Robotic surgery wins converts though results are unproved

At age 42, Dr Jeffrey A Cadeddu feels like a dinosaur in urologic surgery. He was trained to take out cancerous prostates the traditional laparoscopic way: making small incisions in the abdomen and inserting tools with his own hands to slice out the organ.

But now, patient after patient was walking away. They do not want that kind of surgery. They want surgery by a robot, controlled by a physician not necessarily even in the operating room, face buried in a console, working the robot’s arms with remote controls.

“Patients interview you,” said Cadeddu, University of Texas Southwestern Medical Centre at Dallas. “They say: ‘Do you use the robot? OK, well, thank you’.” And they leave.

On one level, robot-assisted surgery makes sense. A robot’s slender arms can reach places human hands cannot, and robot-assisted surgery is spreading to other areas of medicine. But robot-assisted prostate surgery costs more — about $1,500 to $2,000 more per patient. And it is not clear whether its outcomes are better, worse or the same.

One large national study, which compared outcomes among Medicare patients, indicated that surgery with a robot might lead to fewer in-hospital complications, but that it might also lead to more impotence and incontinence. But the study included conventional laparoscopic surgery patients among the ones who had robot-assisted surgery, making it difficult to assess its conclusions.

It is also not known whether robot-assisted prostate surgery gives better, worse or equivalent long-term cancer control than the traditional methods, either with a 4-inch incision or with smaller incisions and a laparoscope. And researchers know of no large studies planned or under way.

Meanwhile, marketing has moved into the breach, with hospitals and surgeons advertising their services with claims that make critics raise their eyebrows. For example, surgeons in private practice at the New Jersey Centre for Prostate Cancer and Urology advertise on their website that robot-assisted surgery provides “cancer cure equally as well as traditional prostate surgery” and “significantly improved urinary control.” And robot-assisted prostate surgery has grown at a nearly unprecedented rate.

Last year, 73,000 American men — 86 per cent of the 85,000 who had prostate cancer surgery — had robot-assisted operations, according to the robot’s maker, Intuitive Surgical, the only official source of such data. Eight years ago there were fewer than 5,000, Intuitive says.

Medical researchers say the robot situation is emblematic of a more general issue. New technology has sometimes led to big advances, which can justify extra costs. But often, technology spreads long before investigators know whether it is worthwhile.

With drugs, the Food and Drug Administration requires extensive tests to determine safety and efficacy. But surgeons are free to innovate, and few would argue that surgery can or should be held to the same standards as drugs. Still, a situation like robot-assisted surgery illustrates how patients may end up making what can be life-changing decisions based on little more than assertive marketing or the personal prejudices of their surgeon.

“A guy who is at the top of his game has little motivation to pick up new tools,” says Dr Jason D Engel, director of urologic robotic surgery at George Washington University Medical Centre in Washington.

Marketing hype

“There is no question there is a lot of marketing hype,” said Dr Gerald L Andriole Jr, chief of urologic surgery at Washington University. Andriole does laparoscopic prostate surgery, and although he tried the robot, he went back to the old ways. “I just think that in this particular instance, with this particular robot,” he said, “there hasn’t been a quantum leap in anything.”

But papers in the new journal tend to report on one surgeon’s experience. Studies like that, which were also published in the past to promote traditional surgery, have methodological problems — biases in patient selection and evaluation are likely and, because the surgeons tend to be much better than average, it is hard to generalise.

In contrast, the national study of Medicare patients from 2003 to 2007, by Dr Jim C Hu of Brigham and Women’s Hospital in Boston, included 6,899 men who had surgery with 4-inch incisions and 1,938 who had laparoscopic surgery, many with a robot.

The study was not ideal — patients were not randomly assigned to have one type of surgery or another, and laparoscopic operations done without a robot were included with the robot-assisted ones because Medicare did not distinguish between the two. But it is the only large national study that compares what is thought to be a largely robot-assisted surgery group to a group that did not have a robot.

Experts in robotic surgery say studies like Hu’s can be misleading. Medicare data, they say, include results from surgeons who may have little experience with robots.
Barry, an author of Hu’s paper, said Medicare data reflect the real world. “Everyone tends to cite data from centres of excellence as though they were their own,” he said.

Highly skilled surgeons, like Dr Ashutosh K Tewari at Weill Cornell Medical College in New York, say it takes about 200 to 300 robot-assisted operations to become highly proficient. Tewari has performed 3,200. Surgeons who do nonrobotic prostate surgery agree.

“What happens is that if you take leading experts, whether they do open or robotic, they are going to get good results,” said Dr Herbert Lepor of New York University, who has done more than 4,000 traditional open prostatectomies.

“I say robotic surgery has to be better to justify its learning curve,” Lepor said, “to justify its unknown cancer control, to justify its increased cost.” Both traditional surgeons and those who do robot-assisted surgery point to patients who did extremely well.

Among them is James Lamb, a 40-year-old New York City police officer who had robot-assisted surgery with Tewari on Jan 5. Two days later, while he was in the hospital and still had a catheter in his penis, Lamb had an erection.

Two days after that, Lamb said, he was home and had sexual intercourse. (In one study by Barry, which surveyed patients a year after surgery, only half the men, regardless of surgical method, were back to their presurgery potency a year later, with or without the use of a drug like Viagra.)

But, Barry and Tewari note, an extraordinary patient or two can be misleading. “The message for patients is not to assume that newer is better,” Barry said. Measures like the number of operations a surgeon has done “still matter a lot,” he said.

Cadeddu, though, said that sort of message is falling on deaf ears. Patients want the robot. So Cadeddu has now begun offering robot-assisted surgery to those who want it. “The battle is lost,” Cadeddu added. “Marketing is driving the case here.”