- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02895347
Proficiency Based Robotics Training Curriculum: Skill Acquisition & Transferability of Skills to Live Porcine Models
Proficiency Based Robotics Training Curriculum: Skill Acquisition & Transferability of Skills
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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District of Columbia
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Washington, District of Columbia, United States, 20037
- George Washington University Medical Faculty Associates
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control Group
Participants in the Control Group (CG) were asked to attend an orientation reviewing the study.
Three weeks later they returned and were filmed timed completing a suturing activity on the porcine model.
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Experimental: Experimental Group
Participants in the Experimental Group (EG) were asked to attend an orientation reviewing the study.
Then they 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 they reached proficiency (91%) in all 4 activities.
4. Participants were asked to return where they were filmed and timed completing a suturing activity on the porcine model.
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The surgical simulation practice modules simulate surgical settings for suturing.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Global Evaluative Assessment of Robotic Skills (GEARS) Scale
Time Frame: 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.
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Three weeks after orientation
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Amount Time to Suture
Time Frame: Three weeks after orientation
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time, measured in minutes, it took each participant to perform the suturing activity
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Three weeks after orientation
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Amount of Time to Achieve Proficiency
Time Frame: assessed after the orientation and prior to the three week date for the final suturing assessment
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time, measured in minutes, it took each participant in the intervention group to achieve surgical proficiency on the robotic simulator.
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assessed after the orientation and prior to the three week date for the final suturing assessment
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Advincula AP, Wang K. Evolving role and current state of robotics in minimally invasive gynecologic surgery. J Minim Invasive Gynecol. 2009 May-Jun;16(3):291-301. doi: 10.1016/j.jmig.2009.03.003.
- Sheth SS, Fader AN, Tergas AI, Kushnir CL, Green IC. Virtual reality robotic surgical simulation: an analysis of gynecology trainees. J Surg Educ. 2014 Jan-Feb;71(1):125-32. doi: 10.1016/j.jsurg.2013.06.009. Epub 2013 Jul 12.
- Gobern JM, Novak CM, Lockrow EG. Survey of robotic surgery training in obstetrics and gynecology residency. J Minim Invasive Gynecol. 2011 Nov-Dec;18(6):755-60. doi: 10.1016/j.jmig.2011.08.004.
- Brenot K, Goyert GL. Impact of robotic surgery on obstetric-gynecologic resident training. J Reprod Med. 2009 Nov-Dec;54(11-12):675-7.
- Hung AJ, Zehnder P, Patil MB, Cai J, Ng CK, Aron M, Gill IS, Desai MM. Face, content and construct validity of a novel robotic surgery simulator. J Urol. 2011 Sep;186(3):1019-24. doi: 10.1016/j.juro.2011.04.064. Epub 2011 Jul 23.
- Kenney PA, Wszolek MF, Gould JJ, Libertino JA, Moinzadeh A. Face, content, and construct validity of dV-trainer, a novel virtual reality simulator for robotic surgery. Urology. 2009 Jun;73(6):1288-92. doi: 10.1016/j.urology.2008.12.044. Epub 2009 Apr 10.
- Stegemann AP, Ahmed K, Syed JR, Rehman S, Ghani K, Autorino R, Sharif M, Rao A, Shi Y, Wilding GE, Hassett JM, Chowriappa A, Kesavadas T, Peabody JO, Menon M, Kaouk J, Guru KA. Fundamental skills of robotic surgery: a multi-institutional randomized controlled trial for validation of a simulation-based curriculum. Urology. 2013 Apr;81(4):767-74. doi: 10.1016/j.urology.2012.12.033. Epub 2013 Feb 26.
- Stefanidis D, Wang F, Korndorffer JR Jr, Dunne JB, Scott DJ. Robotic assistance improves intracorporeal suturing performance and safety in the operating room while decreasing operator workload. Surg Endosc. 2010 Feb;24(2):377-82. doi: 10.1007/s00464-009-0578-0. Epub 2009 Jun 18.
- Aghazadeh MA, Jayaratna IS, Hung AJ, Pan MM, Desai MM, Gill IS, Goh AC. External validation of Global Evaluative Assessment of Robotic Skills (GEARS). Surg Endosc. 2015 Nov;29(11):3261-6. doi: 10.1007/s00464-015-4070-8. Epub 2015 Jan 22.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 111547
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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