Comparison of Complication and Readmission Rates Between Robot-Assisted and Open Radical Cystectomy: Results From the Randomized RAZOR Clinical Trial.

PURPOSE: We assessed differences in complications and readmissions between robot-assisted radical cystectomy (RARC) and open radical cystectomy (ORC).

MATERIALS AND

METHODS

This study uses data from the per-protocol population of the Randomized Robotic-Assisted vs Open Radical Cystectomy (RAZOR) study, a multicenter, open-label, phase 3, noninferiority clinical trial. RAZOR enrolled across 15 academic medical centers in the United States between 2011 and 2014. The median follow-up was 2 years. Complications up to 90 days using the Clavien-Dindo classification, and readmissions at 90 days and 1 year postoperatively were compared. Multivariable logistic regression analyses were performed to determine any predictors of major complications and of postsurgery readmission.

RESULTS

Baseline characteristics were similar, and there was no significant difference in overall and major complication rates between RARC (n = 150) and ORC (n = 152) arms. Simplified frailty index ≥ 3 (HR, 4.22, 95% CI, 2.67-6.66, P < .0001) was a significant predictor of major complications within 90 days. Readmission rates at 90 days were 24.1% for RARC and 23.1% for ORC, and readmission rates at 1 year were 29.5% for RARC and 28.5% for ORC (P = .80). Simplified frailty index ≥ 3 was a significant predictor of readmission at both time points (subdistribution HR 4.43, 95% CI, 1.75-11.2, P = .002 at 90 days and subdistribution HR, 5.28, 95% CI, 2.22-12.6, P < .001, at 1 year).

CONCLUSIONS

No significant differences in major complications and readmission rates between ORC and RARC were noted. Patient frailty was an important predictor of these outcomes, and special attention needs to be taken in ensuring appropriate patient selection and preoperative preparation.

TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01157676.