1758 PROSPECTIVE RANDOMIZED CONTROLLED TRIAL OF ROBOTIC VERSUS OPEN RADICAL CYSTECTOMY FOR BLADDER CANCER: MEDIAN 3-YEAR FOLLOW-UP RESULTS

Abstract

You have accessJournal of UrologyBladder Cancer: Invasive III1 Apr 20121758 PROSPECTIVE RANDOMIZED CONTROLLED TRIAL OF ROBOTIC VERSUS OPEN RADICAL CYSTECTOMY FOR BLADDER CANCER: MEDIAN 3-YEAR FOLLOW-UP RESULTS Ian Udell, Raj Kurpad, Angela Smith, Jeff Nix, Matthew Nielsen, Eric Wallen, Michael Woods, and Raj Pruthi Ian UdellIan Udell Chapel Hill, NC More articles by this author , Raj KurpadRaj Kurpad Chapel Hill, NC More articles by this author , Angela SmithAngela Smith Chapel Hill, NC More articles by this author , Jeff NixJeff Nix Chapel Hill, NC More articles by this author , Matthew NielsenMatthew Nielsen Chapel Hill, NC More articles by this author , Eric WallenEric Wallen Chapel Hill, NC More articles by this author , Michael WoodsMichael Woods Chapel Hill, NC More articles by this author , and Raj PruthiRaj Pruthi Chapel Hill, NC More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2012.02.1774AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES We reported our results on a prospective, randomized trial of open versus robotic cystectomy in 2008. These findings demonstrated no difference in complication rate or hospital stay. However, significant improvements were noted for blood loss, bowel function, and analgesic use in favor of the robotic cohort. 3 years later, we report our findings with regard to overall (OS) and disease-specific survival (DS) as well as recurrence rates and long-term complications. METHODS A prospective, randomized study comparing open vs. robotic cystectomy for bladder cancer was initiated at our institution with IRB approval in 2008. A target accrual of 40 patients was established to evaluate for non-inferiority based upon nodal yield. Peri-operative & pathologic results were reported in 2008. We now report our updated follow-up for this patient cohort with a median of 36 months follow-up. RESULTS Of the 41 patients, 21 were randomized to robotic and 20 to open. On surgical pathology, in the robotic group 14 patients had <= pT2, 3 pT3/T4, and 4 N+ disease. In the open group, 9 had <= pT2, 5 pT3/T4, and 7 N+ disease. No positive margins were noted. With median follow-up of 35 and 36 months in the robotic and open arms, OS was 65% (13/20) and 81% (17/21) respectively (p=0.3058). DSS was also nonsignificant with 68% in the open group (13/19) and 85% in the robotic group (17/20) (p=0.2733). Recurrences, although higher in the open cohort, did not reveal statistically significant differences between the groups with 7 patients undergoing open cystectomy experiencing recurrence (35%) compared to 3 patients undergoing the robotic procedure (14%) (p=0.1589). Examining overall complications, there were no differences between the open and robotic groups when comparing those who experienced 30-day complications (n=7 vs. n=6) compared to >=90 day complications (n=3 vs. n=2) (p=0.8651). The open and robotic cohorts demonstrated 2 strictures in each cohort. 2 parastomal hernias were noted in the open group compared to none in the robotic group. On multivariate analysis, controlling for age, BMI and pathologic stage, cystectomy type did not predict OS or DSS, recurrences, or complications. CONCLUSIONS Median 3-year follow-up with our prospective randomized trial demonstrates no differences with regard to OS and DSS as well as cancer recurrence and long-term complications. Although this study was not powered to assess survival differences, this is the first randomized study to report such data in a non-selected population with 3-year median follow-up. © 2012 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 187Issue 4SApril 2012Page: e709-e710 Advertisement Copyright & Permissions© 2012 by American Urological Association Education and Research, Inc.MetricsAuthor Information Ian Udell Chapel Hill, NC More articles by this author Raj Kur