Does the robot hurt or help?

October 1, 2014

The big question is whether the robot improves outcomes in gynecologic surgery.

Using the robot for gynecologic surgery makes sense  

By Kathy Huang, MD

Dr. Huang is Director, Gynecologic Robotic Surgery, and Assistant Professor, New York University School of Medicine, New York.

She reports receiving consulting fees from Intuitive Surgical.

 

 

Robotic-assisted (RA) laparoscopic surgery is one of the newest innovations in minimally invasive gynecologic surgery (MIGS). The technology was first used in 1999 to perform a tubal anastomosis, and applications have since expanded to many benign gynecologic procedures, including but not limited to hysterectomy, myomectomy, sacrocolpopexy, and treatment of endometriosis.1,2 In 2005, the da Vinci surgical system was approved by the US Food and Drug Administration to be used in gynecology. It provides 3-D visualization of the operative field, 7 degrees of freedom of motion, ergonomic benefits, and elimination of surgeons’ tremors.2,3 It has decreased the percentage of gynecologic cases performed via laparotomy incision by overcoming some of the challenges associated with traditional laparoscopy.4

The robotic platform also has been shown to have a shorter learning curve than conventional laparoscopy.5-7 Many studies have demonstrated the safety and feasibility of robotic surgery in gynecology, but the definitive role of the robot within the realm of MIGS has yet to be established. Here I summarize the evidence regarding the role of the robotic platform in benign gynecologic surgery. 

Hysterectomy

Hysterectomy is the most common surgery performed by gynecologists in the United States. In 2003, 538,722 benign hysterectomies were performed; 66.1% abdominally, 21.8% vaginally, and 11.8% laparoscopically.8 In 2002, Diaz-Arrastia et al demonstrated the safety and feasibility of robotic-assisted hysterectomy (RAH), which has been reaffirmed in multiple studies.9,10 From 2007 to 2010, benign laparoscopic hysterectomy increased from 24.3% to 30.5% as documented in a cohort of 264,758 women; RAH increased from 0.5% to 9.5%.11 Between 1998 and 2010, the number of inpatient hysterectomies performed in the United States decreased by more than 40%, which suggests that more hysterectomies are being performed using a minimally invasive approach.12

The trend toward more minimally invasive procedures continues amidst debate about which minimally invasive approach is optimal. In a recent report on a randomized controlled trial comparing conventional laparoscopic hysterectomy to RAH, 56 women underwent hysterectomy for benign indications and the operative time for RAH was significantly longer, with a mean difference of 77 minutes.13 There were no differences in estimated blood loss or length of stay and no statistically significant differences in complications or postoperative pain. However, this group of 5 skilled laparoscopic surgeons performed 26 RAH in the span of study enrollment. Therefore, they were still in the early part of their learning curve in adoption of robotics, making it difficult to draw valid conclusions from this study.

In another trial, 100 patients with benign indications were randomized to robotic or laparoscopic hysterectomy.14 No statistically significant differences were seen in length of hospital stay, time to return to activity, time to return to work, or analgesic use, nor were there differences in intraoperative complications such as blood loss and conversion rates. However, there was a significant difference in mean operating times. Given that both traditional laparoscopy and RAH have been shown in multiple studies to have similar outcomes, the optimal approach should be individualized depending on a patient’s clinical scenario and a surgeon’s expertise.

Related: Do we really need the robot?

 

 

Martino et al reported on a comparison of quality outcome measures in patients undergoing hysterectomy.15 In their large, retrospective cohort study, 2554 patients underwent hysterectomy for benign disease in an academic community hospital over 4 years. They found that patients who underwent robotic hysterectomy for benign disease had less blood loss, a shorter hospital stay, fewer readmissions <30 days, and reported cost savings related to these readmissions when compared to the laparoscopic, abdominal, and vaginal cohorts. The total readmission cost was $32,946 for robotic procedures, $50,290 for laparoscopic procedures, $328,230 for abdominal procedures, and $51,264 for vaginal hysterectomies. The robotic cohort had the lowest rate of readmission <30 days.

Myomectomy

Myomectomy is an option for women with fibroids who want uterine-sparing surgery. Laparotomy has historically been the most widely used approach, despite its associated increased morbidity; however, minimally invasive myomectomies have gradually been increasing over the past decade largely due to the use of a robot-assisted approach.16

Since publication of the first case series of robot-assisted laparoscopic myomectomies that demonstrated the safety and feasibility of the procedure, multiple studies have demonstrated the benefits of robotic myomectomy versus abdominal myomectomy.17 In fact, the robot may allow patients with larger myomas to have a minimally invasive procedure.18 This may be attributable to the robotic platform’s ability to overcome the technical challenges of laparoscopic myomectomies, specifically multilayer closures.

In a comparison of short-term outcomes between robot-assisted and abdominal myomectomies, the former approach was associated with lower estimated blood loss (195 mL vs 365 mL) and shorter length of hospital stay (1.48 days vs 3.62 days).19 However, it was also associated with longer operative times (231 ±85 minutes vs 154 ±43 minutes) and higher costs ($30,084.20 ±$6689.29 vs $13,400.62 ±$7747.26). Two larger retrospective studies have demonstrated similar results.18,20 No differences in short-term outcomes and complication rates were found in a comparison of robotic laparoscopic myomectomies but the operative time and estimated blood loss were found to be significantly greater in the robotic cohort.21 However, these differences may be attributable to the use of barbed sutures in the laparoscopic cohort only.

Because myomectomies are considered a fertility-sparing surgery, pregnancy outcomes are also an important factor when considering techniques. In a retrospective study of 107 women who conceived resulting in 127 pregnancies and 92 deliveries, results were similar to prior published studies looking at laparoscopic myomectomy outcomes.22 Obstetrical outcomes were also similar and included only 1 uterine rupture and 1 uterine dehiscence, which resulted in no adverse outcomes. Robot-assisted myomectomy is a safe option for women desiring future fertility.

Sacrocolpopexy

Abdominal sacrocolpopexy is a common procedure primarily performed by pelvic surgeons to correct apical pelvic organ prolapse with long-term success rates ranging from 78% to 100%.23 Its proven efficacy makes it an ideal procedure; however the abdominal approach is often associated with significant morbidity and post operative recovery time.

Minimally invasive sacrocolpopexy has been steadily increasing over the past decade. Robotic surgery results in similar long-term outcomes and has been shown to decrease morbidity as it relates to estimated blood loss and length of hospital stay when compared to abdominal sacrocolpopexy.24 Sustained efficacy over 44 months after robotic sacrocolpopexy also has been demonstrated, results similar to abdominal sacrocolpopexy.25 In a randomized controlled trial, robotic sacrocolpopexy was associated with longer operating times, increased cost, and increased pain up to 3 to 5 weeks postoperatively as compared to the laparoscopic procedure.23 As with other robotic procedures, the operative times and increased costs are likely surgeon-dependent, and increased skill will result in a decrease in both parameters.

 

Endometriosis 

In a retrospective cohort study, a comparison of robotic and standard laparoscopy for treatment of endometriosis found significantly decreased operative time with laparoscopy. No differences were reported in estimated blood loss or intraoperative/postoperative complications.27 That study demonstrated the feasibility of using the robot for endometriosis, however, there was no proven benefit to using it rather than laparoscopy. Most patients in both groups had stage I or II endometriosis. There was no comparison between abdominal endometriosis surgeries and robotic laparoscopic surgeries, but the authors suggest that the advantages of the robot would likely be noted in cases of severe endometriosis in which a surgeon may convert an abdominal approach to a robotic one.

The largest series on robot-assisted treatment of deep infiltrating endometriosis included 164 women with stage IV endometriosis who underwent robot-assisted laparoscopic treatment of endometriosis in 8 international clinics. The average operative time was 180 minutes. With a mean follow-up period of 10.2 months, 86.7% of the patients experienced a full recovery. Twenty-eight of the 42 patients desiring pregnancy were able to conceive postoperatively. No increases in surgical time, blood loss, intra- or postoperative complications were observed. The authors concluded that robotic surgery seems to be a promising platform for treatment of deeply infiltrating endometriosis.28

Cost

Many studies have demonstrated the increased costs associated with robotic-assisted surgery as compared to open or laparoscopic surgery. In one study, the average cost of a RAH was €4067 compared to €2151 for traditional laparoscopic hysterectomy.29 In another study, mean hospital charges ($30,084.20 ±$6689.29 vs $13,400.62 ±$7747.26) also were reportedly higher for robotic myomectomies, but professional reimbursement was not statistically significant between the 2 groups.19 Similar findings have been reported for robotic sacrocolpopexy.23 In almost all of these studies, the robotic operative time was significantly longer. However, recent research revealed that once a surgeon and team have surpassed their learning curve, a robotic procedure may take less time than its laparoscopic counterparts.30

In a comprehensive financial review at a high-volume robotics program, profitability was achieved by increased robotic volume and operative efficiency.31 This pattern has spanned surgical fields utilizing the robot. For example, a reduction in case time for sacrocolpopexy to 179 minutes allowed for profitability. Factors that made this feasible include having a coordinated nursing and surgical technician team, appropriate surgical instrumentation, and skilled surgeons. As surgical teams gain experience with the robotic surgical system and surgeons surpass the learning curve, overall costs can be expected to gradually decrease.

 

In our unpublished data, procedural time is significantly shorter in the RAH group when compared to laparoscopic hysterectomies (120 min vs 181 min, P=0.001). Since the primary contributor to cost is operating room time, the significant decrease in the procedural time leads to decreased cost for our robotic cohort when compared to the laparoscopic cohort ($9505 vs $7349). Our experience suggests that operative time is directly related to experience. Surgeons who are proficient on the robot can minimize costs by decreasing operating room time. Rather than focusing solely on the cost of performing the surgery, it is important to account for throughput and volume. The decreased operative time of 1 hr associated with RAH has allowed our group to perform 3 to 4 RAH per day instead of 2 laparoscopic hysterectomies per day, effectively increasing throughput by at least 50%. This increased throughput is highly meaningful in the current economic climate. Cost and revenue aside, increasing throughput safely and effectively enables practitioners to care for more patients. 

 

Summary

Robot-assisted surgery is an additional tool that surgeons can use to decrease the overall morbidity associated with many gynecologic procedures. Most studies cite increased operative time and cost as major limitations, but these factors are largely due to limited surgeon experience with the robotic platform. With increased surgeon knowledge, experience, and skill, robotic surgery will likely prove to be more advantageous for patients and surgeons and will eventually surpass traditional laparoscopic surgery. Finally, the role of the robotic platform is to maximize a patient’s chance of having a minimally invasive procedure. The robotic platform has enabled many to reduce the number of open surgeries performed for benign gynecologic indications.

 

References

1. Falcone T, Goldberg JM, Margossian H, Stevens L. Robotic-assisted laparoscopic microsurgical tubal anastamosis: a human pilot study. Fertil Steril. 2000;73(5):1040–1042.

2. AAGL position statement: Robotic-assisted laparoscopic surgery in benign gynecology. J Minim Invasive Gynecol. 2013;20(1):2–9.

3. Visco AG, Advincula AP. Robotic gynecological surgery. Obstet Gynecol. 2008;112(6):1369–1384.

4. Payne TN, Dauterive FR. A comparison of total laparoscopic hysterectomy to robotic assisted hysterectomy: surgical outcomes in a community practice. J Minim Invasive Gynecol. 2008;15(3):286–291.

5. Lenihan JP Jr, Kovanda C, Seshadri-Kreaden U. What is the learning curve for robotic assisted gynecologic surgery? J Minim Invasive Gynecol. 2008;15(5):589–594.

6. Kenngott HG, Fischer L, Nickel F, Rom J, Rassweiler J, Müller-Stich BP. Status of robotic assistance-a less traumatic and more accurate minimally invasive surgery? Langenbecks Arch Surg. 2012;397(3):333–341.

7. Lim PC, Kang E, Park do H. A comparative detail analysis of the learning curve and surgical outcome for robotic hysterectomy with lymphadenectomy versus laparoscopic hysterectomy with lymphadenectomy in treatment of endometrial cancer: a case-matched controlled study of the first one hundred twenty two patients. Gynecol Oncol. 2011;120(3):413–418.

8. Diaz-Arrastia C, Jurnalov C, Gomez G, Townsend C Jr. Laparoscopic hysterectomy using a computer-enhanced surgical robot. Surg Endosc. 2002;16(9):1271–1273.

9. Kho RM, Hilger WS, Hentz JG, Magtibay PM, Magrina JF. Robotic hysterectomy: technique and initial outcomes. Am J Obstet Gynecol. 2007;197(1):113.e1–4.

10. Patzkowsky KE, As-Sanie S, Smorgick N, Song AH, Advincula AP. Perioperative outcomes of robotic versus laparoscopic hysterectomy for benign disease. JSLS. 2013;17(1):100–106.

11. Wright JD, Ananth CV, Lewin SN, et al. Robotically assisted vs laparoscopic hysterectomy among women with benign gynecologic disease. JAMA. 2013;309(7):689–698.

12. Wright JD, Herzog TJ, Tsui J, et al. Nationwide trends in the performance of inpatient hysterectomy in the United States. Obstet Gynecol. 2013;122(2 Pt 1):233–241.

13. Paraiso MF, Ridgeway B, Park AJ, et al. A randomized trial comparing conventional and robotically assisted total laparoscopic hysterectomy. Am J Obstet Gynecol. 2013;208(5):368.e1–7.

14. Sarlos D, Kots L, Stevanovic N, von Felten S, Schär G. Robotic compared with conventional laparoscopic hysterectomy: a randomized controlled trial. Obstet Gynecol. 2012;120(3):604–611.

15. Martino M, Berger EA, McFetridge JT, et al. A comparison of quality outcome measure in patients having a hysterectomy for benign disease: robotic vs. non-robotic approaches. J Minim Invasive Gynecol. 2014;21(3):389–393.

16. Quaas AM, Einarsson JI, Srouji S, Gargiulo AR. Robotic myomectomy: a review of indications and techniques. Rev Obstet Gynecol. 2010;3(4):185–191.

17. Advincula AP, Song A, Burke W, Reynolds RK. Preliminary experience with robot-assisted laparoscopic myomectomy. J Am Assoc Gynecol Laparosc. 2004;11(4):511–518.

18. Barakat EE, Bedalwy MA, Zimberg S, Nutter B, Nosseir M, Falcone T. Robotic-assisted, laparoscopic, and abdominal myomectomy: a comparison of surgical outcomes. Obstet Gynecol. 2011;117(2 Pt 1):256–265.

19. Advincula AP, Xu X, Goudreau S, Random SB. Robot-assisted laparoscopic myomectomy versus abdominal myomectomy: a comparison of short-term surgical outcomes and immediate costs. J Minim Invasive Gynecol. 2007;14(6):698–705.

20. Ascher-Walsh CJ, Capes TL. Robot-assisted laparoscopic myomectomy is an improvement over laparotomy in women with a limited number of myomas. J Minim Invasive Gynecol. 2010;17(3):306–310.

21. Gargiulo AR, Srouji SS, Missmer SA, Correia KF, Vellinga TT, Einarsson JI. Robot-assisted laparoscopic myomectomy compared with standard laparoscopic myomectomy. Obstet Gynecol. 2012;120(2 Pt 1):284–291.

22. Pitter MC. Gargiulo AR, Bonaventura LM, Lehman JS, Srouji SS. Pregnancy outcomes following robot-assisted myomectomy. Hum Reprod. 2012;28(1):99–108.

23. Paraiso MF, Jelovsek JE, Frick A, Chen CG, Barber MD. Laparoscopic compared with robotic sacrocolpopexy for vaginal prolapse: a randomized controlled trial. Obstet Gynecol. 2011;118(5):1005–1013.

24. Geller EJ, Siddiqui NY, Wu JM, Visco AG. Short-term outcomes of robotic sacrocolpopexy compared with abdominal sacrocolpopexy. Obstet Gynecol. 2008;112(6):1201–1206.

25. Geller EJ, Parnell BA, Dunivan GC. Robotic vs abdominal sacrocolpopexy: 44-month pelvic floor outcomes. Urology 2012;79(3):532–536.

26. ACOG Practice Bulletin 114: Management of endometriosis Obstet Gynecol. 2010 Jul;116(1):223–236.

27. Nezhat C, Lewis M, Kotikela S, et al. Robotic versus standard laparoscopy for the treatment of endometriosis. Fertil Steril. 2010;94(7):2758–2760.

28. Collinet P, Leguevaque P, Neme RM, et al. Robot-assisted laparoscopy for deep infiltrating endometriosis: international multicentric retrospective study. Surg Endosc. 2014;28(8):2474–2479.

29. Sarlos D, Kots L, Stevanovic N, Schaer G. Robotic hysterectomy versus conventional laparoscopic hysterectomy: outcome and cost analyses of a matched case-control study. Eur J Obstet Gynecol Reprod Biol. 2010;150(1):92–96.

30. Giep BN, Giep HN, Hubert HB. Comparison of minimally invasive surgical approaches for hysterectomy at a community hospital: robotic-assisted laparoscopic hysterectomy, laparoscopic-assisted vaginal hysterectomy and laparoscopic supracervical hysterectomy. J Robot Surg. 2010;4(3):167–175.

31. Geller EJ, Matthews CA. Impact of robotic operative efficiency on profitability. Am J Obstet Gynecol. 2013;209(1):20.e1–20.e5.

 

Next: The robot does not improve outcomes >>

 

 

The robot does not improve outcomes

By John F. Steege, MD

Dr. Steege is a Professor in the Department of Obstetrics and Gynecology and former Director, Division of Advanced Laparoscopy and Pelvic Pain, University of North Carolina, Chapel Hill.

He has no conflicts of interest to report with respect to the content of this article.

 

 

Ideally, innovations in medicine that are wildly popular when first introduced later settle into an appropriate clinical niche as data accumulate about clinical outcomes and cost. Medical care would be well served if the use of the robot in gynecologic surgery were to follow this classic pattern.

Opposing this evolution, however, are the powerful forces of heavy marketing of robotics to the public and to surgeons. Hospitals join in and market their robotics programs to show the public that they’re up to date.1 In this marketing, which often uses text and images lifted directly from the robot manufacturer’s website, the robot is described as having improved perioperative outcomes, making it superior to “conventional surgery.” This leaves the reader to figure out whether the comparison is to conventional laparoscopy or to laparotomy. Members of the public who are naïve often assume that the comparison is to conventional laparoscopy.

Any form of laparoscopy is superior to laparotomy in terms of outcomes, including comfort, morbidity, and cost, but comparisons between conventional laparoscopy and the robot-assisted approach have completely failed to support the claims of superiority for the robot in gynecologic surgery. In addition, extensive analysis has shown the robot to be more expensive.2

But why quibble? Hasn’t robotics “enabled” surgeons to do laparoscopy? Perhaps that is true in some instances, but it introduces another set of questions:

How can a gynecologist get good (or better) at minimally invasive gynecologic surgery (MIGS)?

In my view, there are 3 ways to get good at laparoscopic surgery: 1) Teach yourself, expanding your skills gradually over time (this is how most of the surgeons of my vintage learned it); 2) Get trained in a residency that does a high volume of laparoscopic surgery; or 3) Do a fellowship in MIGS. Many practicing ob/gyns did not have a laparoscopy-heavy residency and don’t have a fellowship available to them. The robot appeals to them because they are left with option 1 only, and the robot enthusiasts would suggest that it can accelerate learning.

The robot appeals to 3 types of surgeons: 1) good, experienced laparoscopists who just happen to like to use it; 2) those whose training was not adequate in conventional laparoscopy; and 3) those who wish to take advantage of the marketing in building their surgical practices. I suggest that many gynecologic laparoscopists fit both categories 1 and 3.

The ones who fit categories 2 and 3, however, are the most dangerous. They are most likely to depend on the robot, to use it for most or all of their cases (even diagnostic laparoscopy: Really?!), and to explain it to their patients in a way that allows persistence of the fiction that the robot is inherently superior. In some instances, a clinician’s desire to build an image of surgical competence seems to lead them to spend more time in the retroperitoneal spaces than they have been trained to do, and to tackle ever larger uteri without sufficient training or experience.

 

 

Having marketed themselves as better because they use the robot, these surgeons create their own trap: Even if the robot does help them learn, can they then go back to “straight sticks” without endangering their practices? Ironically, they then become robot-dependent, leaving them in a tough spot when the robot is not available or breaks down. The path of least resistance is overwhelmingly attractive: Just keep telling patients they do it better with the robot.

But wait: There’s another path that the specialty has not taken: better training of people already out in practice. Using a carefully structured and relatively inexpensive program of didactics and proctoring, Kaiser (Southern California Permanente Medical Group) was able to increase the percentage of hysterectomies done laparoscopically in their system from 38% to 78% over a 5-year span. More than 300 gynecologists took the course across 12 medical centers. None of these procedures was done robotically. The instructional materials for this process are available for use by other programs.3

What is the minimum annual surgical volume for maintaining competence?

If every practicing gynecologist did 60 to 80 major surgeries annually, then maybe this wouldn’t be such an issue. But national data suggest that the annual volume is closer to 10 to 15 cases at most. Over the past 3 decades, the number of practicing gynecologists has increased 2.5-fold, while the number of hysterectomies has declined.4

Indeed, for the last several years, I’ve asked resident candidates while interviewing them, “How many surgeries do you think the average gynecologist does in a year?” Answers have ranged from 100 to 800! Our young ob/gyns-to-be seem to have little idea of what they’re getting into. In contrast, each of my fellows does between 200 and 300 cases in each year of their 2-year fellowship. That is equivalent to an entire career of surgery for the average gynecologic surgeon in the country.

Even those who do graduate from laparoscopy-heavy residencies face a problem. In order to establish their practices in the community, they need to present themselves as competent surgeons. If their surgical volumes are not sufficient, they risk a declining reputation as well as true deterioration of their skills. The robotics marketing may serve their needs, as well as the competitive needs of the hospitals in which they practice.

 

 

There is much discussion currently about the number of robotic cases a surgeon should be required to do annually to maintain privileges in that area of MIGS. With the low case volume per surgeon described above, almost any specific number might only serve to inappropriately encourage surgeons to do cases robotically, when, in the vast majority of instances, they could be readily done with conventional laparoscopic techniques. Given recent publications documenting the increased cost of robotics, this has implications for the medical care system in general.

What should the patient be told about the surgeon’s training and experience?

Many patients are becoming more informed consumers, and are asking their providers about their surgical volumes, complication rates, etc. Many others, wanting to trust, don’t ask. Surgeons with low volumes are then in a difficult position regarding what they say on this topic. Is a surgeon really going to say, “I use the robot because it helps overcome the problem of my volume being low”? More likely, the patient will be left with the impression that because the robot is employed, the surgery will be done better.

Summary

Where does this leave us? Feeling that this is just the beginning of a much longer debate, I offer the following thoughts for consideration:

1) The true additive role of the robot may be limited to certain niches of gynecologic surgery (and even these are debated), such as sacral colpopexy and lymph node dissection.

2) The other role of the robot may be as a training tool, the “training wheels” of gynecologic surgery.

3) The healthcare system as a whole needs to carefully review the appropriate use of multiple technologies in general, and robotics in particular.

4) Current marketing practices that present misleading information to the public are unacceptable.

5) The public needs to be made more aware that robotics does not lead to better outcomes. The surgeon does the surgery, not the robot.

6) Surgeons need to be completely honest with their patients about why they use the robot, if they do. 

 

References

1. Schiavone MB, Kuo EC, Naumann RW, et al. The commercialization of robotic surgery: unsubstantiated marketing of gynecologic surgery by hospitals. Am J Obstet Gynecol. 2012;207(3):174.e1–7.

2. Wright JD, Ananth CV, Tergas AI, et al. An economic analysis of robotically assisted hysterectomy. Obstet Gynecol. 2014;123(5):1038–1048.

3. Andryjowicz E, Wray, T. Regional expansion of minimally invasive surgery for hysterectomy: Implementation and methodology in a large multispecialty group. Perm J. 2011;15(4):42–46.

4. Magrina JF. Isn’t it time to separate the O from the G? J Minim Invasive Gynecol. 2014;21(4):501–503.