For all its techno-wonder and new-age appeal, robotic surgery has racked up a host of problems, including unacceptable incidents of tears and burns to internal organs. Now, a new analysis of robotic versus traditional methods showed no difference in the rate of complications for surgical removal of the bladder.
Robotic surgery is a minimally invasive procedure in which surgeon-controlled instruments work in smaller spaces (and with smaller incisions) than traditional, or “open,” surgery. It’s used for a range of disorders involving the prostate gland, uterus, gallbladder and heart valves. In addition to an alarming number of adverse outcomes, training for robotic surgery has been shown to be deficient, and it’s also more expensive.
Hospitals and surgeons, with an investment in the equipment, want to use it as much as possible to justify the cost, but that could conflict with what’s best for the patient.
The recent study, published in the New England Journal of Medicine, (NEJM) looked at robot-assisted cystectomy, a procedure that removes the bladder, for 118 patients with invasive bladder cancer. They all shared similar baseline characteristics. According to MedPage Today.com, it was one of the first randomized comparisons of open versus robot-assisted surgery.
According to the U.S. Department of Health and Human Services, bladder cancer is the fourth most commonly diagnosed cancer in men and 10th most commonly diagnosed cancer in women in the U.S. It’s estimated that more than 72,000 people will be diagnosed with new cases of bladder cancer this year, and that more than 15,000 will die from it.
In the NEJM study, 90 days after surgery, 62 in 100 people who underwent robotic surgery had complications; 66 in 100 who had open surgery did. Complications defined as “severe” also showed comparable rates.
There were some qualifications: Surgeons using one method were different from those using the other, so one doctor’s technique couldn’t be compared exactly with another’s. All of the surgeons were experienced in their techniques, and all surgeries were performed at Memorial Sloan Kettering Cancer Center in New York.
As the researchers wrote, “Because the trial was performed by experienced surgeons at a single, high-volume referral center, the results may not be generalizable to all clinical settings. Nonetheless, these results highlight the need for randomized trials to inform the benefits and risks of new surgical technologies before widespread implementation.”
Cystectomy is the standard of care for nonmetastatic, invasive bladder cancer. “Invasive” means that the tumor has invaded at least the lining of the bladder; “nonmetatstatic” means the cancer has not spread beyond the original site.
Even though removal of the bladder is standard for these patients, it often leads to complications. Patients most likely to experience them are older and have other diseases. The recovery period generally is long.
Earlier studies, reports MedPage Today, suggested that the robot-assisted cystectomy resulted in fewer complications and a shorter hospital stay compared with open surgery but data from randomized trials – the most scientifically sound – were lacking. And a recent report that looked at results internationally showed that almost half of the patients who had the robotic procedure experienced complications within 90 days.
So the NEJM researchers devised a randomized clinical trial to compare open with robot-assisted laparoscopic cystectomy in patients with newly diagnosed invasive bladder cancer. Four surgeons performed all of the open cystectomies, and three did the robot-assisted cystectomy operations for the patients randomly assigned to either group.
In addition to patients in the robotic surgery group experiencing similar rates of complication to the open surgery patients, their stay in the hospital was no shorter – both groups averaged eight days as an inpatient.
Dr. Daniel Barocas told MedPage Today, “The investigators are really to be commended for undertaking this; this is a hard thing to do. The patients are to be commended for trusting their doctors enough to undergo a procedure that is not yet proven to be comparable to the traditional approach.”
And as important as the study is, remember that it evaluated only one outcome of these surgeries – complications. Further studies are required to understand other important outcomes, including cancer control and return to work or to routine activities. As Barocas noted, cystectomy is a major operation, regardless of which technique is used. So a lot of people undergoing it can be expected to experience complications.
Still, if you are facing this procedure, find out all you can about not only the risk factors of each method, but the financial interests of the facility and the practitioners with regard to the possible use of robotic equipment. You can’t make an informed choice if you don’t have all the relevant information.