Robotic surgery is turning out to be an expensive fad

SURGERY performed with the help of a robot has been billed as the next revolution in healthcare: such procedures can be carried out through an incision the width of a finger, causing less scarring and often allowing people to return to their homes more quickly.

The UK’s National Health Service recently announced plans to spend £50 million on more robotic surgical equipment for operating theatres, and yet the benefits of this high-tech approach are debated. Earlier this year, the US Food and Drug Administration (FDA) cautioned against robotic surgery for cancer, citing a lack of evidence for its safety and efficacy.

In Austria, a recent analysis found that there was little quality evidence that the devices were an advantage in thorax and abdomen operations. The team sifted through 28 clinical studies each examining at least 10 people and found that it was impossible to know whether robot-assisted surgery was better than standard surgery for nine out of 13 conditions that required these operations.

“Our recommendation is not to invest in robotic surgery now [for these conditions] because it’s still in a very experimental stage,” says Claudia Wild of the Ludwig Boltzmann Institute for Health Technology Assessment in Vienna, who led the work. “Every new technology has to prove first that it’s better than the given tech, especially if it is far more expensive.”

Despite these doubts, surgical robots have become increasingly popular. The number of procedures done with these devices has jumped six-fold globally in the past decade, and in the past year alone more than a million operations were done worldwide with the da Vinci surgical system, the market leader.

Robotic surgery seems like progress because it is an extension of a technique called minimally invasive laparoscopic surgery, also known as keyhole surgery. In the past, surgeons had to make a large cut to operate. Keyhole methods instead allow them to make several small cuts and insert a thin tube with a camera and light on the end to guide the operation.

With robotic surgery, you aren’t actually being operated on by a machine. Instead, the robot is completely controlled by a human surgeon who sits at a console away from the patient (pictured, below), watching a screen and operating the robot with hand and foot controls – and they don’t even have to be in the operating theatre (see “The doctor won’t see you now”). The robot reduces tremors from the surgeon’s hand during these procedures, as well as offering a better range of motion and zoomed-in 3D visualisations.

Advocates say that, just like laparoscopic methods, robotic surgery results in less pain and less damage to surrounding tissue, allowing people to leave hospital more quickly. In the past, people undergoing hysterectomies would often have to stay in hospital for a week, but now half can go home the same day, says Felix Chan at the University of New South Wales, Australia. This reduces costs and the risks of infection, he says.

These benefits are similar to those from other minimally invasive approaches done without robots. But a draw for surgeons is that sitting at a console is also far more comfortable and less physically demanding than manoeuvring around a patient’s body, which makes it easier for surgeons to continue working into older age and to avoid repetitive strain injury and other musculoskeletal problems.

“When you train surgeons at a certain level, the longer you can get productive and useful work out of them, the better it is for the health system, and the better it is for the patients because they are getting a more experienced surgeon,” says Shomik Sengupta at Monash University in Melbourne, Australia, who is researching the ergonomics of robotic procedures.

But critics have questioned whether robot surgery lives up to its billing. Surgeons Justin Dimick and Kyle Sheetz, both at the University of Michigan, published a call for safeguards around the growing adoption of the tools (JAMA, doi.org/c632). The field lacks high-quality research supporting their use, they wrote: “To date, most studies demonstrating potential benefits of robotic-assisted surgery have been small, single-centered reports without rigorous controls.”

A 2017 study of almost 500 people randomly given either regular laparoscopic surgery or robotic-assisted surgery for rectal cancer found that the use of robots didn’t lead to fewer complications or any other benefit.

Despite this, robot surgery took an average of 37.5 minutes longer and cost an average of $13,668 compared to $12,556, due to longer times in the operating theatre and instrument costs. This is before the high upfront costs of the robots and maintenance fees are factored in.

Meanwhile, a study of 23,800 people having surgery for kidney cancer found that the rates of robotic surgery jumped from 1.5 per cent in 2003 to 27 per cent in 2015. Yet there were no reductions in major post-operative complications. As in the first study, robot surgeries took longer, and direct hospital costs were $2678 more per person.

Even in prostate cancer surgery, where robot use is most prevalent, the results are debated. A two-year follow up of almost 300 men in Australia found that harm to urinary and sexual function as a result of prostate ops were similar for both open and robotic surgery.

“$2m: The cost of a robotic surgery system”

Sydney urologist Eric Chung says commercialisation of this procedure is a problem, as people are over-promised on the results and can get disappointed when they face side effects at similar rates to conventional surgery.

For hospitals and surgeons, being able to offer robotic surgery can be a marketing tool. It signals to the patient that they are getting the most cutting edge technology. But with a price tag of around $2 million per system – not to mention ongoing servicing fees and replacement parts – they may not be the best use of healthcare system funds.

The FDA’s warning about robotic surgery also cited the potential for the devices to cause harm. One randomised trial and one observational study indicated that minimally invasive surgery, including robotic surgery, could lead to shorter survival times in people with cervical cancer.

The randomised trial found that women having a particular kind of minimally invasive hysterectomy were at a raised risk of the disease coming back, death from cervical cancer and death for any reason over the study period, compared with those undergoing an open surgery. Open surgery was also associated with longer survival times in the observational study.

Meanwhile, the FDA has also received reports of broken pieces of instruments falling into people, electrical faults, uncontrolled movements and video or imaging problems. It also says there have been reports of injury and death related to the devices.

Medical devices are often introduced to the market without having to provide regulators with the same level of high quality evidence around their safety and efficacy as for medications. But building this evidence base will be essential to understanding which conditions robotic surgery is best suited for, according to Dimick and Sheetz.

Controversies around harms caused by medical devices such as vaginal mesh implants and breast implants have prompted some governments to set up registries where surgeons input information on all of their procedures and the outcomes. Maybe it is time to do the same for robots.