Caution sounded on robot-aided prostate surgery
A nationwide study published yesterday raises serious concerns about robot-assisted prostate cancer surgery, a procedure that hospitals have widely advertised as having fewer complications than standard operations.
Harvard Medical School researchers found that cancer patients who underwent minimally invasive prostate removal - now usually done with remote-controlled robots - were more than twice as likely to experience incontinence or impotence a year and a half after their operations than patients who had traditional surgery using an open incision.
The study found that 4.7 percent of men who had minimally invasive surgery suffered these complications compared with 2.1 percent of men in the standard-operation group. Success at controlling the cancer was about the same for both operations.
The minimally invasive, or laparoscopic, surgery was found to have some advantages, however: Patients were able to go home from the hospital in two days on average, one day shorter than the standard-surgery group, and had fewer post-surgery respiratory problems and other short-term complications.
Dr. Jim Hu, a urological surgeon at Brigham and Women’s Hospital and the study’s lead author, said the results show how direct-to-consumer marketing can lead to the explosion of an expensive new treatment - even when little evidence exists to support the therapy’s superiority over standard care.
The government data Hu and his colleagues used for the study did not distinguish between minimally-invasive surgery with a robot and without a robot. But during this decade, robot-assisted prostate-removal surgery grew rapidly. It accounted for just 1 percent of such operations in 2001; by 2006, the number had jumped to 40 percent. Today, California-based
“Once hospitals have made that multimillion dollar commitment of buying a robot, they want to market it,’’ Hu said. And patients are particularly receptive to advertising of minimally invasive robotic surgery, he added. “Patients intuitively perceive minimally-invasive procedures to be better because of the new technology and the wow factor that goes into it.’’
However, Ryan Rhodes, an Intuitive spokesman, called the new study misleading because it did not use patient surveys, which he said are the most reliable indicator of whether a patient suffers from post-surgical erectile dysfunction or incontinence. Rhodes also criticized the study because of the uncertainty over how many of the minimally invasive cases involved a robot. He said the da Vinci was not in as wide use in the early years of the study.
The study, published in the Journal of the American Medical Association, reviewed Medicare claims data for 8,837 men age 65 and older who had their prostates removed between 2003 and 2007, in one of the largest multicenter studies yet on a much-debated area of medicine. Long-lasting erectile dysfunction and incontinence are among the most worrisome side effects of prostate surgery, and many surgeons who do robot-assisted procedures insist their patients have lower rates of these complications than when they did open operations.
“In the hands of experienced surgeons like myself, we get at least equal and more likely superior results,’’ said Dr. Ingolf Tuerk, chief of urology at St. Elizabeth’s Medical Center in Brighton. Tuerk, who is featured on a Massachusetts Turnpike billboard promoting robot surgery at the hospital, said he felt the study results were not conclusive because it was done at a time when surgeons were still learning to use the robot for prostate surgery. And he said it’s unfair to criticize advertisements of robotic surgery, since surgeons who do the traditional prostate procedure advertise, too.
Surgeons note that the robot is particularly well-suited for prostate cancer surgery, enabling surgeons to make several small cuts instead of a long, painful incision down the belly. Surgeons sit at a console in the operating room and pump foot pedals and move levers to signal a robotic arm to slice and stitch - an arm they say is more flexible and steadier than the human wrist and than traditional laparoscopic instruments.
Hu said he does not believe the robot technology is the problem. Instead, he believes that many surgeons do not have enough experience using it. Studies suggest that it takes several hundred cases to become proficient at operating with a robot, he said, when the average surgeon does just 12 cases a year. The US Food and Drug Administration, Hu said, mandates that surgeons take a weekend course before starting to use the robot for prostate surgery, and then be monitored briefly by a surgeon who has done at least 20 cases.
“If we were honest with ourselves in the surgery field, we’d say you can’t do this operation well after a two-day course and a proctor helping you on a few cases,’’ he said. Prostate surgery is by far the fastest growing use of robots, but surgeons also are employing them in gastric bypass surgery, hysterectomies, and for removing uterine fibroids. Hospitals also are beginning to offer - and advertise - robotic cardiac surgery, though there are few studies comparing its results to standard heart surgery.
Paul Levy, president and chief executive of Beth Israel Deaconess Medical Center, lamented in his online blog in February 2007 that surgeons at his hospital were lobbying him to spend more than $1 million on a robot, “despite lack of evidence of its benefits.’’ They told him that without it, prostate surgery cases “would likely plummet by 2010 and BIDMC would consequently quickly become a non-entity in regional prostate cancer care.’’
Levy asked his readers, “Do I spend over $1 million on a machine that has no proven incremental value for patients, so that our doctors can become adept at using it and stay up-to-date with the ‘state of the art’, so that I can then spend more money marketing it, and so that I can protect profitable market share against similar moves by my competitors?’’
A year and a half later, in November 2008, in an entry called “Uncle’’, Levy said Beth Israel Deaconess, too, was buying a robot. Dr. Martin Sanda, one of the Beth Israel Deaconess surgeons, said yesterday that Levy “expressed a reasonable skepticism . . . he wanted to be convinced there was reasonable medical evidence for why buying a robot would be advantageous. We did provide him with some of that data.’’
Sanda, who also criticized the methodology used in the JAMA study, said “there are a lot of unanswered questions’’ about the potential benefits of robot-assisted prostate surgery. Beth Israel Deaconess has received $1 million from the National Institutes of Health to lead a national study that will use patient surveys to compare rates of impotence and incontinence for both types of prostate surgery.
Liz Kowalczyk can be reached at firstname.lastname@example.org.