Image: Professor Parekh operating the da Vinci Xi Surgical System (Photo courtesy of the University of Miami).
A major study shows lower blood loss, blood transfusion rates, and shorter hospital stays for minimally invasive surgery (MIS) patients, but overall outcomes are similar.
Researchers at the University of Miami (FL, USA), the University of Texas Health Science Center (UTHSCSA; San Antonio, USA), and other institutions conducted a randomized trial in 350 patients with bladder cancer so as to compare robot-assisted radical cystectomy (176 patients) to open radical cystectomy (174 patients), with treatment allocation masked only from pathologists. In all, 150 in the robotic cystectomy group and 152 in the open cystectomy group were included in the per-protocol analysis, with the primary endpoint being two-year progression-free survival.
The results revealed two-year progression-free survival of 72.3% in the robotic cystectomy group and 71.6% in the open cystectomy group, indicating non-inferiority of robotic cystectomy. Adverse events occurred in 67% of the robotic cystectomy group and 69% of the open cystectomy group, with the most common adverse events being urinary tract infection (35% in the robotic cystectomy group versus 26% in the open cystectomy group), and postoperative ileus (22% in the robotic cystectomy group, versus 20% in the open cystectomy group). The study was published on June 23, 2018, in The Lancet.
“We have done more than four million surgeries with the robotic approach since the device came into existence, and on average we do close to a million robotic surgeries a year globally,” said lead author professor Dipen Parekh, MD, chief clinical officer of the University of Miami Health System. “Close to 5,000 robotic systems installed all over the world, and yet until we did this study there was not a single Phase 3 multicenter randomized trial comparing this expensive new technology to the traditional open approach of doing surgeries.”
“There's a steep cost to robotic technology, and there is a learning curve, so we need to build on this in terms of making rational, data-based decisions,” concluded Professor Parekh. “No one had followed these patients over a period of time to find out if you are impacting their cancer outcomes with this robotic approach. We were able to prove unequivocally that we are not compromising patient outcomes by using robotic surgery.”
University of Miami
University of Texas Health Science Center