Medical Students Naive to Surgical RoboticsNCT02895347
Proficiency Based Robotics Training Curriculum: Skill Acquisition & Transferability of Skills to Live Porcine Models
A study testing Surgical Simulation Practice Modules in people with Medical Students Naive to Surgical Robotics, run by George Washington University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Medical Students Naive to Surgical Robotics
- What is being tested?
- Surgical Simulation Practice Modules
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2015to Nov 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- medical \& physician assistant students at George Washington University with no prior experience using a surgical robot
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
George Washington University Medical Faculty Associates
Washington D.C., District of Columbia, 20037
About this study
Official title: Proficiency Based Robotics Training Curriculum: Skill Acquisition & Transferability of Skills
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.
Read the 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.
- Being tested
- Surgical Simulation Practice Modules
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical Simulation Practice ModulesBehavioural
The surgical simulation practice modules simulate surgical settings for suturing.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | 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 Group | Experimental | 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. Receives: Behavioral: Surgical Simulation Practice Modules |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Three weeks after orientation
Amount Time to Suture
time, measured in minutes, it took each participant to perform the suturing activity
Measured: Three weeks after orientation
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.
Measured: assessed after the orientation and prior to the three week date for the final suturing assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2016 (estimated)
- Study startDec 2015
- Primary completionMar 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Medical Students Naive to Surgical RoboticsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- George Washington University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02895347
- Sponsor's protocol ID
- 111547
- Status last verified
- Sep 2016
- First submitted
- 6 Sep 2016
- Last updated
- 18 Apr 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: Results will be submitted for Association of Processors of Gynecology and Obstetrics Annual Meeting as well as to journals for publication.
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.
PubMed 19423061Sheth 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.
PubMed 24411435Gobern 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.
PubMed 22024262Brenot K, Goyert GL. Impact of robotic surgery on obstetric-gynecologic resident training. J Reprod Med. 2009 Nov-Dec;54(11-12):675-7.
PubMed 20120900Hung 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.
PubMed 21784469Kenney 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.
PubMed 19362352Stegemann 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.
PubMed 23484743Stefanidis 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.
PubMed 19536599Aghazadeh 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.
PubMed 25609318
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proficiency Based Robotics Training Curriculum: Skill Acquisition & Transferability of Skills
- ClinicalTrials.gov ID
- NCT02895347
- Acronym / sponsor ID
- 111547
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- George Washington UniversityUniversity, hospital or other
- Study start
- Dec 2015
- Primary completion
- Mar 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 9 Sep 2016 (estimated)
- Results
- Posted 18 Apr 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –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 Group | Experimental | Behavioral: Surgical Simulation Practice ModulesParticipants 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- medical \& physician assistant students at George Washington University with no prior experience using a surgical robot
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surgical Simulation Practice ModulesThe surgical simulation practice modules simulate surgical settings for suturing. | Behavioural | Experimental Group |
Primary outcome
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.
Amount Time to Suture
Time frame: Three weeks after orientation
time, measured in minutes, it took each participant to perform the suturing activity
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 19423061Advincula 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.
- Background: PubMed 24411435Sheth 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.
- Background: PubMed 22024262Gobern 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.
- Background: PubMed 20120900Brenot K, Goyert GL. Impact of robotic surgery on obstetric-gynecologic resident training. J Reprod Med. 2009 Nov-Dec;54(11-12):675-7.
- Background: PubMed 21784469Hung 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.
- Background: PubMed 19362352Kenney 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.
- Background: PubMed 23484743Stegemann 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.
- Background: PubMed 19536599Stefanidis 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.
- Background: PubMed 25609318Aghazadeh 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.
- Individual participant dataSharing planned: Yes. Results will be submitted for Association of Processors of Gynecology and Obstetrics Annual Meeting as well as to journals for publication.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgical Simulation Practice Modules in people with Medical Students Naive to Surgical Robotics, run by George Washington University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Apr 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Global Evaluative Assessment of Robotic Skills (GEARS) Scale (time frame: Three weeks after orientation). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02895347, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2017.