Papers about robotic surgery outcomes may be swayed by payments from the manufacturer

In 2015 alone, the top 20 surgeons receiving payments from Intuitive Surgical Inc., makers of the da Vinci robot, collected a median of almost $142,000. Of those surgeons, 12 have published 37 papers about the robot with 27 (73%) reaching strongly favorable conclusions about the robot’s effect on clinical outcomes, feasibility, or safety. Nine (24%) were equivocal, and one (2%) study was negative.

These results appeared in a paper published online in the American Journal of Surgery by investigators from the University of Michigan.

The 37 papers consisted of 36 observational studies and 1 randomized controlled trial. Robotic surgery patient outcomes were compared to patients operated on in the same institution or by the same surgeon in 11 papers, patients operated on in a different institution or by a different surgeon in 4 studies, to a database in 4, and to previously published papers in 2 instances. No controls or comparisons were used in 16 (43%) papers.

Intuitive Surgical sponsored six of the studies, all of which had positive outcomes.

According to the CMS Open Payments website, compensation received by the top 20 surgeons ranged from $106,176 to $325,164. Among the top 20 earners were 11 general surgeons, 4 colorectal surgeons, 3 thoracic surgeons, and 2 gynecologists.

Three of the 37 papers contained no conflict of interest disclosure statements.

Several limitations of the study were listed. Most journals favor publishing papers with positive results. It may be that surgeons not receiving any industry payments might have published similar numbers of positive studies. The accuracy of the Open Payments site has been questioned but it is the best resource we have currently.

The authors described their paper as a pilot study and called for more research on not only Intuitive’s effect on the medical literature but also the influence of industry in general.

The paper also illustrates the woeful state of research on robotic surgery—a device that has been used on patients for almost 20 years.

Is an autonomous robot better than a human surgeon?

That was the headline on the website BGR [“a leading online destination for news and commentary focused on the mobile and consumer electronics markets”].

Engineers working with the Smart Tissue Autonomous Robot (STAR) claim it can cut skin and tissue with more precision than a surgeon.

A paper they presented last month at the International Conference on Intelligent Robots and Systems featured a video supposedly proving the point.

STAR works “by visually tracking both its intended cutting path and its cutting tool and constantly adjusting its plan to accommodate movement.” The intended cutting path must be marked by a human beforehand. So, it is not really autonomous; rather it is semi-autonomous.

The video can be seen in its entirety here or you can watch two excerpts below. The first is the robot using cautery to make a straight 5 cm skin incision which is compared to an unidentified surgeon cutting a similar incision. Watch approximately 15 seconds of this clip.



As you can see, the surgeon strays from the intended path about halfway through the process. But note that the surgeon is not holding the cautery the way most surgeons would use it. The proper way to hold the instrument is as if it were a pencil. No human could possibly cut a straight line holding the instrument as far away from the tip as the video depicts.

A second video shows the STAR excising a geometrically shaped pretend tumor.

Note: Although the video is being shown at 4X speed, it is still painfully slow. It is not clear what would happen if the robot encountered a blood vessel that bled despite the use of cautery, which by the way is not the instrument of choice for excising many tumors.

What we have here is a nice example of a “straw man” which is comparing a new technique against a phony one to make the new one look better.

Another website, IEEE Spectrum, went with this headline:

The headline should have read:

[Type straw man or artificial intelligence in the search field to your right on my blog site for more posts about these two topics.]

Will robots eliminate the need for surgeons?

A medical student from Germany emailed me saying he had always wanted to be a surgeon, but someone told him that by 2030 surgeons would no longer be needed because robots would be doing all the operations. He worried that after years of studying and hard work, he might lose his job to “R2-D2.”

He mentioned IBM’s Watson and a recent paper that appeared in the journal Science Translational Medicine about a robot that can handle and suture bowel.

He asks, “What do you think about the future of surgery?”

Thank you for your email and the link to the paper.

I read the paper and was amused by its title "Supervised autonomous robotic soft-tissue surgery" which is an oxymoron. The definition of autonomous is "acting independently or having the freedom to do so." This “supervised” robot is not really autonomous.

The robot is capable of performing a nearly technically perfect intestinal anastomosis but still needs a human surgeon to open the abdomen, prepare the bowel for the procedure, tidy up, and close. I'm not sure that this is any different than when surgical staplers were introduced. This robot is simply making the operation easier and possibly more precise.

Surgeons will still be needed in case the robot makes a mistake like causing bleeding while placing a suture near the mesentery. If bleeding in that area is not promptly controlled, a large hematoma can develop and possibly compromise the blood supply to the anastomosis. And will the robot be able to decide who needs an operation and when to do it?

One worrisome byproduct of surgical stapling is that many graduates of residency programs within the last 15 or 20 years have little experience in performing a hand sewn bowel anastomosis. What will they do if the hospital runs out of staplers? Soon, I guess they could consult the (somewhat) autonomous robot.

I have written about automation and the erosion of surgical skills. This problem also affects pilots. I have also addressed the concept of  robots operating alone. I don't see it happening any time soon.

I think there will always be a need for surgeons. Even the smartest robot is going to have some trouble dealing with a trauma patient who is hypotensive.

The future will take care of itself. In the 1980s, people were concerned about the demise of general surgery. Opinion pieces with titles like “Will the general surgeon become extinct?” and “Is general surgery a dying specialty?” appeared in major journals like JAMA and the World Journal of Surgery.

Then in 1990, laparoscopic cholecystectomy opened the door to a whole new area of general surgery that no one had ever dreamed of.

Good luck with your studies and your surgical career.

How long is too long for robotic surgery?

A surgical chairman writes [some details were changed to obscure the surgeon’s identity]:

We currently have surgeons who are trying to establish themselves as experts in performing a certain robotic operation. As an open case, it rarely takes more than about 4-5 hours.

With the robot, it is generally taking around 6 hours as reported in the literature, and morbidity and mortality in expert hands appears to be pretty good.

What is happening in the real world is that surgeons are taking 12 or more hours to perform these operations robotically. I am aware of one death after a 14 hour procedure in another hospital. One case in my own institution took 16 hours, and luckily the patient did well. Of course this sort of data never gets reported publicly. 

Is do-it-yourself surgery the future of medicine?

Once in a while, I read something on the Internet that is so silly, so outrageous that I can't help myself. I must speak up.

Such a situation occurred a few days ago when I came across an article called "DIY [do it yourself] Surgery: The Future of Medicine?" on a website called FastCompany.

An "interaction designer" named Frank Kolkman has created a robotic Open Surgery Machine which he proposes could fill in need when "middle-class" US citizens who have no access to healthcare require surgery.

My favorite line from the article is an explanation of what Mr. Kolkman's robot can do. "It's designed to perform simple surgeries like laparoscopic surgery in which three or more small keyhole incisions are made to allow a surgeon to operate inside a part of the patient's body after inflating it with CO2."

He proposes that "appendectomies, prostate operations, hysterectomies, and also colon and general inspections" could be done.

Surgery in space: I foresee problems.

The astronauts are halfway to Mars when suddenly one of them develops abdominal pain and requires surgery. What will they do?

According to NASA, a miniature robot capable of assisting in surgery has been developed, tested in pigs, and is soon to be trialed in a weightless environment. The robot, which weighs less than 1 pound, can be inserted into the abdomen via the umbilicus and controlled remotely.

The press release from NASA said types of operations that the robot would be capable of performing were "emergency appendectomies, emergency cholecystectomies, emergency perforation of gastric ulcers [sic], and intra-abdominal bleeding due to trauma." NASA meant to say "repair of perforated gastric ulcers." Not surprisingly, many science reporters for media outlets, for example, SFGate and WiredUK, did not notice the error. New Scientist also missed it, but at least published a later correction.

However, even the famous da Vinci robot is incapable of performing surgery on its own.

The original idea was that a surgeon on the ground would direct the robot's movements, but that will not be possible for two reasons. In deep space, the time lag between the earthbound surgeon's actions and the robot's response would be too long, and a recent article about remote-controlled drone crashes highlighted the problems that can occur when links are lost or computers malfunction.

The plan is to train the astronauts to perform minimally invasive robotic surgery on each other. What could go wrong?

A lot.

Will automation affect surgeons' skills?

Although it has been known for over two years, news outlets are again reporting that automation is degrading pilots' skills. Links are here and here. I blogged about this back then as part of a comparison of pilots to surgeons. My point was that surgeons did not have autopilots to rely on in the operating room.

This new report has prompted some to wonder whether robotic surgery will lead to deterioration of surgeons' skills.

In my opinion, that is not likely at this time because the robot is not really doing the surgery by itself. It is simply a tool that helps the surgeon and is under the surgeon's complete control at all times (except when it runs amok).

However, ever since the advent of laparoscopic surgery over 20 years ago and its popularity for many of the common procedures surgeons do, there has been concern that surgeons may eventually lose proficiency for open procedures. And a number of other open operations have been done less frequently due to alternate ways of treating patients such as non-operative or interventional radiologic techniques.

Here are some examples from the ACGME resident log data for the academic years 1999-2000 and 2011-2012.



We are approaching the critical lower limit for open gallbladder surgery expertise especially when you consider that only the most difficult cholecystectomies will be done as open cases from now on.

What will happen in 20 years when few surgeons will have sufficient skill to do a very inflamed open gallbladder?

Does anyone really believe that a surgeon can confidently remove an enlarged spleen having done fewer than 2 such cases during training?

This is a bigger problem and far more pressing than the possibility that automation will render human surgeons obsolete.

There's another issue too, which is the predicted shortage of general surgeons in the near future. How are more surgeons going to be trained if there are not enough open cases to train the current number of graduating residents, of which there were 1092 in 2012?

Has anyone else thought about these questions?

Gallbladder surgery: Double jeopardy

Last month, I blogged about a paper from China that advocated removing just the gallstones and leaving the gallbladder in place. I wrote that such procedures had been tried in the early days of gallbladder surgery and failed because the stones recurred. You can read that post here.

It's not often that one gets to see almost immediate follow-up on a blog post like this, but I am happy to say that I can share a brief story with you.

A 44-year-old man (who consented to my blogging about him) underwent a cholecystectomy by a friend of mine a few weeks ago. The patient presented with right upper quadrant abdominal pain. He said that he had gallbladder surgery in a South American country in 2009 and had a large right subcostal incision to show for it.

In the emergency department of the hospital, a CT scan showed a large gallstone in what appeared to be a shrunken gallbladder. My friend obtained a copy of the operative report and a handwritten note from the original surgeon. See below.

The surgery that had been performed was a partial cholecystectomy and removal of a 6 cm gallstone.

My friend (and yes, he is still my friend) performed a robotic cholecystectomy. He said the surgery was difficult due to omental adhesions and the small size of the gallbladder. The specimen contained six 2 to 3 mm stones. The patient did well and was discharged.

OK, one case is an anecdote and doesn't prove anything, but its timely appearance doesn't hurt my position that just removing the stones won't cut it. (Pun intended.)

Is advertising by doctors and hospitals worthwhile?

The decline of medicine as a profession began when it became legal for doctors and hospitals to advertise.

Apparently it all started when an Arizona lawyer sued for his first amendment right to advertise his services. In 1977, the US Supreme Court ruled that states could not prohibit advertising by lawyers.

This opened the floodgates for all professionals. Soon advertising by doctors and hospitals became common.

I don't know what it's like where you are, but I can't listen to the radio without being bombarded by doctors advertising their wares like car dealers and ads for bogus "university" hospitals.

Outrageous claims are made. The best, the most advanced, the newest, the latest, the most experienced, the most talented, and many, many more.

Just like car dealers, every hospital in my area is "#1" in something or other. Often more than one hospital is #1 in the same specialty.

Here's a sobering number. In the first half of 2011, hospitals in the US spent $717 million on advertising. This is despite the consensus that hospital advertising has not been shown to be effective at generating business. In fact, hospital CEOs admit that much of their advertising is aimed at stroking the egos of their doctors or boosting staff morale.

Regarding advertising by doctors, I don't know if that works either.

When I was in private practice in the late 1970s and early 1980s, advertising by physicians was mostly limited to the telephone book's Yellow Pages [younger readers may be excused for a minute to google the term].

Every patient who ever came to me via the Yellow Pages either didn't pay his bill, was non-compliant or both. Apparently, only a certain type of individual chooses his surgeon via the Yellow Pages.

I eventually stopped listing myself in the Yellow Pages.

In addition to wasting a lot of money, hospital and physician advertising is harmful because it creates unrealistic expectations among patients. A case in point is the ongoing debate about the supposed, but yet unproven benefits of robotic surgery. The ad below appeared in an airline in-flight magazine. Do you think it is effective? Do you believe it?

Although there is no proof that robotic surgery results in better outcomes than traditional laparoscopic techniques, hospitals have marketed robotic surgery by having potential customers play with the robot in such places as shopping malls and minor league baseball stadiums. [For a comprehensive look at robotic surgery advertising by hospitals, check out the Health News Review blog here and here.]

The public is flooded with advertisements promising miracles that often cannot be delivered. Disappointment surely follows

Is this the only reason for the medical profession's fall from grace? Of course not, but it certainly hasn't helped.

If advertising by hospitals and doctors disappeared tomorrow, we would all be better off.

Whatever happened to robotic thyroidectomy?

In case you missed it, there was a brief romance between thyroid surgeons and robots. Thyroid surgeons, itching to join the crowds migrating to robot-assisted surgery, came up with the idea to use the robot to perform thyroidectomies.

It appears that the push began in Korea, and to add some pizzazz to the mix, a trans-axillary approach to avoid a scar in the neck was incorporated. As is often the case, the initial results were favorable.

Then reality set in.

The early euphoria gave way to the revelation that American patients were larger and more difficult to operate on than patients in Korea. But randomized trials of selected patients were suggested.

A paper from Wayne State in Detroit found complications in 4 (22%) of 18 cases—3 temporary vocal cord pareses and a post-operative hematoma that required re-operation. Hospital stay was a median of 2 days.

More than 90% of conventional thyroidectomy patients are done as same day surgeries.

After receiving 13 reports of complications, Intuitive Surgical, the company that manufactures the robot, decided it could no longer support the use of its robot for thyroid surgery.

At this point, a surgeon from the MD Anderson Cancer Center took the unprecedented step of publicly renouncing her previous stand on robotic-assisted thyroid surgery (RATS).

In an editorial in the December 2012 issue of the journal Surgery, she said, "After performing nearly 40 RATS procedures, we came to the conclusion that the main benefit of RATS—translocation of the surgical incision to the axilla—did not offset the risks and liability of performing an operation that was not supported by the equipment manufacturer, took twice as many resources to perform as open surgery, and faces complex legal hurdles beyond our control that currently prevent implementation of telerobotic/distant access surgery across the United States. Justifying the expense in a time when demands outweigh resources obligated us to focus on outcomes. When we did that, we proved that we could perform RATS, but not that we should."

Here's a link to a series of photos showing exactly how robot-assisted thyroidectomy was done. It looks like one trades a thin scar in the neck for an ugly scar in front of the armpit.

There are still hospital websites that say they offer the procedure. Here is one. Google "robotic thyroidectomy" and you will see. 

Maybe they didn't get the memo.

Read the whole paper not just the abstract

Here is another installment in my series of posts about why you should read the entire paper and not just the abstract. (See others here, here and here.)

A paper in the February 2013 issue of the Journal of the American College of Surgeons describes 15 cases of median arcuate ligament syndrome treated with laparoscopic surgery.

Median arcuate ligament syndrome (MALS) is somewhat controversial. It is said to be due to impingement of the median arcuate ligament (a portion of the diaphragmatic crura) on the celiac artery causing a narrowing and decreased perfusion of the stomach. Symptoms are abdominal pain after eating, nausea and weight loss. It is often diagnosed in patients who have been worked up for many other suspected problems without finding anything.

The paper notes that 10% to 60% of people without symptoms have narrowing of the celiac artery.

The abstract reports resolution of the pain for 14 of the 15 patients who had the surgery as well as a significant mean decrease in celiac velocity indicating resolution of the narrowed area postoperatively.

It also mentions that one patient required conversion to open surgery but doesn't say why.

On reading the whole paper, one learns that the conversion to open occurred in the only case that was done with robotic assistance.

The authors state that the 2 mm injury to the aorta was the result of the robotic instrument being too large and "the absence of haptic feedback," which is robot-speak for "you can't feel anything."

That is one drawback of the robot. With robotic instruments the sense of touch is simply not present. Although the fingertips used in old-fashioned open surgery are much more sensitive than instruments used in standard laparoscopic surgery, those instruments do enable the surgeon to at least feel some variations in tissues

The aortic tear led to two liters of blood loss and an operative time of just under 8 hours.

The abstract says all but one patient had complete resolution of pain, but the paper says the amount of decrease in the Doppler celiac velocity "did not correspond to the degree of symptom resolution."

And you can see that the differences in preop (red) and postop (green) velocities are pretty modest in 7 of the 10 patients who had them measured even though the mean difference was significant at a p of 0.005. In addition, the postop values all hover around 200 cm/sec, which, in the presence of symptoms, was the threshold for doing the operation.

In fairness, of the 13 patients who were interviewed, all said they were satisfied with the outcome of the surgery and would go through it again.

In some ways, MALS reminds me of internal mammary artery ligation, which was once touted as a cure for angina pectoris (chest pain of cardiac origin). Over 50 years ago, randomized trials which included a sham operation—incisions were made, but the arteries were not ligated—showed that ligating the arteries was no better than the sham operation for relieving pain.

It might be time for such a trial in MALS, only let's skip the robot for this one.

Thanks to Dr. Michael Burchett for alerting me to the MALS paper.