Luke Skywalker had his amputated hand repaired by one. The Transformers had one that turned into an ambulance. And they have been among us on Earth, operating quietly since 1985. Robot surgeons are nothing new and they are not science fiction, though the real-life machines may not be instantly familiar to Star Wars fans. Recently, however, research has questioned whether there is evidence to support robot-assisted surgery. We investigate the issue.

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The da Vinci Surgery System was the first robotic system to be approved by the FDA for general laparoscopic surgery, and it has dominated the field of robot-assisted surgery since then.
Image credit: Intuitive Surgical

In 1985, the PUMA 560 robotic surgical arm successfully assisted in a delicate neurosurgical biopsy. This marked the first documented robot-assisted surgery. Two years later, the first laparoscopic procedure - a cholecystectomy - was performed using the robotic system, and in 1988, PUMA was used to perform transurethral resection.

These landmark surgeries opened up the potential for a greater degree of precision in minimally invasive surgeries through the steady, mechanical hand of the robot.

By 1990, the first robot approved by the Food and Drug Administration (FDA) - Computer Motion's AESOP system - was assisting in endoscopic surgery.

But it was not until 2000 that the operating room became acquainted with robotic surgery as we now know it. The da Vinci Surgery System was the first robotic system to be approved by the FDA for general laparoscopic (or "keyhole") surgery, and it has dominated the field of robot-assisted surgery since then.

The da Vinci evolved from the simple arm of the PUMA 560 into an all-encompassing system comprising assorted surgical instruments and camera/scopic devices. Using a 3D magnification screen, the (human) surgeon is able to view the operative area with high-resolution clarity. And where the PUMA's single arm was a bulky chunk of 1980s robotic technology, da Vinci offers four slender surgical arms, each just 1 cm in diameter.

The miniaturization of the surgical instruments was heralded as a breakthrough in minimally invasive surgery. The da Vinci did not require the incision walls to be leveraged when operating, and by minimizing the amount of contact time between instrument and interior tissue, there was less risk of infection.

A feature known as "Endo-wrist," meanwhile, was designed to replicate the skilled movements of the surgeon, who would operate the machine from a set of controls.

In the 14 years since its FDA approval, the da Vinci's manufacturer - Intuitive Surgical - has released 10 updates of the system.

Proponents of robot-assisted surgery say it is no fad. Indeed, in 2013, robots were used in 422,000 surgeries in the US - 15% more than the year before.

But in 2014, medical experts seem more divided than ever on the benefits of robot-assisted surgery.

'No difference' between open surgery and robotic surgery

In particular, a high-profile study by surgical oncologists at Memorial Sloan-Kettering Cancer Center in New York, NY, found no difference in terms of rates of complications or length of hospital stay between traditional open surgery and robotic surgery for bladder cancer.

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In the 14 years since its FDA approval, the da Vinci's manufacturer - Intuitive Surgical - has released 10 updates of the system.
Image credit: Intuitive Surgical

What is more, the researchers found the results so clear-cut that they stopped the trial early. They described their peer-reviewed findings in the New England Journal of Medicine.

However, Intuitive Surgical objected to the Sloan-Kettering research, labeling it "grossly misleading" in a statement.

Speaking with Medical News Today, Dr. Catherine Mohr, vice president of medical research at Intuitive Surgical, explained that the randomized study is misleading because it compares open surgery procedures with hybrid procedures, which are a mixture of robotic and open elements.

When the researchers concluded that there were no differences in complications between the two procedures, Mohr claims that - rather than comparing the robotic and open procedures - they were actually comparing the same open technique used in both arms of the study.

"In essence, this letter to the editor is comparing open surgical complications to open surgical complications with a robotic dissection, and then concludes they are the same," Dr. Mohr asserted. "Attempting to generalize this study, which compares open to hybrid, and then to imply that the latter surgery is entirely minimally invasive is grossly misleading."

Medical News Today contacted Dr. Bernie Bochner, lead author of the Sloan-Kettering study for comment, but he was unable to reply before our deadline.

In gastric surgery, a recent Australian review of six randomized trials also found "no appreciable difference" between conventional minimally invasive anti-reflux surgery and robot-assisted anti-reflux surgery in complication rates, post-operative symptoms, quality of life or functional assessments.

Although older studies comparing the outcomes and costs of open and robotic cystectomy have been favorable toward the robots, it seems that much recent research - with the exception of a survey of hysterectomy patients conducted by Intuitive Surgical employees - is finding few advantages to the robotic system.

Evidence 'does not support the expense'

These trials add to what appears to be a mounting disillusionment with robotic surgery, perhaps expressed most pointedly in a recent Forbes opinion piece by Dr. Robert Pearl, CEO of The Permanente Medical Group.

In his column, Dr. Pearl cuts straight to the issue many recent studies into robot-assisted surgery have been driving at: "The problem is the outcome data doesn't support the hype or the cost."

The da Vinci device is not a cheap tool. The initial cost to hospitals for the machine comes in at up to $2 million. What is more, Dr. Pearl claims, the device has a "built-in obsolescence factor," saying that each of the robotic arms has to be replaced after just 10 uses.

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Some critics claim that the da Vinci has a "built-in obsolescence factor," suggesting that each of the robotic arms has to be replaced after just 10 uses.
Image credit: Intuitive Surgical

"The motivation isn't safety," he continues "It's profit. The manufacturer could have built a robot that could complete 100 procedures. But that would reduce profits dramatically."

If evidence finds that the only difference between traditional surgery and robot-assisted surgery is the cost - a study in the Journal of Urology found robotic bladder removal procedures cost an average of $16,250, 11.2% more than the average cost for open surgery - why is robotic surgery becoming more popular?

Dr. Pearl claims "aggressive advertising" on Intuitive Surgical's part - to consumers as well as hospitals - provides the answer.

"This device will drive up health care costs significantly in the future," he concludes, "while clinical outcomes remain relatively unchanged."

Speaking to MNT, Intuitive Surgical's Dr. Mohr branded Dr. Pearl "woefully wrong in his assertion."

Of his claim that Intuitive Surgical could have designed a robot that could complete 100 procedures, Mohr said it was "patently absurd" and "demonstrates a complete lack of understanding of the physics and challenges involved in instrument design."

She points out that to prevent the surgical instruments from being disposable, they must withstand multiple cleaning and sterilization cycles with harsh chemicals and high temperatures without losing their precision, wearing out or being damaged through human handling.

What is more, the robotic arms themselves, she says, are not disposable and are a structural component of the machinery. She adds:

"As for the triumph of 'aggressive advertising' - to assert that hospitals and surgeons choose robotic surgery because of advertising efforts, rather than based on patient benefits and economic considerations is disrespectful to all involved and inaccurate."

A concern from some robotic surgery critics is that hospitals are increasingly finding themselves in a position where they need to commit to buying the machine purely to attract patients from rival institutions, who might otherwise perceive hospitals as being behind the times if they do not have a da Vinci.

"Hospitals in the US market directly to patients in order to compete with one another," reasons Dr. Mohr. "They use the fact that they have a da Vinci system to highlight that they are providing better access to minimally invasive surgery, and therefore that they are providing better patient care. Ultimately, patient demand is based on the benefits afforded by minimally invasive techniques, including robotic-assisted da Vinci Surgery."

What is the future for robot-assisted surgery?

Despite the rising popularity in robot-assisted surgery, reports have seen Intuitive Surgical's sales fall from $578.5 million to $512.2 million in the past year. So what does the future hold for these leaders of robotic surgery - and what role will robots continue to play in the operating room?

"Microsurgery, surgery outside the abdomen, and natural orifice surgery are all very interesting areas we have explored in the lab," offers Dr. Mohr.

"Robotics can give us greater precision, lower trauma access, changes of scale (such as being able to work on microscopic scale), as well as navigation and imaging integration to provide a 'GPS' of the body and allow the surgeon to more accurately find and treat lesions. These are all exciting capabilities that could result in new therapies that we can only imagine right now."

Some surgeons would like to see robotic surgery systems more capable of replicating the tactility a surgeon experiences during invasive surgery, as sensory information can be helpful in making judgement calls. Other supporters of robotics want to see the distance between surgeon and patient increase to reduce infection - with surgeons operating the technology remotely from a separate room.

One interesting robotic evolution was recently unveiled by the Massachusetts Institute of Technology (MIT), who have pioneered "squishy robots" that could have surgical applications. The robots have been designed to change between hard and soft states on command, so potentially they could squeeze around organs in a soft state, only to harden when they need to perform a surgical function.

You can view MIT's innovation in the video below:

Medical News Today spoke with MIT's squishy bot developer Prof. Anette Hosoi. We asked her, given the current cynicism toward robotics in health care, what the incentive is for developing new surgical robots.

"Technology is not magic," she answered. "It takes a tremendous amount of time, dedication and vision to bring new technologies to fruition."

"The first computers were enormously expensive, cumbersome, and couldn't do much more than a calculator. Imagine if no one had the vision to develop that technology simply because, at that point in time, it was neither advantageous nor cost effective! It is remarkable to me that today, robotic-assisted surgery can be as effective as traditional surgery and there is no doubt in my mind that these machines will continue to improve until they are indispensable."