1. Radical Prostatectomy: A Critical Analysis of Surgical Quality Between the Open and Laparoscopic Approaches. Karim Touijer, MD

2. Critical Quality Indicators Primary Quality Indicators Oncological Efficacy: Nodal Status Positive Surgical Margin Rate Biochemical Recurrence Rate Functional Outcome Potency recovery Urinary Continence Secondary Quality Indicators Equanimity OR Time Hospital stay Blood Loss Morbidity Transfusion Severity of complications Cost Cost

3. Patients Data January 2003 and June 2005 1213 consecutive radical prostatectomies - 485 Transperitoneal laparoscopic - 692 Retropubic - 36 cases excluded for neo-adjuvant hormonal therapy 4 surgeons, 1 uropathologist

4. Clinical – Pathological Features

5. Preoperative Clinical Features LRPRRPP value Number of patients485692 Age59.5 (+ 7)59 (+ 7)0.15 BMI27.8 (+ 3.6)28.1 (+ 4.2)0.4 PSA6.4 (+ 5)6.7 (+ 7)0.31 Clinical stage0.03 T1C72%65% T2A16% T2B7%8.5% T2C3%6% T3A2.5%4% Biopsy Gleason sum (median)660.14 Prostate volume (cc)36.2 (+ 17)37 (+ 24.7)0.64

6. LRPRRPP value Specimen weight (gm)43.9 (+ 15.1)43.3 (+ 22.1)0.73 Pathological Gleason sum0.09 00.6%0.7% 638.4%40.7% 756.4%50.9% 83.1%3.5% 92.1%4.7% Pathological stage0.25 p00.6%1.2% pT273.2%67.5% pT325.1%29.7% pT41%1.4% Pathological Features

7. LRPRRPP value Seminal vesicles invasion3.5%5.1%0.2 Capsular status0.13 No invasion22.3%25.7% Invading into but not through 55.5%46.7% Focal (< 1mm)7.1%11.1% Established15.1%16.5%

8. Detailed Tumor Characteristics LRPRRPP value Total tumor volume (cc)1.7 (+ 2)1.9 (+ 2.9)0.18 Cancer maximum diameter (cm)1.7 (+ 0.8)1.7 (+ 0.9)0.87 Number of tumor foci3 (+ 1.8)2.9 (+ 1.6)0.35 Predominant site0.82 Peripheral zone56.8%58.4% Transitional zone17.1%15.9% Indolent cancer17.9%19%0.75 Organ confined non-indolent59%52.2%0.1

9. Oncological Efficacy 1.Nodal Status 2.Positive Surgical Margin rate 3.Biochemical Recurrence rate

10. Nodal Status LRPRRPP value Mean13.512.8 Median14120.08 Overall % positivity6%5.9%0.96 % Positivity in high risk patients* 15.4%10.2%0.16 * In Patients with Partin’s Table LNI >1%

11. Positive Surgical Margin Rate Overall Positive Surgical Margin rate Positive Surgical margin rate by pathological stage Risk adjusted rate using the Partin Tables predicted probability of Organ confined for risk stratification

12. Positive Surgical Margins Analysis LRPRRPP value Overall PSM rate11.3%11%0.85 pT28.2%5.3%0.12 pT317.2%20.2%0.32

13. Risk Adjusted Analysis of PSM using Partin’s table predicted Probability of Organ Confined Disease p = 0.45 (Odds ratio: 1.156, 95% CI: 0.79 – 1.69)

14. Evolution Over Time of the PSM Rate For Each Surgical Approach LAP OPEN

15. Evolution Over Time of the PSM Rate for pT2 Disease Open: Odds ratio 1.09, 95% CI 0.81-1.48 p=0.5 Lap : Odds ratio 0.6, 95% CI 0.41- 0.9 p=0.01 LAP OPEN

16. Evolution Over Time of the PSM Rate for pT3 Disease Open: Odds ratio 1.35, 95% CI 0.75-2.44 p=0.32 Lap : Odds ratio 0.25, 95% CI 0.06- 1.05 p=0.06 LAP OPEN

17. Nerve Resection During the Study Period for Lap.

18. Analysis of Biochemical Recurrence

19. Biochemical Recurrence Data

20. Functional Outcome Measured prospectively By Patient filled quality of life questionnaires

21. Potency All Preoperatively potent patients Assessed with or without PDE 5 inhibitors

22. Definition of Potency During the last four weeks, when you had erections with sexual stimulation, how often were your erections hard enough for penetration (entering your partner)? 1.No sexual activity 2.Almost never/never 3.A few times (much less than half of time) 4.Sometimes (about half of the time) 5.Most times (much more than half of the time) 6.Almost always / always

23. Potency After Bilateral Nerve Preservation Date of Sx

24. Continence

25. Definition of Continence How many pads or adult diapers per 24-hour period did you use to control urine leakage during the last four weeks? 1.None (or no leakage) 2.An occasional pad or protective material 3.One pad per 24-hour period 4.Two pads per 24-hour period 5.Three pads or more pads per 24-hour period 6.Adult diapers

26. Date of Sx 298 257 (No Pads) 77 50

27. Analysis of Morbidity

28. Methods Intraoperative dataIntraoperative data blood loss, OR time Inpatient dataInpatient data Any departure from standard of care, hospital stay Outpatient dataOutpatient data Phone calls, ER / Urgent care visits, rehospitalization, reoperation, within 30 days postoperatively

29. Methods Prospective:Prospective: Prostate cancer database (for lap only) Reviewed all the complications entered in the DMS for M&M Retrospective:Retrospective: Discharge summary Postoperative Clinic visits Nursing Notes Nursing phone calls documentation Outside correspondence Outside ER visit documentation UCC visit documentation Transfusion records

30. MSKCC SURGICAL SECONDARY EVENTS GRADING SCALE Complication Grade Description 1Oral medication / bedside care 2Intravenous Medication / Minor Bedside Surgical Procedure 3Interventional Radiology / Endoscopy / Operation / Intubation 4Chronic Disability / Major Organ Resection 5Death

31. Patients Data Mean age: 59 years for both groups Thromboprophylaxis: Preoperative and postoperative LMWH (lap only) SCD Antibiotic prophylaxis

32. EQUANIMITY LRPRRP OR Time OR Time (min) 199.4 + 46.6 (90 – 430) 188.5 + 40.5 (90-360) EBL EBL (ml) 314.4 + 186 (50 – 1500) 1267 + 660 (100-3500) Hospital stay Hospital stay (night) 2.0 + 1.5 (1 – 17) 3.3 +1.2 (2-11)

33. Blood Transfusion LRPRRP Autologous only 033.6% (233 pts) Auto + Heterologous 09% (67 pts) Heterologous only 2.9% (14 pts)5.5% (38 pts) Overall2.9% (14 pts)49% (338 pts)

34. Cardiac & Thromboembolic LRPRRP Number (%)GradeNumber (%)Grade DVT1 (0.2%)24 (0.6%)2 PE3 (0.6%)21 (0.14%)2 MI1 (0.2%)21 (0.14%)5 A-Fib3 (0.6%)211 (1.6%)2 Syncope0-8 (1.15%)2

35. Postoperative “Bounce-back” LRPRRP UCC / Local ER Visits 75 patients (15.5%)75 patients (10.8%) Readmissions (MSK or Local) 23 patients (4.7%)8 patients (1.15%) Reoperations 9 patients (1.8% )*3 patients (0.4%)

36. Analysis of Cost

37. Total Hospital Charges

38. Could the difference be explained by Length of stay?

39. Conclusions At our institution the laparoscopic and open approach offer comparable cancer control Recovery of erections is slighly faster with laparoscopy, that of continence is faster with open surgery The blood loss and transfusion rate is significantly reduced after laparoscopy