1. Oliver Hakenberg Department of Urology, Rostock University Rostock, Germany Open vs laparoscopic vs robotic radical prostatectomy

2. NEWSWEEK, December 5, 2005

3. 2002 2003 2004 Alaska 2005 2001 daVinci systems in the USA 2005 Über 16000 Roboter-assistierte RPEs in den USA 2005

4. 5 cm 1 cm

5. What are the criteria? oncological outcome functional results complications increasing case numbers costs and revenues from surgery

6. Oncological results after RPE survival n=787, 1954-1994, 25year survival data survival disease-specific81-99% overall19-93% PSA-recurrence-free54-84% free from local progression88-95% free from systemic progression78-95% Porter et al, Urology 2006

7. Surrogate parameters for oncological results: positive margins n=2029 7,7 %21,8%32,3%59,4% Dept. of Urology, Dresden University, 2007

8. Positive margins Offen (RRP), laparoskopisch (LRP) und Roboter-assistierte (RAP) RPE n+SM/pT2+SM/pT3+ SM Scardino, 2000 1000 12.8 Walsh, 2004 9035 7.726.914.7 Catalona, 2004 3478 19 Blute, 2004 7268 285838 Dresden, 2006 2029 7.721.816.2 Guillonneau 2002 1000 15.53119.2 Rassweiler 2005 500 7.431.821.1 Stolzenburg 2005 700 10.831.220.2 Vallancien 2005 600 14.625.617.7 Menon 2003 200 6 Ahlering 2004 60 4.55016.7 Tewari, 2005 200 4.311.76.3 Van Appledorn 2006 150 17.3

9. „…the available scientific evidence has not been able to confirm any major advantage.“ Touijer & Guilloneau et al, Eur Urol 2009 RPE LRPE recurrence-free survival

10. Perioperative Faktoren offene (RRP), laparoskopische (LRP) und Roboter-assistierte (RAP) RPE n OP time Blood losstransfusionsCatheter time Zinke, 1994 172860031%11 Scardino, 1997 472182800-120028.6% Lepor, 2001 10008189.7%7-21 Rassweiler 2001 180271123031%7 Guillonneau 2002 5672033804.9%5.8 Stolzenburg 2005 7001510.9%6.2 Vallancien 2005 6001733801.2% Menon 2003 2001981530%7 Ahlering 2004 602341030%7 Van Appledorn 2006 1501922.6%

11. functional results continence potency cosmesis duration of hospital stay time out of work complications

12. Continence influence of nerve-sparing n=536 RRPs nerve sparingbilateralunilateralnone incontinence after 12 months 1/75 (1.3%) 11/322 (3.4%) 19/139 (13.7%) 94.2% fully continent, 27 (5%) grade I, 4 (0.8%) grade II stress incontinent Burckhard et al, J Urol 2006

13. reported continence rates after RPE n FU (months) padscontinent Eastham, 1996 5810 91% Walsh, 2004 64180 93% Wie, 2000 4820 88% Catalona, 2004 3477650 93% Rassweiler 2006 5824120 85% Stolzenburg 2005 70060 83% Vallancien 2005 600120 84% Menon 2003 20060-1 96% Ahlering 2004 6030 76% Tewari 2005 10010-1 65% Patel, 2005 200120 98% Joseph 2006 32560 96% open LRP robotic

14. continence after RPE patient based results nVorlagenkontinent Fowler, 1993738069% Murphy, 19941796081% Litwin, 199598 bother score 75% Stanford, 20001291078% Wei, 2002896 no micturition problems 48% Begg, 200211522 no symptoms 81% Karakiewicz, 20042415 no urine loss 51%

15. Continence laparoscopic vs open (n=1430) Touijer et al, J Urol 2008 100 80 60 40 20 0 Full recovery of continence [%] months open laparoskopic p<0.001 27 %

16. 3612 18 0 20 40 60 80 100 potency (%) recovery of potency after ns RPE (n=70, 89% bilateral) Walsh et al, Urology 2000 months after RPE

17. influence of age on potency recovery after RPE age (years)unilateral nerve- sparing bilateral nerve- sparing < 50100% 50-5931%76% 60-6944%65% 70 +40%39% Noh et al, AUA 2002 (n=188)

18. potency open (RRP), laparoscopic (LRP) and robotic (RAP) RPE nFU inter- course spontaneous erections method Walsh, 2004 861886%questionnaire Catalona, 2004 34771875%questionnaire Abbou, 2001 1341256%questionnaire Stolzenburg 2005 700647%questionnaire Vallancien 2005 600643% 64% questionnaire Menon 2003 200660%82%questionnaire Ahlering 2004 45633%questionnaire

19. Montorsi et al, Eur Urol 2008

20. 5-year results for continence and potency n=1288, population-based cohort continenceintercourseuse of sildenafil function after 60 months 86%28%43% Penson et al, J Urol 2005

21. cosmesis Open prostatectomy: mini laparotomy day 12at 6 months 8 cm

22. open vs laparoscopic in-hospital and recovery Open RRP (n=24)laparoscopic RPE (n=36) p surgery time2.85.8<0.0001 blood loss1473533<0.0001 analgesic requirements (Oxycodon tablets) 17±159±13<0.04 days until complete recovery 47±2130±18<0.002 Bhayani et al, Urology 2003

23. Prospective assessment of postoperative pain in open RRP (n=154) versus robotic RPE (n=159) all patients received i.v. ketorolac (clinical pathway) Lickert pain score (0-10)total analgesics (morphine equivalents) day of surgery day 1day 14 open RRP 2,601,732,4223,01 robotic RPE 2,051,762,5122,41 p value< 0,03 n.s. n.s Webster et al, J Urol 2005

24. return to work open RRP, n=537 achieved in 50% of patients part time work full time workunrestricted physical activity after 14 daysafter 21 daysafter 30 days factors of significance were age hematocrit at discharge catheter time Sultan et al, J Urol 2006

25. complications open (RRP), laparoscopic (LRP) and robotic RPE nMinorMajortotalmortality Zinke, 1994 17282.90 Scardino, 1997 47221.49.827.80.4 Catalona, 2000 347754.190 Lepor, 2001 10003.53.16.60.1 Rassweiler 2001 18014.48.818.90 Guillonneau 2002 56714.63.718.50 Stolzenburg 2005 7006.82.49.20 Vallancien 2005 6009.22.311.30 Menon 2003 2001.523.50 Ahlering 2004 603.3 6.70

26. Long term complications RPE in Austria: n=16.524 1992-2003 Mohamad et al, Eur Urol 2007, 51, 684-689

27. increasing case numbers OR time and capacity surgical volume complications costs & revenues

28. Increase in RPE caseload Dept. of Urology, Dresden University 2006

29. influence of hospital case load on oncological outcome RRP, n=12,635, SEER data, cT1c adjusted for age, comorbidity, grade and stage RPE caseload per hospital/year 1-3334-61>108 likelihood of adjuvant treatment within 6 months (HR) 1,251,111 Ellison et al, J Urol 2005

30. Transperitoneal (TLRP) vs extraperitoneal (ELRP) laparoscopic RPE nsurgery time (h) blood loss (ml) in-patient stay (d) catheter time (d) pad-free after 12 months erections after 12 months TLRP1002393103,811.390%61% ELRP1001912012,610.196%82% Eden et al, J Urol 2004

31. costs depend on surgery time LRP vs RRP, cost analysis LRP increases costs by 17.5% factors for cost increase (in this order) –surgery time –in-hospital stay –use of disposables cost equivalence –if surgery time for LRP < 160 minutes –or if LRP is outpatient surgery!! Link et al, J Urol 2004

32. model calculation of relative costs of open, laparoscopic and robotic RPE Literaturrecherche costs per case open (RRP) laparoscopicrobotic (RAP) including robotic investment 0+ 487 $+ 1,726 $ without robotic investment + 1,155 $ assumptionsrobotic investment 1.2 million US$ yearly maintenance costs 120.000 US$ robot use of 300 caeses / year (interdisciplinary) surgery time RAP 140 min vs RRP 160 min hospital stay RAP 1.2 days vs RRP 2.5 days Lotan et al, J Urol 2004

33. costs depend on case numbers and local structures model calculation extra costs of RAP vs RRP of 783 $/case cost effective with 10 cases/week with 14 cases/week or more RAP becomes cheaper if in-patient stay is < 1.5 days Scales et al, J Urol 2005

34. Ficarra et al, Eur Urol, 2009

35. continence rates after 12 months in prospective studies laparoscopic vs open Ficarra et al, Eur Urol, 2009

36. openlaparoscopicrobotic OR timeshorterlonger blood lossmoreless transfusion ratemoreless catheter timelongershorter in-hospital timelongershorter costslowesthigher/much higher complicationsno difference positive marginsno difference potencyno difference continenceno difference Ficarra et al, Eur Urol, 2009

37. Comparing robotic, laparoscopic and open retropubic prostatectomy… the available data were not sufficient to prove the superiority of any surgical approach in terms of functional and oncologic outcome.

38. Outcome of minimally invasive RPE vs open RPE 2003-2005 n= 2702, 5% sample of MediCare patients openminimally invasive p < complications36,4%29,8%0,002 hospital stay4,4 d1,4 d0,001 salvage treatment9,1%27,8%0,001 Hu et al, J Clin Oncol 2008

39. „Minimally invasive“ „modern“ „high tech“ „no blood loss“ „fully continent“ „fully potent“

40. „…wide acceptance of new techniques based on hypothetical benefits or extrapolated proven advantages from other surgical operations such as cholecystectomy…“ „This study is more of a comparison of surgeons and their techniques than a pure comparison of surgical technique.“ Touijer et al, J Urol 2008