1033 A pilot prospective single-centre 3-arm randomised controlled trial of open, robotic and laparoscopic (CORAL) radical cystectomy for bladder cancer

1033

A pilot prospective single-centre 3-arm randomised controlled trial of open, robotic and laparoscopic (CORAL) radical cystectomy for bladder cancer Eur Urol Suppl 2013;12;e1033

Gan C.1, Ismail F. 1, Cheung G.1, Patel A.1, Dasgupta P.2, Rimington P.3, Watkins J.1, O'Brien T.1, Hegarty P.1, Khan M.S.2 1

Guy's Hospital, Dept. of Urology, London, United Kingdom, 2Guy's Hospital, Dept. of Urology, MRC Centre For

Transplantation, King's College London, King's Health Partners, London, United Kingdom, 3Eastbourne District General Hospital, Urology, Eastbourne, United Kingdom INTRODUCTION & OBJECTIVES: Laparoscopic and robotic approaches in radical cystectomy have become increasingly popular, but high levels of evidence comparing these to open radical cystectomy are lacking. We report our results of a pilot 3-arm randomised controlled trial comparing open (ORC), robotic (RARC) and laparoscopic radical cystectomy (LRC) with extra-corporeal urinary diversion. MATERIAL & METHODS:

From March 2009 to July 2012, we assessed 164 patients with muscle invasive or high risk bladder cancer in whom radical cystectomy was indicated. Of these 93 were suitable for trial inclusion; 60 (65%) agreed and 33 (35%) declined, while 71 others were not eligible. Our primary endpoint was 30 and 90 day complications, and secondary endpoints were peri-operative clinical and oncological outcomes. Median length of follow-up was 24.4 months (range = 4-44 months). 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 variables studied. (Table 1)

ORC (n=20)

RARC (n=20)

LRC (n=19)

Median op time, minutes

277.5 (270300)

367.5 (345431.3)

Median EBL, mL

P value ORC vs RARC

ORC vs LRC

RARC vs LRC

300 (270330)

0.00

0.39

0.00

650 (600-1050) 350 (137.5-850)

300 (200525)

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

Positive 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

Median 30D Clavien

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

0.40

Median 90D Clavien

3 (1.75-3)

3 (3-4)

2 (2-2)

0.39

0.40

0.19

All cause death (%)

3/20 (15%)

2/20 (10%)

3/19 (15.8%)

1.00

1.00

0.66

Disease specific death (%)

3/20 (15%)

1/20 (5%)

2/19 (10.5%)

0.61

1.00

0.61

Table-1. Clinical and pathological outcomes. All data are means ± S.D, or medians (inter-quartile range). CONCLUSIONS: Radical cystectomy is a morbid procedure with high complication rates, whichever surgical approach is used. Robotic and laparoscopic approaches have similar outcomes in most respects. 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.