Our findings suggest that robotic hysterectomy offers little short-term benefit over a laparoscopic procedure for women with endometrial cancer. Perioperative morbidity was similar for the two procedures, whereas resource utilization is significantly higher for robotic hysterectomy. Robotic hysterectomy is associated with substantially higher direct hospital costs.
To date, there have been no randomized trials comparing laparoscopic and robotic hysterectomy for endometrial cancer. A recent systematic review of uncontrolled case series of robotic hysterectomy for endometrial cancer that identified 589 procedures found no differences in intraoperative or postoperative complications rates, transfusion requirements, rates of conversion to laparotomy, operative times, or length of stay between women who underwent laparoscopy and women who had a robotically assisted hysterectomy. However, compared with laparoscopy, robotic hysterectomy was associated with clinically insignificant lower blood loss (mean, 182 v
92 mL, respectively). Lymph node yield, a measure of surgical quality, was similar for the two modalities.27
Most of the reports included in this review were from surgeons and centers that possess significant expertise in robotic surgery.4–11
In our population-based analysis, there were no significant differences in the morbidity of robotic and laparoscopic surgery after adjusting for patient, physician, and systems characteristics.
A major concern surrounding the use of robotic surgery is the economic viability of the technology. A single-institution series of 110 patients with endometrial cancer noted that laparoscopic and robotic surgery had similar costs and that both modalities were significantly less costly than open hysterectomy.7
In contrast, a decision model found that laparoscopic hysterectomy was the least expensive treatment from both a hospital and societal perspective.3
In addition to the price of the robot, which ranges from $1 million to $2.25 million, an annual service contract of $140,000 is required, and disposable instruments cost $1,500 to $2,000 per case.13,28
Modeling studies of endometrial cancer have suggested that even if the purchase price of the robot is excluded and the price of disposable instruments is substantially reduced, laparoscopic hysterectomy remains the most economically advantageous.3
A recent analysis of 20 types of robotically assisted procedures noted that the addition of the robot added on average $1,600, or 6% of the total procedure cost.17
In our multivariable model, use of the robot increased direct hospital costs by nearly $1,300, more than 14% of the total hospital cost of a laparoscopic procedure.
Our data are remarkable in that by 2010, more than 60% of all minimally invasive hysterectomies for endometrial cancer were performed robotically despite the limited available data. A number of factors including perceptions, characteristics of early users, and contextual factors have been shown to drive innovation of a new technology.12
For surgical innovations, several studies have demonstrated that the introduction of a new technique often increases aggregate use of a surgical procedure.17,28–30
The introduction of robotic prostatectomy in the United States between 2005 and 2008 was associated with a 60% increase in the number of prostatectomies performed despite a decreasing incidence of prostate cancer.17
Although technologic innovation cannot follow the same developmental process as that of new drugs, there is increasing recognition that more formal regulation is needed.31
The Balliol Collaboration's Innovation, Development, Exploration, Assessment, and Long-Term Study (IDEAL) model proposed that new surgical techniques should evolve from a concept through safety exploration followed by randomized trials before widespread implementation.14,16,31,32
The US Food and Drug Administration is currently revising its regulatory process for medical devices after substantial public criticism.33
We identified a number of disparities in the use of robotic hysterectomy as the technology diffused into practice. Black women were 54% less likely than white women to undergo a robotic procedure, whereas uninsured patients were 44% less likely to have a robotic hysterectomy than patients with commercial insurance. The hospital setting in which patients received care also had a strong impact on the allocation of care. Women treated at large facilities and at nonteaching hospitals were more likely to undergo robotic surgery, whereas women treated at rural hospitals were 50% less likely to undergo a robotic hysterectomy. These disparities mirror those seen with the introduction of laparoscopy for a number of different procedures.34–36
We recognize several important limitations in our study. Because the primary purpose of claims data is for billing, complications are often under-reported. To minimize this bias, we focused our analysis on major perioperative complications that are likely to generate a claim. Any under-reporting of complications would have been equally likely in both cohorts. Although the Perspective database contains a sample of women from throughout the United States, our findings may not be generalizable to the entire US health care system. Perspective lacks data on tumor characteristics such as histology, grade, stage, and depth of invasion that impact treatment. Although we included only patients who underwent minimally invasive surgery, and the indications are the same for both procedures, some degree of procedure selection likely occurred based on tumor characteristics. We cannot exclude the possibility that some patients' procedures were misclassified. However, even during the early months of the study, the relative number of patients who underwent robotic surgery was high, suggesting that ICD-9 coding for robotic surgery was well recognized. With any new procedure, a learning curve exists for physicians, and this is certainly true for robotic surgery.11
We attempted to account for this by including surgical volume as a covariate in our analysis, but we recognize that costs may be lower as surgeons become more familiar with the technology and operative times decrease. Our costing data are based on a nationwide sample of directly reported hospital costs or estimates. Certainly wide variations in cost exist based on whether acquisition and maintenance costs are included and whether costs of disposable instruments are included; however, we feel that, if anything, our costs are likely to underestimate the true costs. A number of factors, including lymphadenectomy, which was more common in the robotic hysterectomy group, also had a strong influence on cost. Finally, it should be recognized that both procedures were associated with low overall morbidity, limiting our power to detect statistically significant differences between groups. Although there were no statistically significant differences in morbidity, there was a trend toward fewer medical complications in the robotic hysterectomy group.
Our findings raise questions as to the role of robotic surgery in the treatment of endometrial cancer. Robotic technology initially gained widespread utilization in urology.2
Because laparoscopic prostatectomy is technically demanding and not routinely performed, robotics introduced a minimally invasive surgical option for prostatectomy.2
In contrast, laparoscopic hysterectomy is well described, technically feasible, and now taught in most training programs.1
However, despite the availability of laparoscopic hysterectomy, a 2008 survey demonstrated that only 8% of gynecologic oncologists used the procedure in more than 50% of their patients.37
Even though laparoscopy is less costly, surgeon preferences for robotics may allow some women to undergo a minimally invasive procedure who may otherwise have undergone laparotomy. Proponents of robotic hysterectomy also argue that robotic capabilities allow surgeons to perform more technically challenging procedures without resorting to laparotomy.3,27
Although difficult to measure, this may be an important advantage of robotics. Finally, further data are needed to compare the oncologic outcomes of robotic and laparoscopic hysterectomy and to compare quality of life after the procedures.
Our study demonstrates that both robotic hysterectomy and laparoscopic hysterectomy are well tolerated and associated with similar morbidity profiles. Despite the rapid uptake of robotic hysterectomy, there seems to be little short-term benefit for the procedure. Compared with laparoscopic hysterectomy, robotic procedures are associated with substantially greater direct hospital costs. Our findings highlight the potential pitfalls of the rapid uptake of new technology before the availability of rigorous data to demonstrate efficacy and cost effectiveness. Defining the comparative effectiveness for new technologies and surgical approaches is necessary before rapid dissemination.