Prostate cancer patients who chose minimally invasive surgery rather than more extensive operations to remove the prostate were less likely to experience complications like pneumonia, but reported higher rates of long-term problems, including impotence and incontinence, according to one of the largest studies to compare outcomes to date.
Patients achieved similar rates of cancer control regardless of which surgery they had, the analysis found.
The study, in Wednesday’s Journal of the American Medical Association, is not considered the last word on the subject, several experts agreed. But it raises questions about claims of superiority of minimally invasive laparoscopic and robotic-assisted surgeries, which have led to a surge in their popularity.
“People intuitively think that a minimally invasive approach has fewer complications, even in the absence of data,” said Dr. Jim C. Hu, the study’s lead author, who is director of urologic robotic and minimally invasive surgery at Brigham and Women’s Hospital in Boston. “Men who were well educated and had higher incomes were actually more likely to embrace this approach, often due to aggressive marketing by hospitals that had spent $1.5 million to acquire the robots. I think the technology has been oversold.”
In one version of prostate removal, called open surgery, a surgeon makes an incision that is several inches long. With minimally invasive surgery, also called laparoscopic surgery, the surgeon operates through a series of small incisions using tools and a camera for the operation. With robotic surgery the surgeon sits at a computer and manipulates a robot to do the operation through the small openings.
In 2003, minimally invasive radical prostatectomies, which include robotic surgeries, made up fewer than 10 percent of prostate removal surgeries. By 2006-7, they constituted 43 percent of procedures.
The Harvard researchers who did the study assessed the outcomes of 1,938 men who had minimally invasive prostate surgery from 2003 to 2007 and 6,899 men who had open surgery. They used Surveillance, Epidemiology and End Results, or SEER, data from the National Cancer Institute representing 26 percent of the American population, linking it with Medicare data.
The men in the study — all of them 65 or older — who underwent minimally invasive surgery had shorter hospital stays, fewer respiratory complications and other surgical complications, and were far less likely to receive a blood transfusion. But they had more complications involving the genital and urinary organs immediately after surgery, with 4.7 percent having those complications, compared with 2.1 percent of open surgery patients.
When the researchers looked at lasting complications more than 18 months later, they found that men who had minimally invasive surgery were at greater risk of suffering from incontinence and erectile dysfunction than those who had open surgery.
For each 100 men who had minimally invasive surgery, some 15.9 percent were at risk of being incontinent each year, while 26.8 percent experienced erectile dysfunction, compared with 12.2 percent and 19.2 percent, respectively, each year for every 100 men who had open surgery, the study calculated.
Several surgeons who specialize in robot-assisted procedures said the study was limited because it was unable to distinguish between those using robot technologies and older minimally invasive techniques.
Many experts said the outcomes of experienced surgeons were better than those reported in the study.
“I almost exclusively do robotic prostatectomy now because I think that, despite this manuscript, there is clear evidence that it is comparable, in terms of continence, potency and tumor control,” said Dr. Joseph Smith, the chairman of urologic surgery at Vanderbilt University School of Medicine.
But Dr. Smith added, “I don’t think there’s anything demonstrating it to be superior.”
Dr. Peter Scardino, chief of surgery at Memorial Sloan-Kettering, said the study was important because it reported on data that did not come just from one medical center or one region.
“At the end of the day,” Dr. Scardino said, “what all the studies will show is that it’s not the tools the doctor uses, but the experience and skill of the surgeon. There’s nothing magical about the laparoscopic or robotic.”
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.”