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First major study comparing robotic to open surgery published in The Lancet

Press releases may be edited for formatting or style | June 22, 2018 Operating Room
MIAMI, June 21, 2018 /PRNewswire-USNewswire/ -- The first comprehensive study comparing the outcomes of robotic surgery to those of traditional open surgery in any organ has found that the surgeries are equally effective in treating bladder cancer. The seven-year study, conducted at 15 institutions, including Sylvester Comprehensive Cancer Center, and directed by Dipen J. Parekh, M.D., chair of urology and director of robotic surgery at the University of Miami Miller School of Medicine, is published in the June 23 issue of The Lancet.

The Randomized Open Versus Robotic Cystectomy (RAZOR) trial showed lower blood loss and blood transfusion rates and shorter hospital stays for patients who received minimally invasive surgery, but there were no differences in complication rates and the two-year progression-free survival was nearly the same.

"We have done more than 4 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 Parekh, who is chief clinical officer of the University of Miami Health System. "There are close to 5,000 robotic systems installed all over the world – each one costs about $2 million – 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."
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A total of 350 patients were involved in the bladder cancer study. Half received the open surgical approach and half received robotic surgery, and they were followed for two to three years so that outcomes could be compared.

"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," Parekh said. "We were able to prove unequivocally that we are not compromising patient outcomes by using robotic surgery."

The most important lesson from the study, Parekh said, is that more trials should be done, on other organs. "It is possible to do well-designed Phase 3 multicenter surgical trials comparing new technology and surgical innovations to traditional ones before proclaiming superiority or success of one over the other," he said. "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."

Patients will also have more solid information as a result of this study and future research, Parekh said. "The patients will ask better questions, and the physicians for the first time will be able to answer these questions, based on data rather than based on intuition. This is the highest level of data one can get."

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