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with Colleen Hutchinson

In his blog, Toby Cosgrove, CEO of Cleveland Clinic Foundation, recently referenced two studies done within his institution comparing robotic surgery with traditional methods for mitral valve repair and prostatectomy. The first study found that technical complexity and longer surgical time were balanced by the benefits of shorter hosptial stays and smaller incisions; the second study showed that robotic surgery was no better or worse than traditional surgery. If you follow my table that appears in this column regularly, you know that I’ve tested the waters to see how surgeons feel about this new surgical approach. The time has come to hear from surgeons beyond sound bytes and to tackle the issues in a dedicated column. While both sides are effectively represented here, and with more objectivity and balance in each individual perspective than one might expect, I was surprised to see agreement on a few major aspects of robotics—most interestingly, the opinion that robotics doesn't necessarily mean more risk of inadvertent injury than with open or laparoscopic surgery. Robotics will continue to be a subject for which spirited debate and technological advancement progress in parallel. General consensus was also reached on one more important point—the robot is not only here to stay, but will continue to advance, and surgeons would be wise to advance with it. Otherwise, as Dan Jones, MD, said, the robotic surgeon may soon be eating your lunch!

Thank you to this month’s contributors for sharing their thoughts and expertise. Please feel free to email me at colleen@cmhadvisors.com with thoughts on this month’s column, or ideas for future ones.

—Colleen Hutchinson

P A R T I C I P A N T S
image Yuman Fong, MD, is the Murray F. Brennan Chair in Surgery at Memorial Sloan-Kettering Cancer Center, New York City.

 

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Daniel Jones, MD, MS, is chief, Minimally Invasive & Bariatric Surgery at Beth Israel Deaconess Medical Center, and professor of surgery, Harvard Medical School, Boston.

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Omar Yusef Kudsi, MD, MBA, is assistant professor of surgery, Tufts University School of Medicine, Boston.

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Marty Makary, MD, MPH, is associate professor, Surgery and Health Policy at Johns Hopkins University, and director, Minimally Invasive HPB Surgery, Johns Hopkins Hospital, Baltimore.

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Frank Rosato, MD, is director of gastrointestinal surgery, Capital Health Hospital, Pennington, New Jersey.

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Noel N. Williams, MD, is professor of surgery at the Perelman School of Medicine at the University of Pennsylvania and director of the Penn Metabolic and Bariatric Surgery Program, Philadelphia.

Statement:The mechanisms and three-dimensional (3D) vision of the robot allow for maneuvering in tight spaces and enhanced viewing of smaller areas compared with the laparoscopic approach, and it provides the surgeon the benefits of the ability to manipulate tissue and provide for improved performance of surgery, as well as reducing surgeon fatigue.

Additionally, it has been proven to provide clinical patient benefits of less pain, less recovery time (and shorter hospital stay and less postoperative pain medication), generally less blood loss and improved cosmesis.

Dr. Jones: Disagree. Despite 3D and maneuverability, there is no proven benefit for most operations. The bigger SILS [single-incision laparoscopic surgery] port may actually cause more pain and more hernias and be more disfiguring than needle laparoscopy.

Dr. Williams: Agree. In transoral robotic surgery [TORS], radical prostatectomy and most gynecologic procedures, the robot is far superior to traditional open and laparoscopic approaches.

Dr. Makary: 3D vision and added degrees of freedom may benefit patients undergoing select operations in which tight spaces cannot otherwise be reached by standard laparoscopy (e.g., posterior pharynx surgery). Future versions of the robot will expand these select indications. The benefit to a surgeon’s spine is noteworthy in some operations (e.g., prostatectomy) where bending over to perform standard laparoscopy is known to cause occupational injury. The framing of the question of whether robotic surgery is proven to yield less pain, recovery time and blood loss is precisely the problem with the robotic surgery controversy—the question of superiority lacks a comparison group (is it open or standard laparoscopic surgery?), does not specify for which operation type, and ignores the publication bias of underreporting of the rare but catastrophic complications associated with the lack of haptic feedback. Sound byte claims of robotic superiority are largely unfounded, unfairly crediting the robot with minimally invasive surgery [MIS] benefits over open surgery.

Dr. Fong: Agree. There is no doubt that the 3D vision and the articulated instruments offer technical advantages and allow more complicated operations to be performed in an MIS environment. Proving that this translates to better patient outcomes has been more difficult because of a lack of studies and poor outcome parameters.

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Dr. Rosato: Disagree. Today’s laparoscopic articulating instruments and scopes provide the ability to navigate in tight spaces with enhanced visualization similar to the robot. Furthermore, the robot’s lack of tactile feedback is a major concern. The initial studies quantifying the benefits of robotic surgery were based on claims made in comparison with open approaches. More recent studies comparing the robot with laparoscopic surgery show no difference related to pain, recovery time, blood loss or cosmesis. Patients need to understand that it is who does your surgery, and not how they do it that is important.

Dr. Kudsi: Agree. I believe that the surgeon’s skill, training and incremental learning are determining factors to successful outcomes in the field of surgery and in particular robotic surgery. In regard to robotics, we, as surgeons, have the chance to shape the future, craft it and define it using our values as our moral compass. And, most importantly, when comparing robotics outcomes, experience is the No. 1 criterion a surgeon should consider prior to judging the results (3D vision, suturing, stability and control). There isn’t a single surgical tool that wasn’t dependent on practice and on a skilled surgeon to achieve the very best results. In the words of Dr. [Francis] Sutter, a robotic cardiac surgeon, “Surgical excellence revolves around one basic principle—improving upon the existing procedure, making surgery safer and easier for the patient and surgeon.” Robotic surgery versus laparoscopic surgery is an ongoing comparison, but those judging are missing the point that robotics is another tool that, in the right hands of dedicated surgeons and programs, could deliver phenomenal outcomes. Robotics is an instrument to achieve excellence.

Statement:Institutions and surgical societies need to establish a standard resident and attending curriculum for learning robotic skills to proficiency—and to not do so is to allow for a continuation of the current environment of the self-made robot expert. Residents and fellows should be trained in the technology so that they can apply it rationally and help develop the next generation of robotic interfaces.

Dr. Fong: Agree. This is where a society such as SAGES [Society of American Gastrointestinal and Endoscopic Surgeons] could be quite helpful, providing guidelines similar to those drafted for laparoscopy. We need sensible guidelines that provide for patient safety while allowing room for innovation. Having experts in the field preemptively define these will prevent onerous guidelines that may result from a reaction to an untoward event.

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Dr. Jones: Agree. Next-generation robots are the future. We will realize technological breakthroughs sooner if we get the robots into the hands of trainees and multiple vendors.

Dr. Kudsi: Agree. The pace of innovation in surgery change has increased substantially over the past decade, and it will continue to accelerate in the near future. We as surgeons and surgical trainees are faced with the dilemma of whether to adopt robotics. We should consider four basic questions: What is the learning curve in robotics? How much commitment is needed to achieve excellent results? Does robotics add value to the existing options? Is it financially viable?

From the point of view of a robotic surgeon, and someone who has done hundreds of robotics in the field of general surgery, I could simply say that it is a phenomenal tool that permits the surgeon to deliver state-of-the-art results to his or her patients. The potential of robotics is yet to be discovered, especially with the new generation of motivated surgeons in the field of robotic surgery. In regard to teaching facilities, robotics might provide a more controlled environment with the teaching console in comparison to laparoscopic surgery.

Dr. Williams: Agree. In our institution, all the residents are required to do a standard simulation curriculum before sitting at the console. We also have a simulation lab with Box Trainers stomach models to do full simulated operations before patient exposure at the console.

Dr. Makary: I agree, for everything we do in surgery.

Dr. Rosato: Agree. If we continue to allow industry to define training criteria and determine proficiency standards, the true indications for robotic use and the maximum benefit of this technology will never be realized.

Statement:Regarding safety, in the event of an acute life-threatening iatrogenic bleed, the entire surgical team needs to respond quickly to remove the robot. Several case reports in the literature now detailing the patient being stuck under the robot call for quick team response to be regularly practiced, yet this practice need is not being met currently within institutions or within the larger scope of surgical education.

Dr. Williams: Agree. If a hospital has a major robotic program, there should be a dedicated OR [operating room] staff that knows how to handle emergencies in an expeditious manner to allow for rapid conversion to an open procedure. This scenario should be practiced in a simulation setting on a regular basis or when new staff members join the team. Teamwork is very important between OR staff and the surgeons.

Dr. Makary: Agree, and it’s for this reason—the need for quick conversion—that I have a preference to not use the robot for laparoscopic Whipples, where major portal vein bleeding can require rapid conversion.

Dr. Rosato: Disagree. At the institutions where I have worked, there has always been a dedicated operating room team for robotics. Each member, from anesthesia through circulating nurse, is well aware of the unique safety concerns presented while performing robotic procedures. Furthermore, for high-risk procedures with the potential for massive hemorrhage, I meet with our robotic team 24 hours before [the procedure] to review the case and expectations of all members should an emergency arise. As the applications of the robot are being applied to more complex and high-risk procedures, the importance of the rapid response will only increase. I am sure that I am not unique in my approach to these cases. Ultimately, it is the responsibility of the surgeon to assure that the team is prepared for any type of robotic emergency.

Dr. Fong: Agree. The essentials for a rapid and potentially lifesaving emergency conversion to an open operation are 1) immediate availability of open instruments and self-retaining open retractors; 2) rehearsal of emergency conversion and emergency time-out at beginning of case to define; and 3) document each participant’s role.

Dr. Jones: Agree. We recently had a robot stuck over a patient when a medical student tripped over the electrical plug. We have simulation labs to practice scenarios as teams. We should mandate that all teams must practice crisis response.

Dr. Kudsi: Agree. Despite the fact that many hospitals have formed robotic committees with rigid restrictions, some of these features are very useful. As surgeons, we should be the most experienced in the room with regard to the machine and troubleshooting. Commitment to understand and go beyond just technical skills will demonstrate leadership skills. Understanding how to dock, drive and position trocars is as important as performing the surgery to prevent instruments and arms collisions. That’s why troubleshooting and emergency conversion should be part of the team training.

Statement:Inadvertent injury to a major structure is a risk inherent in robotics compared with both laparoscopic and open approaches.

Dr. Rosato: Disagree. Inadvertent injury to a major structure is an inherent risk for all surgical approaches.

Dr. Jones: On the fence. Although the surgeon may be able to see better, one gives up haptic feedback.

Dr. Kudsi: Disagree. Robotics might provide a more controlled environment with the teaching console in comparison with laparoscopic surgery, almost similar to open surgery. Injury to a major structure could happen in any approach; it’s related to technical and judgment skills. You can’t blame the slave robot.

Dr. Makary: Agree, but the added risk is minimal, even negligible in the hands of a good robotic surgeon. Robotic surgery can be safe when the surgeon is experienced and is the right surgeon for that operation. Patients should choose a good surgeon first and the approach second.

Dr. Fong: Disagree. Inadvertent enterotomies occur in open, laparoscopic and robotic surgery. It will be important to document those injuries that would not have occurred with open surgery (e.g., trocar, vascular and traction injuries because of excessive robotic force). These should be graded according to 1) no immediate or long-term adverse outcome, 2) immediate adverse outcome but no long-term disability and 3) both immediate and long-term adverse outcome.

Dr. Williams: Disagree. There is a risk for inadvertent injury during all forms of surgery and no more so in robotic surgery if an appropriate training model proctoring has taken place.

Statement:As we continue to learn more regarding safety from SAGES Fundamental Use of Surgical Energy (FUSE) program, we need to appreciate the potential from stray currents and iatrogenic burns with use of the robot and instruments in parallel.

Dr. Fong: Agree. These should be tracked for all forms of surgery: open, laparoscopic and robotic. The lateral spread of heat for each energy instrument in open, CO2 environment and air insufflation environment at common settings should be part of the package insert for each instrument. Education curriculum should teach use of each of these instruments in open, laparoscopic and robotic deployment.

Dr. Kudsi: On the fence. This is the greatest point of all. As a FUSE member and a robotic surgeon, I emphasized this point from day 1 in practice. In robotic surgery you are zoomed in more in comparison with laparoscopic surgery, where you usually have a larger surgical view. In being zoomed in and having long instruments, often you don’t get to see the whole instrument and adjacent structures.

We have to be aware and educated about SAGES [FUSE] and I invite all surgeons to take the course and the actual test.

Dr. Rosato: Agree. This applies to all minimally invasive approaches used for treating surgical problems. Limiting the use of monopolar energy in favor of bipolar or alternative energy devices is paramount for patient safety.

Dr. Jones: Agree. Especially when doing SILS, where instruments are closer together, there is a potential danger. Take FUSE and you will change the way you do SILS forever, if ever again.

Dr. Williams: Agree. The understanding of energy sources is mandatory for all surgeons performing robotic and laparoscopic surgery.

Dr. Makary: I agree; this is true for all minimally invasive surgery.

Statement:Although robots will one day replace many precision human tasks in the OR, currently very few operations are really done better with a robot when performed by a skilled surgeon. Therefore, currently many surgeons and medical centers are really using the robot to gain a marketing edge against competition and to attract new patients, rather than to provide for safer, improved operations and clinical outcomes for their patients.

Dr. Rosato: Agree. A 2011 study published in the Journal for Healthcare Quality [33:48-52] and conducted by Johns Hopkins School of Medicine [Baltimore] researchers found 41% of hospital websites described robotic surgery. Among these, 37% presented robotic surgery on their home page; 73% used manufacturer-provided stock images or text; and 33% linked to a manufacturer website. Statements of clinical superiority were made on 86% of websites, with 32% describing improved cancer control, and 2% described a reference group. None of the hospital websites mentioned risks. These investigators concluded that materials provided by hospitals regarding the surgical robot overestimate benefits and largely ignore risks, and are strongly influenced by the manufacturer. [Editor’s note: Dr. Makary was an author on this paper].

Dr. Fong: Agree and disagree. Although it is true that some medical centers will form robotic surgery programs to be “competitive,” the truly innovative centers that have invested in large academic programs in robotic surgery have included technical development, outcomes research and education as part of the program. Developing new tools, defining the advantage and disseminating the knowledge are key to truly innovative programs.

Dr. Williams: On the fence. This statement applies to lap cholecystectomy. But for example, for cases of patients undergoing laparoscopic sleeve gastrectomy who have a very high BMI [body mass index], I feel it is safer and more precise to use the robot. In our institution, robot setup time does not add any time to the overall procedure.

Dr. Jones: Agree. I usually can do two laparoscopic cholecystectomies and have a cup of coffee in the doctors’ lounge in the time my colleague does one robotic cholecystectomy. But he may soon be eating my lunch since the photo opportunity is with the million-dollar robot and not the laparoscope these days.

Dr. Makary: On the fence. Some surgeons and hospitals may use the robot for marketing, evidenced by robot debuts at community half-time events and shopping malls. And although some even mislead the public with unethical marketing to patients who are in a vulnerable state and shopping for quality surgery, I believe many surgeons are simply trying to be proficient with a futuristic technology. As new robot versions come out and new companies introduce next-generation robots, surgeons are smart to keep an open mind and evaluate the application for their practice mix.

Dr. Kudsi: Disagree. I can say in all confidence that it would take me less time to perform robot-assisted laparoscopic cholecystectomy than laparoscopic cholecystectomy on a personal level—skin to skin in less than 30 minutes with room turnover time less than 15 minutes from a team perspective. It was recently published in HBR [Harvard Business Review] that once you have a dedicated surgical team, the whole day becomes efficient, your outcomes are excellent and it is more fun!

It is similar to many surgeons in their surgical centers. Robotic surgery will not cause less pain and lead to faster recovery, but it will provide control over the operation where you are doing 100% of the cases, whereas in other cases you are dependent on the assistant performance and skill level. How many of us will change his or her face when a lesser-skilled assistant shows up for a morbidly obese male patient who has an acute gallbladder?

Although many centers are marketing themselves to gain a marketing edge, it’s a false hope because this road will lead nowhere.

As I previously stated, robotic versus laparoscopic surgery is an ongoing point of comparison, but misses the point that robotics is a tool that in the hands of dedicated surgeons and programs can deliver remarkable outcomes—an instrument to achieve excellence. Hundreds of robots have been sold worldwide and the approach is being adopted across the universe. Focus should be on excellence—you better choose one surgeon and make him the robotic expert. At the end of the day, it will be a more expensive option; thus, we should find a dedicated surgeon who would ensure superb results.

Statement:There is catch-up work to be done: Generally speaking, at centers where the robot is currently used, protocols that both ensure proper patient selection and fully inform patients of risks and benefits of all surgical options are lacking.

Dr. Fong: Disagree. At most academic medical centers, robotic surgical time is a valuable commodity. It is usually assigned to the procedures and programs of greatest promise. Credentialing processes are rigorous and include auditing of outcomes. Patients certainly must give informed consent before undergoing such an operation.

Dr. Jones: The robot is marketed as “cool” and “cutting-edge.” The surgeons who use it say it makes their operations easier and possibly better; so, no surprise, the patient signs. If the patient, rather than the insurance company were paying part of the added costs, the patient might have more questions or find a surgeon who does as well without the need for costly robotic assistance.

Dr. Kudsi: I agree, despite the fact that many hospitals have formed robotic committees with rigid restrictions and details beyond practicality at some hospitals and others driven by media and fear of lawsuits. Developing high-performance robotic surgery teams requires leadership—not the authoritarian leadership of the past, but the kind of leadership that fosters exceptional communication, mutual respect and support, and the development of the best and most straightforward to achieve the goals of our surgical society. Recently, SAGES created Minimally Invasive Robotic Association guidelines, and it will continue to evolve.

Dr. Makary: The key is for patients to be fully informed of all their options. Stakeholders should have created a robust, “capture-all” registry for all robotic surgery patient outcomes 12 years ago when the robot was FDA-approved. This endeavor would have allowed researchers to evaluate the benefit or harm to patients in real time. National registries in health care require a broad investment, but are badly needed.

Dr. Rosato: Agree. It is time for a national database for robotic procedures. This will allow for the evaluation of proper indications, as well as short- and long-term outcomes.

Statement:The effectiveness of the robot is proven in many operations but it is clearly more expensive. As we are a society with ample resources, the extra cost of this technology should be paid by third-party payors so that it is available to all.

Dr. Fong: Disagree. The way to make this technology available to all is not to just pass it off into the “third-party payor pool.” To make it available to all, we need to optimize robot use by using standard laparoscopy for those MIS procedures where robotics adds no advantage but does add cost. Because surgical robotic products are currently a monopoly, we should consider having it regulated as such. All essential services that are monopolies are usually regulated by the government for charges.

Dr. Williams: On the fence. Clearly there are operations where the robot is far superior to standard laparoscopic approaches. In these instances, they should be reimbursed by the third-party payors.

Dr. Jones: Disagree. No reason to jack up health care costs and insurance premiums. Technology must prove to be cost-effective.

Dr. Makary: Any medical intervention that benefits our patients should be paid for, but is it really better for gallbladder surgery? As a society, how do we justify doing robotic cholecystectomy when there is an established, safe laparoscopic approach that costs thousands less per operation? We should remember that we currently have rationing of health care in America. Arizona has let, and continues to let, patients die on transplant waitlists simply because the state insurance program cannot afford the expensive procedure. We should consider our larger mission to the public.

Dr. Rosato: Disagree. Although the effectiveness of the robot has been shown in a myriad of surgical procedures, its superiority over more traditional and less costly approaches has never been proven. The goal of every physician should be to deliver effective and efficient health care. The robot adds expense to every case performed. Using it for surgeries in which there is no proven superiority is not cost-effective. We are not a society of unlimited resources, and although third-party payors are covering the added expense of robotic cases currently, it will be only a matter of time before that extra cost will be passed along to patients.

Dr. Kudsi: Agree. Most famous institutions and schools in the United States have a fair amount of their resources paid by third parties (donations), and many surgical centers in Europe, Middle East and Asia were donated. I do believe that [robotics] shouldn’t be considered as the only approach, but the percentage for the next decade will definitely grow.


Gut Reaction: Robots and More

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Question 1:
IBM’s Watson
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Question 2:
Worst abuse of the robot right now
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Question 3:
American College of Surgeons (ACS)
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Question 4:
Society of American Gastrointestinal and Endoscopic Surgeons (SAGES)
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Question 5:
Best advice to the community surgeon on robot adoption
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Question 6:
FDA’s approval process for medical devices
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Question 7:
The one thing residents and fellows forget most is…
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Question 8:
The one thing patients forget most is…
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Question 9:
The one thing I forget most is…
Yuman Fong, MD ‘Get to work.’ ‘Small procedures where laparoscopy is equivalent’ ‘Need to advocate for reimbursement’ ‘Need to help with guidelines’ ‘Need to be educated’ ‘Reasonable’ ‘Importance of setup of room’ ‘It’s just another tool’ ‘How hard laparoscopy was’
Dan Jones, MD ‘Not Apple’ ‘Lap chole’ ‘Too conservative’ ‘Too little’ ‘Replaces first assistant’ ‘Innovation with competition’ ‘Duty hours’ ‘Medications’ ‘ICD-10’
Noel Williams, MD ‘Loser’ ‘None’ ‘Great organization’ ‘Great organization’ ‘Proper preparation and proctoring’ ‘Fair’ ‘To come to clinic’ ‘To follow up’ ‘My jawbone, up at the gym’
Frank Rosato, MD ‘The beginning of Sky-Net’ ‘Transaxillary thyroidectomy’ ‘Should develop curriculum for robotic certification’ ‘Should develop curriculum for robotic certification’ ‘Practice; do easy cases; then more practice’ ‘Typical government agency’ ‘Use both hands when operating’ ‘Tiny incisions don’t mean painless surgery’ ‘Humpty Dumpty can’t always be put back together’
Martin Makary, MD ‘A good start’ ‘Cholecystectomy’ ‘Inspiring quality’ ‘Futuristic’ ‘Consider it on a case-by-case basis.’ ‘Is better than their post-approval monitoring process’ ‘The value of visiting other centers’ ‘The name of their anesthesiologist’ ‘What book chapter deadline just passed’
Omar Kudsi, MD ‘da Vinci surgery’ ‘Giving credential to everyone who asks’ ‘Quality and standards’ ‘FLS/FUSE’ ‘You are either all in or out.’ ‘Painful reality’ ‘Last chance before it’s all You’ ‘Surgery hurts’ ‘You got cool ideas’

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Colleen Hutchinson is a communications consultant who specializes in the areas of general surgery and bariatrics. She can be reached at colleen@cmhadvisors.com.