No Difference in Complication Rates or Hospital Stay With Robot-Assisted vs Open-Surgery Cystectomy in Bladder Cancer
In a trial reported in The New England Journal of Medicine, Bochner et al found no difference in complication rates or length of hospital stay with robot-assisted laparoscopic radical cystectomy vs open surgery in patients with bladder cancer. Blood loss was greater and procedure time shorter with open surgery.
Study Details
In the trial,118 patients with clinical stage Ta–3, N0–3, M0 bladder cancer scheduled for definitive treatment with radical cystectomy at Memorial Sloan Kettering Cancer Center between March 2010 and March 2013 were randomly assigned to receive robot-assisted surgery (n = 60) or open surgery (n = 58). Four surgeons with experience in open surgery performed all open procedures, and three surgeons with experience in robot-assisted pelvic surgery performed the robotic procedures.
The primary outcome measure was the 90-day rate of Clavien grade 2 to 5 complications on intention-to-treat analysis. Four patients assigned to robot-assisted surgery declined the assignment and underwent open surgery.
Outcomes
Enrollment was closed early after interim analysis showed that results met predefined criteria for futility. Grade 2 to 5 complications occurred in 62% of patients in the robot-assisted surgery group vs 66% of patients in the open-surgery group (difference = −4%, 95% confidence interval = −21% to 13%, P = .66). Grade 3 to 5 complications occurred in 22% vs 21% (P = .90).
Intraoperative blood loss was lower in the robot-assisted surgery group (mean difference = 159 cm3). Length of surgery was significantly shorter in the open-surgery group (mean difference = 127 minutes, P < .001). Mean length of hospital stay was 8 days in both groups (P = .53).
The investigators noted, “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. Nonetheless, these results highlight the need for randomized trials to inform the benefits and risks of new surgical technologies before widespread implementation.”
The study was supported by Memorial Sloan Kettering Cancer Center, Pin Down Bladder Cancer, and the Michael A. and Zena Wiener Research and Therapeutics Program in Bladder Cancer.
The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.
