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
Since the introduction of robotic surgery in onco-urology, numerous studies have aimed to compare the outcomes of open versus robotic approaches to radical cystectomy (RC). While RC remains the gold standard treatment for localised muscle-invasive bladder cancer (MIBC), it is still associated with considerable morbidity. Robot-assisted RC (RARC) has been shown to reduce blood loss and shorten hospital length of stay. Furthermore, survival and quality of life outcomes appear comparable to those of open RC (ORC). However, prospective data on postoperative complications in this setting remain limited. In this commentary we discuss the findings of a recently published secondary analysis from the RAZOR clinical trial by Venkatramani et al., which evaluates complication and readmission rates following RARC versus ORC.
The RAZOR trial is a multi-centre phase 3 non-inferiority clinical trial conducted in 15 academic medical centres in the United States between 2011 and 2014. A total of 302 patients undergoing RC were included in the per-protocol analysis set (RARC n=150; ORC n=152) 1.
The cumulative rate of complications of any Clavien-Dindo grade within 90-days was similar between the RARC and ORC arm (65.3% vs. 68%; p=0.59). Likewise, the cumulative rates of major complications (Clavien-Dindo grade III-V) at 1-year were comparable (21.3% vs. 21.8%; p=0.91). Gastro-intestinal and urinary tract infections were the most common complications in both groups. Readmission rates within 90-days were 24.1% for the RARC group and 23.1% for the ORC group. In multivariable logistic regression analyses including surgical approach, urinary diversion type, lymphadenectomy, neoadjuvant and adjuvant chemotherapy, tumoral and nodal stage, gender, age and patients simplified Frailty Index (sFI), sFI was an independent predictor of major complications (HR=4.22; 95%CI=[2.67-6.66]; p<0.001) and readmission (HR=4.43; 95%CI=[1.75-11.2]; p=0.002) within 90-days, while the surgical approach was not significantly associated with major complications (HR=1.09; 95%CI=[0.80-1.49]; p=0.57) or readmission (HR=1.11; 95%CI=[0.68 -1.80]; p=0.69) within 90-days.
The RAZOR trial confirms that RARC and ORC have comparable safety profiles, with similar complication and readmission rates. The sFI emerged as a strong predictor of postoperative complications and readmissions, highlighting the value of frailty assessment. A key limitation is that all urinary diversions were extra-corporeal, potentially underestimating the benefits of a fully minimally invasive approach. Future studies should assess intracorporeal techniques and frailty optimisation to further improve outcomes. To conclude, and as recommended by the EAU Guidelines 2, while outcomes appear comparable between RARC and ORC, the choice of surgical approach should ultimately be guided by surgeon expertise and institutional experience to ensure optimal patient care.