Basic+Concepts

=Definitions=

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“Robotic surgery” is an imprecise term, but it has been widely used by both the medical and lay press and is now generally accepted. The term refers to surgical technology that places a computer-assisted electromechanical device in the path between the surgeon and the patient. A more scientifically accurate term for current devices would be “remote tele-presence manipulators” since available technology does not generally function without the explicit and direct control of a human operator. For the purposes of the document, we define robotic surgery as a surgical procedure or technology that adds a computer technology enhanced device to the interaction between a surgeon and a patient during a surgical operation and assumes some degree of control heretofore completely reserved for the surgeon.As an example, in laparoscopic surgery the surgeon directly controls and manipulates tissue, albeit at some distance from the patient and through a fulcrum point in the abdominal wall. This differs from current robotic devices, where the surgeon sits at a console – typically in the operating room but outside the sterile field – directing and controlling the movements of one or more robotic arms. While the surgeon still maintains control over the operation, the control is indirect and is effected from an increased distance.This definition of robotic surgery encompasses micromanipulators as well as remotely-controlled endoscopes in addition to console-manipulator devices. The key elements are enhancements of the surgeon’s abilities, be they vision, tissue manipulation, or tissue sensing, and alteration of the traditional direct local contact between surgeon and patient.======

=Clinical Environment=

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Surgical robots are considerably more complex, both electrically and mechanically, than traditional devices used in the operating room environment. In addition, they involve direct contact with the patient, both externally and internally. These important features differentiate surgical robots from other equipment such as operating microscopes, intraoperative imaging devices and traditional operating room instruments. In addition to the surgeon and surgical assistant, all personnel in the operating room must be appropriately trained to handle this equipment. There are currently no standard criteria set forth for registered nurses, operating room technicians, or surgeons with respect to appropriate training for managing these instruments in the operating room. However, at a minimum, operating room personnel should be trained according to the manufacturer’s training guidelines, and should have the opportunity to be “doubled up” with an experienced nurse or operating room technician during their early experience. It is highly recommended that teams using such instruments – surgeons, technicians, nurses, and possibly manufacturing representative – meet on a periodic basis to stay current in their training and to learn of updates or changes to the hardware or software. In this way, emerging problems may be quickly identified and addressed.======

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Length of StayComparison of robotic surgery to alternative techniques requires procedure by procedure analysis since there will be instances where robotic surgery is appropriately compared to minimally invasive techniques and others where it is compared to open techniques. Also, it should be remembered that length of stay affects cost centers outside the operating room. Decreased length of stay will counterbalance some of the increased operating room expenses associated with all forms of MIS. Length of stay may be affected by postoperative pain, intraoperative blood loss and complication rates. The differences between robotic and conventional surgery in these categories has not yet been adequately studied.======

=General Benefits=

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The desirable characteristics of current therapeutic robotic systems include platform stability, motion scaling, tremor reduction, excellent visualization, and articulating end effectors. Taken in combination these characteristics create a highly effective therapeutic system for performing surgical procedures. Robotics have made minimally invasive techniques accessible to patients in whom the procedures could not be performed using conventional laparoscopic techniques. Furthermore, enhancements in precision may aid in the conduct of a variety of advanced MIS procedures.======

=Ergonomics=

Both open and laparoscopic surgical procedures may be physically strenuous and have been associated with surgeon morbidity from repetitive use injury. Since the robotic surgeon sits comfortably in an ergonomically-designed workstation, the conduct of robotically-controlled procedures is generally more ergonomic for the operating surgeon. However, this benefit may not apply to the patient-side assistant. Such ergonomic differences will be magnified for lengthier procedures.

=Learning Curve=

Technically complex surgical tasks such as suturing present a substantial learning curve. These may be facilitated by the additional degrees of freedom inherent in articulated-arm robotic operating systems. Thus, articulated arm robots will potentially reduce technical skill acquisition time. They may enable surgeons to access difficult anatomic regions more easily, potentially speeding the introduction and clinical adoption of new MIS techniques.

=Patient Return to Usual Activity=

Some robotic surgical procedures may have better patient outcomes than their open or standard minimally invasive counterparts. Return to work benefits will vary based on the type of procedure and the population served.

=Risks of Robotic Surgery=

Current surgical robots are continuously controlled by the surgeon and do not move autonomously. They possess neither artificial intelligence nor independent functioning. The robot remains a high-level, sophisticated tool used by the surgeon in the conduct of an operative procedure. Risks of robotic surgery can be categorized into those pertaining directly to the use of the robotic system and the general risks of the operative procedure.

Theoretically, the lack of haptic feedback in current robotic systems could lead to an increased risk of inadvertent tissue injury. However, to date, robotically performed operations have not been associated with higher clinical complication rates than their standard laparoscopic or open counterparts in experienced hands. In certain instances evidence exists that robotically performed procedures may be associated with a lower complication rate.

Robotic telesurgery, in which the surgeon may be located at some distance from the patient, poses unique risks. For example, precise control of the robot will be dependent upon the quality of the data connection between the surgeon’s console and the operating room robot. Issues pertaining to the quality and maintenance of such data connections may be beyond the control of the surgical team, but still represent a risk management challenge.

=Mechanical Risks=

All mechanical and electronic devices are subject to failure. Surgical robots – complex systems relying on a delicate interplay of hardware and software – are no exception. Current systems are designed with features intended to minimize the potentially deleterious effect of such failures on patients. Such features include system redundancy, so called “graceful” performance degradation or failure, fault tolerance, just-in-time maintenance, and system alerting. These are standards to which all high level systems should be held.

=Institutional Risks=

Healthcare institutions that employ high level technology as surgical robots in clinical practice need to develop and follow credentialing guidelines. The initiation of a robotic surgical program is similar to the introduction of any other novel, high-level, direct patient care technology, and should require appropriate training and credentialing (see Appendix I and II). In addition, each institution needs to develop a consistent policy concerning the nature of the procedures to be performed with regard to the need for IRB oversight. Such policy must take into account the nature of the proposed procedure itself. The institution also has an obligation to maintain the system consistent with manufacturer’s guidelines.

=Instrumentation=

Current robotic instruments have evolved to provide a miniaturized ‘endowrist’ with degrees of freedom rivaling human capability. Future instrumentation will evolve in size and variety to further expand surgical capability. ‘Smart instruments’ are evolving so that dissection instruments can be imbued with capability to provide the user not only with mechanical dissection and retraction capabilities, but with ‘smart sensing’ capabilities, to provide the surgeon with information about tissue oxygenation, blood flow, molecular information, even tumor margin information.

=Visualization=

Computer enhanced vision has already restored 3-dimensional vision. Additional visual enhancement systems can further enhance the operator’s vision, importing anatomic overlays, even ‘help’ heads-up displays. Visual system enhancements can also offer an array of ‘optical biopsy’ capabilities, as confocal microscopy, optical coherent tomography (OCT), and others, which can further enhance computer assisted visualization, enabling real-time microscopy, even molecular imaging.

=Integrated Surgery=

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Robotic surgery presents an excellent opportunity to integrate anatomic and physiologic data into the operative field. Preoperative or even intraoperative imaging (e.g., CT, MRI, or ultrasound imaging) can reveal the three-dimensional topology of the operative field even before tissue is disturbed. Since the spatial coordinates (x, y, z axis) of the surgical instruments are “known” at all times by the surgical robot, the robotic interface provides an excellent platform through which this information can be integrated, registered, with the surgical device, so that the imaging information can be fused with the computer visual field, providing the potential for visual overlays of anatomy, function, even tumor mapping, such that the surgeon could ‘see into’ the tissues. Virtual barriers could be mapped into the operative field, identifying danger, or ‘no fly zones’, with the computer helping guide the surgeon away from potential hazard. This information could be used to guide surgical procedures intraoperatively, or even to simulate a proposed procedure before it is carried out. One of the more exciting potential areas of computer assisted interventional research relates to integrating imaging with interventional platforms.======

=Simulation=

Robot workstations can serve as both consoles controlling robotic systems, but can also have potential to serve as simulator environments, with the capability to import patient specific information and allow rehearsal of patient specific procedures toward reduction in complications rates, learning curves, even development of new technical approaches. In addition to providing input integration of imaging registered with an interventional robotic platform, robots can capture data regarding how a surgeon performs specific tasks. These ‘black box’ data could be used for quality control, teaching purposes, or even to “train” the computer to perform similar tasks independently.

=Miniaturization=

Future electromechanical technology may allow robots to be miniaturized to the point where they can enter the human body and perform surgery by remote control, or even autonomously. Such robots would potentially permit novel access paths to internal organs and could substantially decrease the invasiveness of surgical procedures. If such miniaturization is extended down to the level of “micro-machines”, then surgery could theoretically be performed at the cellular level. Such extreme miniaturization, while beyond current realization, would require extensive reworking of current surgical paradigms. However, the potential for new minimally invasive approaches is great.

In the near term, robotic platforms and instrumentation may evolve to enable single access port (SAP) surgery, with a device, that once deployed, provides, through a single port, a multi-capable platform providing vision and multiple effectors devices.

=Improved Mobility=

Current robots work best when the surgical field is limited to a relatively small area, such as a single quadrant of the abdomen. Future devices will need improved flexibility so that they can easily be deployed to access entire body cavities without reconfiguration. Mobility of the robotic device itself is also an issue – current devices are large and difficult to move, and do not lend themselves to use outside an operating room environment, such as in the battlefield. Mobility of robotic devices will improve as they miniaturization improves and the footprint of the devices becomes smaller.

=True Independent / Autonomous Robotic Surgery=

Current devices do not exercise independent logic or reason and do not even serve to automate repetitive tasks in the way that a sewing machine does. A first step in this direction for future robots would be the automation of routine tasks such as sewing; i.e. the surgeon indicates a start point and a finish point and the robot completes the suture line. Robots could use “artificial intelligence” to learn from the surgeon operating the device. Thus, robots could move from telemanipulators to skilled assistants in the future. If a robot acquired technical or cognitive knowledge from a large group of surgeons, it could ultimately serve as a computerized “colleague” to provide technical assistance in routine or unusual operative situations.

=Safety and Documentation of Outcomes=

Ultimately, all research in surgical robots must be undertaken with the goal of improving patient care and safety. Patient safety and clinical outcomes must remain foremost in future research efforts.

To adequately assess the risks and benefits of robotic surgery now and in the future, and to assist in guiding future research efforts, it will be essential to have outcomes registries for robotic surgery. Only through such registries will it be possible to accurately compare robotic surgery to traditional approaches, to document quality of outcomes, and to help identify needed no directions for development.

=Surgical Team Robotic Augmentees=

Just as current surgical robots can enhance human surgeon performance, devices already exist to enhance the surgical team. ‘Penelope’ is a commercially available robot to replace the scrub technicians. Next generation devices under development can enhance the work of scrub nurses, supply workers, among others. Future devices can further augment human capability, task performance, and enhance the surgical team.

=Operating Room Integration=

Just as an imaging system as a CT scanner is a computer with eyes, and a robot is a computer with arms, an operating room can become a computer system, with surgical robots integrated into perioperative workflow and process. Integrated computerized tracking of surgical activity, workflow, use of materials, devices, consumables, can enhance task performance, quality of care, and ultimately patient safety. Key will be standards development, ‘plug and play’ interoperability, modularity, and better understanding of human-system integration and limitations.

=Enabling Steps=

To fully realize the future of computer assisted intervention/ robotics evolution, we will need transdisciplinary collaboration across not only surgical, interventional, and imaging disciplines, but with engineers and computer experts, backed with significant funding to realize the potential of the human-system interface. The prospects for enhancing patient care, quality, and safety are substantial. Further consensus efforts will be needed to define ‘white papers’ to serve as roadmaps for future research and development.