Clinical trial NCT02895347: Proficiency Based Robotics Training Curriculum: Skill Acquisition & Transferability of Skills to Live Porcine Models
Official title: Proficiency Based Robotics Training Curriculum: Skill Acquisition & Transferability of Skills
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Medical Students Naive to Surgical Robotics
Lead sponsor: George Washington University
Sponsor class: OTHER
First posted: 2016-09-09
Enrollment: 36
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Global Evaluative Assessment of Robotic Skills (GEARS) Scale
timeFrame: Three weeks after orientation
measure: Amount Time to Suture
timeFrame: Three weeks after orientation
measure: Amount of Time to Achieve Proficiency
timeFrame: assessed after the orientation and prior to the three week date for the final suturing assessment
Secondary outcomes:
Other outcomes:
Locations:
city: Washington
country: United States
facility: George Washington University Medical Faculty Associates
state: District of Columbia
Study officials:
References:
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citation: 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.
citation: 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.
citation: 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.