Health News Review

The surgeon who blogs as Skeptical Scalpel writes that he (she?) is unable to contain him(her)self any longer and then lunges into a review of evidence (or lack thereof) for robotic surgery.

You may disagree with Skeptical Scalpel’s decision to be anonymous, but he/she explains:

“I’ve been a surgeon for almost 40 years and a surgical department chairman for over 23 of those years. During much of that time, conforming to the norms, rules and regulations of government agencies, accrediting bodies, hospitals, societies, and social convention was necessary for survival. I was always somewhat outspoken but in a controlled way most of the time. I now have a purely clinical surgery practice with no meetings, site visits or administrative hassles. I am free to speak my mind about medicine or anything else.”

Operating-Room.jpg

On robotics, Skeptical Scalpel writes:

The problem with robotic surgery is that it has never been shown to improve patient outcomes for any procedure. Let’s look at the literature. The review articles cited below are almost exclusively based on non-randomized studies.

Laparoscopic Cholecystectomy. A review by the noted Cochrane Group involving five studies and 453 patients showed no differences in any outcome measure when comparing robotic surgery to conventional laparoscopic surgery.

Esophageal Reflux Disease. A review of 11 papers comparing standard laparoscopic anti-reflux surgery to Robot-Assisted Laparoscopic Fundoplication [acronym "RALF"] in 533 patients showed no differences in peri-operative complication rates or length of hospital stay. The robotic procedure took significantly longer. Another recent paper demonstrates the lack of quality research on this topic.

Colorectal Surgery. A review of 17 studies, one of which was randomized and controlled, showed no difference in the rates of complications and cancer outcomes. Robotic procedures took longer an cost more than conventional laparoscopic colon surgery. Despite the results, the authors felt that “Robotic colorectal surgery is a promising field and may provide a powerful additional tool…”

Gynecologic Surgery. A review of 22 non-randomized studies found that robotic surgery resulted in less blood loss [statistically significant but not clinically significant differences] and shorter hospital stays but no differences in overall complication rates when compared to conventional laparoscopic or open surgery. The authors commented that the methods used in the papers reviewed were poor and better studies are needed before concluding that robotic surgery offered any true advantages.

Abdominal Surgery. A paper from 2010 looked at 31 studies of nine different abdominal operations [robotic vs. conventional laparoscopic], 6 of which were randomized, controlled trials [RCTs]. The total number of patients included in all the studies was 2166. The number of patients who were participants in RCTs was 230. No RCT involved more than 50 patients. Not surprising was that the results were mixed with robotic surgery offering no clear advantage. These authors also called for larger and better designed studies.

Prostate Cancer. To date, there are no good RCTs comparing robotic to open or standard laparoscopic prostatectomy. This quote from a recent review of the literature on prostate cancer surgery says it all:

“Robotic prostatectomy is definitely here to stay and although a randomized, controlled trial comparing the open to robotic techniques would be ideal, it is clear that this is unlikely to occur.”

The issue may already be settled. According to the New York Times, patients are voting with their feet, preferring to have robotic surgery when it is available. This appears to be true in Wisconsin as well. A recent paper reveals that when hospital purchase a robot, their volume of prostate cancer surgery doubles.

Questions. Can anything be done about this? Should Medicare and private insurance companies pay for expensive, unproven treatments?

See the comment left on the blog by an anonymous commenter about a lawsuit involving a death 10 days after robotic prostatectomy….and Skeptical Scalpel’s response that this may be just the tip of the iceberg.

I always remind readers that the plural of anecdote is not data. But with any technology for which we only hear about benefits and rarely hear about harms, one wonders how many such anecdotes we never hear about.

Comments

Barry F. Cohen posted on July 31, 2011 at 7:38 pm

If a person is truly free to speak their mind, then it is an important piece of Data to identify whose mind it is, if we are to belive their need for Data
I can easily note that in the US alone there were approx. 33 million surgeries performed last year. Out of that number only were 160,000 were performed by the da Vinci surgical robot.I am sure that were proportionatly more complaints to the regular procedures than for the robotic operations. The patient consumer speaks to other patients as well as surgeons, and they know what the patient outcomes were. You do not require a big data collection to know what the people already know.The prostatectomy patients in some hospitals have to be separated from the open radical patients because of the extreme differences in the patient experience. If a surgeon does not believe that leaving a hospital bed 2 or 3 days earlier is not an important step forward as a result of robotic surgery, then he or she has a real problem, and it is not with robotics.
Robotic surgery is in it’s infancy and there are the naysayers to all advances vitually in all fields….Gen Billy Mitchell spoke in 1926 to the US Navy senior staff to warn that Battleships were not able to be defended from aerial attack, and was rebuffed saying that was impossible to sink a Battleship or Cruiser with airplanes.
The rest is history……I would guess the “Skeptical Scapel” to be close to 70 plus or minus a few years and has no experience with a robot for surgery. I think he or she should try observing a case and then offer their view pro or con for your readers after an experience. Any layman who witnesses an open radical procedure vs a robotic procedure, and see’s the outcome for the patient, and the lack of wear and tear on the surgeon who may do 3 or 4 operations that same day, would have to come to a positive conclusion……call it anecdote or fact, the results are overwhelming in support of robotics in surgery and of course more advances will come with time and experience. After all the proven manual methods have 5,000 years of experience so far.
Try taking a lumberjack’s power chain saw away from him, and give him an axe back to work with; see what the results would be.
The Intuitive Surgical Company has broken the ice with their daVinci surgical robot and has advanced surgery in great measure, and the owners or users of those new robots are not looking back.
They are expensive now but as time goes on newer robots will come onstream and pricing will adjust, but it is also the responsibility of the hospitals to take advantage of this highly productive machine and develop profitability with it on their own. It is also the responsibility of surgeons all, for the benefit of their patients to try this new system of operating to determuine if they can deliver better results for themselve as well as the patients.

Gary Schwitzer posted on July 31, 2011 at 9:51 pm

Mr. Cohen,
Thanks for your comment, which I posted although my comments policy states that I routinely delete comments that make product pitches.
Clearly, as one who describes himself as an entrepeneur who promotes this technology, you have a conflicted view.
You seem to have a disdain for evidence, for data, almost mocking anyone with “a need for Data” in your opening sentence. Then you go on to urge surgeons and laymen to “witness” or “observe” a case in person. That is not the scientific method. That’s not the way decisions about technology proliferation should be made.
That’s why there’s a call for better outcomes data to steer individual and institutional decision-making.
Finally, your business interests shout out when you strong-arm hospitals and even surgeons – chiding both these institutions and these professionals that it is their “responsibility”… “to take advantage of this highly productive machine and develop profitability with it on their own.”
Health care providers have a responsibility to “first, do no harm”…to deliver safe, effective care based on the best evidence. They have no obligation to adopt a technology about which there are unanswered questions for some of the uses for which it is promoted.
In your comment you hypothesize that the Skeptical Scalpel is about 70 years old with no experience with a robot. On the Skeptical Scalpel’s blog, a surgeon who DOES have experience with the robot left a comment ( http://skepticalscalpel.blogspot.com/2011/07/is-robotic-surgery-all-hype-and-no.html#comments ) that reads, in part:
“I think the facts in this post are correct. …I do wish as (Skeptical Scalpel) points out that studies would be done since my opinion is that some surgeries are not complicated enough to warrant the extra expense of a robot. The actual expenses would need to be looked at as well as the outcomes.”
In other words, a call for outcomes data.
There’s that troublesome word again!

Gregory D. Pawelski posted on August 1, 2011 at 12:35 pm

There are very few prospective, randomized trials to prove the value one type of surgery versus another type of surgery. What studies exist are simply retrospective comparisons of outcomes of patients having have various studies or therapies. By definition, these studies can only be done if the modality in question (robotic surgery) is already in widespread use.
In point of fact, it is precisely because mammography was performed decades before it was validated for “efficacy” that it was possible to improve mammography (e.g lower the radiation dosage; improve the resolution, etc.), to reduce the per unit cost, and perform retrospective analyses to gauge whether mammography was or was not “efficacious” and, if so, in what situations was it of sufficient “efficacy” that it’s continued use should be supported.
Proving “efficacy” in a single, given situation would say nothing at all about the efficacy in another situation. If one demands “efficacy,” intellectual honesty and consistency would demand proof of efficacy in all situations where this testing was to be applied. This is simply impossible.

Skeptical Scalpel posted on August 1, 2011 at 1:03 pm

A Google search reveals that Barry F. Cohen is president of a company that promotes robotic surgery. ( http://allaboutroboticsurgery.com/aboutus.html )
In his comment Mr. Cohen states, “You do not require a big data collection to know what the people already know.” Well, actually I and many others do “…require a big data collection…” to convince ourselves that robotic surgery is better than conventional surgery.
Here is just one example of a medical device that was used for more than 25 years that “everyone knew” it was efficacious. For most of that time, it was considered unethical to propose a study that contained an arm calling for no PA catheter to be used. Finally, a few intrepid souls began question its use because some adverse outcomes were surfacing and it had never been subjected to a randomized prospective trial. Several studies were then done that confirmed the device did not improve outcomes and in fact, probably caused more harm than good. The device is called a pulmonary artery (Swan-Ganz) catheter. In its heyday, one million PA catheters costing more than $150.00 each were sold per year. Over the 25 years of its popularity, hundreds of millions of dollars were wasted.
Mr. Cohen is right about one thing. I have not used the robot, nor do I intend to until it is proven to be better. But I have treated patients who have suffered complications after robotic surgery. Mr. Cohen suggests that one should observe a robotic case to see how great it is. What if I had observed the case that was described in the comments section of my blog? I will reprint it here:
“A well known hospital in Southern CA and the surgeon will probably paying quite a lot for one of their robotic prostatectomies. A relative via marriage had robotic prostatectomy and died ~10 days post op – I suspect due to perfed bowel not seen during surgery. Pain disregarded at f/u visit, then distension -> AKF -> re-op -> ARDS -> MSOF -> death. Litigation pending. But hey, if he had survived he would have had a nerve sparing surgery done by a robot.”
Mr. Cohen’s argument, based upon no facts, is as unconvincing as it is disingenuous.

Elaine Schattner posted on August 8, 2011 at 3:17 pm

basic question: How do you know the skeptical scalpel author is a surgeon or a physician of any kind?
(For the record, I’m skeptical about robotic surgery and more or less agree with the articulated concern.)

Catherine A. posted on August 21, 2011 at 7:22 pm

A local woman (Bham AL) died about two weeks after a robot accidentally pierced her heart. I’m not certain but I believe this occurred at Trinity Medical Center. She coded twice, then developed renal failure, pneumonia, and sepsis, then liver failure, then she died. She was 49. Nightmare.