Robotic surgery has fascinated surgeons since its inception almost 30 years ago. US Food and Drug Administration (FDA) approval of the Da Vinci surgical system in 2000 led to the expansion of robotic-assisted laparoscopic surgery—most rapidly in urology but also in gynaecology, cardiothoracics, head and neck, and general surgery. But has this innovation in surgery translated to benefits for patients?
The Da Vinci surgical system (Intuitive Surgical Inc) is the only robot approved by the FDA for soft tissue surgery. The device provides a magnified 3D view of the operative field from a console, from which the surgeon controls the robot which holds a camera and tremor-free instruments with a greater range of movement than laparoscopic instruments. “The benefits to the surgeon are fantastic. There is improved vision and precision. It brings a lot of the benefits of laparoscopic surgery but it’s easier. In terms of surgeon fatigue it’s similar to open surgery”, explains urologist Prokar Dasgupta, Chair of Robotic Surgery and Urological Innovation at King’s College London.
What is less clear, however, is whether these surgical advantages translate into benefit for the patient. There have been no large randomised trials to compare robotic with open or laparoscopic surgery. Much of the data come from single-centre studies, so it’s difficult to separate out the confounding influences of institutional factors and the skill of an individual surgeon, as Dasgupta admits: “I think there is evidence now for robotic prostatectomy but it’s less clear for other procedures.” He estimates that about 80—85% of prostatectomies in the USA are now done robotically and that this proportion is lower in the UK and Europe but is increasing.
Critics have attributed the huge growth of robotic surgery to excitement about a novel technique and aggressive marketing—to both the patient and the surgeon. “There is no question that some of the gains achieved with the robot have been generalised by both doctors and patients”, says US urologist Bernard Bochner from Memorial Sloan Kettering Cancer Center. He also points out that the dominance of robotic surgery in certain fields can make undertaking further trials difficult.
Accepting randomisation between open and minimal access surgery can be a challenge. “Many doctors and patients feel that robotic surgery is so much better that it would be unethical to randomise patients to an inferior procedure. The window of opportunity for recruiting patients to randomised trials has passed now”, says Ben Challacombe, a urologist at Guy’s and St Thomas’ Hospitals in London. Bochner agrees that this is a problem, but as a coauthor with Vincent Laudone of a recent randomised trial comparing robotic with open cystectomy he takes a different perspective. “Public perception and widespread advertising related to robotic surgery has perhaps closed the window of opportunity. However, this is not universal. We recognised that patients were still willing to accept a study of new technology, and in fact about one third of the patients accepted randomisation in our study.”
Bochner also argues that “the cost of robotic surgery versus the benefits achieved must be carefully and thoughtfully studied and addressed”. Robotic surgery is more expensive than open surgery due to the cost of the robot (an initial outlay of some £1·5 million) and disposable equipment. The difference in cost is a difficult equation, says Challacombe, “it’s probably about £1500 extra per case, but this may be offset by other savings, such as reduced length of stay or reduction in complications. Start-up costs are high so you need 150—200 cases per year to break even.” However, not all robotic centres are able to generate such a caseload, which has particular relevance outside large cities and in low-income and middle-income countries. However, the ability of a robotic surgeon to attract referrals for all types of surgery has led some hospitals to accept this cost.
Quality assurance had also been a concern with the rapid growth of robotic surgery, but both the USA and Europe now have accredited training programmes and certification in robotic surgery. This type of surgery requires a different skill set from open surgery, which has raised questions about whether robotic surgeons have the skills required if they need to convert to an open procedure. “We’ll always need our open surgery colleagues”, says Dasgupta. “The best centres will offer two teams working closely together.”
It’s inevitable that surgeons will try a promising new technique to see what it can offer. However, experienced robotic surgeons are now looking carefully at each operation and patient to work out where this tool offers a real advantage. As Bochner says, “Accepting new technology only makes sense if it allows doctors to do things better or if patients experience better outcomes. If not, we have to question the added costs and the efforts needed to develop these new skills. The fascination with robotic surgery should not be allowed to drive surgical care.”
Source: The Lancet – Read full article here.