Abstract
Robotic thyroidectomy is a new approach to thyroid surgery that offers the benefit of eliminating the anterior neck incision utilized in traditional approaches. Although no level I evidence exists to strongly support a robotic approach to thyroid surgery, initial non-randomized reports of robotic surgical approaches, in a variety of surgical specialty areas such as cardiothoracic, urologic, gynecologic and head and neck surgery suggest possible advantages of robot assisted techniques. These include platform and instrument stability, tremor reduction, articulating end effectors, three-dimensional, magnified imaging, and improved surgeon ergonomics. Potential negatives associated with robotic surgery include its expense, the lack of haptic feedback, instrument limitations, and the implicit learning curve. Robotic thyroidectomy introduces new potential risks, not typically associated with thyroid surgery. These risks are related to a new approach to the surrounding anatomy and are also associated with the learning curve. The introduction of new technology to any surgery mandates a rational framework for initial assessment and safe implementation. A New Technology Task Force was convened to draft guiding principles which may serve as a framework for the safe implementation of emerging technologies in thyroid surgery. This document suggests initial minimum steps that surgeons should consider during initial implementation of robotic thyroidectomy.
Introduction
While consumer-oriented healthcare demands attention to new technologies, it also poses new challenges to patient safety and has implications for healthcare costs. Similarities can be drawn between this technology and the introduction of laparoscopic cholecystectomy and endoscopic sinus surgery during the 1980s. Thus, there are serious concerns that rapid adoption and implementation of this emerging technology may be fraught with unintended patient risk. Robotic thyroidectomy introduces new risks, not typically associated with thyroid surgery, related to a new approach to the surrounding anatomy that may include, but are not limited to, stretch injury to the brachial plexus, perforation of the esophagus, and injury to the carotid artery and/or internal jugular vein. These risks and those associated with the learning curve for introduction of new technology mandate a rational framework for initial assessment and early phases of implementation of this new technology.
New technology is introduced into surgical practice on a regular basis, enabling advances in patient care. Advances such as endoscopic lighting and magnification resulting in improved observation; intraoperative monitoring of nerve and hormone levels providing supplemental operative information; and gamma probes enabling more directed surgical resection through mapping of sentinel lymph nodes are among a few examples of technologies that have paved the way for radical shifts from traditional surgical practice. However, the rapid pace with which technology is evolving, coupled with the often limited initial outcomes data that are available, makes it difficult to safely introduce and rationally assess new technologies. In addition, even what is considered new technology is a complex and changing target. The introduction of the pulse oximeter and even the stethoscope presented similar issues in the past.
The difficulties of responsible introduction of novel technology have been recognized. The initial study and implementation of new technologies has often been a chaotic process and has been largely unregulated by any overarching rational surgical–medical processes. As early as 1994, the American College of Surgeon's Committee on Emerging Surgical Technology and Education provided several basic principles regarding the implementation of new technology entitled “Statement on Emerging Surgical Technologies.” This statement noted that the rapid dissemination of new technology has brought into focus the importance of a rational assessment of the safety, efficacy, and costs of new devices. As we move into the future, we can be certain that surgical practice will continually change. Innovations need to be evaluated and when appropriate, incorporated into surgical practice.
Rational introduction of new techniques offers an opportunity for the medical profession to take responsibility to develop a clearly articulated vision for the safe introduction, and proper evaluation of new technology as it applies to surgical practice. As with the examples of endoscopic sinus surgery and laparoscopic cholecystectomy, both procedures were initially met with resistance. At their introduction they were felt by many to be unworthy of evaluation; however, both procedures have presaged revolutions in surgical practice. Qualified surgeons thoughtfully pushing the envelope may provide unexpected results and benefits for all surgical patients. These results may, or may not, be realized for robotic thyroidectomy, but we must be committed to safe exploration of this technology or forfeit the chance for possible change or improvement. Through these guidelines we endeavor to create a framework wherein technology may be safely introduced into the surgical arena.
The authors of this article were convened as a New Technology Task Force to draft guiding principles that may serve as a framework for the safe implementation of emerging technologies in thyroid surgery. While suggestions for the introduction of robotic thyroid surgery into clinical practice are discussed in great detail, it is the Task Force's hope that these principles will be applicable to other emerging technologies as well. This process was, at its foundation, quality driven and is intended to provide a framework to help guide physicians to safely implement new complex, and potentially beneficial, technology into clinical practice.
Given the multidisciplinary nature of thyroid surgery, this Task Force incorporated general surgery, endocrine surgery, head and neck surgery, and otolaryngology–head and neck surgery perspectives by including representation from the American Academy Otolaryngology–Head and Neck Surgery, the American Association of Endocrine Surgeons, the American Head and Neck Society, the American Association of Clinical Endocrinologists, and the American Thyroid Association. The group includes individuals with substantial endoscopic and robotic thyroidectomy experience, as well as individuals with significant open thyroidectomy experience, but limited or no robotic experience. The group also includes members who have previously published on the evaluation of appropriate and safe implementation of novel surgical techniques.
This Task Force strived to generate a specific framework for the introduction of robotic thyroidectomy, as well as to create a flexible template that could provide strategies for the introduction of other complex surgical technologies. This document is not intended to represent a comprehensive method by which new surgical technology should be assessed, but rather to suggest initial minimum steps, guided by many sources (1
–16), that thoughtful surgeons should consider during initial implementation. At all times, we strived to ensure patient safety and to fulfill the commitment each surgeon must have to fully explore the potential benefits and pitfalls of new technology. Through this framework we endeavor to create an environment wherein technology may be safely introduced into the surgical arena. The recommendations are divided into (I) Major goals of a technology assessment program (II) Elements of technology implementation programs
The implementation of new technology into the discipline of surgery without the key elements outlined here leads to a process that may be unduly influenced by industry's financial imperatives, physician/hospital financial incentives, and lay public's impressions instead of optimal clinical outcomes. Ultimately, the physician-surgeon must recognize these conflicting incentives, ask appropriate questions, and act responsibly in the adoption of new skills. Because a technology is available and marketed, does not mean it is necessary or desirable. Surgeons, of course, must first yield to their ethical and fiduciary duty to their patients.
Two important ethical questions/points also need to be examined when assessing technology: 1. What is the appropriate role of industry in new technology education efforts?
Although residency training programs offer a proctored environment for teaching young physicians complex technologies, no such proctored environment formally exists for practicing physicians. Company representatives may serve as a technical resource, but they should not be the main source of physician education for complex surgical procedures. At this time, the primary responsibility for surgical education and the achievement of proficiency resides with the practicing physician-surgeon. An organized system focused on uniform, safe, and effective education and training in the use of complex technologies directed toward existing practitioners is imperative and would be a great improvement. Continuing medical education programs are one arena for such training, but for more complex technologies, such as robotic thyroidectomy, additional training is clearly necessary.
While there is an essential role for physicians to collaborate with industry in developing new technology and in surgical education, these relationships make matters complicated. These financial arrangements should be publically disclosed to patients and in academic activities. The absence of direct financial relationships with industry does not eliminate potential conflicts of interest, as physician's practice reputation, academic reputation, and other factors may bias their personal views. 2. What role do media and public expectations and desires play in driving the application of new technology?
Physician-surgeons and their professional organizations share responsibility to help set the expectation of the lay public with regard to new technology through evidence-based analysis. Often times, evidence-driven statements lag behind industry-based marketing.
Major Goals of a Technology Assessment Program
New devices are regulated by the Center for Devices and Radiological Health of the Food and Drug Administration (FDA), itself a division of the Department of Health and Human Services. The FDA approval process for devices differs substantially from pharmaceuticals and focuses primarily on safety without the need to demonstrate effectiveness. In fact, 95% of FDA devices are approved through an expedited review process (“501K” substantial equivalency clause) that requires only limited demonstration of safety. If a given device is demonstrated to be similar to an existing device, then it may be approved. FDA approval therefore implies clinical availability. This is a limited review relative to safety, and effectiveness is not necessarily implied and sometimes may lead to extended uses other than originally approved by the FDA.
Some of the key questions to be answered as part of any assessment of new technology include: (1) Is the technology safe?
The experience published from Korea (2
–6) suggests that robotic thyroidectomy can be performed safely. Initial unpublished experiences in the United States suggest that significant training is required to successfully perform this technique. Complications rates for conventional thyroidectomy techniques are very low and a large number of cases need to be performed to demonstrate both safety and equivalency. The steps outlined below, as part of the “Suggested Elements of a Technology Implementation Program,” should help surgeons gain proficiency safely keeping risk to patients at a minimum. Although following these steps may make implementing this technology safer, ongoing assessment of patient outcomes is necessary and may be helpful in suggesting modifications to these elements over time. (2) Is the technology effective for the intended purpose? How does its effectiveness compare to that of existing treatments? Are the benefits of the technology balanced with the cost and how do it s benefits compare to existing treatments relative to their costs?
Even if a surgeon can safely perform a technique, further assessment is ultimately going to be required to determine the effectiveness and cost–benefit profile of this technique relative to existing treatments. These evaluations are critical to ultimately justify the application of new technology in practice and may not be initially apparent.
This task force asserts that the initial experience with robotic thyroid surgery must be wedded with acquisition of surgical outcome data in initial patient groups to further justify its wide acceptance. Timely, comparative effectiveness research is essential so that healthcare systems can make rational decisions regarding the incorporation of new equipment and techniques, particularly so in our current healthcare environment.
Despite the difficulty inherent in answering these three questions, it is our responsibility to patients to investigate new technologies as they become available so that we can permit surgical progress based on their incorporation. The degree of caution in the implementation of the skills should be related to the degree of risk the technology poses. One must also note a priori that a learning curve implicitly exposes patients to measurable risk. Although evidence acquired through prospective comparative trials is desirable, it is not always feasible in making these determinations initially.
Suggested Elements of a Technology Implementation Program
The suggested elements of a technology implementation program are presented in Table 1. These recommendations are specific for robotic thyroidectomy but may have broader application to other complex surgical technologies.
These elements are considered the basic building blocks of a process through which technology can be safely evaluated and implemented. They address the key elements of surgical education, informed consent, and transparency.
Evaluating candidacy of a surgeon
(1) Before undertaking robotic thyroidectomy, the surgeon should meet the following criteria to fulfill the first suggested step of adequate training:
• The surgeon must be a member in good standing of the department or service that will be granting privileges and must be knowledgeable about the management of surgical diseases of the thyroid gland.
• The surgeon must have expertise in the standard approach to thyroidectomy with documentation of successful outcomes. The surgeon should have mastery of standard open thyroidectomy with a significant annual case load. This is important because, at this time, the indications for this technique are limited, and a sufficient volume of cases is required to master this approach. Currently, occasional thyroid surgeons will not garner sufficient operative experience to adequately learn the technique. Approaching the thyroid from a lateral perspective, rather than anteriorly, requires a thorough understanding of the anatomy and exposes critical structures that could potentially be injured. Additionally, the surgical robot is a complex instrument with its own learning curve. Also, the technique is more complex than routine open surgery due to the added complexity of the mechanics of operating the robot in a relatively small anatomic space.
Surgical education
(1) Preparation
• The surgeon should become familiar with the available literature before making a commitment to explore the robotic technique.
• The surgeon should observe the regional pattern of practice with the new technology and determine whether the target patient population for the procedure is a large part of his/her practice.
• An assessment of whether the home institution has the appropriate equipment (or funding to acquire and maintain the equipment, and associated supportive staff) required to perform the procedure should be made.
• The surgeon should discuss access to the robotic equipment with the operating room medical director.
• Approval and support from the division and/or department chief, when appropriate.
• Anesthesia, nursing, and operating room personnel should be informed of the pursuit of robotic skills.
(2) Team Identification
• A team consisting of multiple personnel experienced with treating thyroid diseases should be identified. Depending on the institution, these should include attending surgeons, anesthesia personnel, fellows, residents, nurses, and surgical physician assistants.
• Operating room personnel who will be participating in the procedure should be included in the educational process. Ideally, these individuals should have experience with open thyroidectomy and robotic technology.
• The team should also include a support technologist for content reference such as a trained industry representative.
• The consistency of team members will yield the greatest efficiencies over time, and every effort should be made to ensure this consistency. Hospital and operating room administrators should be committed to this concept.
(3) Skill Acquisition
• Online training modules, manuals, and other educational materials (typically offered by the technology manufacturer) for robotic thyroidectomy should be reviewed and completed.
• All team members should master robotic console skills. Each should receive a minimum of 8 hours of simulation training. Proficiency of knot-tying, control of active bleeding using both energy sources and surgical clips, and console hand- and foot-pedal management should be demonstrated by the surgeon(s).
• Surgeons should have experience utilizing the same energy source in open procedures as used to obtain coagulation and control of bleeding with the robotic system.
• All team members should become familiar with the robot mechanism, instruments, camera, and all other devices, including their setup, positioning, and entry/exit. Members should also be knowledgeable about reusability of equipment and costs.
(4) Case Observations
• Ideally, key members of the group should travel together to learn the procedure from a surgical team with extensive experience.
• The team members should interact with the operating staff, including nurses, fellows, and anesthesiologists, and observe multiple cases, including operating room setup, patient positioning, incision placement, and instrument assignment.
• The surgeon should obtain surgical videos of the technique for self-study and reference.
(5) Best-Practice Checklist
• A best-practice checklist to ensure the safety and efficiency of each step of the procedure should be created.
• Responsibilities should be assigned to each team member. The checklist should specify defined tasks for each team member during every step of the procedure. Roles include
Console surgeon—main surgeon
Bedside assistant—individual at the bedside who has access to the operative space for suction, to remove the specimen, or help in case of an emergency. This could be another surgeon, nurse, surgical assistant, or experienced scrub technician.
Tower/Monitor assistant to help with supplies in the room, operation of the video tower, inspection of trocar angles, retractor setup, and to assist other personnel
Dedicated anesthesia personnel
Consideration for support technologist, especially for initial cases.
• The main operating surgeon(s) should be able to perform each step of the technical procedure.
• The operating room personnel should be prepared for the technical needs of the team. An inventory of all expected equipment should be reviewed and obtained with help from the support staff, including contingency supplies available for emergencies. The availability of all necessary back-up equipment, including cameras, endoscopes, and energy source generators, should be ascertained.
• The robotic surgical system should be tested and the availability of all necessary equipment should be ensured before anesthetizing the patient.
(6) Cadaver Dissections
After observing the procedure performed by an experienced surgeon, the physician-surgeon should return to the cadaver lab to perform the procedure with the guidance and availability of an experienced surgeon, before performing their first case. Ideally, the team should perform a minimum of two procedures on cadavers. Practical points of equipment position, incision placement, retractor placement and attachment, robotic docking, instrument exchanges, and patient positioning should be reviewed. Proficiency should be demonstrated in the cadaver lab before performing surgery on patients. (7) Systems Failure Preparation • Potential systems failures should be discussed and strategies planned to prevent mechanical collapses. • Preparation for other contingencies, such as uncontrolled hemorrhage, should also be made, and necessary supplies should be available in the operating room. • All team members should be able to perform timely review of best practices check lists, time-outs, as well as emergency removal and redeployment of the robotic devices. Criteria for time threshold for phases of the procedure and guidelines as to when to abort the procedure and convert to open should be generated. • A troubleshooting algorithm should be printed and posted where it can be seen during the operation. A clear plan when to convert to an open technique and how to convert to an open operation should be rehearsed by all robotic team members.
Credentialing
Physicians should ensure that they are adequately trained and are ready to perform the procedure before being credentialed by their healthcare facility should that be required.
Hospital credentialing standards vary widely between institutions. The incentives of credentialing may not coincide with the best interests of patients, and the surgeon should not confuse credentialing with skill acquisition.
Data collection
Even if research is not the intent of the program, outcomes need to be tracked. An organized registry should be in place with entry of all patients undergoing robotic thyroidectomy.
Quality assessment and improvement strategies should be established and data acquisition forms with definite endpoints designed. A commitment should be made to continuous refinement of the operative technique, including staying abreast of developments at other institutions. Data acquired should consist of, at minimum, surgical indication, final pathologic diagnosis, blood loss, complications, and operative time. Recording of demographics such as sex and body mass index is also recommended. This will allow a means of tracking to identify ideal candidates for the operation and those for whom the procedure may not be appropriate.
Ideally, a timeline should be established and strategic planning meetings scheduled at predetermined intervals to objectively review the outcomes and alter the practice as indicated. Such meetings should include all robotic team members, institutional representation, and, if possible, the initial teaching preceptor. This should take place during the initial experience and after any complication. A master log of the results should be maintained, with critical review by all team members. The minimum outcome parameters recorded should include death, major vascular injury, bleeding, conversion to open, recurrent laryngeal nerve injury, hypocalcaemia, infection, peripheral nerve injury, numbness, breast distortion, skin breakdown, and bruising, and the need for reoperation.
Patient selection
Ideal patient selection criteria should be established. Patients should be screened for contraindications such as rotator cuff issues, shoulder/neck mobility problems, cervical spine disease, previous neck, chest wall or axillary surgery, and possible complicating conditions, such as breast implants and previous irradiation, obesity, certain thyroid pathologies such as locally advanced cancers, Graves' disease, Hashimoto's thyroiditis, or substernal goiter.
Informed consent
The surgeon must discuss the procedure with each patient, including the number of cases personally performed, the novelty of the technique, risks related to the new technology, and document the discussion in the medical record. This discussion should include potential unknowns, advantages (elimination of obvious scar, better visibility of structures during surgery, and elimination of surgeon tremor) and disadvantages (possible complications in addition to those of the standard operation, such as numbness, brachial plexus stretch injury, esophageal injury, vascular injury, and conversion to an open procedure).
The patient should sign a consent form that includes information on outcomes and risks of routine and standard thyroid/parathyroid/other neck operations and additional potential complications related to this new approach.
Preceptored cases
Given the complexity of this technology and the potential risk to patients, the initial cases are best preceptored by an experienced robotic thyroid surgeon. The characteristics of a legitimate preceptor include known expertise in the procedure and documented favorable outcomes. The preceptor should be involved in discussions relevant to patient selection, setup, and logistics. The preceptor should be present until proficiency is achieved.
Conclusions
Robotic thyroidectomy is an exciting new technology that is complex and requires substantial commitment on behalf of the thyroid surgeon and surgical team to ensure safe implementation. The educational paradigm outlined in this document applies to all surgeons, in private or academic arenas. The adoption of new technology in the operating room offers potential benefits as well as challenges. Our existing healthcare system and market forces add additional factors that may make implementation complicated. Ultimately, it is the surgeon's responsibility to the patient that must override all other concerns and requires a thoughtful, measured, and cautious approach during the initial implementation of developing technologies. Safe assessment and adoption combined with methodical analysis of results will ultimately determine the relative benefits and costs as well as success or failure of any new surgical technology. Methods of quality assessment and improvement should be applied to assure patient safety. Attempts to circumvent safe adoption may result in premature questioning of the benefits of a potentially valuable technology and result in unnecessary harm to patients, surgeons, and society.