A seven-year study comparing outcomes from robotic and open cystectomy procedures showed no statistically significant difference in complications or survival rate between the two methods.
The randomized open versus robotic cystectomy study, known as the Razor trial, is touted as the first comprehensive study to compare outcomes between robotic and traditional open surgeries in any organ. Results from the trial were recently published in the journal The Lancet.
“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. 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,” study director and University of Miami Health System chief clinical officer Dr. Dipen Parekh said in a press release.
The study recruited an initial 350 patients, with data from 302 patients eventually included in the analysis set. A total of 150 patients underwent robotic cystectomy procedures and 152 received open cystectomy treatments.
Two-year progression free survival was reported at 72.3% for patients who underwent robotic procedures and 71.6% for those who underwent open cystectomy treatments.
Adverse events were reported in 67% of the patients in the robotic cohort and 69% in the open cohort. The most common adverse events were urinary tract infections, which occurred in 35% of the robotic cystectomy group and and 26% of the open cystectomy group. Postoperative ileus were reported in 22% of the robotic cohort and 20% of the open cohort, according to study findings.
“In patients with bladder cancer, robotic cystectomy was non-inferior to open cystectomy for 2-year progression-free survival. Increased adoption of robotic surgery in clinical practice should lead to future randomized trials to assess the true value of this surgical approach in patients with other cancer types,” study authors wrote.
Study authors suggested that more trials would need to be performed on multiple organs to gain an accurate view of the difference in outcomes between robotic and open surgery, as robotic procedures are often perceived as superior, despite a lack of evidence.
“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. 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,” Parekh said in a prepared statement. “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.”
Intuitive Surgical enjoyed a nearly two-decade monopoly in the robot-assisted surgery space. At DeviceTalks West, we'll delve into that history as longtime CEO Gary Guthart tells us how he got his start in medtech, how Intuitive came to enjoy such a commanding lead and what the future holds for medical robotics.
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