Prospective randomized controlled trial of robotic versus open radical cystectomy for bladder cancer: Median 3-year follow-up.

摘要

284 Background: We reported our results on a prospective, randomized trial of open vs. robotic cystectomy in 2008. Three years later, we report our findings with regard to overall (OS) and disease-specific survival (DS), 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 and pathologic results were reported in 2008. We now report our median 36-month follow-up for this patient cohort. 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 68% in the open group (13/19) and 85% in the robotic group (17/20) (p=0.2733). There were 7 recurrences (35%) in the open cohort compared to 3 patients (14%) undergoing the robotic procedure (p=0.1589). Examining overall complications, there were no differences between the open and robotic groups when evaluating 30-day complications and >=90 day complications (p=0.8651). The open and robotic cohorts demonstrated 2 strictures in each cohort. Two 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 evaluating open versus robotic cystectomy demonstrates no differences with regard to OS, DSS, cancer recurrence or 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.