Radical Prostatectomy: A Critical Radical Prostatectomy: A Critical Analysis of Surgical Quality Between Analysis of Surgical Quality Between

the Open and Laparoscopic the Open and Laparoscopic Approaches.Approaches.

Karim Touijer , MDKarim Touijer , MD

Critical Quality Indicators Primary Quality IndicatorsPrimary Quality Indicators

• Oncological Efficacy: Nodal Status Positive Surgical Margin Rate Biochemical Recurrence Rate

• Functional Outcome Potency recovery Urinary Continence

Secondary Quality IndicatorsSecondary Quality Indicators

• Equanimity OR Time Hospital stay Blood Loss

• Morbidity Transfusion Severity of complications

CostCost

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

Clinical – Pathological FeaturesClinical – Pathological Features

Preoperative Clinical FeaturesPreoperative Clinical FeaturesLRP RRP P value

Number of patients 485 692

Age 59.5 (+ 7) 59 (+ 7) 0.15

BMI 27.8 (+ 3.6) 28.1 (+ 4.2) 0.4

PSA 6.4 (+ 5) 6.7 (+ 7) 0.31

Clinical stage 0.03

T1C 72% 65%

T2A 16% 16%

T2B 7% 8.5%

T2C 3% 6%

T3A 2.5% 4%

Biopsy Gleason sum (median) 6 6 0.14

Prostate volume (cc) 36.2 (+ 17) 37 (+ 24.7) 0.64

LRP RRP P value

Specimen weight (gm) 43.9 (+ 15.1) 43.3 (+ 22.1) 0.73

Pathological Gleason sum 0.09

0 0.6% 0.7%

6 38.4% 40.7%

7 56.4% 50.9%

8 3.1% 3.5%

9 2.1% 4.7%

Pathological stage 0.25

p0 0.6% 1.2%

pT2 73.2% 67.5%

pT3 25.1% 29.7%

pT4 1% 1.4%

Pathological FeaturesPathological Features

Pathological FeaturesPathological FeaturesLRP RRP P value

Seminal vesicles invasion 3.5% 5.1% 0.2

Capsular status 0.13

No invasion 22.3% 25.7%

Invading into

but not through

55.5% 46.7%

Focal (< 1mm) 7.1% 11.1%

Established 15.1% 16.5%

Detailed Tumor CharacteristicsDetailed Tumor Characteristics

LRP RRP P 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 foci 3 (+ 1.8) 2.9 (+ 1.6) 0.35

Predominant site 0.82

Peripheral zone 56.8% 58.4%

Transitional zone 17.1% 15.9%

Indolent cancer 17.9% 19% 0.75

Organ confined non-indolent 59% 52.2% 0.1

Oncological EfficacyOncological Efficacy

1. Nodal Status

2. Positive Surgical Margin rate

3. Biochemical Recurrence rate

Nodal Status

LRP RRP P value

Mean 13.5 12.8

Median 14 12 0.08

Overall % positivity 6% 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 AnalysisPositive Surgical Margins Analysis

LRP RRP P value

Overall PSM rate 11.3% 11% 0.85

pT2 8.2% 5.3% 0.12

pT3 17.2% 20.2% 0.32

Risk Adjusted Analysis of PSM using Partin’s table Risk Adjusted Analysis of PSM using Partin’s table predicted Probability of Organ Confined Diseasepredicted 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 Evolution Over Time of the PSM Rate For Each Surgical ApproachEach Surgical Approach

LAPLAP

OPENOPEN

Evolution Over Time of the PSM Rate for Evolution Over Time of the PSM Rate for pT2 DiseasepT2 Disease

01

02

03

04

05

0P

roba

bili

ty o

f a

positiv

e s

urg

ica

l m

arg

in

0 100 200 300 400 500Number of surgeries completed

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

LAPLAPOPENOPEN

Evolution Over Time of the PSM Rate for Evolution Over Time of the PSM Rate for pT3 DiseasepT3 Disease

01

02

03

04

05

0P

roba

bili

ty o

f a

posi

tive s

urg

ica

l marg

in

0 50 100 150 200Number of surgeries completed

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

LAPLAP

OPENOPEN

Nerve Resection During the Study Period for Lap.

0.1

.2.3

Pro

babi

lity

of a

sig

nific

ant n

erve

dam

age

0 100 200 300Number of surgeries completed

Analysis of Biochemical Recurrence Analysis of Biochemical Recurrence

Biochemical Recurrence Data

Time (months) after Surgery

Fre

ed

om

fro

m B

ioch

em

ica

l R

ecu

rre

nce

0 6 12 18 24 30 36

0.0

0.2

0.4

0.6

0.8

1.0

481 413 271 154 81 21 1 LP

692 565 424 270 154 46 5 RP

LP

RP

Log rank = 0.2

Type of Surgery

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 Potency After Bilateral Nerve PreservationPreservation

0.0

00

.20

0.4

00

.60

0.8

01

.00

0 2 4 6 8 10 12 14 16Months after Surgery (T0 is date of surgery)

Recovery of potency after Surgery

Log Rank p 0.19

At Risk 100 58 21 193 148 57

18%

LAP

RRP 26%

43%

51% 74%

76%

Date of Sx

ContinenceContinence

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

0.0

00

.20

0.4

00

.60

0.8

01

.00

0 2 4 6 8 10 12 14 16Months after Surgery (Time 0 is time of surgery)

Recovery of Continence after Surgery (No leak)

RRP

LAP

Log Rank p<0.001

At Risk 248 149 31 147 89 30

39%

30%

79%

59%

97%

69%

Date of Sx

298

257

(No Pads)

77

50

Analysis of MorbidityAnalysis of Morbidity

MethodsMethods

• 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

MethodsMethods

• 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 MSKCC SURGICAL SECONDARY EVENTS GRADING SCALEGRADING SCALE

Complication Grade

Description

1 Oral medication / bedside care

2 Intravenous Medication / Minor Bedside Surgical Procedure

3 Interventional Radiology / Endoscopy / Operation / Intubation

4 Chronic Disability / Major Organ Resection

5 Death

Patients DataPatients Data

• Mean age: 59 years for both groups

• Thromboprophylaxis:

Preoperative and postoperative LMWH (lap only) SCD

• Antibiotic prophylaxis

EQUANIMITY

LRP RRP

OR TimeOR Time (min) 199.4 + 46.6 (90 – 430) 188.5 + 40.5 (90-360)

EBLEBL (ml) 314.4 + 186 (50 – 1500) 1267 + 660 (100-3500)

Hospital stayHospital stay (night) 2.0 + 1.5 (1 – 17) 3.3 +1.2 (2-11)

Blood Transfusion

LRP RRP

Autologous only 0 33.6% (233 pts)

Auto + Heterologous 0 9% (67 pts)

Heterologous only 2.9% (14 pts) 5.5% (38 pts)

Overall 2.9% (14 pts) 49% (338 pts)

Cardiac & ThromboembolicCardiac & Thromboembolic

LRP RRP

Number (%) Grade Number (%) Grade

DVT 1 (0.2%) 2 4 (0.6%) 2

PE 3 (0.6%) 2 1 (0.14%) 2

MI 1 (0.2%) 2 1 (0.14%) 5

A-Fib 3 (0.6%) 2 11 (1.6%) 2

Syncope 0 - 8 (1.15%) 2

Postoperative “Bounce-back”

LRP RRP

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 CostAnalysis of Cost

Total Hosp

27380

16474

0

10000

20000

30000

open lap

Total Hospital Charges

Room/board

10610

4584

0

3000

6000

9000

12000

open lap

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