Robot-assisted and open cystectomy led to similar complication rates among patients with invasive bladder cancer, according to a new study.
Researchers at Memorial Sloan Kettering Cancer Center (MSKCC; New York, NY, USA) conducted a prospective, randomized clinical trial to compare open and robot-assisted laparoscopic cystectomy in 118 patients with newly diagnosed invasive bladder cancer. All surgeries were performed by the same seven surgeons, four experienced in open technique and three with extensive background in robot-assisted cystectomy. The primary outcome was complication rate during the first 90 days after surgery, as defined in accordance with the Clavien grading system.
During the study, 58 patients were randomized to open cystectomy and 60 to robot-assisted laparoscopic cystectomy. Subsequently, four patients in the robotics group refused randomized treatment and underwent open cystectomy. The results showed that 90-day complication rate was 62% with robotic surgery and 66% with open surgical resection of the bladder, with a similar proportion of severe complications. Enrollment stopped when an interim analysis showed that outcomes at that point met predefined criteria for futility. The study was published in the July 24, 2014, issue of the New England Journal of Medicine (NEJM).
“Because the trial was performed by experienced surgeons at a single, high-volume referral center, the results may not be generalizable to all clinical settings,” concluded lead author Bernard Bochner, MD, and colleagues. “Nonetheless, these results highlight the need for randomized trials to inform the benefits and risks of new surgical technologies before widespread implementation.”
Radical cystectomy remains standard of care for non-metastatic, invasive bladder cancer. However, the procedure often leads to clinically significant perioperative complications, exacerbated by older age, comorbidities, and other patient characteristics. Not uncommonly, patients require an extended recovery period.
Memorial Sloan Kettering Cancer Center