Health Letter, August 2013
A recent Journal of the American Medical Association (JAMA) study documented that between 2007 and 2010, there was a significant increase in U.S. hospitals’ use of robot technology to assist in hysterectomy (surgical removal of the uterus) for benign, or noncancerous, disorders.
Robotic surgery is a new medical technology that has been rapidly embraced and promoted by many hospitals in what has been described as a “technology arms race,” and hysterectomy is one of several procedures for which this new technology has been developed and marketed over the past several years.
Many hospitals eager to attract patients, compete with other nearby hospitals and increase revenue advertise that their doctors use the newest technologies available, implying that these technologies represent significant advances in medicine that are better than older treatments. Too often, however, new technologies are introduced into clinical practice without having undergone rigorous clinical testing comparing them to older, more proven treatments. As a result, many new medical technologies are widely and rapidly adopted without evidence that they are safer or more effective than their predecessors. Indeed, the JAMA study showed that robotic hysterectomy was more expensive than laparoscopic hysterectomy but offered no advantage in terms of medical complication rates.
Approximately 600,000 women in the U.S. undergo a hysterectomy annually, making it one of the most frequently performed surgeries. The majority of hysterectomies are for benign conditions, most commonly including symptomatic leiomyomas (also called “fibromas”), endometriosis and uterine prolapse (bulging of uterus into or outside the vagina).
There are four hysterectomy techniques available: vaginal, abdominal, laparoscopic and robotic. A vaginal hysterectomy involves removing the uterus through incisions made within the vagina, whereas an abdominal hysterectomy involves removal of the uterus through a large incision in the abdominal wall. Laparoscopic hysterectomy is considered a minimally invasive procedure that involves making small incisions in the abdominal wall though which fiberoptic scopes and surgical instruments are inserted to remove the uterus. Robotic hysterectomy, also minimally invasive, is very similar to laparoscopic surgery but involves a surgeon sitting at a video console to control the robotic instruments inserted via small abdominal incisions.
The technique chosen for a hysterectomy is influenced by many factors, including the size and shape of the vagina and uterus, the scope of the disorder (whether it extends beyond the uterus), the need for other surgical procedures (such as for urinary bladder prolapse), the surgeon’s training and experience, the nature of the surgery (elective or emergency), and the preference of the patient.
A recent systematic review of 34 randomized clinical trials of abdominal hysterectomy, vaginal hysterectomy and laparoscopic hysterectomy, involving a total of 4,495 subjects, demonstrated that vaginal hysterectomy had the best outcomes from among these three techniques. The review also found that for patients who are not candidates for a vaginal hysterectomy, laparoscopic hysterectomy offers some advantages over an abdominal approach, including a faster return to normal activities, shorter hospital stay, less blood loss and fewer wound infections. However, laparoscopic surgery takes more time and is associated with higher rates of injury to the urinary tract (bladder and ureter, the tubes that drain urine from the kidneys into the bladder).
In 2005, robotic devices for hysterectomy surgery were first cleared by the Food and Drug Administration (FDA) for marketing in the U.S. under a process known as 510(k) premarket notification. Under this regulatory process — a process long criticized by Public Citizen’s Health Research Group as being inadequate for ensuring the safety and effectiveness of medical devices — the manufacturer of the device was not required to provide data from clinical trials demonstrating that the robotic device was safe and effective for use in performing hysterectomy. Instead, the manufacturer only had to demonstrate that the device was “substantially equivalent” or similar to another device already on the market. The few randomized clinical trials comparing robotic and laparoscopic hysterectomy conducted after FDA clearance of the robotic device revealed that robotic surgery for treatment of benign gynecologic diseases was not safer or more effective than laparoscopic surgery. However, these studies were small, involving a total of 158 subjects.
Percentage of Hysterectomies by Technique, 2007 Versus 2010
|1st Quarter 2007
|1st Quarter 2010
Overview of the JAMA study
To examine the trend of robotic hysterectomy and to better compare laparoscopic and robotic hysterectomy, researchers at Columbia University conducted a large observational study, published on Feb. 20, 2013.
The researchers used a medical database containing comprehensive clinical and demographic data on all inpatient admissions from more than 600 acute care hospitals across the U.S., including approximately 5.5 million patient discharges, or roughly 15 percent of all hospitalizations in the U.S. Using this database, the researchers identified all women ages 18 and older who underwent a hysterectomy for benign disorders between January 2007 and March 2010. The patients were classified into one of the four hysterectomy techniques discussed above. Demographic data, such as age, year of surgery, race and insurance status, and reason for the hysterectomy were collected for each patient. The hospital in which the surgery was performed and the number of surgeries performed at each hospital and by each surgeon also were recorded.
The researchers then collected data on mortality rates and complications that occurred during or after the surgery. Finally, the researchers calculated the actual costs of the surgical procedures.
JAMA study results
The researchers identified 264,758 women who underwent hysterectomy at 441 hospitals across the U.S. from 2007 to 2010. Of these, a total of 123,288 (46.6 percent) underwent an abdominal hysterectomy, 54,912 (20.7 percent) had a vaginal hysterectomy, 75,761 (28.6 percent) had laparoscopic surgery and 10,797 (4.1 percent) had robotic surgery. The table on page 6 provides the percent of hysterectomies for each technique for the first quarters of 2007 and 2010. During the study period across all hospitals, the use of abdominal and vaginal hysterectomies declined (by 13.5 and 1.9 percent as a share of all hysterectomies, respectively), while laparoscopic hysterectomies increased (by 6.2 percent) and robotic hysterectomies increased significantly (by 9 percent).
Not all hospitals within the database performed robotic hysterectomies, so the researchers also assessed trends in the relative rates of the different surgical procedures only for those hospitals that did perform robotic procedures. They found that three years after the first robotic surgery was performed at these hospitals in 2007, robotic hysterectomies accounted for 22.4 percent of all hysterectomy procedures. The relative rates of the three other types of hysterectomies declined over this same time period. In contrast, for those hospitals that did not adopt the robotic technology, the relative rates of abdominal and vaginal hysterectomies decreased, whereas the rate of laparoscopic surgeries increased.
The researchers found that patients with private health insurance underwent robotic surgery more often than those with Medicare, Medicaid or no insurance. Patients treated at larger hospitals and at metropolitan medical centers also were more likely to have a robotic procedure.
The investigators compared outcomes and costs in a sample of 4,971 patients who underwent robotic hysterectomy with an appropriately matched sample of an equal number of patients who underwent a laparoscopic procedure. Matching took into account patient demographic and clinical factors (age, year of diagnosis, race, marital status, insurance status, reason for the surgery, other concomitant procedures and other diseases) and hospital factors (location, bed size, and hospital and surgeon hysterectomy volume). There were no significant differences in the rates of complications during and after surgery for the two patient groups. There also were no deaths in either group. However, laparoscopic hysterectomy patients were more likely than robotic surgery patients to have hospital stays longer than two days (25 percent versus 20 percent, respectively), whereas the total cost of the surgery was lower for the laparoscopic hysterectomy than the robotic procedure (an average of $6,700 versus $8,900, respectively).
Implications of the study
Too often, new medical technologies are adopted and aggressively promoted by hospitals before evidence has been obtained from well-designed clinical trials demonstrating that the new technologies are as safe, clinically effective and economical as older, more established treatments. The use of robotic technology for hysterectomy is an example of such circumstances.
In considering potential causes of the rapid adoption of robotic hysterectomy, the JAMA study authors noted:
- Robotic surgery may be easier for surgeons to learn than the laparoscopic technique because it is more similar to traditional open abdominal surgery;
- Robotic techniques may allow a minimally invasive approach for more technically demanding surgeries that would otherwise have required the more invasive, open abdominal hysterectomy.
- Extensive marketing of robotic surgery to surgeons, hospitals and medical consumers may contribute to increased use of the technology.
An editorial commenting on the hysterectomy study in the same JAMA issue noted that the “national fascination with technology and innovation” also likely affects the rapid expansion of the use of robotic hysterectomy. Slick marketing campaigns by hospitals and surgeons that offer robotic surgery clearly take advantage of this.
Continuing along these lines, the JAMA editorial noted the following:
Considerable debate surrounded the emergence of direct-to-consumer advertising of prescription drugs in the 1990s. Robotic surgery takes this marketing to a higher level with advanced campaigns not only by industry, but also by surgeons and the hospitals that own the machines. Such consumer-directed advertising is not without merit if it uses consumer awareness to advance underused medical discoveries that benefit the population. However, when the innovation being advertised is of questionable advantage, direct-to-consumer promotion may only fuel unnecessary utilization.
We agree with the editorial writers.
Although there may be a subset of patients needing a hysterectomy who could benefit from robotic surgery, well-designed clinical studies have yet to identify such patients. Today, many patients are undergoing the more expensive robotic hysterectomy without evidence that it is improving patient outcomes. Until such evidence is obtained, patients considering hysterectomy should avoid being swayed by the advertising campaigns promoting robotic hysterectomy.