Inception Cohort. Center for Evidence-Based Medicine, Oxford VIP-- Inception Cohort (2008) Nov Dec

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1 VIP-- Inception Cohort (28) Robotic Prostatectomy: Oncological and Functional Outcomes after 4 cases The Donald Smith Lecture Nov 2- Dec patients Patient 1 to patient 38 PSA follow-up patients (92%) Level 1b evidence (Center for Evidence- Bases Medicine Inception Cohort A group of patients assembled at the time of onset of disease or treatment Cohort study : the observation of a cohort over time to measure outcomes (AKA: longitudinal, follow-up studies) Center for Evidence-Based Medicine, Oxford 1a Randomized Control study Systemic review of inception cohort studies 1b.. Individual inception cohort study with> 8% follow- up 2a..Review of retrospective cohort groups( homogeneous) 2b..same (heterogeneous) 2c..outcomes analysis 4..Case series or poor quality cohort studies 5..Expert opinion

2 PATHOLOGY GLEASON BY YEAR PLND Complications Extending the template Bader et. al. 365 Pts 88 Met (+) LN 51(58%) Int Iliac LN Internal Iliac Lymphnode Dissection High risk patients.extended node dissection both internal and external iliac D Amico low and intermediate risk patients Internal iliac PLND done without dissecting External iliac LN J Urol 22; 168:514

3 Internal Iliac PLND D Amico low and intermediate risk patients Internal iliac PLND- 58 Standard Template group matched by the distribution of the variables (Bx. Gleason, PSA and Clinical Stage) Internal Iliac PLND Internal Iliac PLND LN Met + No LN Mets Totals Standard PLND Totals LN Met + Rates Int. iliac 6.8% Std. template.45% CI 99% Fisher Exact Test Two tailed p-value.1 OR =15.1 ( )

4 Overall BCR BCR after VIP K a pla n -M e ie r s u rv iv al e s tim a te Survival Probability Censored by PSA >.4 95% CI: Grey lines N u m b e r a t ri s k T i m e ( m o n th s ) Time to Follow-Up (Months) # At risk # Failures # Censored Cumulative death estimate Probability of BCR VUI 21-8 MSKCC 2-6

5 AUA BCR Panel guideline for BCR Overall BCR.15 Recurrence Probability Follow-up Time (months) At Risk 3,457 2,365 1, BCR by Pathology Gleason BCR by Pre-Operative PSA to 1.5 < ">=2" Recurrence Probability Recurrence Probability Follow-up Time (months) Follow-up Time (months) 6 1, ,892 1, < ,361 1,632 1, >=

6 BCR by Pathological Stage OC EPE SV/T4 STD.3.5 Recurrence Probability Recurrence Probability.6 BCR by Nerve Sparing VEIL WIDE Follow-up Time (months) OC 2,518 EPE 752 SV/T , , Follow-up Time (months) T3 disease, veil nerve sparing 8 STD VEIL WIDE 1,687 1, ,127 1, T3 disease, conventional nerve sparing 96

7 Relationship of BCR to death from cancer Johns Hopkins, (Median =9y) BCR PSA>.1 = 2% 926 BCR, 635 in whom doubling time could be measured 118 deaths from prostate cancer (18% of patients with doubling times) No deaths without BCR 5 of 6 men with BCR will not die of prostate cancer within 6 years after recurrence Trock et al, 28, JAMA:299, 276 Techniques to Improve Continence Mani Menon VIP Team pts in percentage Number of patients with incontinence on follow up 3 months 6 months 9 months 12 months time of follow up standard unilateral veil bilateral veil super veil Techniques to improve continence Posterior reconstruction of the rhabdosphincter (Rocco stitch) 84% pad/1 diaper at 3 d Anterior reconstruction (Tewari) 62% -1 1 pad at 6 weeks Combined reconstruction? Rocco et al. Eur. Urol. 27, 51: Tewari et al. Urology, ogy, 27, 69: 726

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9 -1 pad (<3 g/day leak) 8% 6% Percentage 4% Continent 2% % 1d 2d 7d 31d Double Layer 34% 46% 54% 8% Single Layer 26% 49% 51% 74% Days after catheter removal pads ( gr/day leak) 5% 4% Percent 3% continent 2% 1% % 1d 2d 7d 31d Double Layer 15% 14% 2% 42% Single Layer 7% 14% 16% 47% Days after catheter removal Primary outcome: Shows pad usage after robotic prostatectomy in patients undergoing either single- or double layer vesicourethral anastomosis. There is no statistically significant difference in outcomes Secondary outcome: : Proportion of patients with grams per day urinary loss after single- or double layer anastomosis.

10 Techniques to improve continence No-touch sphincteric dissection (Menon) 8% at 3 d Posterior reconstruction of the rhabdosphincter (Rocco stitch) 84% at 3 d Anterior and post reconstruction (Tewari( Tewari) 83% pad at 6 weeks The median urinary losses, at days 1, 2, 7 and 3 days were 81 grams g and 7 grams, 33 grams and 57 grams, 33 grams and 2 grams and 2 grams and 1 grams for the single-layer layer or the double-layer layer anastomosis, respectively. Technique to Decrease Discomfort 8% of patients complained of Foley 6% severe discomfort Mani Menon VIP Team

11 Patient Discomfort after RP Veil (Intrafascial dissection, High anterior release)

12 Veil: The Ground Work Pelvic Plexus and Bundle Dissection of Walsh s s bundles Walsh s s Nerves

13 Nerves in lateral pelvic fascia

14 How radical is a radical prostatectomy? Closest distance between cancer and resection margins was.5 mm Veil closest distance was.2 mm

15 Histopathology SHIM Scores: Veil of Aphrodite Intercourse 34/35(97%) SM+ SHIM>21 no PDE5I 18/35(51%) SHIM>21 with PDE5I 3/35(86%) Every spoke in this graph represents an individual patient ():Patients on PDE5I, (SM+ ):Surgical Margin Positive SHIM Scores: Std. Nerve Sparing and Veil Results Every spoke in this graph represents an individual patient Classical Veil P Value Intercourse 74% 97%.2 Normal Erection(+/-) ) PDE5I 26% 86%.1 Normal Erection (-)( ) PDE5I 17% 51%.1 Parsons Criteria (SHIM >15) 52% 93%.2 Post op SHIM; Mean (SD) Median 14.8(8.6) (4.8) 22.1 Mean change in SHIM 9.1(38%) 2.6(11%).2 Pts using PDE5I 7(3%) 15(43%).57

16 Why does the veil work? More nerves preserved Less traction injury Increased maintenance of blood supply to cavernous tissues more enos Cost of Robotic Prostatectomy No additional cost to patient No additional insurance premium Hospital cost of capital equipment similar to CT/MRI One-half that of IMRT, 1% of proton beam Menon et al. J. Urol, 25, 174:

17 SHIM Scores: Standard Nerve Sparing Intercourse 17/23(74%) SM+ SHIM>21 no PDE5I 4/23(17%) SHIM>21 with PDE5I 6/23(26%) Results: Conclusions: At 12 Potency months rates of followup after radical 17 of 23 prostatectomy control (74%) vary and with 34 of the 35 measure study (97%) used patients to define potency. achieved Irrespective erections strong of the enough definition for used intercourse patients (p undergoing.2). Four prostatic control fascia (17%) preserving and 18 study radical (51%) patients prostatectomy achieved have normal significantly erections better (SHIM potency greater outcomes than 21) than without patients medication undergoing (p conventional.1). Six nerve control sparing (26%) robotic and 3 prostatectomy study (86%) patients 12 months achieved of followup. normal erections with or without phosphodiesterase 5 inhibitors (p.1). Every spoke in this graph represents an individual patient ():Patients on PDE5I, (SM+):Surgical Margin Positive