opportunities for recognition, distinction..& marketing. Preparing a generation of well-trained and confident gynecologic surgeons will allow providers to administer safe care to women.
Interventions
BEHAVIORALSurgical Simulation Practice Modules
The surgical simulation practice modules simulate surgical settings for suturing.
Sponsors
George Washington University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
Inclusion criteria
* medical & physician assistant students at George Washington University with no prior experience using a surgical robot
Exclusion criteria
* medical & physician assistant students at George Washington University with prior experience using a surgical robot * students not enrolled in the medical or physician assistant program at George Washington University
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Global Evaluative Assessment of Robotic Skills (GEARS) Scale | Three weeks after orientation | GEARS is a validated assessment tool for grading overall technical proficiency for robotic surgery. The overall proficiency score is a composite score of five different measures: depth perception, bimanual dexterity, efficiency, force sensitivity, and robotic control. Each of these subscale scores are graded 1-5, with 1 being poor and 5 being excellent. The total score is the summation of the scores from each of the five subscales and ranges from 5 to 25. |
| Amount Time to Suture | Three weeks after orientation | time, measured in minutes, it took each participant to perform the suturing activity |
| Amount of Time to Achieve Proficiency | assessed after the orientation and prior to the three week date for the final suturing assessment | time, measured in minutes, it took each participant in the intervention group to achieve surgical proficiency on the robotic simulator. |
Countries
United States
Participant flow
Pre-assignment details
Of the 40 subjects who consented to participate in the study, 4 subjects failed to complete study procedures and dropped out of the study. Reason for this included inability to attend the final assessment and subjects unwilling to perform the final study assessment on a live porcine model.
Participants by arm
| Arm | Count |
|---|---|
| Control Group Participants in the Control Group (CG) were asked to attend an orientation reviewing the study. Three weeks later participants returned and were filmed timed completing a suturing activity on the porcine model. | 20 |
| Experimental Group Participants in the Experimental Group (EG) were asked to attend an orientation reviewing the study. Then participants were instructed to complete 4 activities on the dvSS ® that modeled suturing techniques in minimally invasive robotics-assisted surgery. EG participants repeated these 4 activities over a period of 2 weeks until proficiency (91%) in all 4 activities was reached. Participants were asked to return and were filmed and timed completing a suturing activity on the porcine model. | 20 |
| Total | 40 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 3 | 1 |
Baseline characteristics
| Characteristic | Control Group | Experimental Group | Total |
|---|---|---|---|
| Age, Continuous | 25 years | 25 years | 25 years |
| Region of Enrollment United States | 20 participants | 20 participants | 40 participants |
| Sex: Female, Male Female | 7 Participants | 11 Participants | 18 Participants |
| Sex: Female, Male Male | 13 Participants | 9 Participants | 22 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
Amount of Time to Achieve Proficiency
time, measured in minutes, it took each participant in the intervention group to achieve surgical proficiency on the robotic simulator.
Time frame: assessed after the orientation and prior to the three week date for the final suturing assessment
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Control Group | Amount of Time to Achieve Proficiency | 116 minutes |
Primary
Amount Time to Suture
time, measured in minutes, it took each participant to perform the suturing activity
Time frame: Three weeks after orientation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group | Amount Time to Suture | 9.9 minutes | Standard Deviation 2.07 |
| Experimental Group | Amount Time to Suture | 9.2 minutes | Standard Deviation 2.65 |
Primary
Global Evaluative Assessment of Robotic Skills (GEARS) Scale
GEARS is a validated assessment tool for grading overall technical proficiency for robotic surgery. The overall proficiency score is a composite score of five different measures: depth perception, bimanual dexterity, efficiency, force sensitivity, and robotic control. Each of these subscale scores are graded 1-5, with 1 being poor and 5 being excellent. The total score is the summation of the scores from each of the five subscales and ranges from 5 to 25.
Time frame: Three weeks after orientation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group | Global Evaluative Assessment of Robotic Skills (GEARS) Scale | 15.25 units on a scale | Standard Deviation 3.38 |
| Experimental Group | Global Evaluative Assessment of Robotic Skills (GEARS) Scale | 15.37 units on a scale | Standard Deviation 2.51 |