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

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

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

Clinical – Pathological Features

Preoperative Clinical Features LRPRRPP value Number of patients 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) Prostate volume (cc)36.2 (+ 17)37 (+ 24.7)0.64

LRPRRPP value Specimen weight (gm)43.9 (+ 15.1)43.3 (+ 22.1)0.73 Pathological Gleason sum %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

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%

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

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

Nodal Status LRPRRPP value Mean Median 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%

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

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

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)

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

Evolution Over Time of the PSM Rate for pT2 Disease Open: Odds ratio 1.09, 95% CI p=0.5 Lap : Odds ratio 0.6, 95% CI p=0.01 LAP OPEN

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

Nerve Resection During the Study Period for Lap.

Analysis of Biochemical Recurrence

Biochemical Recurrence Data

Functional Outcome Measured prospectively By Patient filled quality of life questionnaires

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

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

Potency After Bilateral Nerve Preservation Date of Sx

Continence

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

Date of Sx (No Pads) 77 50

Analysis of Morbidity

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

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

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

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

EQUANIMITY LRPRRP OR Time OR Time (min) (90 – 430) (90-360) EBL EBL (ml) (50 – 1500) ( ) Hospital stay Hospital stay (night) (1 – 17) (2-11)

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)

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

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%)

Analysis of Cost

Total Hospital Charges

Could the difference be explained by Length of stay?

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