A new study debating the effectiveness of minimally invasive prostate surgery is not telling the whole story, warns Dr. David B. Samadi, Chief of the Division of Robotics and Minimally Invasive Surgery in the Department of Urology at The Mount Sinai Medical Center in New York.
Authored by Dr. Jim Hu, a surgeon in the Urology Division of Brigham and Women's Hospital in Boston, the study appears in the Journal of the American Medical Association and suggests that minimally invasive radical prostatectomy (MIRP) carries a higher risk of impotence and incontinence than traditional surgery. Dr. Samadi feels that there is not enough comprehensive data to make this determination as the study did not demonstrate the number of patients that actually had robotic surgery, pre-existing urinary and sexual dysfunctions prior to surgery, and most importantly, the experience and skill of the surgeons involved.
Dr. Hu's robotic prostate surgery study acknowledged that MIRP patients had shorter hospital stays, were less likely to need a blood transfusion, had less post-surgical respiratory complications and less urethral stricture. However, it also left out too much important data to accurately base a final conclusion, said Dr. Samadi, who has successfully performed over 2,100 robotic surgeries in his practice. Samadi believes that the author considered only the study's parameters, which does not paint an accurate picture.
Data was analyzed from the years 2003 to 2006 of a group of nearly 2,000 Medicare prostate cancer patients who had minimally invasive surgical treatment. "Right out of the gate, we can challenge the findings of the study based on the fact that, out of the group of patients that had minimally invasive surgeries, we are not sure how many specifically had robotic surgeries," stated Dr. Samadi. Additionally, the study grouped all surgeries together, including laparoscopic and robotic surgery data, which does not single out either procedure, and was based on Medicare billing codes, which typically includes all prostate surgeries, regardless of type. By analyzing just Medicare patients, Samadi stated that the study group consists of a population that tends to be older with larger prostates, thereby adding to the risk of side effects.
However, most importantly, states Dr. Samadi, during the years of the study, robotics was a new and emerging treatment. And, with the bulk of the data coming from Michigan and California, Samadi believes the public is only getting part of the story. "This study was conducted during a time when not only the modality was new, but the doctors and hospitals offering it were few and far between," he says, "Not surprisingly, back then, patients opted for the closest surgeon, and this does not guarantee the best surgeon."
What is vital to note is that there is no information from validated questionnaires, which Dr. Samadi routinely uses in his practice for outcome research. These questionnaires are given to patients prior to their surgeries specifically to ascertain any pre-existing conditions, such as incontinence and impotence. They are also administered every three months after their surgeries to discuss their experiences and complications, if any. "Without the validated questionnaire data, we don't know exactly how many of these patients had urinary or sexual problems to begin with," muses Samadi. "If the problem already existed, then of course it will still exist after the surgery." Dr. Samadi believes that this ambiguity casts doubt on the study's conclusion and could potentially confuse patients during a difficult time in their lives.
Ironically, it was the study's author who delivered the biggest rebuttal. Dr. Hu admitted that in both minimally invasive and traditional surgeries with reported post-surgical complications of incontinence and impotency, the doctors might have been inexperienced, which may have contributed to these complications. "The data would suggest both procedures are equivalent in the hands of a skilled surgeon," said Hu. Hu also acknowledged that there "are advantages to each type of surgery," and that a prostate cancer patient "should talk with his surgeon about their level of experience performing each type of surgery and what the outcomes are."
The FDA currently mandates that surgeons take a weekend course to learn how to use the robot for prostate surgery, and then be monitored by a surgeon who has done at least 20 cases. Studies have shown that it takes several hundred cases to become proficient at operating with a robot. Dr. Samadi believes that the learning curve for robotics is too steep to be learned with just a weekend of training. Dr. Hu also supported this in his study when he said, "As with any new procedure, there is a learning curve."
"Of course, you can't just buy a robot, market it and be good at it just like that," says Dr. Samadi, "The concept of 'see one, do one, teach one' doesn't work in a complex surgery such as this. It's not the technology. It is important for patients to remember that the robot doesn't perform the surgery -- the surgeon does."
Samadi believes that the average surgeon barely performs enough robotic prostatectomy procedures to be considered proficient. He further explains that robotics are used just for an extra surgical edge, but that there is an actual surgeon at the controls -- hopefully, an experienced one. "The surgeon must possess all three skills (traditional, laparoscopic an robotic experience) and not just rely on one modality," he explains. "With an experienced surgeon, who is also an oncologist and possesses all of these skills, patients should not experience these kinds of side effects."
Dr. Hu acknowledged that the findings are based on an average of the outcomes of many surgeries performed by many different surgeons with different skill levels throughout the country. "This uncertainty by the author himself is worrisome," says Dr. Samadi, "By grouping together surgeons of many different experience and skill levels, you can send the wrong message to patients." Samadi's philosophy is simple: bad surgeons get bad results and good surgeons get good results. "The bottom line is that many surgeons just do not have the right combination of experience with robotic surgery," says Samadi.
With regards to the post-surgical complications from robotic surgery, Dr. Samadi has data of his own to refute Dr. Hu's robotic surgery study. "Out of my last 1,100 cases, within one year, 97% of my patients regained their urinary control and 85% regained their sexual function," he said. "The average patient blood loss is 70cc and less than half a percent of my patients experiences urethral stricture scarring." And the outlook is even more promising with a reported positive margin of 4% for T2 disease.
The take-home message for his patients is a cautionary one: patients beware. "Be careful of what you read and make sure you get all of the information from the experts before you decide on a treatment," counsels Dr. Samadi. "Remember to look for surgeons who are also oncologists and who are not only trained in da vinci surgery, but who are also trained in laparoscopic and traditional surgeries as well. Knowing all three modalities is the key to true success in da vinci robotic prostatectomy surgery." Source:
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