1624 A PILOT PROSPECTIVE SINGLE-CENTRE 3-ARM RANDOMISED CONTROLLED TRIAL OF OPEN, ROBOTIC AND LAPAROSCOPIC (CORAL) RADICAL CYSTECTOMY FOR BLADDER CANCER

Abstract

You have accessJournal of UrologyBladder Cancer: Invasive (II)1 Apr 20131624 A PILOT PROSPECTIVE SINGLE-CENTRE 3-ARM RANDOMISED CONTROLLED TRIAL OF OPEN, ROBOTIC AND LAPAROSCOPIC (CORAL) RADICAL CYSTECTOMY FOR BLADDER CANCER Christine Gan, Fahim Ismail, Grace Cheung, Amit Patel, Jane Watkins, Tim O' Brien, Paul Hegarty, Prokar Dasgupta, Peter Rimington, and Muhammad Shamim Khan Christine GanChristine Gan London, United Kingdom More articles by this author , Fahim IsmailFahim Ismail London, United Kingdom More articles by this author , Grace CheungGrace Cheung London, United Kingdom More articles by this author , Amit PatelAmit Patel London, United Kingdom More articles by this author , Jane WatkinsJane Watkins London, United Kingdom More articles by this author , Tim O' BrienTim O' Brien London, United Kingdom More articles by this author , Paul HegartyPaul Hegarty London, United Kingdom More articles by this author , Prokar DasguptaProkar Dasgupta London, United Kingdom More articles by this author , Peter RimingtonPeter Rimington Eastbourne, United Kingdom More articles by this author , and Muhammad Shamim KhanMuhammad Shamim Khan London, United Kingdom More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2013.02.3174AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES Laparoscopic and robotic approaches in radical cystectomy have become increasingly popular, but a high level of evidence comparing these to open radical cystectomy is lacking. We report results of a pilot 3-arm randomised controlled trial comparing open (ORC), robotic (RARC) and laparoscopic radical cystectomy (LRC) with extra-corporeal urinary diversion. METHODS From March 2009 to July 2012, 164 patients with muscle invasive or high risk bladder cancer were seen. Of these 93 were suitable for inclusion in the trial; 60 (64.5%) agreed and 33 declined. 71 others were not eligible. (Figure 1: Consort diagram) Primary endpoint was 30 and 90 day complications, and secondary endpoints were peri-operative clinical and oncological outcomes, and quality of life analyses. Results were analysed on an intention to treat basis. RESULTS There were no significant differences in patient demographics between the 3 groups. RARC and LRC were equivalent in peri-operative outcomes. ORC was associated with higher estimated blood loss (EBL), longer hospital stays (LOS) and delayed bowel function, but shorter operating times compared to RARC and LRC. There were no significant differences in any of the other clinical and pathological variables studied. (Table 1) There were also no significant differences between the 3 groups in terms of scores for physical, social, emotional, functional, and sexual wellbeing. CONCLUSIONS Radical cystectomy is a morbid procedure with high complication rates, whichever surgical approach is used. Randomisation into surgical trials is feasible, but recruitment from a single centre is slow and logistically challenging. We propose multicentre, multinational trials for such procedures. ORC (n=20) RARC (n=20) LRC (n=19) P value (ORC vs RARC) P value (ORC vs LRC) P value (RARC vs LRC) Median op time (minutes) 277.5 (270-300) 367.5 (345-431.3) 300 (270-330) 0.00 0.39 0.00 Median EBL (mL) 650 (600-1050) 350 (137.5-850) 300 (200-525) 0.02 0.00 0.69 Median LOS (days) 13 (10-16) 10 (8-17) 9 (7.5-11) 0.07 0.002 0.48 Median time to solids (days) 7.5 (4-10) 4 (3.75-5.25) 4 (3-6) 0.049 0.01 0.61 Postive margin (%) 1/20 (5%) 2/20 (10%) 0/20 (0%) 1.00 1.00 0.49 Mean number of lymph nodes 18.8±7.59 16.25±8.02 16.33±6.23 0.13 0.11 0.97 30D complications (%) 13/20 (65%) 10/20 (50%) 7/19 (36.8%) 0.39 0.61 0.25 30D median Clavien grades 2 (2-3) 2 (2-3) 2 (1.5-2) 0.28 0.44 0.88 90D complications (%) 3/20 (15%) 5/20 (25%) 2/19 (10.5%) 0.70 1.00 0.401 90D median Clavien grades 3 (1.75-3) 3 (3-4) 2 (2-2) 0.39 0.40 0.19 Death - all cause (%) 3/20 (15%) 2/