EDITORIAL For reprint orders, please contact: [email protected]
Comparative effectiveness of robotic gynecologic surgery Over the last decade robotic surgery has been introduced as an alternative minimally invasive surgical approach for a variety of conditions. For robotic procedures the operative field is accessed through small incisions called ports. Instruments are placed through these ports and then articulated to robotically controlled arms. The surgeon is then able to manipulate the robotic instrumentation from a remote console. In addition to the small incision, other benefits of robotic surgery include 3D optics, increased range of motion of the instrumentation and improved ergonomics for the operating surgeon [1–4]. Robotic-assisted surgery first gained prominence for the performance of prostatectomy. Prior to the introduction of robotic prostatectomy, the majority of these procedures were performed via open laparotomy and required a longer recovery time. Although laparoscopic prostatectomy had been described, the operation is technically demanding and was performed by very few urologic surgeons. Roboticassisted prostatectomy essentially offered the only minimally invasive option for prostatectomy and the operation rapidly disseminated into practice. Comparative effectiveness studies of robotic radical prostatectomy suggest that the procedure is associated with shorter hospital stays, fewer perioperative surgical complications and strictures but is accompanied by increased genitourinary complications, incontinence and erectile dysfunction when compared with retropubic prostratectomy [5]. Despite the potential limitations of robotic radical prostatectomy, the procedure has gained widespread acceptance and is now the most common surgical approach for prostatectomy [6]. Use of robotic-assisted surgery in urology generated interest for a number of other surgical procedures. In 2005, the US FDA provided approval for a robotic surgical system for gynecologic surgery despite the fact that laporoscopic minimally invasive surgery is also an additional option for these procedures [7]. Use of robotic assistance has now been described for a number of gynecologic surgeries including hysterectomy, radical hysterectomy, myomectomy and pelvic reconstructive surgery [3,8,9]. Robotic-assisted surgery has been used for both oncologic and noncancerrelated procedures but has gained the greatest use for gynecologic cancer surgery. Despite the enthusiasm for robotic gynecologic surgery, data are largely lacking and based predominately on small institutional observational studies [3,7,8]. Our group recently completed a population-based study to examine the comparative effectiveness of robotic hysterectomy for endometrial cancer. Using a nationwide database that captures admissions at more than 600 hospitals, we compared the outcomes of 2464 women who underwent either robotic or laparoscopic hysterectomy for endometrial cancer from 2008 to 2010. We noted that the uptake of robotic hysterectomy was dramatic: in October 2008, 42% of the procedures were robotic and this increased over time, such that in March 2010 over 61% of the hysterectomies were robotic. There were a number of disparities in access to robotic hysterectomy. Women treated at large hospitals and those managed at nonteaching hospitals were more likely to undergo a robotic hysterectomy. By contrast, black women, those without insurance and patients in rural areas were less likely to undergo a robotic hysterectomy [9].
10.2217/CER.12.42 © 2012 Future Medicine Ltd
1(5), 377–379 (2012)
Jason D Wright*1,4
Dawn L Hershman2,3,4 Division of Gynecologic Oncology, Department of Obstetrics & Gynecology, Columbia University College of Physicians & Surgeons, 161 Fort Washington Avenue, 8th Floor, NY 10032, USA 2 Department of Medicine, Columbia University College of Physicians & Surgeons, 161 Fort Washington Ave, 8th Floor, NY 10032, USA 3 Department of Epidemiology, Mailman School of Public Health, 722 West 168th Street, NY 10032, USA 4 Herbert Irving Comprehensive Cancer Center, St Nicholas Avenue, NY 10032, USA *Author for correspondence: Tel.: +1 212 305 3410 Fax: +1 212 305 3412 [email protected] 1
part of
ISSN 2042-6305
377
EDITORIAL
Wright & Hershman
When outcomes were examined we found that the overall complication rates were similar for robotic and laparoscopic hysterectomy (adjusted odd ratio: 0.76; 95% CI: 0.56–1.03). There were no statistically significant differences in the rates of intraoperative complications, surgical-site complications, medical complications or prolonged hospitalization between the procedures. Likewise, perioperative mortality was rare for both procedures. When cost was analyzed, we noted that robotic hysterectomy was substantially more costly. The mean unadjusted cost of laparoscopic hysterectomy was US$8996 compared with US$10,618 for robotic hysterectomy. In a multivariable model the cost of robotic hysterectomy remained US$1291 greater than laparoscopic hysterectomy. These findings were largely unchanged in a number of sensitivity analyses. Based on our cohort alone, if all 1680 minimally invasive hysterectomies performed in 2009 were carried out robotically, costs would have been more than US$2,000,000 greater [9]. These findings clearly question the comparative effectiveness of robotic hysterectomy for endometrial cancer. Despite limited data, robotic hysterectomy already appears to be in widespread use. The evolution of robotic hysterectomy is unlike prostatectomy in that an alternative minimally invasive approach for hysterectomy, laparoscopy, is already well described. Laparoscopic hysterectomy has been performed for more than two decades, is routinely taught in gynecology training programs and has been evaluated in randomized, controlled trials for endometrial cancer [10]. A number of factors likely influence the diffusion of robotic hysterectomy. Although laparoscopic hysterectomy is widely performed, the procedure requires substantial technical skill. A 2007 survey of gynecologic oncologists reported that only a small minority of surgeons performed more than 50% of their cases laparoscopically [11]. Robotic hysterectomy may provide an easier learning curve than laparoscopy. Another potential advantage of robotic hysterectomy is that it may allow for the completion of more difficult procedures via a minimally invasive approach [7]. If true, this may increase the number of women who have access to a minimally invasive surgical procedure. Finally, there has been substantial marketing of robotic surgery [12,13]. The marketing of robotic surgery has not only been from industry, but also from direct marketing to patients by physicians and hospitals. While the
378
J. Compar. Effect. Res. (2012) 1(5)
validity of some of these claims has been questioned, nonetheless, these marketing influences have placed competitive pressures on physicians as many patients request robotic surgery [13]. A major concern for robotic hysterectomy centers on cost. Our data and others have shown that robotic hysterectomy is the most expensive modality for hysterectomy [2,9]. The high cost of robotic surgery is driven predominately by equipment costs. Currently, there is one company that dominates the market for robotic surgery. The initial purchasing cost of the robot itself ranges from US$1 million to well over US$2 million. In addition, hospitals must purchase an annual service contract of US$140,000 and the disposable instrumentation is estimated to cost US$1500– 2000 per case [13,14]. If robotic surgery were to replace open surgery, it’s been estimated that the cost burden to the US healthcare system would be more than US$2.5 billion [15]. Robotic hysterectomy highlights the difficulty with introducing a new technology into clinical practice. Current data suggest minimal quantifiable benefits for robotic hysterectomy but substantially increased cost. Despite these data, the technology has already been rapidly incorporated into practice. A number of suggestions have been proposed to guide the more rational implementation of new technologies. Although new devices and technologies cannot follow the same approval process as new drugs, many have called for a more ordered development and testing process for devices. One such proposal, the Balliol Collaboration’s innovation, development, exploration, assessment and long-term study (IDEAL) model, calls for surgical techniques to evolve from a concept through safety studies followed by randomized trials prior to widespread dissemination into practice [16]. There have also been proposals to reform the way devices are regulated by the FDA. Currently, devices are regulated through the FDA’s 510(K) process, which clears new devices if it can be demonstrated that they are ‘substantially equivalent’ to a product that is already marketed [17]. The Institute of Medicine has endorsed more stringent efficacy and safety standards prior to device approval [17,18]. Finally, limiting reimbursement for unproven procedures has been proposed [19]. Pearson and Bach endorsed a tiered payment system in which payments would be based on demonstrated effectiveness of treatments. In this system, payment for services with no comparative advantage would be lowered [19].
future science group
Comparative effectiveness of robotic gynecologic surgery
Robotic hysterectomy demonstrates the importance of comparative effectiveness research for new technologies. While surgical innovation and the development of new devices must be encouraged, these new devices also require rigorous investigation. In the current climate of cost containment for healthcare spending, comparative effectiveness data must be used to guide the dissemination of new technologies.
1
Wilson EB. The evolution of robotic general surgery. Scand. J. Surg. 98, 125–129 (2009).
2
Barnett JC, Judd JP, Wu JM, Scales CD Jr, Myers ER, Havrilesky LJ. Cost comparison among robotic, laparoscopic, and open hysterectomy for endometrial cancer. Obstet. Gynecol. 116, 685–693 (2010).
3
Liu H, Lu D, Wang L, Shi G, Song H, Clarke J. Robotic surgery for benign gynaecological disease. Cochrane Database Syst. Rev. 2, CD008978 (2012).
4
Maeso S, Reza M, Mayol JA et al. Efficacy of the Da Vinci surgical system in abdominal surgery compared with that of laparoscopy: a systematic review and meta-analysis. Ann. Surg. 252, 254–262 (2010).
5
6
7
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. hysterectomy for endometrial cancer compared with traditional laparoscopic and laparotomy approaches: a systematic review. Obstet. Gynecol. 116, 1422–1431 (2010).
References
8
Sarlos D, Kots LA. Robotic versus laparoscopic hysterectomy: a review of recent comparative studies. Curr. Opin. Obstet. Gynecol. 23, 283–288 (2011).
9
Wright JD, Burke WM, Wilde ET et al. Comparative effectiveness of robotic versus laparoscopic hysterectomy for endometrial cancer. J. Clin. Oncol. 30, 783–791 (2012).
10
Walker JL, Piedmonte MR, Spirtos NM et al. Recurrence and survival after random assignment to laparoscopy versus laparotomy for comprehensive surgical staging of uterine cancer: Gynecologic Oncology Group LAP2 Study. J. Clin. Oncol. 30, 695–700 (2012).
Hu JC, Gu X, Lipsitz SR et al. Comparative effectiveness of minimally invasive vs open radical prostatectomy. JAMA 302, 1557–1564 (2009).
11
Yu HY, Hevelone ND, Lipsitz SR, Kowalczyk KJ, Hu JC. Use, costs and comparative effectiveness of robotic assisted, laparoscopic and open urological surgery. J. Urol. 187, 1392–1398 (2012).
12 Jin LX, Ibrahim AM, Newman NA,
Gaia G, Holloway RW, Santoro L, Ahmad S, Di Silverio E, Spinillo A. Robotic-assisted
future science group
EDITORIAL
Naumann RW, Coleman RL. The use of adjuvant radiation therapy in early endometrial cancer by members of the Society of Gynecologic Oncologists in 2005. Gynecol. Oncol. 105, 7–12 (2007). Makarov DV, Pronovost PJ, Makary MA. Robotic surgery claims on United States hospital websites. J. Health. Qual. 33, 48–52 (2011).
www.futuremedicine.com
13 Kolata G. Results unproven, robotic surgery
wins converts. The New York Times, 13th February (2010). 14
Makarov DV, Yu JB, Desai RA, Penson DF, Gross CP. The association between diffusion of the surgical robot and radical prostatectomy rates. Med. Care 49, 333–339 (2011).
15
Barbash GI, Glied SA. New technology and health care costs – the case of robot-assisted surgery. N. Engl. J. Med. 363, 701–704 (2010).
16
McCulloch P, Altman DG, Campbell WB et al. No surgical innovation without evaluation: the IDEAL recommendations. Lancet 374, 1105–1112 (2009).
17
Curfman GD, Redberg RF. Medical devices – balancing regulation and innovation. N. Engl. J. Med. 365, 975–977 (2011).
18
Challoner DR, Vodra WW. Medical devices and health – creating a new regulatory framework for moderate-risk devices. N. Engl. J. Med. 365, 977–979 (2011).
19
Pearson SD, Bach PB. How Medicare could use comparative effectiveness research in deciding on new coverage and reimbursement. Health Aff. (Millwood) 29, 1796–1804 (2010).
379
Comparative effectiveness of robotic gynecologic surgery Over the last decade robotic surgery has been introduced as an alternative minimally invasive surgical approach for a variety of conditions. For robotic procedures the operative field is accessed through small incisions called ports. Instruments are placed through these ports and then articulated to robotically controlled arms. The surgeon is then able to manipulate the robotic instrumentation from a remote console. In addition to the small incision, other benefits of robotic surgery include 3D optics, increased range of motion of the instrumentation and improved ergonomics for the operating surgeon [1–4]. Robotic-assisted surgery first gained prominence for the performance of prostatectomy. Prior to the introduction of robotic prostatectomy, the majority of these procedures were performed via open laparotomy and required a longer recovery time. Although laparoscopic prostatectomy had been described, the operation is technically demanding and was performed by very few urologic surgeons. Roboticassisted prostatectomy essentially offered the only minimally invasive option for prostatectomy and the operation rapidly disseminated into practice. Comparative effectiveness studies of robotic radical prostatectomy suggest that the procedure is associated with shorter hospital stays, fewer perioperative surgical complications and strictures but is accompanied by increased genitourinary complications, incontinence and erectile dysfunction when compared with retropubic prostratectomy [5]. Despite the potential limitations of robotic radical prostatectomy, the procedure has gained widespread acceptance and is now the most common surgical approach for prostatectomy [6]. Use of robotic-assisted surgery in urology generated interest for a number of other surgical procedures. In 2005, the US FDA provided approval for a robotic surgical system for gynecologic surgery despite the fact that laporoscopic minimally invasive surgery is also an additional option for these procedures [7]. Use of robotic assistance has now been described for a number of gynecologic surgeries including hysterectomy, radical hysterectomy, myomectomy and pelvic reconstructive surgery [3,8,9]. Robotic-assisted surgery has been used for both oncologic and noncancerrelated procedures but has gained the greatest use for gynecologic cancer surgery. Despite the enthusiasm for robotic gynecologic surgery, data are largely lacking and based predominately on small institutional observational studies [3,7,8]. Our group recently completed a population-based study to examine the comparative effectiveness of robotic hysterectomy for endometrial cancer. Using a nationwide database that captures admissions at more than 600 hospitals, we compared the outcomes of 2464 women who underwent either robotic or laparoscopic hysterectomy for endometrial cancer from 2008 to 2010. We noted that the uptake of robotic hysterectomy was dramatic: in October 2008, 42% of the procedures were robotic and this increased over time, such that in March 2010 over 61% of the hysterectomies were robotic. There were a number of disparities in access to robotic hysterectomy. Women treated at large hospitals and those managed at nonteaching hospitals were more likely to undergo a robotic hysterectomy. By contrast, black women, those without insurance and patients in rural areas were less likely to undergo a robotic hysterectomy [9].
10.2217/CER.12.42 © 2012 Future Medicine Ltd
1(5), 377–379 (2012)
Jason D Wright*1,4
Dawn L Hershman2,3,4 Division of Gynecologic Oncology, Department of Obstetrics & Gynecology, Columbia University College of Physicians & Surgeons, 161 Fort Washington Avenue, 8th Floor, NY 10032, USA 2 Department of Medicine, Columbia University College of Physicians & Surgeons, 161 Fort Washington Ave, 8th Floor, NY 10032, USA 3 Department of Epidemiology, Mailman School of Public Health, 722 West 168th Street, NY 10032, USA 4 Herbert Irving Comprehensive Cancer Center, St Nicholas Avenue, NY 10032, USA *Author for correspondence: Tel.: +1 212 305 3410 Fax: +1 212 305 3412 [email protected] 1
part of
ISSN 2042-6305
377
EDITORIAL
Wright & Hershman
When outcomes were examined we found that the overall complication rates were similar for robotic and laparoscopic hysterectomy (adjusted odd ratio: 0.76; 95% CI: 0.56–1.03). There were no statistically significant differences in the rates of intraoperative complications, surgical-site complications, medical complications or prolonged hospitalization between the procedures. Likewise, perioperative mortality was rare for both procedures. When cost was analyzed, we noted that robotic hysterectomy was substantially more costly. The mean unadjusted cost of laparoscopic hysterectomy was US$8996 compared with US$10,618 for robotic hysterectomy. In a multivariable model the cost of robotic hysterectomy remained US$1291 greater than laparoscopic hysterectomy. These findings were largely unchanged in a number of sensitivity analyses. Based on our cohort alone, if all 1680 minimally invasive hysterectomies performed in 2009 were carried out robotically, costs would have been more than US$2,000,000 greater [9]. These findings clearly question the comparative effectiveness of robotic hysterectomy for endometrial cancer. Despite limited data, robotic hysterectomy already appears to be in widespread use. The evolution of robotic hysterectomy is unlike prostatectomy in that an alternative minimally invasive approach for hysterectomy, laparoscopy, is already well described. Laparoscopic hysterectomy has been performed for more than two decades, is routinely taught in gynecology training programs and has been evaluated in randomized, controlled trials for endometrial cancer [10]. A number of factors likely influence the diffusion of robotic hysterectomy. Although laparoscopic hysterectomy is widely performed, the procedure requires substantial technical skill. A 2007 survey of gynecologic oncologists reported that only a small minority of surgeons performed more than 50% of their cases laparoscopically [11]. Robotic hysterectomy may provide an easier learning curve than laparoscopy. Another potential advantage of robotic hysterectomy is that it may allow for the completion of more difficult procedures via a minimally invasive approach [7]. If true, this may increase the number of women who have access to a minimally invasive surgical procedure. Finally, there has been substantial marketing of robotic surgery [12,13]. The marketing of robotic surgery has not only been from industry, but also from direct marketing to patients by physicians and hospitals. While the
378
J. Compar. Effect. Res. (2012) 1(5)
validity of some of these claims has been questioned, nonetheless, these marketing influences have placed competitive pressures on physicians as many patients request robotic surgery [13]. A major concern for robotic hysterectomy centers on cost. Our data and others have shown that robotic hysterectomy is the most expensive modality for hysterectomy [2,9]. The high cost of robotic surgery is driven predominately by equipment costs. Currently, there is one company that dominates the market for robotic surgery. The initial purchasing cost of the robot itself ranges from US$1 million to well over US$2 million. In addition, hospitals must purchase an annual service contract of US$140,000 and the disposable instrumentation is estimated to cost US$1500– 2000 per case [13,14]. If robotic surgery were to replace open surgery, it’s been estimated that the cost burden to the US healthcare system would be more than US$2.5 billion [15]. Robotic hysterectomy highlights the difficulty with introducing a new technology into clinical practice. Current data suggest minimal quantifiable benefits for robotic hysterectomy but substantially increased cost. Despite these data, the technology has already been rapidly incorporated into practice. A number of suggestions have been proposed to guide the more rational implementation of new technologies. Although new devices and technologies cannot follow the same approval process as new drugs, many have called for a more ordered development and testing process for devices. One such proposal, the Balliol Collaboration’s innovation, development, exploration, assessment and long-term study (IDEAL) model, calls for surgical techniques to evolve from a concept through safety studies followed by randomized trials prior to widespread dissemination into practice [16]. There have also been proposals to reform the way devices are regulated by the FDA. Currently, devices are regulated through the FDA’s 510(K) process, which clears new devices if it can be demonstrated that they are ‘substantially equivalent’ to a product that is already marketed [17]. The Institute of Medicine has endorsed more stringent efficacy and safety standards prior to device approval [17,18]. Finally, limiting reimbursement for unproven procedures has been proposed [19]. Pearson and Bach endorsed a tiered payment system in which payments would be based on demonstrated effectiveness of treatments. In this system, payment for services with no comparative advantage would be lowered [19].
future science group
Comparative effectiveness of robotic gynecologic surgery
Robotic hysterectomy demonstrates the importance of comparative effectiveness research for new technologies. While surgical innovation and the development of new devices must be encouraged, these new devices also require rigorous investigation. In the current climate of cost containment for healthcare spending, comparative effectiveness data must be used to guide the dissemination of new technologies.
1
Wilson EB. The evolution of robotic general surgery. Scand. J. Surg. 98, 125–129 (2009).
2
Barnett JC, Judd JP, Wu JM, Scales CD Jr, Myers ER, Havrilesky LJ. Cost comparison among robotic, laparoscopic, and open hysterectomy for endometrial cancer. Obstet. Gynecol. 116, 685–693 (2010).
3
Liu H, Lu D, Wang L, Shi G, Song H, Clarke J. Robotic surgery for benign gynaecological disease. Cochrane Database Syst. Rev. 2, CD008978 (2012).
4
Maeso S, Reza M, Mayol JA et al. Efficacy of the Da Vinci surgical system in abdominal surgery compared with that of laparoscopy: a systematic review and meta-analysis. Ann. Surg. 252, 254–262 (2010).
5
6
7
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. hysterectomy for endometrial cancer compared with traditional laparoscopic and laparotomy approaches: a systematic review. Obstet. Gynecol. 116, 1422–1431 (2010).
References
8
Sarlos D, Kots LA. Robotic versus laparoscopic hysterectomy: a review of recent comparative studies. Curr. Opin. Obstet. Gynecol. 23, 283–288 (2011).
9
Wright JD, Burke WM, Wilde ET et al. Comparative effectiveness of robotic versus laparoscopic hysterectomy for endometrial cancer. J. Clin. Oncol. 30, 783–791 (2012).
10
Walker JL, Piedmonte MR, Spirtos NM et al. Recurrence and survival after random assignment to laparoscopy versus laparotomy for comprehensive surgical staging of uterine cancer: Gynecologic Oncology Group LAP2 Study. J. Clin. Oncol. 30, 695–700 (2012).
Hu JC, Gu X, Lipsitz SR et al. Comparative effectiveness of minimally invasive vs open radical prostatectomy. JAMA 302, 1557–1564 (2009).
11
Yu HY, Hevelone ND, Lipsitz SR, Kowalczyk KJ, Hu JC. Use, costs and comparative effectiveness of robotic assisted, laparoscopic and open urological surgery. J. Urol. 187, 1392–1398 (2012).
12 Jin LX, Ibrahim AM, Newman NA,
Gaia G, Holloway RW, Santoro L, Ahmad S, Di Silverio E, Spinillo A. Robotic-assisted
future science group
EDITORIAL
Naumann RW, Coleman RL. The use of adjuvant radiation therapy in early endometrial cancer by members of the Society of Gynecologic Oncologists in 2005. Gynecol. Oncol. 105, 7–12 (2007). Makarov DV, Pronovost PJ, Makary MA. Robotic surgery claims on United States hospital websites. J. Health. Qual. 33, 48–52 (2011).
www.futuremedicine.com
13 Kolata G. Results unproven, robotic surgery
wins converts. The New York Times, 13th February (2010). 14
Makarov DV, Yu JB, Desai RA, Penson DF, Gross CP. The association between diffusion of the surgical robot and radical prostatectomy rates. Med. Care 49, 333–339 (2011).
15
Barbash GI, Glied SA. New technology and health care costs – the case of robot-assisted surgery. N. Engl. J. Med. 363, 701–704 (2010).
16
McCulloch P, Altman DG, Campbell WB et al. No surgical innovation without evaluation: the IDEAL recommendations. Lancet 374, 1105–1112 (2009).
17
Curfman GD, Redberg RF. Medical devices – balancing regulation and innovation. N. Engl. J. Med. 365, 975–977 (2011).
18
Challoner DR, Vodra WW. Medical devices and health – creating a new regulatory framework for moderate-risk devices. N. Engl. J. Med. 365, 977–979 (2011).
19
Pearson SD, Bach PB. How Medicare could use comparative effectiveness research in deciding on new coverage and reimbursement. Health Aff. (Millwood) 29, 1796–1804 (2010).
379
