Robotic Surgery Gaining Popularity But Lacking Safety, Training Standards

September 22, 2009

Surgeons are increasingly turning to high-tech robotic equipment to operate on patients with prostate cancer and other conditions but some medical authorities worry about inadequate training and lax standards among practitioners.

Doctors are opting for Intuitive Surgical’s popular da Vinci Surgical System over conventional surgery, especially for removing the prostate gland, because it is less invasive and allows for greater precision. There were some 80,000 robotic prostatectomy procedures in the United States last year.

The device’s robotic arms are equipped with tiny instruments and a camera. The instruments, inserted through small incisions, do the actual prodding and cutting with the surgeon operating the controls while viewing the procedure via a magnified three-dimensional screen.

The rate of failure for such surgeries is comparable to that of traditional surgeries but patients are more at risk if inexperienced surgeons use the robots.

“The more you do, the better you’re going to get. The question is at what point are you doing safe surgery,” said , said Dr. Kevin Zorn, chief of urology at Weiss Memorial Hospital at the University of Chicago.

Zorn was lead author of an article in the September issue of the Journal of Urology that proposed instituting training standards for surgeons using the equipment. Currently, there is no credentialing system to evaluate a surgeon’s competency and surgeons cannot practice on simulators before taking on live patients. Zorn believes such machines ought to exist.

He recounted one case of a surgeon who was using the system for the fourth time. After eight hours of surgery, the proctor — an experienced surgeon who supervises the operation — told the surgeon that progress was too slow. He recommended the surgeon switch to conventional surgery, where an incision is made from the navel to the pubic bone to access the prostate.

After the proctor left the operating room, the surgeon continued using the robot. The patient later died from complications.

STANDARDS TO BE ADDRESSEDThe issue of standards will be addressed at next month’s World Congress of Endourology in Munich. The American Urology Association (AUA) will consider the recommendations.

Robotic surgery is used on patients suffering from gynecological cancer, coronary artery disease, kidney cancer, and bladder cancer and in about 85 percent of all radical prostatectomies in the United States. Mistakes in the delicate procedure can lead to incontinence and impotence.

Some scientists believe doctors, especially in the United States, are too eager to operate in cases of prostate cancer and would often do better to wait to see if tumors develop.

Prostate cancer is the second most common cancer in men worldwide, killing 254,000 men each year.

As of mid-2009, there were 1,242 da Vinci Surgical Systems in place throughout the world, up from 286 in 2004. Prices range from $700,000 to $2.25 million per system.

Zorn, who said he has performed more than 500 robot-assisted surgeries, reckoned a surgeon must use the system at least 20 times before becoming familiar enough with the set-up and the procedure to do the surgery safely.

Hospitals have different guidelines and some have none, Zorn said in an interview.

“Intuitive did a great job getting out (and) promoting it, but really didn’t think about making sure we’re doing safe robotic surgery,” he said.

But Zorn said that surgeons, not manufacturers, carry ultimate responsibility for proper training.

Ben Gong, vice president of finance at Intuitive, agreed, saying that while the company is committed to training, it is not the manufacturer’s responsibility to set standards.

“That’s up to the hospitals and the medical societies. We work very closely with the medical societies,” Gong said. “We are in favor of more training. We are all about training, and we put a lot of money and resources into training.”

Zorn, who has served as an expert witness in court actions and as a proctor, said robotic surgery can take longer than it should if the surgeon is still learning the equipment, creating a risk of neurological problems or poor renal function.

“If you’re not good at the surgery and you don’t know what you are doing, it could take you twice as long,” he said.

However, doctors say in most cases the da Vinci system produces better results than conventional surgery because patients experience less trauma, blood loss, risk of infection, scarring and pain. Hospital stays are also generally shorter.

“Robotic surgery is a major improvement,” said Dr. H. Pat Hezmall, director of USMD Prostate Cancer Center in Arlington, Texas. “The patient is home eating dinner that night.”

“Patients are demanding it,” added Dr. Michael McGuire, surgical director of Urology Oncology and co-director of the Prostate Cancer Center at Northshore University Health Systems in suburban Chicago.

As many as nine out of 10 prostate cancer patients who opt for surgery prefer robotic-assisted surgery, said McGuire, who has done hundreds of procedures.

“If you don’t do robotic surgery, you may as well get out of the prostate surgery business,” McGuire said.

(Editing by Alan Elsner)

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