A first-of-its-kind randomized trial comparing robot-assisted keyhole surgery vs. open prostatectomy found the two procedures had similar cancer outcomes and quality of life measures at 12 weeks post-op, according a study published July 26, 2016 in the journal The Lancet.
“Surgery has long been the dominant approach for the treatment of localized prostate cancer, with many clinicians now recommending the robotic method to patients,” said Robert A. (“Frank”) Gardiner, MBBS, MD, of the University of Queensland Centre for Clinical Research at Royal Brisbane & Women's Hospital, in Brisbane, Australia.
“Contrary to common clinical belief, our research found no significant statistical differences between the robotic approach and open surgery at this early time-point,” Dr. Gardiner reported.
Since the introduction of robot-assisted prostatectomy more than 15 years ago, patients and clinicians alike have embraced the less-invasive approach on the assumption that it results in better patient outcomes than open prostatectomy, which has been associated with a high incidence of iatrogenic morbidities. However, the robotic approach was introduced without high-level evidence, Dr. Gardiner and colleagues noted.
“Perhaps no other topic in the current era of urology has attracted so much attention, controversy, and debate in our community as has robot-assisted laparoscopic prostatectomy versus radical retropubic prostatectomy,” the authors wrote in the article.
For this trial, the researchers enrolled 328 men who were newly diagnosed with localized prostate cancer, and randomly assigned half of them to open radical retropubic prostatectomy and half to robot-assisted laparoscopic prostatectomy.
At 6 weeks and 12 weeks post-surgery, urinary function scores and sexual function scores did not differ significantly between the two treatment groups. In addition, the researchers found no notable differences in oncological outcomes, as determined by positive surgical margin status.
Patients in both groups spent about the same time recovering after the surgery. They also reported similar levels of pain at both 6 weeks and 12 weeks—although the open prostatectomy patients reported significantly more pain in the very first few days post-surgery. Patients in either group were able to return to work after about the same amount of time as well.
One significant difference: patients who had robot-assisted prostatectomy reported higher physical quality of life at 6 weeks compared with those who had open prostatectomy, but this difference evaporated by 12 weeks. Another significant difference was that men in the open surgery group were significantly more distressed (as measured by the Hospital Anxiety and Depression Scale) at 12 weeks compared with men in the robot-assisted group; however, the effect size was small, the researchers noted.
“Many clinicians claim the benefits of robotic technology lead to improved quality of life and oncological outcomes—but our randomized clinical trial has found no statistical difference between the two groups at 12 weeks follow-up,” Dr. Gardiner concluded.
The researchers will continue to follow these patients and they plan to report any other differences at the 2-year mark post-surgery. If the short-term findings from this study are maintained with longer follow-up results, this could have implications for patient choice and for health provider decision making, they noted.
“In the interim, we encourage patients to choose an experienced surgeon they trust and with whom they have a rapport, rather than choose a specific surgical approach,” they wrote.