Surg Endosc DOI 10.1007/s00464-013-3373-x
and Other Interventional Techniques
Validation of a virtual reality-based robotic surgical skills curriculum Michael Connolly • Johnathan Seligman • Andrew Kastenmeier • Matthew Goldblatt Jon C. Gould
•
Received: 20 August 2013 / Accepted: 9 December 2013 Ó Springer Science+Business Media New York 2013
Abstract Background The clinical application of robotic-assisted surgery (RAS) is rapidly increasing. The da Vinci Surgical SystemTM is currently the only commercially available RAS system. The skills necessary to perform robotic surgery are unique from those required for open and laparoscopic surgery. A validated laparoscopic surgical skills curriculum (fundamentals of laparoscopic surgery or FLSTM) has transformed the way surgeons acquire laparoscopic skills. There is a need for a similar skills training and assessment tool specific for robotic surgery. Based on previously published data and expert opinion, we developed a robotic skills curriculum. We sought to evaluate this curriculum for evidence of construct validity (ability to discriminate between users of different skill levels). Methods Four experienced surgeons ([20 RAS) and 20 novice surgeons (first-year medical students with no surgical or RAS experience) were evaluated. The curriculum comprised five tasks utilizing the da VinciTM Skills Simulator (Pick and Place, Camera Targeting 2, Peg Board 2, Matchboard 2, and Suture Sponge 3). After an orientation to the robot and a period of acclimation in the simulator, all subjects completed three consecutive repetitions of each task. Computer-derived performance metrics included time, economy of motion, master work space, instrument collisions, excessive force, distance of instruments out of Presented as a poster at the 2013 SAGES Annual Meeting, Baltimore, MD, USA. M. Connolly J. Seligman A. Kastenmeier M. Goldblatt J. C. Gould (&) Division of General Surgery, Department of Surgery, Medical College of Wisconsin, 9200 W. Wisconsin Avenue, Milwaukee, WI 53226, USA e-mail: [email protected]
view, drops, missed targets, and overall scores (a composite of all metrics). Results Experienced surgeons significantly outperformed novice surgeons in most metrics. Statistically significant differences were detected for each task in regards to mean overall scores and mean time (seconds) to completion. Conclusions The curriculum we propose is a valid method of assessing and distinguishing robotic surgical skill levels on the da Vinci SiTM Surgical System. Further study is needed to establish proficiency levels and to demonstrate that training on the simulator with the proposed curriculum leads to improved robotic surgical performance in the operating room. Keywords Robotic surgery Simulation da Vinci Skills Simulator Robotic training
Beginning with the introduction of the da Vinci Surgical System (Intuitive Surgical, Sunnyvale, CA, USA) in 1999, robotic-assisted surgery has seen a rapid, accelerating expansion in both number and type of procedures performed. By 2010, almost 1,800 da Vinci Systems were in use worldwide, performing a wide variety of surgeries in fields such as urology, gynecology, and thoracic surgery [1]. According to Intuitive Surgical, robotic-assisted prostatectomies are estimated to exceed 80 % of the market share as opposed to open or laparoscopic approaches [2]. In the early days of laparoscopic surgery, surgeons with experience in open cholecystectomy began to perform laparoscopic cholecystectomy with little training or experience in laparoscopy other than a weekend course. Complications were observed at an unexpectedly high rate leading many surgeons to conclude that laparoscopic surgical skills are not derivative from those attained in open
123
Surg Endosc
surgery. In laparoscopic surgery, extensive research has since been conducted documenting the value of simulation for both surgical skills assessment and laparoscopic skills development. Standardized training curricula have been developed, notably the simulation-based laparoscopic skills curriculum known as fundamentals of laparoscopic surgery (FLS). The FLS curriculum is composed of five standardized tasks performed in a video trainer. Validated performance metrics have been established for each task [3]. Robotic surgical systems are now accessible to surgeons in thousands of hospitals throughout the United States. Reminiscent of the introduction to laparoscopic surgery, it is clear that robotic surgical skills are not necessarily derivative, and in some ways are extremely different, from those attained in either laparoscopic or in open surgery. Several high fidelity, virtual-reality robotic surgical simulators exist including the da VinciÒ Skills SimulatorTM, which has been previously studied and uses the da Vinci SiTM surgeon console as the training interface [4]. This is an advantage to trainees as they develop robotic skills while also acclimating to the layout and operation of the surgeon’s console. The simulator provides learners with objective performance metrics, which can be difficult to interpret. A large number of exercises and skill levels are programmed into the simulator (30 and counting). Considering the fact that the da Vinci surgical system cannot be in use clinically at the same time as the da Vinci Skills Simulator is utilized for robotic skills training, we sought to develop a concise, validated curriculum to be used as an efficient training tool.
curriculum. Suture Sponge 3 was chosen as the most difficult task of the curriculum and emphasizes needle control while requiring the use of both hands for needle driving. After institutional review board approval was attained, first-year medical students and practicing robotic surgeons were recruited to participate. The experienced robotic surgeon group consisted of four trained and credentialed robotic surgeons who had performed at least 20 robotassisted surgeries on the da Vinci Si System. Our novice group was comprised of 20 first-year medical students who had no prior robotic surgical experience. All subjects were given an oral introduction to the console controls and components after which they were allowed to acclimate themselves to the master controls and three-dimensional image. Each simulator task was preceded by a short verbal explanation of the task and its objectives. All subjects completed three consecutive attempts of each exercise. Computer-derived performance metrics displayed at the completion of each attempt included time to completion, economy of motion, master work space, instrument collisions, excessive force, distance of instruments out of view, drops (when applicable), missed targets (when applicable), and overall score (a composite of all metrics). All metrics were recorded following each attempt. Statistical analysis was conducted using MStat v5.5 (University of Wisconsin). Continuous variables were analyzed using the Wilcoxon rank-sum test. Statistical significance was set at p \ 0.05.
Results Materials and methods The da VinciÒ Skills SimulatorTM integrates with the da Vinci SiTM surgeon console to synchronize master control movement and simulated surgical instruments in a computer generated environment. From among the 30 different simulated tasks on the da Vinci Skills Simulator, based on previously published data [4–6] and with input from experienced robotic surgeons at our institution, we selected five tasks of incremental difficulty and relevance to robotic surgical procedures for our curriculum. These tasks are known as Pick and Place, Camera Targeting Level 2, Peg Board Level 2, Matchboard Level 2, and Suture Sponge Level 3. Pick and Place was considered to be a good introduction to robotic surgery for novices and an appropriate warm-up for experienced surgeons, involving a simple task while allowing for acclimation to the hand-eye coordination involved with the simulator. Camera Targeting 2 was chosen given its emphasis on camera movement and control as well as the necessary use of the clutch. Peg Board 2 is similar to the peg transfer task of the FLS
123
Experienced surgeons outperformed novice surgeons on all selected tasks and in nearly all recorded performance metrics. The most reliable metrics for discriminating experienced versus novice subjects were overall score and time to completion. These scores and times for the five tasks are listed in Table 1.
Discussion We have demonstrated that a robotic skills curriculum based in the da VinciÒ Skills Simulator is capable of discriminating experienced from novice robotic surgeons. Our curriculum is composed of five exercises of varied complexity, much like the FLS curriculum in laparoscopic surgery. Of the various pre-programmed computer derived metrics, time to complete a task and ‘‘overall score’’ were found to correlate most closely with robotic experience. This suggests that our curriculum demonstrates construct validity. Construct validity is defined as the degree to which a test measures what it claims, or purports, to be
Surg Endosc Table 1 Mean ‘‘overall score’’ and time to complete a task (in seconds) for experienced compared to novice robotic surgeons Task
Overall score experienced
Overall score novice
P value
Time experienced
Time novice
P value
Pick and Place
94.9
91.7
0.03
27.9
45.4
\0.01
Camera Target 2
87.2
62.8
\0.01
86.5
259.7
\0.01
Peg Board 2
95.9
78.2
\0.01
73.1
140.3
\0.01
Matchboard 2
81.1
57
\0.01
96.3
192.5
\0.01
Suture Sponge 3
85.3
42
\0.01
200.4
530.6
\0.01
P \ 0.05 is significant
measuring. In this case, overall score and time to complete the tasks relate to robotic surgical experience and likely robotic surgical skill as well. When laparoscopic surgery was introduced in the late 1980s and early 1990s, general surgeons rapidly embraced the techniques and technologies. The goal of minimally invasive surgery at the time was to decrease patient morbidity. Unfortunately, especially during the early days of laparoscopy, this was not always the case. The value of simulation and training in laparoscopic surgery has been demonstrated repeatedly in recent years. Simulation-based skills’ training allows learners to develop many of the necessary basic laparoscopic skills (instrument targeting, nondominant hand dexterity, two-handed coordination) in a low-risk, controlled, reproducible environment. Previous work has demonstrated that surgeons who practice skills in simulators perform better in the operating room and commit fewer errors than surgeons not provided this opportunity [7–10]. Laparoscopic surgery is now pervasive, and laparoscopic simulation training is currently a required component of accredited surgical residencies and mandated by the American Board of Surgeons to become board certified. Compared with an open approach, the benefits of a minimally invasive robotic approach are similar to those observed in laparoscopy. A recently published, populationbased analysis using the Nationwide Inpatient Sample (NIS) suggests that compared with open surgery, roboticassisted surgery results in decreased length of stay and diminished likelihood of death for the top 90 % of patients who had a code for robotic surgery (23 different procedures) [11]. When robotic surgery was compared to conventional laparoscopic surgery, the benefits were not as apparent. Potential advantages for robotic surgery compared to conventional laparoscopy include greater precision, better visualization, and better ergonomics for the operating surgeon. Unfortunately, this has not been demonstrated to translate consistently to improved outcomes for the patient, particularly in general surgery [12, 13]. Robotic surgery has seen tremendous growth in recent years. Robotic surgical systems are being used in more disciplines (cardiothoracic surgery, urology, gynecology,
general surgery, otolaryngology) and for an expanded array of increasingly complex procedures every year. Recently, a number of lawsuits have been brought forward naming Intuitive Surgical as a defendant and alleging that surgeons were inadequately trained to perform a particular robotic procedure [14]. A spike in the number of adverse event reports (AERs) to the food and drug administration (FDA) manufacturer and user facility experience (MAUDE) database related to the da Vinci surgical system prompted the FDA to ask surgeons whose hospitals belong to the agency’s medical product safety network to participate in a ten-question telephone survey about the da Vinci surgical system. From 2011 to 2012, AERs related to the da Vinci system increased 34 % while the number of robotic surgical procedures performed increased 26 % [15]. In 2013, the Massachusetts Board of Registration in Medicine issued an advisory on robot-assisted surgery in response to what it called a growing number of reported patient complications. The state medical board recommended that healthcare facilities take greater pains to credential surgeons, train surgical support staff, select appropriate patients, and explain the risks to them. ‘‘Patients should be advised on the experience of the surgeon in performing the recommended robotic procedure,’’ the board said. With an increased focus on patient safety in healthcare, it will be important to ensure that surgeons possess the necessary skills to safely perform robotic surgery. The surgical community would be wise to heed the lessons learned in the early days of laparoscopic cholecystectomy and from the past ten plus years of research demonstrating the value of simulation for skills training and assessment. A reliable, feasible, reproducible, and validated simulation based curriculum, and a standardized approach to robotic training and credentialing (not driven by industry) is needed. Some of the skills and conditions unique to robotic surgery include three-dimensional visualization, the lack of tactile feedback, the master controls, clutch, and motion scaling. Perrenot and colleagues developed a five-task robotic curriculum on the dV-trainer (Mimic dV-TrainerTM, Mimic Technologies Inc., Seattle, WA, USA) [16]. The dV-trainer is a stand-alone simulator on which the da Vinci Skills Simulator that docks to the da Vinci console is
123
Surg Endosc
based. Seventy-five subjects of varying skill and experience completed a curriculum that was very similar to ours. Face and content validity of the curriculum on the dVtrainer were high. Reliability of scoring was high, and the global scores on the simulator were strongly correlated with previous experience in robotic surgery (construct validity). The authors concluded that the dV-trainer is a valid tool to assess the skills of robotic surgery. Other investigators have demonstrated the face, content, and construct validity of the dV-trainer and da Vinci Skills Simulator using different combinations of the tasks available [17–19]. Future research should focus on establishing proficiency levels for training and proving that the robotic skills acquired in the simulator can be carried to the actual da Vinci platform in real robotic surgery. Professional societies and certifying bodies should carefully consider the issues surrounding training and credentialing in robotic surgery. A uniform, evidence-based standard that can be adopted nationwide should prove to be a step towards safer robotic surgery.
6.
7.
8.
9.
10.
11.
12. Acknowledgments The authors acknowledge Dario Icardi, Robotic Specialist for Froedtert Hospital, and Froedtert Memorial Lutheran Hospital, Milwaukee, WI, and finally the Medical College of Wisconsin Department of Surgery for their generous support of this project. Disclosures Michael Connolly, Johnathan Seligman, Dr. Andrew Kastenmeier, Dr. Mathew Goldblatt, and Dr. Jon Gould have no relevant conflicts of interest with this work.
References 1. Kenngott HG, Fischer L, Nickel F, Rom J, Rassweiler J, Mu¨llerStich BP (2012) Status of robotic assistance—a less traumatic and more accurate minimally invasive surgery? Langenbecks Arch Surg 397(3):333–341 2. Annual report 2010 (2011) Intuitive Surgical Inc 3. Okrainec A, Soper NJ, Swanstrom LL, Fried GM (2011) Trends and results of the first 5 years of fundamentals of laparoscopic surgery (FLS) certification testing. Surg Endosc 25(4):1192–1198 4. Hung AJ, Zehnder P, Patil MB, Cai J, Ng CK, Aron M, Gill IS, Desai MM (2011) Face, content and construct validity of a novel robotic surgery simulator. J Urol 186:1019–1025 5. Kenney PA, Wszolek MF, Gould JJ, Libertino JA, Moinzadeh A (2009) Face, content, and construct validity of dV-trainer, a novel
123
13.
14.
15. 16.
17.
18.
19.
virtual reality simulator for robotic surgery. Urology 73(6):1288– 1292 Lyons C, Goldfarb D, Jones SL, Badhiwala N, Miles B, Link R, Dunkin BJ (2013) Which skills really matter? Proving face, content, and construct validity for a commercial robotic simulator. Surg Endosc 27(6):2020–2030 Grantcharov TP, Kristiansen VB, Bendix J, Bardram L, Rosenberg J, Funch-Jensen P (2004) Randomized clinical trial of virtual reality simulation for laparoscopic skills training. Br J Surg 91:146–150 Seymour NE, Gallagher AG, Roman SA, O’Brien MK, Bansal VK, Andersen DK, Satava RM (2002) Virtual reality training improves operating room performance: results of a randomized, double-blinded study. Ann Surg 236:458–463 Sroka G, Feldman LS, Vassiliou MC, Kaneva PA, Fayez R, Fried GM (2010) Fundamentals of laparoscopic surgery simulator training to proficiency improves laparoscopic performance in the operating room: a randomized controlled trial. Am J Surg 199(1):115–120 Beyer L, De Troyer J, Mancini J, Bladou F, Berdah SV, Karsenty G (2011) Impact of laparoscopy simulator training on the technical skills of future surgeons in the operating room: a prospective study. Am J Surg 202(3):265–272 Anderson E, Chang DC, Parsons JK, Talamini MA (2012) The first national examination of outcomes and trends in robotic surgery in the United States. J Am Coll Surg 215(1):107–114 Gurusamy KS, Samraj K, Fusai G, Davidson BR (2009) Robot assistant for laparoscopic cholecystectomy. Cochrane Database Syst Rev 21(1):CD006578 Maeso S, Reza M, Mayol JA, Blasco JA, Guerra M, Andradas E, Plana MN (2010) Efficacy of the da Vinci surgical system in abdominal surgery compared with that of laparoscopy: a systematic review and meta-analysis. Ann Surg 252:254–262 Tanner L (2013) Robot hot among surgeons but FDA taking a fresh look. http://bigstory.ap.org/article/robot-hot-among-sur geons-fda-taking-new-look. Accessed 9 Aug 2013 Intuitive Surgical Form 10-k filed 2/4/13. http://phx.corporate-ir. net/phoenix.zhtml?c=122359&p=irol-sec. Accessed 9 Aug 2013 Perrenot C, Perez M, Nguyen T, Jehl J, Felblinger J, Bresler L, Hubert J (2012) The virtual reality simulator dV-trainer is a valid assessment tool for robotic surgical skills. Surg Endosc 26:2587– 2593 Kenney PA, Wszolek MF, Gould JJ, Libertino JA, Moinzadeh A (2009) Face, content, and construct validity of dV-trainer: a novel virtual reality simulator for robotic surgery. Urology 73(6):1288– 1292 Sethi AS, Peine WJ, Mohammadi Y, Sundaram CP (2009) Validation of a novel virtual reality robotic simulator. J Endourol 23(3):503–508 Lendvay TS, Casale P, Sweet R, Peters C (2008) VR robotic surgery: randomized blinded study of the dV-trainer robotic simulator. Stud Health Technol Inform 132:242–244
and Other Interventional Techniques
Validation of a virtual reality-based robotic surgical skills curriculum Michael Connolly • Johnathan Seligman • Andrew Kastenmeier • Matthew Goldblatt Jon C. Gould
•
Received: 20 August 2013 / Accepted: 9 December 2013 Ó Springer Science+Business Media New York 2013
Abstract Background The clinical application of robotic-assisted surgery (RAS) is rapidly increasing. The da Vinci Surgical SystemTM is currently the only commercially available RAS system. The skills necessary to perform robotic surgery are unique from those required for open and laparoscopic surgery. A validated laparoscopic surgical skills curriculum (fundamentals of laparoscopic surgery or FLSTM) has transformed the way surgeons acquire laparoscopic skills. There is a need for a similar skills training and assessment tool specific for robotic surgery. Based on previously published data and expert opinion, we developed a robotic skills curriculum. We sought to evaluate this curriculum for evidence of construct validity (ability to discriminate between users of different skill levels). Methods Four experienced surgeons ([20 RAS) and 20 novice surgeons (first-year medical students with no surgical or RAS experience) were evaluated. The curriculum comprised five tasks utilizing the da VinciTM Skills Simulator (Pick and Place, Camera Targeting 2, Peg Board 2, Matchboard 2, and Suture Sponge 3). After an orientation to the robot and a period of acclimation in the simulator, all subjects completed three consecutive repetitions of each task. Computer-derived performance metrics included time, economy of motion, master work space, instrument collisions, excessive force, distance of instruments out of Presented as a poster at the 2013 SAGES Annual Meeting, Baltimore, MD, USA. M. Connolly J. Seligman A. Kastenmeier M. Goldblatt J. C. Gould (&) Division of General Surgery, Department of Surgery, Medical College of Wisconsin, 9200 W. Wisconsin Avenue, Milwaukee, WI 53226, USA e-mail: [email protected]
view, drops, missed targets, and overall scores (a composite of all metrics). Results Experienced surgeons significantly outperformed novice surgeons in most metrics. Statistically significant differences were detected for each task in regards to mean overall scores and mean time (seconds) to completion. Conclusions The curriculum we propose is a valid method of assessing and distinguishing robotic surgical skill levels on the da Vinci SiTM Surgical System. Further study is needed to establish proficiency levels and to demonstrate that training on the simulator with the proposed curriculum leads to improved robotic surgical performance in the operating room. Keywords Robotic surgery Simulation da Vinci Skills Simulator Robotic training
Beginning with the introduction of the da Vinci Surgical System (Intuitive Surgical, Sunnyvale, CA, USA) in 1999, robotic-assisted surgery has seen a rapid, accelerating expansion in both number and type of procedures performed. By 2010, almost 1,800 da Vinci Systems were in use worldwide, performing a wide variety of surgeries in fields such as urology, gynecology, and thoracic surgery [1]. According to Intuitive Surgical, robotic-assisted prostatectomies are estimated to exceed 80 % of the market share as opposed to open or laparoscopic approaches [2]. In the early days of laparoscopic surgery, surgeons with experience in open cholecystectomy began to perform laparoscopic cholecystectomy with little training or experience in laparoscopy other than a weekend course. Complications were observed at an unexpectedly high rate leading many surgeons to conclude that laparoscopic surgical skills are not derivative from those attained in open
123
Surg Endosc
surgery. In laparoscopic surgery, extensive research has since been conducted documenting the value of simulation for both surgical skills assessment and laparoscopic skills development. Standardized training curricula have been developed, notably the simulation-based laparoscopic skills curriculum known as fundamentals of laparoscopic surgery (FLS). The FLS curriculum is composed of five standardized tasks performed in a video trainer. Validated performance metrics have been established for each task [3]. Robotic surgical systems are now accessible to surgeons in thousands of hospitals throughout the United States. Reminiscent of the introduction to laparoscopic surgery, it is clear that robotic surgical skills are not necessarily derivative, and in some ways are extremely different, from those attained in either laparoscopic or in open surgery. Several high fidelity, virtual-reality robotic surgical simulators exist including the da VinciÒ Skills SimulatorTM, which has been previously studied and uses the da Vinci SiTM surgeon console as the training interface [4]. This is an advantage to trainees as they develop robotic skills while also acclimating to the layout and operation of the surgeon’s console. The simulator provides learners with objective performance metrics, which can be difficult to interpret. A large number of exercises and skill levels are programmed into the simulator (30 and counting). Considering the fact that the da Vinci surgical system cannot be in use clinically at the same time as the da Vinci Skills Simulator is utilized for robotic skills training, we sought to develop a concise, validated curriculum to be used as an efficient training tool.
curriculum. Suture Sponge 3 was chosen as the most difficult task of the curriculum and emphasizes needle control while requiring the use of both hands for needle driving. After institutional review board approval was attained, first-year medical students and practicing robotic surgeons were recruited to participate. The experienced robotic surgeon group consisted of four trained and credentialed robotic surgeons who had performed at least 20 robotassisted surgeries on the da Vinci Si System. Our novice group was comprised of 20 first-year medical students who had no prior robotic surgical experience. All subjects were given an oral introduction to the console controls and components after which they were allowed to acclimate themselves to the master controls and three-dimensional image. Each simulator task was preceded by a short verbal explanation of the task and its objectives. All subjects completed three consecutive attempts of each exercise. Computer-derived performance metrics displayed at the completion of each attempt included time to completion, economy of motion, master work space, instrument collisions, excessive force, distance of instruments out of view, drops (when applicable), missed targets (when applicable), and overall score (a composite of all metrics). All metrics were recorded following each attempt. Statistical analysis was conducted using MStat v5.5 (University of Wisconsin). Continuous variables were analyzed using the Wilcoxon rank-sum test. Statistical significance was set at p \ 0.05.
Results Materials and methods The da VinciÒ Skills SimulatorTM integrates with the da Vinci SiTM surgeon console to synchronize master control movement and simulated surgical instruments in a computer generated environment. From among the 30 different simulated tasks on the da Vinci Skills Simulator, based on previously published data [4–6] and with input from experienced robotic surgeons at our institution, we selected five tasks of incremental difficulty and relevance to robotic surgical procedures for our curriculum. These tasks are known as Pick and Place, Camera Targeting Level 2, Peg Board Level 2, Matchboard Level 2, and Suture Sponge Level 3. Pick and Place was considered to be a good introduction to robotic surgery for novices and an appropriate warm-up for experienced surgeons, involving a simple task while allowing for acclimation to the hand-eye coordination involved with the simulator. Camera Targeting 2 was chosen given its emphasis on camera movement and control as well as the necessary use of the clutch. Peg Board 2 is similar to the peg transfer task of the FLS
123
Experienced surgeons outperformed novice surgeons on all selected tasks and in nearly all recorded performance metrics. The most reliable metrics for discriminating experienced versus novice subjects were overall score and time to completion. These scores and times for the five tasks are listed in Table 1.
Discussion We have demonstrated that a robotic skills curriculum based in the da VinciÒ Skills Simulator is capable of discriminating experienced from novice robotic surgeons. Our curriculum is composed of five exercises of varied complexity, much like the FLS curriculum in laparoscopic surgery. Of the various pre-programmed computer derived metrics, time to complete a task and ‘‘overall score’’ were found to correlate most closely with robotic experience. This suggests that our curriculum demonstrates construct validity. Construct validity is defined as the degree to which a test measures what it claims, or purports, to be
Surg Endosc Table 1 Mean ‘‘overall score’’ and time to complete a task (in seconds) for experienced compared to novice robotic surgeons Task
Overall score experienced
Overall score novice
P value
Time experienced
Time novice
P value
Pick and Place
94.9
91.7
0.03
27.9
45.4
\0.01
Camera Target 2
87.2
62.8
\0.01
86.5
259.7
\0.01
Peg Board 2
95.9
78.2
\0.01
73.1
140.3
\0.01
Matchboard 2
81.1
57
\0.01
96.3
192.5
\0.01
Suture Sponge 3
85.3
42
\0.01
200.4
530.6
\0.01
P \ 0.05 is significant
measuring. In this case, overall score and time to complete the tasks relate to robotic surgical experience and likely robotic surgical skill as well. When laparoscopic surgery was introduced in the late 1980s and early 1990s, general surgeons rapidly embraced the techniques and technologies. The goal of minimally invasive surgery at the time was to decrease patient morbidity. Unfortunately, especially during the early days of laparoscopy, this was not always the case. The value of simulation and training in laparoscopic surgery has been demonstrated repeatedly in recent years. Simulation-based skills’ training allows learners to develop many of the necessary basic laparoscopic skills (instrument targeting, nondominant hand dexterity, two-handed coordination) in a low-risk, controlled, reproducible environment. Previous work has demonstrated that surgeons who practice skills in simulators perform better in the operating room and commit fewer errors than surgeons not provided this opportunity [7–10]. Laparoscopic surgery is now pervasive, and laparoscopic simulation training is currently a required component of accredited surgical residencies and mandated by the American Board of Surgeons to become board certified. Compared with an open approach, the benefits of a minimally invasive robotic approach are similar to those observed in laparoscopy. A recently published, populationbased analysis using the Nationwide Inpatient Sample (NIS) suggests that compared with open surgery, roboticassisted surgery results in decreased length of stay and diminished likelihood of death for the top 90 % of patients who had a code for robotic surgery (23 different procedures) [11]. When robotic surgery was compared to conventional laparoscopic surgery, the benefits were not as apparent. Potential advantages for robotic surgery compared to conventional laparoscopy include greater precision, better visualization, and better ergonomics for the operating surgeon. Unfortunately, this has not been demonstrated to translate consistently to improved outcomes for the patient, particularly in general surgery [12, 13]. Robotic surgery has seen tremendous growth in recent years. Robotic surgical systems are being used in more disciplines (cardiothoracic surgery, urology, gynecology,
general surgery, otolaryngology) and for an expanded array of increasingly complex procedures every year. Recently, a number of lawsuits have been brought forward naming Intuitive Surgical as a defendant and alleging that surgeons were inadequately trained to perform a particular robotic procedure [14]. A spike in the number of adverse event reports (AERs) to the food and drug administration (FDA) manufacturer and user facility experience (MAUDE) database related to the da Vinci surgical system prompted the FDA to ask surgeons whose hospitals belong to the agency’s medical product safety network to participate in a ten-question telephone survey about the da Vinci surgical system. From 2011 to 2012, AERs related to the da Vinci system increased 34 % while the number of robotic surgical procedures performed increased 26 % [15]. In 2013, the Massachusetts Board of Registration in Medicine issued an advisory on robot-assisted surgery in response to what it called a growing number of reported patient complications. The state medical board recommended that healthcare facilities take greater pains to credential surgeons, train surgical support staff, select appropriate patients, and explain the risks to them. ‘‘Patients should be advised on the experience of the surgeon in performing the recommended robotic procedure,’’ the board said. With an increased focus on patient safety in healthcare, it will be important to ensure that surgeons possess the necessary skills to safely perform robotic surgery. The surgical community would be wise to heed the lessons learned in the early days of laparoscopic cholecystectomy and from the past ten plus years of research demonstrating the value of simulation for skills training and assessment. A reliable, feasible, reproducible, and validated simulation based curriculum, and a standardized approach to robotic training and credentialing (not driven by industry) is needed. Some of the skills and conditions unique to robotic surgery include three-dimensional visualization, the lack of tactile feedback, the master controls, clutch, and motion scaling. Perrenot and colleagues developed a five-task robotic curriculum on the dV-trainer (Mimic dV-TrainerTM, Mimic Technologies Inc., Seattle, WA, USA) [16]. The dV-trainer is a stand-alone simulator on which the da Vinci Skills Simulator that docks to the da Vinci console is
123
Surg Endosc
based. Seventy-five subjects of varying skill and experience completed a curriculum that was very similar to ours. Face and content validity of the curriculum on the dVtrainer were high. Reliability of scoring was high, and the global scores on the simulator were strongly correlated with previous experience in robotic surgery (construct validity). The authors concluded that the dV-trainer is a valid tool to assess the skills of robotic surgery. Other investigators have demonstrated the face, content, and construct validity of the dV-trainer and da Vinci Skills Simulator using different combinations of the tasks available [17–19]. Future research should focus on establishing proficiency levels for training and proving that the robotic skills acquired in the simulator can be carried to the actual da Vinci platform in real robotic surgery. Professional societies and certifying bodies should carefully consider the issues surrounding training and credentialing in robotic surgery. A uniform, evidence-based standard that can be adopted nationwide should prove to be a step towards safer robotic surgery.
6.
7.
8.
9.
10.
11.
12. Acknowledgments The authors acknowledge Dario Icardi, Robotic Specialist for Froedtert Hospital, and Froedtert Memorial Lutheran Hospital, Milwaukee, WI, and finally the Medical College of Wisconsin Department of Surgery for their generous support of this project. Disclosures Michael Connolly, Johnathan Seligman, Dr. Andrew Kastenmeier, Dr. Mathew Goldblatt, and Dr. Jon Gould have no relevant conflicts of interest with this work.
References 1. Kenngott HG, Fischer L, Nickel F, Rom J, Rassweiler J, Mu¨llerStich BP (2012) Status of robotic assistance—a less traumatic and more accurate minimally invasive surgery? Langenbecks Arch Surg 397(3):333–341 2. Annual report 2010 (2011) Intuitive Surgical Inc 3. Okrainec A, Soper NJ, Swanstrom LL, Fried GM (2011) Trends and results of the first 5 years of fundamentals of laparoscopic surgery (FLS) certification testing. Surg Endosc 25(4):1192–1198 4. Hung AJ, Zehnder P, Patil MB, Cai J, Ng CK, Aron M, Gill IS, Desai MM (2011) Face, content and construct validity of a novel robotic surgery simulator. J Urol 186:1019–1025 5. Kenney PA, Wszolek MF, Gould JJ, Libertino JA, Moinzadeh A (2009) Face, content, and construct validity of dV-trainer, a novel
123
13.
14.
15. 16.
17.
18.
19.
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