Proficiency Based Robotics Training Curriculum: Skill Acquisition & Transferability of Skills to Live Porcine Models

Study Will be Focused on Medical Students Naive to Surgical Robotics Clinical Trial

Official title:

Proficiency Based Robotics Training Curriculum: Skill Acquisition & Transferability of Skills

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02895347
• Other study ID #: 111547
• Status: Active, not recruiting
• Phase: N/A
• First received: September 6, 2016
• Last updated: September 6, 2016
• Start date: December 2015
• Est. completion date: December 2016

Study information

• Verified date: September 2016
• Source: George Washington University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: George Washington University Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The goal of our project is to define the optimal learning environment and protocol for dvSS® simulation activities using medical students as robotic-naïve research participants.

Description:

The goal of our project is to define the optimal learning environment and protocol for dvSS® simulation activities using medical students as robotic-naïve research participants. We 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. Our 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.

Our 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, our 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. Our study seeks to enhance the current GWU GYN robotics- curriculum and assist with the development of a specific curriculum within the next year. Although our 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 we serve." 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 us to provide safe care to women.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 36
• Est. completion date: December 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator)

Related Conditions & MeSH terms

• Study Will be Focused on Medical Students Naive to Surgical Robotics

Intervention

Behavioral:
• Surgical Simulation Practice Modules
The surgical simulation practice modules simulate surgical settings for suturing.

Locations

Country	Name	City	State
United States	George Washington University Medical Faculty Associates	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
George Washington University

Country where clinical trial is conducted

United States, 

References & Publications (9)

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. Review. — View 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. — View Citation

Brenot K, Goyert GL. Impact of robotic surgery on obstetric-gynecologic resident training. J Reprod Med. 2009 Nov-Dec;54(11-12):675-7. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of suturing	Quality, as assessed by surgeons using a verified assessment tool, to perform the suturing activity	Three weeks after orientation	No
Primary	Amount time to suture	time, measured in minutes, it took each participant to perform the suturing activity	Three weeks after orientation	No
Primary	Amount of time to achieve proficiency	time, measured in days, it took each participant in the intervention group to achieve surgical proficiency on the robotic simulator.	assessed after the orientation and prior to the three week date for the final suturing assessment	No