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Robotic and minimal access surgery: technology and surgical outcomes of radical prostatectomy for prostate cancer ab
a
a
a
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Stig Müller , Leif Erik Grønning , Frode S Nilsen , Vegard Mygland & Hiten RH Patel a
Department of Urology, Akershus University Hospital, Sykehusveien 23, Lørenskog 1478, Norway b
Department of Urology, Division of Surgery, Institute of Clinical Medicine, University of Oslo, Sykehusveien 23, Lørenskog 1478, Norway c
University hospital North Norway Urology Centre, Harley St, London Published online: 30 Sep 2014.
Click for updates To cite this article: Stig Müller, Leif Erik Grønning, Frode S Nilsen, Vegard Mygland & Hiten RH Patel (2014) Robotic and minimal access surgery: technology and surgical outcomes of radical prostatectomy for prostate cancer, Expert Review of Anticancer Therapy, 14:11, 1317-1321 To link to this article: http://dx.doi.org/10.1586/14737140.2014.965689
PLEASE SCROLL DOWN FOR ARTICLE Taylor & Francis makes every effort to ensure the accuracy of all the information (the “Content”) contained in the publications on our platform. However, Taylor & Francis, our agents, and our licensors make no representations or warranties whatsoever as to the accuracy, completeness, or suitability for any purpose of the Content. Any opinions and views expressed in this publication are the opinions and views of the authors, and are not the views of or endorsed by Taylor & Francis. The accuracy of the Content should not be relied upon and should be independently verified with primary sources of information. Taylor and Francis shall not be liable for any losses, actions, claims, proceedings, demands, costs, expenses, damages, and other liabilities whatsoever or howsoever caused arising directly or indirectly in connection with, in relation to or arising out of the use of the Content. This article may be used for research, teaching, and private study purposes. Any substantial or systematic reproduction, redistribution, reselling, loan, sub-licensing, systematic supply, or distribution in any form to anyone is expressly forbidden. Terms & Conditions of access and use can be found at http:// www.tandfonline.com/page/terms-and-conditions
SPECIAL FOCUS y Prostate Cancer
Review
Robotic and minimal access surgery: technology and surgical outcomes of radical prostatectomy for prostate cancer Downloaded by [] at 11:19 01 September 2015
Expert Rev. Anticancer Ther. 14(11), 1317–1321 (2014)
Stig Mu¨ller*1,2, Leif Erik Grønning1, Frode S Nilsen1, Vegard Mygland1 and Hiten RH Patel3 1 Department of Urology, Akershus University Hospital, Sykehusveien 23, Lørenskog 1478, Norway 2 Department of Urology, Division of Surgery, Institute of Clinical Medicine, University of Oslo, Sykehusveien 23, Lørenskog 1478, Norway 3 University hospital North Norway Urology Centre, Harley St, London *Author for correspondence: [email protected]
informahealthcare.com
Since the 1990s, minimal access surgery has been utilized in urology. In the past 15 years, robotic surgery has evolved and become a natural part of minimal access surgery. The dissemination has been fast and the opportunity of prospective trials has been missed. Nevertheless, robotic surgery has obvious benefits for the surgeon and patient. Even though the scientific evidence is not strong, robotic surgery is here to stay. However, there are lessons to learn from the implementation of the da Vinci system with regards to patient safety and prospective evaluation of the new technology. The future of surgery will include technologies derived from robotic surgery. KEYWORDS: laparoscopy • minimal invasive surgery • prostate cancer • prostatectomy • robotic surgery
Background
The use of medical robots evolved in the late 1980s with the first recorded robotic procedure in 1985 [1]. An industry robot was used to position a needle for a brain biopsy based on CT scan of the patient. The background for the use of a robot was to improve the accuracy of the needle positioning without using a stereotactic frame. In spite of the successful procedure, the technique did not become clinical practice due to safety issues concerning the use of the industry robot. Over two decades later, neurosurgeons still use frame-based stereotactic techniques and robotic systems have not been widely adopted [2]. The da Vinci Surgical SystemTM (Sunnyvale, California, USA) was developed by Intuitive Surgical in the late 1990s. The system was designed as a master-slave software-driven system applicable in minimal access surgery. The key features of the initial design were 3D immersive vision and articulating robotic instruments with 7 degrees of freedom. The robotic instruments were controlled by tip-to-tip
10.1586/14737140.2014.965689
control of the surgeon’s fingers in the master console to the jaws of the instruments inside the patient. The system was equipped with elaborate safety systems that ensured safe handling of the instruments. The first robotic procedure was a robotic cholecystectomy, performed by Jacques Himpens and Guy Cardie`re of Brussels, Belgium in April 1997. After a trial including 200 patients undergoing robotic cholecystectomy or Nissen fundoplication, the system was US FDA approved in July 2000 [3]. In the early years, the da Vinci system was utilized in cardiac surgery, that is, in coronary artery bypass grafting and mitral valve surgery. However, the system did lengthen the operative times without improving outcome. A possible explanation is that cardiac surgeons were technically as precise without the robot. Also, the benefits of minimal access surgery (e.g., attenuated inflammatory response to surgical trauma) might not play a role in patients operated on cardiopulmonary bypass. In general, any innovation in surgery has to bring about a significant benefit for the patient. In theory, this benefit can be a direct effect of
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Mu ¨ eller, Grønning, Nilsen, Mygland & Patel
the innovation (e.g., improved excision of a tumor) or the innovation improves a parameter in the surgical pathway (e.g., operative time) that might result in better outcome. In addition, the innovation must come at a cost that is justified by the better outcome. In this appraisal, it is most important that outcome is well-defined and that outcome measuring tools are comparable and reproducible. For radical prostatectomy, the more specific outcomes of interest are oncological outcome and functional outcome, that is, continence and erectile function.
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Outcomes of radical prostatectomy for prostate cancer
Radical prostatectomy has long been the gold standard of surgical treatment for localized prostate cancer. It is recommended for patients with low and intermediate risk localized prostate cancer and life expectancy >10 years. The latest guidelines have been expanded to include radical prostatectomy as optional treatment for more advanced cancers [4]. Radical prostatectomy increases survival compared to watchful waiting [5]. Given the varying courses of the disease and generally good prognosis after radical treatment, survival studies are time-consuming. Therefore, surrogate markers for oncological outcome, such as prostate-specific antigen recurrence, are often used in prostate cancer studies. With regards to radical prostatectomy, positive surgical margins (PSMs) are frequently used to determine the oncological success of a radical prostatectomy. To some extent, the PSM rate after prostatectomy represents a quality indicator, as it varies for individual surgeons depending on the surgeon’s volume [6]. Interestingly, PSM rates hardly ever reach zero percent, even for organ-confined disease. In other words, even high-volume, excellent surgeons ‘fail’ to remove the cancer in a radical prostatectomy in terms of how PSMs are often interpreted by patients. Unfortunately, this interpretation is far too simple. PSM rates depend on tumor stage, Gleason score and PSA level [7]. In addition, the histopathological analysis of surgical margins can be difficult and inconsistencies in the reporting of PSMs complicate the comparison of data [8]. Thus, the PSA level 2–3 months after surgery is used in many cases to assess the need for adjuvant treatment. The next issue is the significance of PSMs. PSMs increase the risk of PSA recurrence and hence the need for adjuvant treatment [9]. In a recent analysis of 11,521 patients, however, there was no significant association between PSMs after radical prostatectomy and cancer-specific mortality [10]. Although still considered an adverse oncological outcome, PSMs increase the risk for secondary cancer treatment. A potential negative effect on survival is so far not clear [11]. Minimal access surgery was first utilized in prostatectomy in the late 1990s [12]. In the initial experience with laparoscopic prostatectomy, operative times were long and minimal access technique offered no advantage compared to open surgery. However, after refinement and standardization of the surgical technique, minimal access surgery reduced the length of stay, postoperative pain, transfusion rates and catheterization times compared to open surgery [13] and became standard of care at many European centers. To a certain extent, the initial experience also created the notion that laparoscopic radical prostatectomy (LRP) was associated with a steep and long learning curve along 1318
with increased costs compared to open surgery. Consequently, LRP was regarded as a method for highly specialized, highvolume centers. The technical difficulty of LRP is mainly due to 2D visualization and the resulting demanding hand–eye coordination in combination with limited space in the pelvis, reduced tactile feedback and limited range of motion of the rigid laparoscopic instruments. These disadvantages are, in large part, overcome by the da Vinci system [14]. The superior vision, minimal access technique and the less cumbersome handling of the instruments, compared to conventional laparoscopic surgery, have obvious benefits for the surgeon. Initially, surgeons were confident that these advantages would improve the technical aspects of the operation and thereby the outcome. Since the first reported robot-assisted laparoscopic prostatectomy [15], the technique has been widely implemented in the western world to date. The first patient series showed very promising results [16] and soon the new technology was sought after among both surgeons and patients. The advantages of robotic surgery were attractive for surgeons and obvious for many prostate cancer patients. Naturally, patients believed that state-of-the-art equipment would improve their result. However, the new technique was not sufficiently studied in randomized, prospective trials. Therefore, most of the data available today result in lower level of evidence and the question about the true benefits of robotic technique are still somewhat open. Unfortunately, the opportunity to do prospective, randomized comparisons of robotic and another technique in prostatectomy has passed due to the widespread dissemination of robotic systems. Most patients would not accept randomization, as there is evidence of better outcome after robotic surgery. A systematic review of comparative studies on open, laparoscopic and robotic prostatectomy was published in 2009 [17]. It demonstrated a significantly lower blood loss and transfusion rate for laparoscopic and robotic technique, which is often observed in minimal access surgery. Apart from that, the available data were not sufficient to show that any technique is superior with regards to functional or oncological outcome. However, there were some interesting trends. With regards to the PSM rate, there was a trend in favor of robotic technique, even when filtering for prospective studies or limiting the data only to include pT2 cancers (organ-confined disease). Thus, robotic technique appears to be advantageous with regards to tumor excision (PSM rate). The review did not conclude with this statement, since there was potential heterogeneity in the histopathological data. Apart from oncological outcome, functional outcome after radical prostatectomy is crucial, namely continence and erectile function. In fact, the change in sexual function after prostatectomy affects the patient’s quality of life, even without signs of recurrence [18]. There are a number of methodological issues to consider when assessing erectile function after prostatectomy. First, potency rates after surgery must only include patients with intact erectile function before surgery. Second, a standardized, validated questionnaire (e.g., International Index of Erectile Function 5) should be used. Finally, it is important to appreciate that the return of erectile function can take up to Expert Rev. Anticancer Ther. 14(11), (2014)
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4 years postoperatively. These premises have been applied to the literature in a review with a standard definition, that is, common denominator of potency, ability to have an erection sufficient for intercourse [19]. From 33 original articles and over 12,000 patient data points, a statistical prediction model was developed concluding that the most important factor for regaining erectile function after surgery is patient’s age followed by the operative technique. The predicted benefit of robotic versus open technique for a 60-year-old was a 25% higher likelihood of regaining erectile function after prostatectomy [19]. There are obviously potential biases in these data, but the findings, nevertheless, point to a potential benefit of robotic technique.
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Surgical training
However, is it man or machine that makes the difference? All new technologies, especially as complex as the da Vinci system, require training and are associated with a learning curve [20]. The two most important assets of the da Vinci system are its user-friendliness and the intuitive handling of the instruments and the 3D immersive vision. The latter allows the same visual surgical field and center of attention for the surgeon, trainee and the rest of the surgical team. In clinical training, especially when using dual-console system, this facilitates the standardization of procedures and modular training [21,22]. These properties also shorten the learning curve, especially for surgeons with no prior laparoscopic experience. The shorter learning curve might be an argument for the purchase of a robotic system and against a conventional laparoscopic prostatectomy program requiring a high volume of cases due to the presumptive long learning curve. Laparoscopic prostatectomy is without doubt a technically challenging procedure. However, the learning curve does not necessarily have to be long, that is, presumably 150 cases. Modern training principles such as modular training can be applied. The basic principle of modular training is that the complex procedure is divided into steps with a different level of difficulty. In operative training, the trainee performs the steps of the procedure with increasing level of difficulty and does not try to do the complete procedure from the beginning. This stepwise approach results in a shortened learning curve without compromising the outcome, that is, this training model also includes a quality control aspect. Modular training has been applied in the training of laparoscopic prostatectomy and inexperienced residents were competent after 36–48 cases [23]. Certainly, modular training is also applicable to robotic surgery and open surgery. However, the immersive 3D vision in robotic surgery provides superior anatomical insight compared to conventional laparoscopy and open surgery and is, therefore, particularly convenient in surgical training. The possibility of recording the procedure for later review by the trainee and mentor is an excellent way to improve training. This selfassessment, preferably done by the trainee and the mentor, increases the volume and improves the trainee’s skills [24]. Better ergonomics for the surgeon
Laparoscopic pelvic surgery, for example, LRP, requires advanced technical skills and operative times often exceed 3 h [25,26]. informahealthcare.com
Review
The surgeon has to remain concentrated and accurate in the handling of the instruments for several hours. The supine position of the patient determines the surgeon’s position, which is normally on the left side of the patient working in the direction of the pelvis. The surgeon has to lean over the patient to access the rightsided ports, which is tiring and stressful to arms and shoulders. In a survey among members of the British Society of Gynaecological Endoscopy [27], approximately 75% of the surgeons had experienced shoulder/neck stiffness and/or pain in association with laparoscopic surgery. Moreover, 15% of them were diagnosed with a disc prolapse and there was a statistically significant association between the length of practice/number of hours per week and the risk of disc prolapse. The posture of the surgeon in the da Vinci system is undoubtedly more comfortable. Interestingly, the improved ergonomics seems to result in better performance. Lee et al. [28] assessed the physical and cognitive ergonomics of the da Vinci system compared to conventional laparoscopy in a simulated setting. Laparoscopic experts, robotic experts and novices of both were asked to perform a number of tasks using a robotic system or a box trainer. Both physical and cognitive ergonomics were significantly less challenging in the robotic system. Most surgeons who ‘convert’ from laparoscopic surgery to robotics experience this effect as they find longer procedures less exhausting. The better ergonomics in robotic surgery may, therefore, potentially improve the outcome. However, the fixed position in the console can also lead to musculoskeletal disorders [29]. Most importantly, one has to acknowledge the importance of ergonomics and the potential impact on surgeon’s performance. Does technology alone lead to better outcome?
The computer scientist and software architect Grady Booch once stated, ‘A fool with a tool is still a fool’. In some respects, the saying applies to the implementation of new technology in surgery. Any new technology or device can potentially do harm when not used correctly. At the same time, the implementation of robotic surgery consists of more than the mere purchase of equipment. Proper certification of the surgeon and training of the whole surgical team are mandatory requirements. Over the past decade, the da Vinci system has had a tremendous sale success and a rapid dissemination across North America and Europe. Interestingly, recent reports point out that the implementation of robotic systems has advanced too quickly. In a US national cohort of patients with open or minimal invasive prostatectomy between 2001 and 2011, iatrogenic injuries were more likely to occur in the early years of robotic surgery [30]. As the learning curve is overcome, minimal invasive prostatectomy appears to be safer. In another US cohort study of 401,325 patients in the Nationwide Inpatient Sample, who underwent radical prostatectomy between 2003 and 2009, minimal invasive prostatectomy was associated with an increased risk of patient safety indicators during the periods where rapid diffusion of robotic systems occurred [31]. In other words, rapid diffusion of new technology, as shown for the da Vinci system, potentially compromises patient safety and, therefore, implementation processes need to focus on patient safety and a prospective evaluation of the new technology. 1319
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Finally, the cost of any new technology as robotic surgery has to be justified by improved outcome. Whether robotic surgery is cost– effective or not is difficult to answer since the benefits of robotic surgery are not necessarily credited to the same budget that purchased the equipment. Benefits like reduced length of stay, less bleeding (i.e., less need for blood transfusion) and fewer complications are cost-saving for hospitals. However, a reduced sick leave after robotic prostatectomy compared to open technique [32] has obvious economic benefits that are not counted in health budgets in most countries. The initial costs of a da Vinci system are undoubtedly high. Apart from the staggering costs, the revenue from prostatectomy differs across countries and health systems, which complicates cost analyses. Even on the open market in the US, the costs for prostatectomy vary remarkably, with a 10-fold variation of the pricing between hospitals [33]. This complicates the cost analysis even further. However, there is no doubt that robotic surgery is associated with significant costs that still represent the biggest obstacle for many centers aspiring robotic surgery. One might argue that the lack of high-level evidence of the advantages of robotic surgery does not justify the implementation of robotics. Some have, with regards to the relative paucity of high-level evidence, called for ‘the end of robot-assisted laparoscopy’ [34]. Even though the call for randomized studies is reasonable, that ship has sailed. One has to acknowledge robotic surgery as a widely used, minimally invasive technique that is here to stay. There are far too many welltrained robotic surgeons and implemented systems in the world today, so restricting robotic surgery does not seem realistic. Expert commentary & five-year view
Surgery is in constant development and new technologies are evolving. In the past decade, minimal invasive surgery was
characterized by the differences between robotic surgery and conventional laparoscopic surgery. The focus with regards to radical prostatectomy has been to compare the three techniques: open, laparoscopic and robotic prostatectomy. This comparison has been challenging due to many factors influencing the outcome after prostatectomy, irrespective of the surgical access technique. First and foremost, patient selection, that is, clinical stage and Gleason score, comorbidities and age affect oncological and functional outcome. Also, surgeon factors play a significant role since the results with a given access technique can differ substantially from one center to another. Over a decade after the introduction of robotic surgery in prostatectomy, there is still a lack of clear evidence for the true benefits of robotic surgery. Despite this, robotic surgery has become a natural part of minimal access surgery. Along with the increased dissemination of robotic systems, the discussion of evidence, benefits and the pros and cons of robotics is no longer a question if one should pursue robotic surgery, but how robotics are best utilized and which patients benefit the most. Hopefully, competition in the market of robotic systems will reduce the costs and stimulate the further improvement of robotic surgery. New technology must still be properly assessed and implementation has to include safety systems, training programs and a critical appraisal of early results. Financial & competing interests disclosure
The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties. No writing assistance was utilized in the production of this manuscript.
Key issues • Any innovation or new technology in surgery should improve the outcome. • Robotic surgery has not prevailed in neurosurgery and cardiac surgery. • Robotic surgery has been widely implemented in pelvic surgery, especially for radical prostatectomy. • During the rapid dissemination of robotic surgery, the opportunity of well-powered, randomized trials comparing robotics to standard of care was lost. • In retrospect, the rapid dissemination of robotics compromised patient safety. • Robotic surgery is established as a natural part of minimal access surgery. • New technologies for robotics are evolving and must still be properly assessed.
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Expert Review of Anticancer Therapy Publication details, including instructions for authors and subscription information: http://www.tandfonline.com/loi/iery20
Robotic and minimal access surgery: technology and surgical outcomes of radical prostatectomy for prostate cancer ab
a
a
a
c
Stig Müller , Leif Erik Grønning , Frode S Nilsen , Vegard Mygland & Hiten RH Patel a
Department of Urology, Akershus University Hospital, Sykehusveien 23, Lørenskog 1478, Norway b
Department of Urology, Division of Surgery, Institute of Clinical Medicine, University of Oslo, Sykehusveien 23, Lørenskog 1478, Norway c
University hospital North Norway Urology Centre, Harley St, London Published online: 30 Sep 2014.
Click for updates To cite this article: Stig Müller, Leif Erik Grønning, Frode S Nilsen, Vegard Mygland & Hiten RH Patel (2014) Robotic and minimal access surgery: technology and surgical outcomes of radical prostatectomy for prostate cancer, Expert Review of Anticancer Therapy, 14:11, 1317-1321 To link to this article: http://dx.doi.org/10.1586/14737140.2014.965689
PLEASE SCROLL DOWN FOR ARTICLE Taylor & Francis makes every effort to ensure the accuracy of all the information (the “Content”) contained in the publications on our platform. However, Taylor & Francis, our agents, and our licensors make no representations or warranties whatsoever as to the accuracy, completeness, or suitability for any purpose of the Content. Any opinions and views expressed in this publication are the opinions and views of the authors, and are not the views of or endorsed by Taylor & Francis. The accuracy of the Content should not be relied upon and should be independently verified with primary sources of information. Taylor and Francis shall not be liable for any losses, actions, claims, proceedings, demands, costs, expenses, damages, and other liabilities whatsoever or howsoever caused arising directly or indirectly in connection with, in relation to or arising out of the use of the Content. This article may be used for research, teaching, and private study purposes. Any substantial or systematic reproduction, redistribution, reselling, loan, sub-licensing, systematic supply, or distribution in any form to anyone is expressly forbidden. Terms & Conditions of access and use can be found at http:// www.tandfonline.com/page/terms-and-conditions
SPECIAL FOCUS y Prostate Cancer
Review
Robotic and minimal access surgery: technology and surgical outcomes of radical prostatectomy for prostate cancer Downloaded by [] at 11:19 01 September 2015
Expert Rev. Anticancer Ther. 14(11), 1317–1321 (2014)
Stig Mu¨ller*1,2, Leif Erik Grønning1, Frode S Nilsen1, Vegard Mygland1 and Hiten RH Patel3 1 Department of Urology, Akershus University Hospital, Sykehusveien 23, Lørenskog 1478, Norway 2 Department of Urology, Division of Surgery, Institute of Clinical Medicine, University of Oslo, Sykehusveien 23, Lørenskog 1478, Norway 3 University hospital North Norway Urology Centre, Harley St, London *Author for correspondence: [email protected]
informahealthcare.com
Since the 1990s, minimal access surgery has been utilized in urology. In the past 15 years, robotic surgery has evolved and become a natural part of minimal access surgery. The dissemination has been fast and the opportunity of prospective trials has been missed. Nevertheless, robotic surgery has obvious benefits for the surgeon and patient. Even though the scientific evidence is not strong, robotic surgery is here to stay. However, there are lessons to learn from the implementation of the da Vinci system with regards to patient safety and prospective evaluation of the new technology. The future of surgery will include technologies derived from robotic surgery. KEYWORDS: laparoscopy • minimal invasive surgery • prostate cancer • prostatectomy • robotic surgery
Background
The use of medical robots evolved in the late 1980s with the first recorded robotic procedure in 1985 [1]. An industry robot was used to position a needle for a brain biopsy based on CT scan of the patient. The background for the use of a robot was to improve the accuracy of the needle positioning without using a stereotactic frame. In spite of the successful procedure, the technique did not become clinical practice due to safety issues concerning the use of the industry robot. Over two decades later, neurosurgeons still use frame-based stereotactic techniques and robotic systems have not been widely adopted [2]. The da Vinci Surgical SystemTM (Sunnyvale, California, USA) was developed by Intuitive Surgical in the late 1990s. The system was designed as a master-slave software-driven system applicable in minimal access surgery. The key features of the initial design were 3D immersive vision and articulating robotic instruments with 7 degrees of freedom. The robotic instruments were controlled by tip-to-tip
10.1586/14737140.2014.965689
control of the surgeon’s fingers in the master console to the jaws of the instruments inside the patient. The system was equipped with elaborate safety systems that ensured safe handling of the instruments. The first robotic procedure was a robotic cholecystectomy, performed by Jacques Himpens and Guy Cardie`re of Brussels, Belgium in April 1997. After a trial including 200 patients undergoing robotic cholecystectomy or Nissen fundoplication, the system was US FDA approved in July 2000 [3]. In the early years, the da Vinci system was utilized in cardiac surgery, that is, in coronary artery bypass grafting and mitral valve surgery. However, the system did lengthen the operative times without improving outcome. A possible explanation is that cardiac surgeons were technically as precise without the robot. Also, the benefits of minimal access surgery (e.g., attenuated inflammatory response to surgical trauma) might not play a role in patients operated on cardiopulmonary bypass. In general, any innovation in surgery has to bring about a significant benefit for the patient. In theory, this benefit can be a direct effect of
Ó 2014 Informa UK Ltd
ISSN 1473-7140
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Review
Mu ¨ eller, Grønning, Nilsen, Mygland & Patel
the innovation (e.g., improved excision of a tumor) or the innovation improves a parameter in the surgical pathway (e.g., operative time) that might result in better outcome. In addition, the innovation must come at a cost that is justified by the better outcome. In this appraisal, it is most important that outcome is well-defined and that outcome measuring tools are comparable and reproducible. For radical prostatectomy, the more specific outcomes of interest are oncological outcome and functional outcome, that is, continence and erectile function.
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Outcomes of radical prostatectomy for prostate cancer
Radical prostatectomy has long been the gold standard of surgical treatment for localized prostate cancer. It is recommended for patients with low and intermediate risk localized prostate cancer and life expectancy >10 years. The latest guidelines have been expanded to include radical prostatectomy as optional treatment for more advanced cancers [4]. Radical prostatectomy increases survival compared to watchful waiting [5]. Given the varying courses of the disease and generally good prognosis after radical treatment, survival studies are time-consuming. Therefore, surrogate markers for oncological outcome, such as prostate-specific antigen recurrence, are often used in prostate cancer studies. With regards to radical prostatectomy, positive surgical margins (PSMs) are frequently used to determine the oncological success of a radical prostatectomy. To some extent, the PSM rate after prostatectomy represents a quality indicator, as it varies for individual surgeons depending on the surgeon’s volume [6]. Interestingly, PSM rates hardly ever reach zero percent, even for organ-confined disease. In other words, even high-volume, excellent surgeons ‘fail’ to remove the cancer in a radical prostatectomy in terms of how PSMs are often interpreted by patients. Unfortunately, this interpretation is far too simple. PSM rates depend on tumor stage, Gleason score and PSA level [7]. In addition, the histopathological analysis of surgical margins can be difficult and inconsistencies in the reporting of PSMs complicate the comparison of data [8]. Thus, the PSA level 2–3 months after surgery is used in many cases to assess the need for adjuvant treatment. The next issue is the significance of PSMs. PSMs increase the risk of PSA recurrence and hence the need for adjuvant treatment [9]. In a recent analysis of 11,521 patients, however, there was no significant association between PSMs after radical prostatectomy and cancer-specific mortality [10]. Although still considered an adverse oncological outcome, PSMs increase the risk for secondary cancer treatment. A potential negative effect on survival is so far not clear [11]. Minimal access surgery was first utilized in prostatectomy in the late 1990s [12]. In the initial experience with laparoscopic prostatectomy, operative times were long and minimal access technique offered no advantage compared to open surgery. However, after refinement and standardization of the surgical technique, minimal access surgery reduced the length of stay, postoperative pain, transfusion rates and catheterization times compared to open surgery [13] and became standard of care at many European centers. To a certain extent, the initial experience also created the notion that laparoscopic radical prostatectomy (LRP) was associated with a steep and long learning curve along 1318
with increased costs compared to open surgery. Consequently, LRP was regarded as a method for highly specialized, highvolume centers. The technical difficulty of LRP is mainly due to 2D visualization and the resulting demanding hand–eye coordination in combination with limited space in the pelvis, reduced tactile feedback and limited range of motion of the rigid laparoscopic instruments. These disadvantages are, in large part, overcome by the da Vinci system [14]. The superior vision, minimal access technique and the less cumbersome handling of the instruments, compared to conventional laparoscopic surgery, have obvious benefits for the surgeon. Initially, surgeons were confident that these advantages would improve the technical aspects of the operation and thereby the outcome. Since the first reported robot-assisted laparoscopic prostatectomy [15], the technique has been widely implemented in the western world to date. The first patient series showed very promising results [16] and soon the new technology was sought after among both surgeons and patients. The advantages of robotic surgery were attractive for surgeons and obvious for many prostate cancer patients. Naturally, patients believed that state-of-the-art equipment would improve their result. However, the new technique was not sufficiently studied in randomized, prospective trials. Therefore, most of the data available today result in lower level of evidence and the question about the true benefits of robotic technique are still somewhat open. Unfortunately, the opportunity to do prospective, randomized comparisons of robotic and another technique in prostatectomy has passed due to the widespread dissemination of robotic systems. Most patients would not accept randomization, as there is evidence of better outcome after robotic surgery. A systematic review of comparative studies on open, laparoscopic and robotic prostatectomy was published in 2009 [17]. It demonstrated a significantly lower blood loss and transfusion rate for laparoscopic and robotic technique, which is often observed in minimal access surgery. Apart from that, the available data were not sufficient to show that any technique is superior with regards to functional or oncological outcome. However, there were some interesting trends. With regards to the PSM rate, there was a trend in favor of robotic technique, even when filtering for prospective studies or limiting the data only to include pT2 cancers (organ-confined disease). Thus, robotic technique appears to be advantageous with regards to tumor excision (PSM rate). The review did not conclude with this statement, since there was potential heterogeneity in the histopathological data. Apart from oncological outcome, functional outcome after radical prostatectomy is crucial, namely continence and erectile function. In fact, the change in sexual function after prostatectomy affects the patient’s quality of life, even without signs of recurrence [18]. There are a number of methodological issues to consider when assessing erectile function after prostatectomy. First, potency rates after surgery must only include patients with intact erectile function before surgery. Second, a standardized, validated questionnaire (e.g., International Index of Erectile Function 5) should be used. Finally, it is important to appreciate that the return of erectile function can take up to Expert Rev. Anticancer Ther. 14(11), (2014)
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4 years postoperatively. These premises have been applied to the literature in a review with a standard definition, that is, common denominator of potency, ability to have an erection sufficient for intercourse [19]. From 33 original articles and over 12,000 patient data points, a statistical prediction model was developed concluding that the most important factor for regaining erectile function after surgery is patient’s age followed by the operative technique. The predicted benefit of robotic versus open technique for a 60-year-old was a 25% higher likelihood of regaining erectile function after prostatectomy [19]. There are obviously potential biases in these data, but the findings, nevertheless, point to a potential benefit of robotic technique.
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Surgical training
However, is it man or machine that makes the difference? All new technologies, especially as complex as the da Vinci system, require training and are associated with a learning curve [20]. The two most important assets of the da Vinci system are its user-friendliness and the intuitive handling of the instruments and the 3D immersive vision. The latter allows the same visual surgical field and center of attention for the surgeon, trainee and the rest of the surgical team. In clinical training, especially when using dual-console system, this facilitates the standardization of procedures and modular training [21,22]. These properties also shorten the learning curve, especially for surgeons with no prior laparoscopic experience. The shorter learning curve might be an argument for the purchase of a robotic system and against a conventional laparoscopic prostatectomy program requiring a high volume of cases due to the presumptive long learning curve. Laparoscopic prostatectomy is without doubt a technically challenging procedure. However, the learning curve does not necessarily have to be long, that is, presumably 150 cases. Modern training principles such as modular training can be applied. The basic principle of modular training is that the complex procedure is divided into steps with a different level of difficulty. In operative training, the trainee performs the steps of the procedure with increasing level of difficulty and does not try to do the complete procedure from the beginning. This stepwise approach results in a shortened learning curve without compromising the outcome, that is, this training model also includes a quality control aspect. Modular training has been applied in the training of laparoscopic prostatectomy and inexperienced residents were competent after 36–48 cases [23]. Certainly, modular training is also applicable to robotic surgery and open surgery. However, the immersive 3D vision in robotic surgery provides superior anatomical insight compared to conventional laparoscopy and open surgery and is, therefore, particularly convenient in surgical training. The possibility of recording the procedure for later review by the trainee and mentor is an excellent way to improve training. This selfassessment, preferably done by the trainee and the mentor, increases the volume and improves the trainee’s skills [24]. Better ergonomics for the surgeon
Laparoscopic pelvic surgery, for example, LRP, requires advanced technical skills and operative times often exceed 3 h [25,26]. informahealthcare.com
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The surgeon has to remain concentrated and accurate in the handling of the instruments for several hours. The supine position of the patient determines the surgeon’s position, which is normally on the left side of the patient working in the direction of the pelvis. The surgeon has to lean over the patient to access the rightsided ports, which is tiring and stressful to arms and shoulders. In a survey among members of the British Society of Gynaecological Endoscopy [27], approximately 75% of the surgeons had experienced shoulder/neck stiffness and/or pain in association with laparoscopic surgery. Moreover, 15% of them were diagnosed with a disc prolapse and there was a statistically significant association between the length of practice/number of hours per week and the risk of disc prolapse. The posture of the surgeon in the da Vinci system is undoubtedly more comfortable. Interestingly, the improved ergonomics seems to result in better performance. Lee et al. [28] assessed the physical and cognitive ergonomics of the da Vinci system compared to conventional laparoscopy in a simulated setting. Laparoscopic experts, robotic experts and novices of both were asked to perform a number of tasks using a robotic system or a box trainer. Both physical and cognitive ergonomics were significantly less challenging in the robotic system. Most surgeons who ‘convert’ from laparoscopic surgery to robotics experience this effect as they find longer procedures less exhausting. The better ergonomics in robotic surgery may, therefore, potentially improve the outcome. However, the fixed position in the console can also lead to musculoskeletal disorders [29]. Most importantly, one has to acknowledge the importance of ergonomics and the potential impact on surgeon’s performance. Does technology alone lead to better outcome?
The computer scientist and software architect Grady Booch once stated, ‘A fool with a tool is still a fool’. In some respects, the saying applies to the implementation of new technology in surgery. Any new technology or device can potentially do harm when not used correctly. At the same time, the implementation of robotic surgery consists of more than the mere purchase of equipment. Proper certification of the surgeon and training of the whole surgical team are mandatory requirements. Over the past decade, the da Vinci system has had a tremendous sale success and a rapid dissemination across North America and Europe. Interestingly, recent reports point out that the implementation of robotic systems has advanced too quickly. In a US national cohort of patients with open or minimal invasive prostatectomy between 2001 and 2011, iatrogenic injuries were more likely to occur in the early years of robotic surgery [30]. As the learning curve is overcome, minimal invasive prostatectomy appears to be safer. In another US cohort study of 401,325 patients in the Nationwide Inpatient Sample, who underwent radical prostatectomy between 2003 and 2009, minimal invasive prostatectomy was associated with an increased risk of patient safety indicators during the periods where rapid diffusion of robotic systems occurred [31]. In other words, rapid diffusion of new technology, as shown for the da Vinci system, potentially compromises patient safety and, therefore, implementation processes need to focus on patient safety and a prospective evaluation of the new technology. 1319
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Finally, the cost of any new technology as robotic surgery has to be justified by improved outcome. Whether robotic surgery is cost– effective or not is difficult to answer since the benefits of robotic surgery are not necessarily credited to the same budget that purchased the equipment. Benefits like reduced length of stay, less bleeding (i.e., less need for blood transfusion) and fewer complications are cost-saving for hospitals. However, a reduced sick leave after robotic prostatectomy compared to open technique [32] has obvious economic benefits that are not counted in health budgets in most countries. The initial costs of a da Vinci system are undoubtedly high. Apart from the staggering costs, the revenue from prostatectomy differs across countries and health systems, which complicates cost analyses. Even on the open market in the US, the costs for prostatectomy vary remarkably, with a 10-fold variation of the pricing between hospitals [33]. This complicates the cost analysis even further. However, there is no doubt that robotic surgery is associated with significant costs that still represent the biggest obstacle for many centers aspiring robotic surgery. One might argue that the lack of high-level evidence of the advantages of robotic surgery does not justify the implementation of robotics. Some have, with regards to the relative paucity of high-level evidence, called for ‘the end of robot-assisted laparoscopy’ [34]. Even though the call for randomized studies is reasonable, that ship has sailed. One has to acknowledge robotic surgery as a widely used, minimally invasive technique that is here to stay. There are far too many welltrained robotic surgeons and implemented systems in the world today, so restricting robotic surgery does not seem realistic. Expert commentary & five-year view
Surgery is in constant development and new technologies are evolving. In the past decade, minimal invasive surgery was
characterized by the differences between robotic surgery and conventional laparoscopic surgery. The focus with regards to radical prostatectomy has been to compare the three techniques: open, laparoscopic and robotic prostatectomy. This comparison has been challenging due to many factors influencing the outcome after prostatectomy, irrespective of the surgical access technique. First and foremost, patient selection, that is, clinical stage and Gleason score, comorbidities and age affect oncological and functional outcome. Also, surgeon factors play a significant role since the results with a given access technique can differ substantially from one center to another. Over a decade after the introduction of robotic surgery in prostatectomy, there is still a lack of clear evidence for the true benefits of robotic surgery. Despite this, robotic surgery has become a natural part of minimal access surgery. Along with the increased dissemination of robotic systems, the discussion of evidence, benefits and the pros and cons of robotics is no longer a question if one should pursue robotic surgery, but how robotics are best utilized and which patients benefit the most. Hopefully, competition in the market of robotic systems will reduce the costs and stimulate the further improvement of robotic surgery. New technology must still be properly assessed and implementation has to include safety systems, training programs and a critical appraisal of early results. Financial & competing interests disclosure
The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties. No writing assistance was utilized in the production of this manuscript.
Key issues • Any innovation or new technology in surgery should improve the outcome. • Robotic surgery has not prevailed in neurosurgery and cardiac surgery. • Robotic surgery has been widely implemented in pelvic surgery, especially for radical prostatectomy. • During the rapid dissemination of robotic surgery, the opportunity of well-powered, randomized trials comparing robotics to standard of care was lost. • In retrospect, the rapid dissemination of robotics compromised patient safety. • Robotic surgery is established as a natural part of minimal access surgery. • New technologies for robotics are evolving and must still be properly assessed.
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