Robotic surgery technologies such as the Da Vinci® system are growing increasingly popular and are used in a range of cancer surgeries. But while some patients may benefit from having their procedure performed with a surgical robot, experts have yet to determine exactly in what types of surgery and for what patients the tool is helpful.
Now Memorial Sloan Kettering researchers have carried out the most robust clinical trial to date to learn whether robot-assisted radical cystectomy (removal of the bladder), a common treatment for advanced bladder cancer, causes fewer complications in patients compared with standard open surgery. According to their findings, there is no evidence that the use of surgical robots lowers the risk of experiencing a complication, nor reduces the length of stay in the hospital.
In a letter published today in the New England Journal of Medicine (NEJM), the physicians report that while conventional and robotic surgery techniques appear to be equally safe, patients whose surgery was robot assisted did not generally recover faster, leave the hospital earlier, or have fewer complications.
“There’s a lot of excitement about robotic surgery, and in some cases there are good reasons for that,” says urologic surgeon Bernard Bochner, who co-directed the research. “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 the new skills necessary to use these tools.”
What Is Robotic Surgery?
Robotic surgery is a type of laparoscopic surgery, a minimally invasive approach done through several small incisions. The surgeon sits at a console in the operating room, viewing the tissue through scopes while using hand and foot controls to manipulate instruments attached to the robot’s interactive arms.
“The technology can enable extraordinary precision and is very valuable in certain surgical settings,” says urologic surgeon Vincent Laudone, a co-author of the study who specializes in robotic surgery. “But our experience with it suggests it’s not necessarily the right tool for every surgeon or for every type of surgery.”
Why the Study?
Cystectomy is traditionally done as an open surgery procedure, in which the surgeon uses manual instruments to remove the bladder and reconstruct the urinary system through an incision. Until now, most studies comparing robotic and open cystectomy have retrospectively gathered data from small groups of patients.
But the best way to reliably assess the usefulness of a new treatment, Dr. Bochner notes, is by conducting a randomized trial — a study in which patients are assigned to one of two treatment groups at random and followed over time.
How the Research Was Done
Bladder cancer patients scheduled to undergo radical cystectomy and urinary diversion, a procedure in which the bladder is removed and the urine flow is surgically rerouted, were eligible for the study. The trial enrolled 118 patients who were randomly assigned to undergo surgery done either robotically or by open surgery. All procedures were performed by MSK surgeons who had extensive expertise and more than ten years of experience performing open or robotic cystectomy.
The researchers then followed the patients for 90 days, collecting data about the length of their hospitalization and recovery and a range of post-surgery complications such as infection and delay in the return of bowel function. “We designed the study to look for any improvement in patient outcome indicating that robotics can make the surgery easier on our patients,” Dr. Bochner explains. “Based on prior experience we were expecting to see that. Many people who need this surgery have other medical problems, and their recovery is often difficult after major surgery.”
However, the researchers found no major improvements in outcomes in patients who had robot-assisted surgery. For post-surgery complication there was no significant difference between the robotic and open surgery groups, and the length of hospitalization was largely the same: eight days on average. The only significant differences observed were that robotic operations generally took longer but resulted in less blood loss.
“Contrary to our expectations that the robot would make it easier for our patients to recover, our findings provide the highest level of evidence that there’s no clear advantage of having a cystectomy done robotically,” Dr. Bochner says. However, the researchers note that moderate differences between the two types of surgery cannot be ruled out.
Unjustifiable Healthcare Costs
He adds that this is particularly sobering given that the procedure is more expensive when done robotically than by open surgery. According to one study, the price difference is about 11 percent and comes mainly from the cost of acquiring and maintaining robotic equipment and instruments.
In their NEJM report, the MSK researchers underscore the need to conduct randomized trials of new surgical procedures before implementing them. This not only will increase safety and maintain quality but also could help control the rising cost of cancer care in the United States, which, according to experts, is already unsustainable and must be addressed. In fact, a 2009 report issued by the Institute of Medicine and requested by Congress in the American Recovery and Reinvestment Act called for a cost- benefit comparison between robotic and conventional methods for common surgical procedures.
What It Means for Our Patients
“Based on our findings, it appears that both open and robotic techniques can provide safe and effective care,” Dr. Bochner notes. However, given the lack of clear benefit, he and his colleagues continue to recommend open surgery to bladder cancer patients at MSK who need to undergo cystectomy, while still offering the robotic option for those who request it.
Watch a video about the study on CBS Online or read more in The Wall Street Journal.