(1)
University Hospitals—Case Medical Center, 11100 Euclid Avenue, LKS-5047, Cleveland, OH 446, USA
Abstract
The use of robotic surgery has increased dramatically despite a paucity of data demonstrating clinical benefits of the technology. While the technical advantages of the da Vinci platform may facilitate a minimally invasive approach to difficult operations in confined spaces, many of the procedures for which it is being used could be accomplished more efficiently with conventional laparoscopy. Such is the case with segmental colectomy, where laparoscopic resection is quickly becoming the gold standard for benign and malignant disease. The da Vinci system may improve success rates of minimally invasive rectal resection, especially in select patients, but robotic colorectal surgery is not for everyone; not every patient and not every surgeon.
Keywords
RoboticColorectalTotal mesorectal excisionCost-effectiveLearning curve23.1 Maintaining Perspective
The authors of this book have offered their collective knowledge and experience to provide the reader with a comprehensive guide to robotic colorectal surgery (RCS). While colorectal surgery may lag behind urology and gynecology in the widespread application of robotics, the very publication of this text is a testament to the growing interest in the technology. Anyone who has sat at the platform of the da Vinci Surgical System (Intuitive Surgical®, Inc., Sunnyvale, CA) can appreciate the technical advantages offered by the three-dimensional high-definition optics, stable camera platform, articulating instruments, and ergonomic interface. Surgeons with extensive experience in RCS report excellent clinical outcomes and an overwhelmingly positive surgeon experience. There is great enthusiasm among surgeons and patients for increased access to robotic surgery.
While the technological advantages of robotic surgery may help overcome some shortcomings of conventional laparoscopy, it is important to realize that there is a relatively small number of procedures in which the “limitations” of laparoscopy are actually limiting. The benefits of the robot are best realized when working in confined spaces with limited visualization, particularly when precise movements and complex maneuvers such as suturing and knot tying are required. This explains the overwhelming application of the technology to prostatectomy, as well as its growing presence in otolaryngology and cardiac surgery, where other minimally invasive options are unavailable. In these cases, this highly sophisticated and expensive piece of medical technology may allow surgeons to offer minimally invasive procedures that would otherwise not be possible. Advocates of robotic surgery for rectal cancer suggest that total mesorectal excision (TME), particularly in a narrow male pelvis, is an example of such a procedure. On the contrary, cholecystectomy, hysterectomy, and segmental colectomy are routinely and efficiently performed laparoscopically with a high degree of success and excellent clinical outcomes. The growing application of robotics to procedures such as these calls into question the judgment of surgeons and hospital administrators alike. This situation is further complicated when “key opinion leaders” on robotic TME attempt to demonstrate advantages of the robot over routine laparoscopic colectomy. This perfunctory approach presents a credibility issue that may dampen the enthusiasm by all to adopt robotics for the difficult proctectomy, where it may truly be advantageous.
Before advocating for the expansion of RCS, we should review the facts. First, the use of the da Vinci robot has exploded across surgical specialties in recent years, largely driven by aggressive marketing. General surgery, including colorectal surgery, is one of the fastest growing segments of the robotic market. Secondly (contrary to sales pitches and marketing strategies) every aspect of robotic surgery, from the platform itself, to the service contract, to the instruments, is associated with a significant expense. As neither private nor public payers increase reimbursement for use of the robot, these costs are borne by the institution [1]. In some settings, this is countered by the ability to offer an otherwise unavailable operation, but often this is simply the price of being modern. Third, minimally invasive approaches to colorectal surgery have been utilized for over 20 years [2]. Laparoscopic colorectal surgery (LCS) has been proven to decrease length of stay, lower complication rates, and reduce hospital costs, while achieving equivalent oncologic outcomes [3–5]. The number of surgeons offering LCS is growing annually in community and teaching hospitals of all sizes [6]. Lastly, at present there are no large studies suggesting that RCS is associated with improved outcomes compared to conventional LCS. There may be a benefit of robotics in the treatment of rectal cancer, with recent studies showing lower conversion rates and similar oncologic outcomes for robotic TME compared to conventional laparoscopy [7, 8]. However, competent minimally invasive surgeons must resist the temptation of technology and the pressure from industry and administrators to use da Vinci for all colorectal resections, just because they can. We must maintain perspective.
23.1.1 Robotic Surgery is on the Rise
Sales of the da Vinci Surgical System and the prevalence of robotic surgery have increased dramatically in last decade. As of December 31, 2013 Intuitive Surgical had installed 2966 da Vinci systems in over 2000 hospitals worldwide, including 2083 units in the United States and 476 in Europe [9]. This is a more than threefold increase from the roughly 800 units installed by 2007 [10]. More striking is that 1166 of these units were sold in 2012 and 2013 alone. In the last 10 years, over 1.5 million operations worldwide have been conducted with the use of the da Vinci system [11]. In 2013, an estimated 523,000 robotic operations were performed, up 16 % compared to approximately 450,000 in 2012. This annual rate of growth was considered modest in light of the overall 155 % increase since 2009 [9, 10].
Historically, the most common applications of the robot have been in urology and gynecology. According to market share data from Intuitive Surgical, in 2011, 83 % of prostatectomies in the United States were performed robotically [11]. Since its approval for use in gynecology in 2005, da Vinci has become a commonly utilized platform for performance of benign hysterectomy. In a 6-year period, robotic hysterectomy has expanded to account for more than 25 % of the more than 600,000 hysterectomies performed annually in the United States [11, 12]. By comparison, over the same period the rate of laparoscopic hysterectomy remained stable at just over 35 %. In recent years, there has been a substantial increase in robotic use for abdominal procedures, including cholecystectomy, foregut surgery, and colorectal surgery. In 2013, general surgery overtook urology as the second most common category of da Vinci use in the United States [9].
The first robotic-assisted colectomy was described by Weber et al. in 2002 [13]. Prior to 2007 only five series of more than ten patients appeared in the literature, focused primarily on segmental colectomy [14–18]. Specific data on the current frequency of RCS are limited but a recent analysis of the Premier Hospital Database found that, for minimally invasive segmental colectomy performed between 2009 and 2011, the robotic approach was used for 548 out of 25,758 cases (2.1 %) [19]. In data from the US Nationwide Inpatient Sample, the robotic approach was used for 0.9 % of all segmental colectomies in 2010, but appears to be increasing at an exponential rate [20]. Based on the volume of publications in the literature, robotic TME for rectal cancer appears to be gaining more traction than robotic colectomy in recent years. Over 1000 robotic pelvic dissections for rectal cancer have been described in the literature, with rectal resections outpacing colon resections since 2008 [21, 22]. Clearly, robotic surgery is on the rise. The challenge is to remember that the robot is a highly sophisticated and very expensive tool, and not an exciting new toy. As such, not every operation, every surgeon, or even every hospital needs a robot.
23.1.2 The Robot Is Expensive
Perhaps the most consistent finding in the existing literature on the surgical robot is the significant increase in cost associated with its use. Turchetti et al. recently published a systematic review of the cost analysis literature on robotic vs. conventional laparoscopic surgery from 2000 to 2010 [23]. One hundred percent of the articles analyzed, covering eight different procedures from four different specialties, found the robotic approach to be significantly more expensive than conventional laparoscopy, despite most studies excluding the purchase and maintenance costs from their analyses. Regarding (RCS), Juo et al. recently reported data on segmental colectomy from the US Nationwide Inpatient Sample [20]. In a propensity score-matched cohort, robotic colectomy was associated with significantly higher per hospital day ($3407 vs. $2617) and total hospitalization cost ($14,847 vs. $11,966) than laparoscopic colectomy. Interestingly, patients treated by robotics were more likely to have private insurance and had a higher household income than patients treated by laparoscopic colorectal surgery or open colectomy.
Financial considerations of robotic surgery must include direct equipment costs, utilization costs, and revenue impact. Depending on the model and specifications, the da Vinci surgical system retails for between $1 and $2.5 million [23]. The cost of the system can be paid upfront or can be amortized over the first 3000–6000 procedures performed on the machine. In addition to the direct cost of the platform, Intuitive Surgical requires an annual service agreement ranging from $100,000 to $170,000 per year. The impact of these costs on an institution is often considered in light of the volume of robotic cases, where cost per case is calculated by dividing expenditures by number of robotic procedures performed. Lost in this equation, however, is the fact that no additional funds are collected on a per case basis when the robot is used, as Medicare and private insurers do not pay for a robot surcharge. Whether a hospital uses it for 5 cases or 500 cases, it will still pay roughly $3 million in the first 5 years to own a robot. Considering that in 2010, 131 of the hospitals in the United States with a da Vinci robot had 200 beds or fewer [24], these upfront costs may be impossible to overcome by any potential increases in market share or procedure volume.
Even if the price of purchase and maintenance of the robot is ignored, there is still a direct, measurable increase in cost per case due to consumables and utilization costs. The da Vinci system requires the use of proprietary, limited-use, disposable instruments, which are not covered under the service agreement. Intuitive Surgical reports that for 2013 instruments and accessories generated an average of $1980 in revenue per case, and over $1 billion annually [25], with future target revenue for instruments and accessories exceeding that of system and service revenue combined. Utilization costs associated with robotic surgery are difficult to calculate and variably reported, but most series report an increase in operating room times for robotic procedures compared to conventional laparoscopy owing to time spent docking and undocking the platform, as well as exchanging instruments [26–30]. Length of hospital stay has been reported to be shorter after robotic surgery compared with open surgery, but no different than conventional laparoscopy [20, 31]. Rates of postoperative complications and readmission are not significantly affected by use of the robot [18, 32–34]. The revenue impact of robot surgery must also be considered, including the effects on hospital volume, surgeon recruitment and retention, marketing, and public perception. These measures are difficult to calculate.
23.1.3 Minimally Invasive Colorectal Surgery Is Accomplished Well by Conventional Laparoscopy
LCS has been shown by multiple randomized controlled trials to be safe and effective, with improved short-term outcomes when compared to open surgery. The use of laparoscopy results in decreased pain, faster recovery, less blood loss, and improved lymph node harvest when compared to open surgery. Not surprisingly, as a result of these benefits, (LCS) is associated with fewer postoperative complications [4]. Furthermore, (LCS) is associated with shorter hospital stays and, despite higher per day costs, an overall reduction in hospital costs compared to open surgery [20]. Oncologic outcomes of laparoscopic resection for colorectal cancer have been proven to be equivalent to open surgery [35–37]. Consequently, (LCS) is now considered the gold standard for colon resection for benign and malignant disease.
After a prolonged period of adoption, met with some early resistance, the use of LCS is now steadily increasing. In the University Health System Consortium from 2008 to 2011, LCS was attempted in 42.2 % of colon resections, with a conversion rate of 15.8 %. During the study period, the rate of laparoscopic colon surgery increased, while the rate of open surgery and conversion decreased [6]. In 2010, the Nationwide Inpatient Sample reported 48.3 % of all segmental colectomies were performed laparoscopically [20]. General surgery resident experience with (LCS) has also increased dramatically in the last 10 years [38]. In a recent survey of graduating chief residents, 93 % reported feeling comfortable performing laparoscopic colectomy [39]. The American Board of Colon and Rectal Surgery and the Accreditation Council for Graduate Medical Education (ACGME) recently increased the minimum requirement for laparoscopic colorectal resections from twenty to fifty, though specific requirements for disease process and type of resection are still lacking. As current and future generations of trainees enter practice, the rate of (LCS) will continue to increase.
The learning curve for laparoscopic colectomy has been studied extensively with varying results. Most authors agree that roughly 50 cases are required for a surgeon to reach full proficiency [40–42]. Beyond this point, conversion rates and complications tend to reach a steady state, while ongoing reductions in operative time are realized with increased experience. The utilization of a hand-assist device may shorten the learning curve and permit performance of LCS in challenging and complex cases, while retaining the benefits of laparoscopy [43, 44]. Much as it did for cholecystectomy in the 1990s, laparoscopy is rapidly becoming the standard rather than the exception in segmental colectomy. In the era of value-based medicine, the use of expensive new technologies for procedures we already do well should be strongly discouraged in the absence of a proven benefit.
23.1.4 Data Showing Superiority of Robotics over Laparoscopy Are Lacking
The number and frequency of publications on RCS have increased dramatically in the last few years. The body of literature on RCS has grown from a few single-institution studies to include large meta-analyses [45–47], long-term oncologic follow-ups [8], and two, small randomized trials [48, 49]. Of more than 20 studies directly comparing robotics with LCS, only one has shown a significant reduction in complications with the use of robotics. In a series of 113 low anterior resection (56 robotic vs. 57 laparoscopic colorectal surgeries) Baik et al. [50] reported serious complications in 5.4 % of robotic vs. 19.3 % of laparoscopic resections (P = 0.025). The authors also found that conversion to open surgery (0.0 % vs. 10.5 %, P = 0.013) and mesorectal specimens graded as less than complete (7.1 % vs. 24.6 %, P = 0.033) occurred less frequently in the robotic group. While this low conversion rate is impressive and may highlight the true benefit of RCS for low rectal dissections, nineteen other studies comparing RCS and laparoscopic colorectal surgery have failed to show a significant difference in conversion rates [51]. Furthermore, the serious complication rate of nearly twenty percent in the laparoscopic group is higher than expected in expert hands.
In the only prospective, randomized trial to date, Park et al. [49] examined short-term outcomes in 70 patients with right-sided colon cancer randomized to robotic and laparoscopic right colectomies. The authors reported no difference in conversion, pain scores, time to resumption of diet, length of stay, lymph node harvest, or morbidity between the two groups. Use of the robot was associated with statistically significant increases in operative time (195 min vs. 130 min, P < 0.001) and total costs ($12,235 vs. $10,320, P = 0.013). The authors concluded that RCS cannot be proposed as a routine approach for right colectomy.
23.2 The Right Place for the Robot
The primary advantages of the da Vinci system are realized in procedures confined to a small space where improved exposure and intricate movements are required. Most minimally invasive colorectal operations require operating in more than one region of the abdomen and typically do not require precision tasks like suturing and knot tying. For this reason, robotics offers little advantage in the minds of most advanced laparoscopists [52, 53]. The likely exception to this point may be for low rectal cancer in a male pelvis. As opposed to segmental colectomy, laparoscopic TME in a narrow male pelvis is technically challenging even to experienced laparoscopists. In the CLASICC trial, which included both colon and rectal resections, conversion rates for rectal cancer approached 35 %, with both male sex and rectal cancer identified as risk factors for conversion [54]. In the United States, a limited number of centers possess both a sufficient volume of rectal cancer and surgeons with advanced laparoscopic skills to consistently perform minimally invasive TME with low rates of conversion. The technological advantages offered by the da Vinci robotic system, especially the latest generation da Vinci Xi, may make the dissection slightly more favorable and allow completion of the dissection in difficult cases where conversion rates are highest. Any tool that improves our ability to offer a minimally invasive operation, especially in the most challenging low rectal cancers should be considered. Data to substantiate this theory of improved performance for low rectal cancer with robotic surgery is lacking but will likely be published over the next 5 years.
23.3 Is It for Everyone?
“Does the robot make sense for me?” is a difficult question asked by patients, surgeons, and hospital administrators alike. A discussion of the complex healthcare economics influencing a hospital or Accountable Care Organization’s decision on whether or not to invest in a da Vinci robot is beyond the scope of this chapter. In today’s climate, it is much less likely that a physician group will have to make a decision on the purchase of a robot, than on whether or not to incorporate the use of a hospital-owned robot into their practice. Surgeons with prior experience in robotics will likely be drawn to positions offering access to the da Vinci system. As organizations seek to maximize the use of their robots to offset the cost, surgeons may be encouraged or even pressured to acquire robotic training and begin using the system. With regard to (RCS), sound judgment is required to ensure that this expensive and specialized technology is utilized in a cost-effective manner, with an emphasis on quality rather than novelty. While each surgeon and circumstance is unique, we present four generalized, hypothetical surgeons who may be considering RCS, with our opinion on the appropriateness of RCS in their practices. In the sections that follow the term “colorectal surgeon” refers to a surgeon performing both colon and rectal resections, as opposed to one with specific board certification.
23.3.1 The Experienced Robotic Colorectal Surgeon
A surgeon who has had extensive experience with (RCS), who has already mastered the learning curve, will likely make meaningful use of the robot if given the opportunity. At present, a handful of surgical oncology fellowships and colorectal residencies at specialized centers offer trainees a significant exposure to robotic TME for rectal cancer. Surgeons trained in these programs will likely seek out or be recruited to institutions with easy access to the da Vinci system and are uniquely qualified to build high-volume robotic rectal cancer practices early in their careers. Based on fellowship training, these surgeons can assemble dedicated OR teams, streamline equipment pick sheets, and establish protocols to maximize efficiency. Similarly, a surgeon who has already developed a robust robotic rectal cancer practice will be able to transfer these skills to a new institution if necessary. It is practical for surgeons with this level of experience, when working in a hospital that already owns a robot, to use the technology for this specific purpose.
Though unlikely, it is possible that in centers performing a high volume of robotic TME the application of robotics to segmental colectomy may bear some consideration. If highly efficient systems are in place to streamline robotic surgery across the spectrum, it may become easier and more efficient to use the robot for colectomy than to switch to conventional laparoscopy on a case-by-case basis. Recognizing that this will result in a higher per-case cost to the institution, it may help to reinforce existing protocols and maximize efficiency of all robotic surgery across the institution. However, for the reasons already stated, we find it unlikely that an experienced and skilled laparoscopic surgeon will find any advantage in using the robot for routine colectomy.
23.3.2 The Experienced Laparoscopic Colorectal Surgeon
For experienced surgeons routinely performing both colon and rectal operations laparoscopically, the adoption of robotics should be strongly scrutinized prior to consideration. In the hands of an expert surgeon, LCS is extremely safe and highly efficient. With the refinements of modern laparoscopic instrumentation, the da Vinci system offers a few alluring features but little true advantage to proficient laparoscopic surgeons. For these surgeons the robot may be safe and feasible, as well as fun and exciting, but it is certain to be more expensive and time-consuming than a procedure they already do quite well. Akin to the general surgeon using the robot to remove a gallbladder, we must be careful not to let the lure of a new toy drive us away from what already works.
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