[T]hese results highlight the need for randomized trials to inform the benefits and risks of new surgical technologies before widespread implementation.
—Bernard H. Bochner, MD, and colleagues
Retrospective analyses indicate that robot-assisted laparoscopic surgery for radical cystectomy in patients with bladder cancer is associated with reduced risk of complications and shorter hospital stay compared with open surgery. In a small single-institution randomized trial reported in a letter to The New England Journal of Medicine, Bernard H. Bochner, MD, and colleagues at Memorial Sloan Kettering Cancer Center, New York, found no difference in complication rates or length of hospital stay with robot-assisted laparoscopic surgery vs open surgery in this setting.1 Intraoperative blood loss was greater and procedure time shorter with open surgery.
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 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.
The robot-assisted surgery and open-surgery groups were generally well balanced for age (median, 66 and 65 years), sex (85% and 72% male), body mass index (median, 27.9 and 29.0 kg/m2), American Society of anesthesiologists score (2 in 28% and 21%, 3 in 70% and 74%, 4 in 2% and 5%), and clinical stage (Tis in 14% and 4%, Ta in 2% and 5%, T1 in 36% and 33%, T2 in 41% and 49%, T3 in 7% and 9%, T4 in 2% and 0%).
Enrollment was closed early after an 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 = 456 vs 329 minutes, mean difference = 127 minutes, P < .001). Mean length of hospital stay was 8 ± 3 days in the robot-assisted surgery group and 8 ± 5 days in the open-surgery group (difference = 0, 95% CI = −2 to 1, 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.” ■
Disclosure: 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. For full disclosures of the study authors, visit www.nejm.org.
1. Bochner BH, Sjoberg DD, Laudone VP: A randomized trial of robot-assisted laparoscopic radical cystectomy (letter). N Engl J Med 371:389-390, 2014.
We read the letter to the editor in the July 24, 2014, issue of The New England Journal of Medicine entitled, “A Randomized Trial of Robot-Assisted Laparoscopic Radical Cystectomy,” with great interest.1
In the letter, reviewed in this issue of The ASCO Post, Bochner and...