World’s first randomised trial of robotic prostatectomies finds no benefit compared to open surgery
It may have been sold as a safeguard against infection, impotence and incontinence, but the world’s first randomised controlled trial of robotic prostatectomies has found no benefit compared to open surgery on key outcomes.
The expensive procedure was not statistically superior for sexual and urinary function, or post-operative complications, Queensland researchers found.
This data is from the first 12 weeks of a two-year trial of 308 men with prostate cancer who were randomly assigned to receive either robot-assisted laparoscopic prostatectomy or radical retropubic prostatectomy.
“Surgery has long been the dominant approach for the treatment of localised prostate cancer, with many clinicians now recommending the robotic method to patients,” lead author Professor Robert ‘Frank’ Gardiner, University of Queensland Centre for Clinical Research, said in a statement.
Despite an earlier meta-analysis showing functional outcomes were better after robotic surgery, their own comparison did not echo these findings, the authors wrote.
But differences may become apparent later on, as urinary and sexual function continue to improve for up to three years after the operation, they cautioned.
“In the meantime, patients should choose an experienced surgeon they trust and with whom they have a rapport, rather than basing their decision on a specific surgical approach,” Professor Gardiner said.
Though days away from work were equal in both groups, patients who underwent open surgery spent more time in hospital after the surgery.
They also lost more blood – around three times as much as those in the robot-assisted group – although no transfusions were needed.
Robot-assisted surgery also reduced pain in day-to-day activities at one week and was linked to a higher physical quality of life at six weeks, but by 12 weeks this had become non-significant.
To keep the findings consistent, one surgeon performed all of the robotic surgeries and another all of the open surgeries. Each were the most experienced available in their field.
By the trial’s end, the former had completed more than 1000 robot-assisted laparoscopic prostatectomy procedures, and the latter had done more than 2000 radical procedures.
But these findings should not necessarily be cause to disregard robotic prostatectomies, the author of an accompanying editorial, said.
Non-inferiority should be seen as a positive that proved the new technology had met outcomes similar to the status quo, the UK researcher wrote.
Lancet 2016; online July 26
