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.


METHODS
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.


METHODS
ORC, RARC, or LRC with extracorporeal urinary diversion.


METHODS
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.


CONCLUSIONS
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.


RESULTS
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.
Department of Urology, Guy's and St. Thomas' NHS Foundation Trust, London, UK; MRC Centre for Transplantation, NIHR Biomedical Research Centre, King's College London, Guy's Hospital, London, UK. Electronic address: shamim.khan@gstt.nhs.uk.
Muhammad Shamim
MS
Khan
Department of Urology, Guy's and St. Thomas' NHS Foundation Trust, London, UK.
Christine
C
Gan
Department of Urology, Guy's and St. Thomas' NHS Foundation Trust, London, UK.
Kamran
K
Ahmed
Department of Urology, Guy's and St. Thomas' NHS Foundation Trust, London, UK.
Ahmad Fahim
AF
Ismail
Department of Urology, Guy's and St. Thomas' NHS Foundation Trust, London, UK.
Jane
J
Watkins
Division of Health and Social Care Research, King's College London, London, UK.
Jennifer A
JA
Summers
Division of Health and Social Care Research, King's College London, London, UK.
Janet L
JL
Peacock
Department of Urology, Eastbourne District General Hospital, Eastbourne, East Sussex, UK.
Peter
P
Rimington
Department of Urology, Guy's and St. Thomas' NHS Foundation Trust, London, UK; MRC Centre for Transplantation, NIHR Biomedical Research Centre, King's College London, Guy's Hospital, London, UK.
Prokar
P
Dasgupta
D000368:Aged; D015653:Cystectomy / Q000009:adverse effects / Q000379:methods* / Q000401:mortality; D006801:Humans; D010535:Laparoscopy / Q000009:adverse effects / Q000401:mortality; D008131:London; D008297:Male; D008875:Middle Aged; D061646:Operative Time; D011183:Postoperative Complications / Q000209:etiology; D011446:Prospective Studies; D020127:Recovery of Function; D012307:Risk Factors; D065287:Robotic Surgical Procedures / Q000009:adverse effects / Q000401:mortality; D013997:Time Factors; D016896:Treatment Outcome; D001749:Urinary Bladder Neoplasms / Q000401:mortality / Q000473:pathology / Q000601:surgery*
Complications; Minimally invasive surgery; Muscle-invasive bladder cancer; Radical cystectomy; Robotic surgery