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Download a PDF of the Current Issue 2015 Volume 12 Number 3 July- September

ROBOTIC SURGERY

Michael S. Nussbaum, M.D., F.A.C.S. Professor and Chair, Department of Surgery University of Florida College of Medicine, Jacksonville
Surgeon-in-Chief, Shands, Jacksonville
7-1-1 The minimally invasive surgical revolution began in the late 1980’s with the advent of video-chip technology. This allowed surgeons to perform a wide variety of operations using small incisions, videoscopes and long instruments where the surgeon did not have to have his or her hands directly in the human body. The benefits of minimally invasive procedures are many including decreased length of hospital stay, less pain and scarring with smaller less obvious incision(s), less risk of infection, less blood loss and fewer transfusions, an accelerated return to normal activities, decreased need for post-surgery narcotics, and an overall faster recovery. The early 2000’s brought the convergent digital technology revolution, leading to significant enhancements in information technology, simulation technology, telecommunication technology, and robotic technology. Historically, current commercial robotic systems for medical use originated from two major research efforts. The National Aeronautics and Space Administration (NASA) developed robotics for space operations which were later adapted for surgery. In parallel, the Defense Advanced Research Projects Agency (DARPA) was developing robotics for battlefield needs including providing remote surgical care in the field. Commercial robotic systems followed shortly thereafter. A surgical robot is a powered, computer-controlled manipulator with artificial sensing that can be programmed to move and position tools to carry out a wide range of surgical tasks. Robotic integration allows a surgeon to perform more complex minimally invasive procedures utilizing enhanced 3-dimensional visualization, improved dexterity, increased  range  of  motion, and improved access to difficult to reach areas of the body. This translates to more minimally invasive procedures with increased technical precision. The next generation of robots are being built smaller, smarter, and less expensively.  There is a long delay between the idea and commercialization of products, and robotic surgery is currently only in its infancy.   The da Vinci® Surgical System was developed by Intuitive Surgical (Sunnyvale, California) as a direct result from the research developments from DARPA and the Stanford Research Institute. It became the first surgical robotics system cleared in 2000 by the US Food and Drug Administration (FDA) for use in general laparoscopic surgery, thorascopic, urologic, and gynecologic surgeries, as well as an adjunct to some cardiac procedures. The system has three-dimensional (3-D) visualization of the operating field, a 7-degree range of motion, tremor elimination, and comfortable seated operating posture. These advantages allow surgeons hand-like dexterity and enhanced precision through minimally invasive techniques. The shortcomings of surgical robotics are the lack of haptic feedback while operating, the inability to rapidly switch instruments as well as operating field during the procedure, the large size of the robot with bulky arms, and the high cost of the technology. Nevertheless, the da Vinci® system has proved useful for a wide variety of applications in cardiothoracic, urologic, gynecologic, and general surgery Urologists have been especially pleased with the added dexterity provided by the da Vinci® in removal of the prostate. The operative field is typically in the deep pelvis, and the need for wrist-like dexterity is hard to duplicate with conventional laparoscopic as well as open techniques. Suturing is especially challenging in the narrow male pelvis, and the da Vinci® excels in that area. Multiple studies have shown that, with enough experience, robotic prostatectomy is safe and effective with improved outcomes for men who have prostate cancer.   Robotic surgery is a fast-growing area in minimally invasive surgery. In most institutions, robotic techniques are used primarily for prostate surgery. Surgeons in the University Of Florida College Of Medicine, Department of Surgery – Jacksonville now use the da Vinci S® robotic system to perform minimally invasive operations for a range of procedures in addition to the prostate including operations on the esophagus, stomach, colon, pancreas, kidney, bladder, lung, spleen, uterus, and soon, the heart. The da Vinci S® System consists of an ergonomic surgeon’s console, a patient-side cart with four interactive robotic arms, a high-performance 3-D High Definition vision system and proprietary EndoWrist® instruments.   The da Vinci S® System’s high-resolution 3-D stereo viewer is designed to provide surgeons with an immersive experience. Unlike conventional approaches, the target anatomy appears at high magnification, in brilliant color and with natural depth of field. The Endo-Wrist® instruments exceed the natural range of motion of the human hand; sophisticated motion scaling and tremor reduction further interpret and refine the surgeon’s hand movements. Another key hallmark of the da Vinci S® System is its fail-safe design, incorporating multiple, redundant safety features all intended to minimize opportunities for human error when compared with traditional approaches.   For the patient, a da Vinci S® procedure offers all of the potential benefits of a minimally invasive operation: less pain; nominal scarring; and minimal blood loss, hence the reduced need for blood transfusions.  Moreover, the da Vinci S®  System enables a shorter hospital stay, less chance of infection, a quicker recovery and faster return to normal daily activities. Clinical studies also suggest the da Vinci S® System may help surgeons provide better clinical outcomes than conventional technologies allow—for example, better cancer control, less blood loss, and a lower incidence of impotence and incontinence with Da Vinci S® prostatectomy.   Other robotic systems being developed today include RoboDoc® and Acrobat® orthopedic surgery systems which will allow orthopedic surgeons improved accuracy in preparing bones for prosthetic implants. The significant differences made by these devices have led to the acceptance and realization that information technology could be applied to other fields in surgery.   Robotics provides a unique possibility of separating the surgeon from the patient. This separation can be measured in feet or in thousands of miles. Telesurgery along with telementoring has now been tested in several environments and shown to be feasible and beneficial. The removal of a gallbladder across the Atlantic Ocean and the mentoring of surgeons in Canada are examples of how technology is rapidly approaching the day when any surgeon can be connected to a number of colleagues who may be able to consult and in some cases assist during complex surgical procedures. Other robotic technology allows the surgeon to make rounds while sitting in a remote location allowing “telepresence”. This enables the physician to be remotely present by controlling robot movements via the Internet. Patients surveyed felt that the encounter was a positive one and were able to completely believe that they were communicating with their physician in person even if the physician was far removed from the patient’s bedside.   Several additional developments may change how we use robotics in the near future. These new technologies are still in an experimental stage but offer a glimpse of what the next generation of robots will offer.    Miniaturization of robotic technology appears to be the theme of the new generation of devices. Robots that are smaller than current systems have a natural advantage because they are easier to deploy and can be used in more settings. Further, these can be deployed in remote areas and teleoperated from afar.   As minimally invasive surgical techniques continually develop toward reducing the invasiveness of surgical procedures, robotics technology becomes more crucial. Natural orifice translumenal endoscopic surgery (NOTES) is a new approach to abdominal surgery that promises to further reduce invasiveness by accessing the peritoneal cavity via a natural orifice such as the mouth, nose, vagina, rectum or penis, leaving no external scar… Theoretically, the elimination of external incisions avoids wound complications, further reduces pain, and improves cosmesis and recovery times. The first transvaginal assisted cholecystectomy in the United States was performed in March 2007. Subsequently, the first transgastric cholecystectomy, also in the United States, was performed in June 2007. University of Florida surgeons Drs. Ziad Awad and Brent Seibel performed the first NOTES procedure at Shands Jacksonville in December 2008. The patient was given the option to have a cancerous tumor removed from her colon using transabdominal surgery or by way of her vagina, using NOTES. The patient chose natural orifice surgery because it meant less scarring, minimization of pain and a quicker recovery. The surgeons performed the operation entirely laparoscopically by removing a segment of the colon through the patient’s vagina. This is one of the first times that this particular type of operation was performed in the United States. The Department is currently expanding its NOTES and single incision laparoscopic surgery (SILS) program to include other types of operations in the future. Significant limitations have been identified with the use of conventional laparoscopic and endoscopic tools and new tools are needed to perform such procedures because simply slipping a hand inside is not possible. Robotics offers the best solutions under these circumstances.   A flexible endoscopy platform for natural orifice surgery with robotic actuation and visualization enhancement is the next area of development. Work has been performed toward the development of an endolumenal robotic system for providing visualization and dexterous instrumentation for the performance of NOTES operations. Miniaturization of robotic tools and the ability to place robots entirely inside the peritoneal cavity offers significant benefits in natural orifice procedures as well. Once inserted, the robots can be used inside the peritoneum without the typical constraints of an externally actuated flexible endoscopic device. The robots can be positioned to provide visualization and tissue manipulation within each quadrant of the peritoneal cavity. Multiple miniature robots can be placed inside the peritoneal cavity, with the number of devices not limited by the small diameter of the natural orifice. Such robots equipped with stereoscopic imaging could provide much needed depth perception for the surgeon and could allow triangulation between the image plane and the motion of the tools. Mobile miniature robots provide a remotely controlled platform for vision and surgical task assistance.   With the exponential growth of robotic surgery, guidelines for safe initiation of this technology have become a necessity. As time goes by, robotic surgery will be incorporated in surgical training. However, mechanisms are required for training and credentialing surgeons who are currently in practice and want to integrate robotics into their practice.  Currently no standardized credentialing system exists to evaluate surgeon competency and safety with robotic surgery performance. It is incumbent upon each local hospital credentialing body to develop privileging guidelines for surgeons who want to perform robotic procedures in their institutions.  The vendor(s) will usually provide training on the specific device however; the surgeon must demonstrate proficiency in the specific procedure(s) in order to be granted hospital privileges. Proctoring is an essential mechanism for robot assisted surgery credentialing and should be a prerequisite for granting unrestricted privileges on the robot.  This should be differentiated from preceptoring, wherein the expert is directly involved in hands-on training. Advanced technology has opened new avenues for long-distance observation through teleproctoring. Although the medicolegal implications of an active surgical intervention by a proctor are not clearly defined, the role as an observer should grant immunity from malpractice liability in this setting. Although proctoring is a modality by which such competency can be evaluated, other training tools and guidelines are needed to ensure that the requisite knowledge and technical skills to perform this procedure have been acquired. The implementation of guidelines and proctoring recommendations at each institution is necessary to protect surgeons, proctors, institutions and, above all, the patients who are associated with the institutional introduction of a robotic surgery program…   The following guidelines were developed at Shands Jacksonville for the granting of privileges for computer assisted (robotic) surgery:   Documentation of successful completion of six (6) Robotic surgical cases from a previous hospital where the provider had privileges, OR Credentialed to perform open and laparoscopic/ endoscopic surgery, AND evidence of completion of the training course provided by the vendor, AND evidence of two (2) proctored cases or must be proctored for the first two (2) cases performed. In the absence of a credentialed proctor, a second surgical attending who has met all of the criteria for this pathway may serve as the proctor, OR Documentation of successful completion of three (3) cases as primary operator for robotic surgery from the residency/fellowship program director that trained the surgeon.   REAPPOINTMENT CRITERIA Documentation of at least six (6) procedures to be provided at the time of reappointment, or be proctored for an additional two (2) cases   SUMMARY The da Vinci® system remains the only commercially available therapeutic robotic system currently available. It has allowed surgeons to perform procedures that previously were thought to be either too complicated or too risky to be performed in a laparoscopic fashion.  New technology has since improved, allowing one to reach areas that could not be reached before and to perform operations without scars, such as natural orifice surgery. With the development of new types of devices that are smaller, cheaper, and based on more modular components, each device will be tailored to a given operation. New technologies are sure to follow along, and this field will not look the same in 10 to 15 years. It can be expected that we will continue to move toward more automation, more computer interface, and more mechanical assist and further away from the open surgical techniques that were pioneered in the years before. As technological advances occur, we will be challenged to assure appropriate training and credentialing on these new devices and technology.