A Single-centre Early Phase Randomised Controlled Three-arm Trial of Open, Robotic, and Laparoscopic Radical Cystectomy (CORAL).

BACKGROUND Laparoscopic radical cystectomy (LRC) and robot-assisted radical cystectomy (RARC) are increasingly popular, but high-level evidence for these techniques remains lacking. OBJECTIVE To compare the outcomes of patients undergoing open radical cystectomy (ORC), RARC, and LRC. DESIGN, SETTING, AND PARTICIPANTS From March 2009 to July 2012, 164 patients requiring radical cystectomy for muscle-invasive bladder cancer or high-risk non-muscle-invasive bladder cancer were invited to participate, with an aim of recruiting 47 patients into each arm. Overall, 93 were suitable for trial inclusion; 60 (65%) agreed and 33 (35%) declined. INTERVENTION ORC, RARC, or LRC with extracorporeal urinary diversion. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS Primary end points were 30- and 90-d complication rates. Secondary end points were perioperative clinical, pathologic, and oncologic outcomes, and quality of life (QoL). The Fisher exact test and analysis of variance were used for statistical analyses. RESULTS AND LIMITATIONS The 30-d complication rates (classified by the Clavien-Dindo system) varied significantly between the three arms (ORC: 70%; RARC: 55%; LRC: 26%; p=0.024). ORC complication rates were significantly higher than LRC (p<0.01). The 90-d complication rates did not differ significantly between the three arms (ORC: 70%; RARC: 55%; LRC 32%; p=0.068). Mean operative time was significantly longer in RARC compared with ORC or LRC. ORC resulted in a slower return to oral solids than RARC or LRC. There were no significant differences in QoL measures. Major limitations are the small sample size and potential surgeon bias. CONCLUSIONS The 30-d complication rates varied by type of surgery and were significantly higher in the ORC arm than the LRC arm. There was no significant difference in 90-d Clavien-graded complication rates between the three arms. PATIENT SUMMARY We compared patients having open, robotic, or laparoscopic bladder removal surgery for bladder cancer and found no difference in Clavien-graded complication rates at 90 d.