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

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ClinicalTrials.gov Identifier: NCT02895347
Recruitment Status : Completed
First Posted : September 9, 2016
Results First Posted : April 18, 2017
Last Update Posted : April 18, 2017
Sponsor:
Information provided by (Responsible Party):
George Washington University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Medical Students Naive to Surgical Robotics Behavioral: Surgical Simulation Practice Modules Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Other
Official Title: Proficiency Based Robotics Training Curriculum: Skill Acquisition & Transferability of Skills
Study Start Date : December 2015
Actual Primary Completion Date : March 2016
Actual Study Completion Date : November 2016
Arms and Interventions
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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.
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.
 Behavioral: Surgical Simulation Practice Modules
The surgical simulation practice modules simulate surgical settings for suturing.


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. Amount Time to Suture [ Time Frame: Three weeks after orientation ]
    time, measured in minutes, it took each participant to perform the suturing activity

  3. Amount of Time to Achieve Proficiency [ Time Frame: 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.


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02895347


Locations
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United States, District of Columbia
George Washington University Medical Faculty Associates
Washington, District of Columbia, United States, 20037
Sponsors and Collaborators
George Washington University
More Information
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Publications:

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Responsible Party: George Washington University
ClinicalTrials.gov Identifier: NCT02895347    
Other Study ID Numbers: 111547
First Posted: September 9, 2016    Key Record Dates
Results First Posted: April 18, 2017
Last Update Posted: April 18, 2017
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Results will be submitted for Association of Processors of Gynecology and Obstetrics Annual Meeting as well as to journals for publication.