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.

The robot is here to draw your blood

A company has produced prototype robots that can draw blood from human arms. Here is a 48 second video showing one of them in action.



Using an infrared camera, the robot identifies a suitable vein and accesses the vein with ultrasound guidance.

A second video, not embedded in this post, explains that the robot is about 83% successful at drawing blood which compares favorably to the success rate of experienced human phlebotomists. The robot's inventor hopes to refine the procedure to get the success rate up to 90%.

It also says that there are 9 billion blood draws per year in the United States suggesting that a market is certainly there.

The second video also mentions the discomfort patients experience when a phlebotomist misses or damages the vein.

How does a 16-year-old boy receive 38 times the normal dose of an antibiotic?

If you are a doctor, nurse, patient, or just someone interested in patient safety, you should read a five-part story called "The Overdose: Harm in a Wired Hospital" excerpted from a book "The Digital Doctor" by Dr. Robert Wachter.

Dr. Wachter and the hospital are to be commended for publicizing this incident so others may learn from it. The hospital staff, the patient, and his mother, also deserve credit for allowing their stories to be told.

A synopsis does not do justice to this well-written account of the boy's near-death experience in a top hospital in San Francisco. In short, he somehow received a massive overdose of the antibiotic Septra despite the presence of a sophisticated electronic medical record and multiple systems in place that were supposed to prevent such a thing from happening.

After the patient recovered from receiving 38½ pills when he should have been given only one, a root cause analysis found numerous faulty system issues such as an electronic ordering program that was overly complex, a nurse "floating" to an unfamiliar floor, a satellite pharmacy that was too busy and susceptible to distractions, "alert fatigue" among hospital staff, and a culture, like that of most hospitals, that may have discouraged questioning both authority and the almighty computer.

The effect of the robot on surgical education

Having taken an extended break from writing about the problems associated with robotic surgery, I think it’s time to explore an area not previously discussed.

What is the effect of the robot on surgical resident education?

The robot at the OR table (babe not included).

Let’s review a few points about robot-assisted surgery. The surgeon actually doing the case is not scrubbed. He sits at a console away from the patient and manipulates the instruments. Another doctor has to scrub and insert the instruments through small incisions and “dock” (connect the instruments) to the part of the robot that is next to the patient. 

The assistant at the patient’s side views the operation on a video screen. Sources tell me that residents get to do a lot of docking, observing, inserting and removing instruments and closing incisions but not much time, if any, at the console doing the operation.

There is a dual console capability but many hospitals do not invest in it because of the added cost of the fully equipped second console.

Two consoles. Resident (left) shown participating in the operation.

So how are the residents going to learn to perform surgery? There is already evidence that they lack confidence in their ability to operate independently. See my earlier blog on this subject.

The majority of graduating chief residents in surgery take at least one year of fellowship training. One can only hope that they train in a hospital that has at least one dual-console robot or they may end up practicing on you and me.