Complications Associated with Surgery for Bladder Cancer
San Diego—An interim analysis of a prospective, randomized trial found that there was no significant difference in 90-day complications after patients with bladder cancer underwent robotic radical cystectomy with extracorporeal urinary diversion or open radical cystectomy.
Vincent Laudone, MD, co-director of robotic surgery at Memorial Sloan-Kettering Cancer Center, presented the results during a late-breaking abstract session at the AUA meeting. He said that the interim findings support the pre-specified criteria for trial closure because there were no observed differences in the groups. He added that the study would close to accrual, although the authors would continue to collect data on longer-term secondary outcomes and would also evaluate cost and quality of life outcomes.
Patients with high-risk bladder cancer are typically treated through radical cystectomy with lymph node dissection and urinary diversion, although the procedure is associated with significant perioperative morbidity of up to 60%, according to Dr. Laudone. To decrease complications, the use of robot assisted radical cystectomy is increasing.
In this study, patients with bladder cancer requiring cystectomy were eligible except if they had received prior pelvic radiation therapy, had undergone an extensive prior pelvic surgery, or were unable to tolerate the Trendelenburg position. They were then randomized in a 1:1 ratio to receive robotic assisted radical cystectomy with open urinary diversion or open radical cystectomy.
At the interim analysis, the authors had collected data from 116 patients who had been randomized and undergone surgery: 59 in the robotic group and 57 in the open group. Of those patients, 109 were followed for at least 90 days.
The groups were well balanced. The mean age was approximately 65 years, the mean body mass index was approximately 29 kg/m2, and approximately 80% of patients were males. In addition, 38% of patients underwent neoadjuvant chemotherapy. More than half of patients in each arm underwent a neobladder diversion.
Patients were operated on by high volume bladder cancer surgeons and were managed on the same, standardized post-operative pathway. The authors obtained data using the institution’s complications databases, the Caisis electronic outcome recording system, and a separate, independent review of patients’ electronic medical records.
The authors used a modified Clavien Complication Scale and defined grade 0 as no event observed; grade 1 as the use of oral medications or bedside intervention; grade 2 as the use of intravenous medications; grade 3 as undergoing interventional radiology, operation, intubation, therapeutic endoscopy, or angiograpy; grade 4 as residual and lasting disability or organ loss; and grade 5 as death.
The authors found that 61% of patients in the robotic group and 62% of patients in the open group had a grade 2 to 5 complication, while 24% of patients in the robotic group and 22% of patients in the open group had a grade 3 to 5 complication. Neither of the differences were statistically significant. In each group, the mean number of grade 2 to 5 complications per patient was 1.5, while the mean number of grade 3 to 5 complications per patient was 0.3.
The surgical time in the robotic arm was 126 minutes longer than in the open arm (P<.001), while blood loss was significantly less for the robotic arm (P=.015). In addition, 78% of patients in the robotic group and 47% of patients in the open group had extended lymph node dissection, which Dr. Laudone defined as at the level of aortic bifurcation or above. However, there was no significant difference in the groups in the number of patients with positive nodes (17% in the robotic group and 16% in the open group). There was also no difference in the incidence of positive soft tissue surgical margins, and the hospital length of stay was equivalent at 8 days in each arm.
