PREDICTORS OF POSTOPERATIVE COMPLICATIONS AFTER ROBOTIC AND OPEN RADICAL CYSTECTOMY: AN ANALYSIS FROM THE RAZOR TRIAL

INTRODUCTION AND OBJECTIVE: Radical cystectomy (RC) has significant perioperative complications and the use of robotic surgery was predicted to reduce this morbidity. Prior retrospective publications do report lower complication rates with robot-assisted RC (RARC). We compared postoperative complication rates and evaluated predictors of complications up to 3 months following RC in patients from the RAZOR trial; a multicenter, open-label non-inferiority phase III randomized trial comparing RARC to open cystectomy (OC). METHODS: The per-protocol population of the RAZOR trial was used. Complications up to 90 days postoperatively were graded using the Clavien-Dindo system. Frailty was evaluated by the validated simplified frailty index (sFI) (ECOG≥2, history of diabetes mellitus, chronic obstructive pulmonary disease, congestive cardiac failure, and hypertension requiring treatment). Multivariable logistic regression analysis was conducted to identify factors predicting major complications (Clavien-Dindo grade 3 and above) up to 90days postoperatively. RESULTS: There was no significant difference in overall and major complication rates between RARC and OC. Gastrointestinal (predominantly ileus) and urinary tract infections were the most common complications in both groups. Female sex (OR 1.84, 1.08-3.16, p=0.026) and sFI ³3 (OR 5.90, 2.65-13.14, p<0.0001) were significant predictors of major complications at 90days. Surgical approach (RARC or OC), diversion type, chemotherapy, lymphadenectomy extent, age, T or N stage, and BMI were not predictive (Table 1). CONCLUSIONS: Postoperative complication rates do not differ between RARC and ORC in this analysis from the RAZOR trial. Women and frail patients had a significantly higher rate of major complications. Surgical approach, chemotherapy and extent of lymphadenectomy were not significant predictors. This data suggests that inherent patient factors like frailty contribute significantly to recovery from a major procedure like RC.Source of Funding: The RAZOR trial was supported by the National Institutes of Health (NIH) National Cancer Institute (NCI; grant number 5RO1CA155388).