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Robotic Hysterectomy Takes Off, Causing Concern


 

A recent explosion of interest in robotic surgery for routine hysterectomies and treatment of other nononcologic gynecologic conditions is raising concern about the cost and comparative value of the robot over conventional laparoscopy, as well as the future of vaginal hysterectomy and current and future training needs.

In 2010, for the first time, more hysterectomies were performed with the da Vinci Surgical System than any other procedure, including prostatectomy. The number of robotic-assisted hysterectomies performed worldwide grew to 110,000 in 2010, from approximately 69,000 the year before.

Approximately 32,000 of these hysterectomies were for treatment of cancer, and the remaining 78,000 were related to benign conditions, according to Chris Simmonds, senior director of marketing for Intuitive Surgical, which makes the da Vinci, the only such system currently on the market.

Gynecologic oncologists swiftly embraced the robotic surgical system after it was approved in 2005 for gynecologic surgical procedures because it enabled them to perform minimally invasive endometrial cancer staging – something most surgeons found too technically challenging with pure laparoscopy.

While issues of cost and training have been part of an ongoing debate in gynecologic oncology, such issues have taken on new meaning – and more urgency – with the more recent rise in robotically assisted routine hysterectomy. It can be argued, some experts explain, that an advantage exists for robotics in gynecologic oncology that, overall, does not exist for benign disease.

“Robotics will probably be the future of surgery,” said Dr. Resad P. Pasic, professor of obstetrics and gynecology and director of operative gynecologic endoscopy at the University of Louisville (Ky.). “We need to [better understand] what the real advantages are, however, especially for routine laparoscopic hysterectomies, because the cost is higher than traditional laparoscopy and vaginal surgery.”

Robotic assistance “is great for some procedures, like myomectomies, where there is more suturing. But I really don't see a huge benefit overall for less complex, benign cases,” he said in an interview. “We're even seeing supracervical hysterectomies being done [robotically] – that doesn't make any sense.”

A study published last year, which Dr. Pasic coauthored, found higher per-case hospital costs with robotic-assisted hysterectomies, compared with conventional laparoscopic hysterectomies, without any significant differences in complications, postsurgical infections, or frequency of hemorrhage.

Robot-assisted hysterectomies were associated with longer surgical times and cost an average of $2,600 more, the investigators reported (J. Minim. Invasive Gynecol. 2010;17:730-8).

Using the Premier hospital database, they analyzed patient records and billing and insurance data for more than 36,000 women who received minimally invasive hysterectomy during 2007-2008 in more than 350 hospitals. Their cost analysis reflected the cost of the robotic procedure to the hospital but did not include the acquisition or maintenance costs of the robotic device over time.

The robotic unit costs between $1 million and $2.3 million and is associated with annual maintenance costs of $100,000-$170,000 a year, and instrumentation/accessories costs of $1,300-$2,200 per procedure, according to Intuitive Surgical.

“Further decisions regarding the diffusion of robot technology in routine laparoscopic hysterectomy,” they concluded, must be informed by randomized controlled studies of comparative effectiveness.

At the annual meeting of the American Association of Gynecologic Laparoscopists last month, the paper won the organization's Robert Hunt Award for the “best article” published in the Journal of Minimally Invasive Gynecology in the past year. The study may cause some to pause, however, in that it was funded by Ethicon Endo-Surgery, and because three of the six coauthors have notable ties with Ethicon – one is employed by the company, one is a consultant, and Dr. Pasic is a speaker for the company.

Dr. Pasic, who said he uses the da Vinci for about 10% of his procedures, dismissed any suggestions of bias. “We're not the only paper concluding there is a high cost to robotics, and we made every effort to be as impartial as possible,” he said.

Authors of a broader recently published analysis of robotic-assisted surgery and health care costs drew similar conclusions about comparative value. The investigators examined all the cost studies of robot-assisted procedures published since 2005 and reported that, on average, “across the full range of 20 types of surgery for which studies exist,” the additional cost of using a robot-assisted procedure was about $1,600, or about 6% of the cost of the procedure in 2007 (N. Eng. J. Med. 2010;363:701-4).

There have not been any large-scale randomized trials of robot-assisted surgery, and the “limited observational evidence fails to show that the long-term outcomes of robot-assisted surgery are superior to those of conventional procedures,” said Dr. Gabriel I. Barbash of the medical school at Tel Aviv University and Sherry A. Glied, Ph.D., of the school of public health at Columbia University, New York.

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