Training in Robotic Surgery




The use of robot-assisted laparoscopic surgery has increased rapidly and with it, the need to better define a structured curriculum and credentialing process. Numerous efforts have been made by surgical societies to define the requisite skills for robotic surgeons, but individual institutions have the responsibility for granting privileges. Recently, efforts have focused on creating a standardized curriculum with competency-based assessments. A competency-based approach offers a better hope of honoring the principle of “above all, do no harm” and obtaining continued acceptance of new operative technologies such as robot-assisted surgery.


Key points








  • Recently, increased attention has been given to reports of adverse events related to robotic surgery, which has put an emphasis on robotic training and credentialing.



  • Robotic training should include cognitive, psychomotor, and teamwork/communication skills.



  • Simulation should be an integral part of a robotic surgical curriculum and could use inanimate models, animal models, or virtual reality simulators.



  • Assessments for credentialing and certification should not be based only on number of surgeries performed but also on proven proficiency.






Introduction


As technology brings new tools to the operating room, there is increasing pressure to ensure patient safety and cost-effectiveness. The Halstedian motto of “see one, do one, teach one” is inadequate as new complex tools such as robot-assisted surgery are adopted. On the other hand, the even older motto of primum non nocere or “above all, do no harm” remains a guiding principle for the adoption of new tools.


Since its approval by the US Food and Drug Administration (FDA) in 2000, the use of robot-assisted laparoscopic surgery has surpassed that of pure laparoscopy for not only radical prostatectomy but also dismembered pyeloplasty and partial nephrectomy. Between 2007 and 2011, the annual number of total robotics cases according to Intuitive Surgical increased by nearly 400% in the United States ( Fig. 1 ). Despite numerous institutional and surgical societal efforts to define a standardized curriculum for training and certification of robotic surgeons, no unifying pathway exists. Thus, robotics residency training is heterogeneous and certification requirements vary by hospital, as was reported in a recent FDA survey.




Fig. 1


Estimated number of robot-assisted cases worldwide.

( Data from Intuitive Surgical investor presentation, 2014. Available at: investor.intuitivesurgical.com/phoenix.zhtml?c=122359&p=irol-irhome . Accessed April 21, 2014.)


Adverse Events in Robotic Surgery


In 2013, public awareness of complications related to robotic surgery increased through information released by the FDA and other media outlets. The FDA updated their Web site on computer-assisted surgical systems to note that an increasing number of medical device reports were being filed. The FDA stated that it was not clear whether this increase represented worse complication rates or was the result of the increasing number of overall procedures and improved reporting. More recently, a report by Alemzadeh and colleagues on 5374 adverse robotic events (86 deaths and 455 injuries) reported to the FDA between 2000 and 2012 noted conflicting trends. Although the overall likelihood of adverse events reported has been decreasing, the trend of significant events (injury or death) increased from 12.8 events per 100,000 in 2004 to 35 events per 100,000 in 2012. The report noted that lower-risk urologic and gynecologic procedures had a lower rate of injury or death than higher risk cardiothoracic surgeries.


Also in 2013, a study compared reports of robotic complications in an FDA database with reports found in the Public Access to Court Electronic Records and LexisNexis. Finding that 8 of 253 (3%) complications were improperly reported to the FDA, the study questioned whether the true incidence of robotic complications is known. This question prompted editorials and articles in prominent publications to question the safety of robotic surgery and the training methods used. That same year, the Massachusetts Board of Registration in Medicine made recommendations on training, patient selection, and credentialing in response to an increasing number of reports of patient complications related to robotic surgery.


This review focuses on the progress toward creating a unified curriculum for training and credentialing in robotic surgery. The following topics are addressed:




  • Available cognitive resources



  • Efforts to validate and incorporate surgical simulation



  • Examples of currently used institutional curricula



  • The Fundamentals of Robotic Surgery (FRS): a 14-society consensus template of outcomes measures and curriculum development



  • Credentialing models





Introduction


As technology brings new tools to the operating room, there is increasing pressure to ensure patient safety and cost-effectiveness. The Halstedian motto of “see one, do one, teach one” is inadequate as new complex tools such as robot-assisted surgery are adopted. On the other hand, the even older motto of primum non nocere or “above all, do no harm” remains a guiding principle for the adoption of new tools.


Since its approval by the US Food and Drug Administration (FDA) in 2000, the use of robot-assisted laparoscopic surgery has surpassed that of pure laparoscopy for not only radical prostatectomy but also dismembered pyeloplasty and partial nephrectomy. Between 2007 and 2011, the annual number of total robotics cases according to Intuitive Surgical increased by nearly 400% in the United States ( Fig. 1 ). Despite numerous institutional and surgical societal efforts to define a standardized curriculum for training and certification of robotic surgeons, no unifying pathway exists. Thus, robotics residency training is heterogeneous and certification requirements vary by hospital, as was reported in a recent FDA survey.




Fig. 1


Estimated number of robot-assisted cases worldwide.

( Data from Intuitive Surgical investor presentation, 2014. Available at: investor.intuitivesurgical.com/phoenix.zhtml?c=122359&p=irol-irhome . Accessed April 21, 2014.)


Adverse Events in Robotic Surgery


In 2013, public awareness of complications related to robotic surgery increased through information released by the FDA and other media outlets. The FDA updated their Web site on computer-assisted surgical systems to note that an increasing number of medical device reports were being filed. The FDA stated that it was not clear whether this increase represented worse complication rates or was the result of the increasing number of overall procedures and improved reporting. More recently, a report by Alemzadeh and colleagues on 5374 adverse robotic events (86 deaths and 455 injuries) reported to the FDA between 2000 and 2012 noted conflicting trends. Although the overall likelihood of adverse events reported has been decreasing, the trend of significant events (injury or death) increased from 12.8 events per 100,000 in 2004 to 35 events per 100,000 in 2012. The report noted that lower-risk urologic and gynecologic procedures had a lower rate of injury or death than higher risk cardiothoracic surgeries.


Also in 2013, a study compared reports of robotic complications in an FDA database with reports found in the Public Access to Court Electronic Records and LexisNexis. Finding that 8 of 253 (3%) complications were improperly reported to the FDA, the study questioned whether the true incidence of robotic complications is known. This question prompted editorials and articles in prominent publications to question the safety of robotic surgery and the training methods used. That same year, the Massachusetts Board of Registration in Medicine made recommendations on training, patient selection, and credentialing in response to an increasing number of reports of patient complications related to robotic surgery.


This review focuses on the progress toward creating a unified curriculum for training and credentialing in robotic surgery. The following topics are addressed:




  • Available cognitive resources



  • Efforts to validate and incorporate surgical simulation



  • Examples of currently used institutional curricula



  • The Fundamentals of Robotic Surgery (FRS): a 14-society consensus template of outcomes measures and curriculum development



  • Credentialing models





Cognitive resources


The American Urological Association (AUA) recommends that residency program directors document satisfactory training and competence of residents to independently perform robotic surgery. Although simulators are not specifically addressed, recommendations are made regarding online curriculum and case participation. The AUA has included a section on robotics in their core curriculum ( The Basics of Urologic Laparoscopy and Robotics ) and also have separate e-learning modules. The e-learning site has both a general module ( Fundamentals of Urologic Robotic Surgery ) and multiple procedure specific modules. The AUA recommends 80% or higher on the module posttests to show proficiency. These modules are also recommended for practicing urologists who have no formal training in robotic surgery.


The AUA also recommends completing online modules provided by Intuitive Surgical. The da Vinci Online Community offers technical modules and evaluations on topics such as operating room setup, docking, draping, safety features, and troubleshooting. Platform-specific modules for each generation of the robot are also provided.




Surgical simulation


Simulation is a critical component of avoiding patient harm and adopting complex surgical technologies. Operating room time is viewed as both a limited and expensive commodity. Surveys of program directors in both the United Kingdom and the United States showed a unanimous conclusion that simulators play a role in improving the quality of resident training. Furthermore, reports from other surgical fields such as plastic surgery, neurosurgery, and gynecology support the integration of simulation into surgical training.


Surgical simulation refers to multiple methods of training, including inanimate (box trainer), animal laboratories, and virtual reality (computer-assisted). Simulators can be categorized as either physical (inanimate or animal laboratory) or virtual reality (computer-assisted). In addition, the simulators can be further subdivided as either low or high fidelity. Low fidelity describes simple tasks and skills and is represented by virtual reality exercises involving rings and cones and inanimate exercises such as placing letters on a checkerboard. High-fidelity or full-scale simulation attempts to simulate procedural steps ( Table 1 ).



Table 1

Comparing low-fidelity and high-fidelity surgical simulators








































Low vs High Fidelity Type of Simulation Examples/Materials
Low fidelity
Console controls, spatial skills, basic surgical skills Virtual reality/inanimate String running
Checkerboard
Pattern cutting
Suturing
Pegboard
High fidelity
Urethrovesical anastomosis Chicken (dead)
Chicken (dead)
Inanimate
Porcine
Virtual reality
Esophagostomach junction
Chicken skin
Latex model
Urethrovesical anastomosis
Augmented reality (Robotic Surgery Simulator)
Prostatectomy Canine Prostatectomy and reconstruction
Ureteral reimplant Inanimate Water-based hydrogel
Pyeloplasty Inanimate Organosilicate: Black Light Assessment of Surgical Technique
Partial nephrectomy, tumor mimic Porcine
Porcine
Virtual reality
Agarose
Psyllium and gelatin
Augmented reality (Mimic)
Nephrectomy Virtual reality a
Porcine
Procedicus MIST (Mentice)

a Available only as a pure laparoscopic simulator.



An example of a high-fidelity simulator is using a tumor mimic model in a porcine laboratory to simulate partial nephrectomy. A report in 2008 showed the ability to create pseudotumors in a porcine model using bulking materials such as gelatin and psyllium. The tumor mimic model was used as a simulator for tumor biopsy, partial nephrectomy, nephrectomy, and renal vein thrombectomy.


Another example of a high-fidelity simulator is a recently reported inanimate simulator of a pyeloplasty model. Studies using the model at the 2011 and 2012 AUA mentored renal laparoscopy courses showed construct, face, and content validity. Cadaver simulation has been used for procedural training and specifically for experts during the design of novel procedures. The FRS curriculum supports low fidelity for training, but recommends only high-fidelity simulator exercises for examination of psychomotor skills for credentialing.


Validity


A challenge of surgical simulation is verifying the conversion of simulator skills to the operating room. There are few studies showing a direct association between simulator and operating room robotic skills regardless of simulator type. Initial simulator studies attempted to confirm validity by comparing expert surgeons and novices (construct validity). Surveying of simulator participants has also been completed to determine how well the simulator mimicked the real procedure or task (face validity) or how useful (content validity) the task was. Two other forms of validity testing are assessing whether simulator performance predicts future performance (predictive validity) and comparing the simulator with the gold standard for teaching surgical skills (concurrent validity).


Only 2 studies have attempted to associate simulator time or performance to intraoperative performance on the robot. Syan and colleagues reported on a small group (n = 9) of residents and fellows who performed 6 exercises on the da Vinci simulator and were then graded on taking down the bladder during a robotic prostatectomy using the Global Evaluative Assessment of Robotic Skills. Overall scores did not correlate, although the score for controller clutching efficiency was associated with the time required to drop bladder. The investigators concluded that low-fidelity simulation is important for basic robotic skills, but that high-fidelity simulation is needed to improve advanced steps of robotic surgery.


Culligan and colleagues reported that a simulation protocol improved operative times during robotic hysterectomy. Twenty hours of virtual reality simulation (time to reach expert level simulator scores) was followed by a porcine animal laboratory for credentialed gynecologic surgeons naive to robotics. The trainees then performed their first robotic hysterectomy, and their operative time was comparable with expert surgeons and better than controls with no simulator training.


Commercially Available Virtual Reality Simulators


At least 3 robotic virtual reality simulators that incorporate a three-dimensional display have been reported in the literature ( Fig. 2 ). Mimic produced the first prototype for testing in 2007. Validation studies have been performed for each simulator, but few comparative studies have been performed. Details of virtual reality simulators can be found in Table 2 . Lerner and colleagues evaluated concurrent validity by comparing virtual reality simulation on the dV Trainer (Mimic Technologies) to inanimate simulation on the da Vinci robot. These investigators found that the dV Trainer provided similar improvements to the inanimate training and concluded that virtual reality simulation is helpful for junior trainees. Similarly, Korets and colleagues evaluated the dV Trainer by randomizing trainees to virtual reality training on the dV Trainer, inanimate training on the da Vinci robot, or no training. These investigators found significant improvements for both the virtual reality and inanimate exercises, but none for the no training group.


Mar 3, 2017 | Posted by in UROLOGY | Comments Off on Training in Robotic Surgery
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