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E U R O P E A N U R O L O G Y 6 5 ( 2 0 1 4 ) 6 1 0 – 6 1 9
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Prostate Cancer
Comparisons of the Perioperative, Functional, and Oncologic
Outcomes After Robot-Assisted Versus Pure Extraperitoneal
Laparoscopic Radical Prostatectomy
Guillaume Ploussard *, Alexandre de la Taille, Morgan Moulin, Dimitri Vordos,Andras Hoznek, Claude-Clement Abbou, Laurent Salomon
Department of Urology, Hospital Henri Mondor, 51 Avenue du Marechal de Lattre de Tassigny, 94010 Creteil, France
Article info
Article history:Accepted November 22, 2012Published online ahead ofprint on December 1, 2012
Keywords:
Prostate neoplasm
Laparoscopy
Prostatectomy
Robotic surgery
Continence
Potency
Recurrence
Abstract
Background: In spite of the increasing use of robot-assisted radical prostatectomy(RALP) worldwide, no level 1 evidence-based benefit favouring RALP versus purelaparoscopic approaches has been demonstrated in extraperitoneal laparoscopic proce-dures.Objective: To compare the operative, functional, and oncologic outcomes between purelaparoscopic radical prostatectomy (LRP) and RALP.Design, setting, and participants: From 2001 to 2011, 2386 extraperitoneal LRPs wereperformed consecutively in cases of localised prostate cancers.Intervention: A total of 1377 LRPs and 1009 RALPs were performed using an extraperi-toneal approach.Outcome measurements and statistical analysis: Patient demographics, surgical param-eters, pathologic features, and functional outcomes were collected into a prospectivedatabase and compared between LRP and RALP. Biochemical recurrence–free survivalwas tested using the Kaplan-Meier method. Mean follow-up was 39 and 15.4 mo in theLRP and RALP groups, respectively.Results and limitations: Shorter durations of operative time and of hospital stay werereported in the RALP group compared with the LRP group ( p < 0.001) even beyond the100 first cases. Mean blood loss was significantly lower in the RALP group ( p < 0.001).The overall rate and the severity of the complications did not differ between the twogroups. In pT2 disease, lower rates of positive margins were reported in the RALP group( p = 0.030; odds ratio [OR]: 0.396) in multivariable analyses. The surgical approach didnot affect the continence recovery. Robot assistance was independently predictive forpotency recovery ( p = 0.045; OR: 5.9). Survival analyses showed an equal oncologiccontrol between the two groups. Limitations were the lack of randomisation and theshort-term follow-up.Conclusions: Robotic assistance using an extraperitoneal approach offers better resultsthan pure laparoscopy in terms of operative time, blood loss, and hospital stay. Therobotic approach independently improves the potency recovery but not the continencerecovery. When strict indications of nerve-sparing techniques are respected, RALP givesbetter results than LRP in terms of surgical margins in pathologically organ-confineddisease. Longer follow-up is justified to reach conclusions on oncologic outcomes.
sociation of Urology. Published by Elsevier B.V. All rights reserved.
# 2012 European As* Corresponding author. Tel. +33 1 49 81 25 53; Fax: +33 1 49 81 25 64.sard@gmail.com (G. Ploussard).
E-mail address: g.plous0302-2838/$ – see back matter # 2012 European Association of Urology. Published by Elsevier B.V. All rights reserved.http://dx.doi.org/10.1016/j.eururo.2012.11.049
E U R O P E A N U R O L O G Y 6 5 ( 2 0 1 4 ) 6 1 0 – 6 1 9 611
1. Introduction
Radical prostatectomy (RP) is a standard treatment for
localised prostate cancer. The first laparoscopic radical
prostatectomy (LRP) was performed in 1991 and thought
not to be feasible because of the excessive operative time
[1,2]. However, in the following years, the development of
minimally invasive surgery was driven by work in Europe.
Some centres can now report considerable experience and
are able to standardise the technique. Experienced surgeons
have described the various advantages of laparoscopy [3,4].
And yet LRP remains a technically demanding procedure and
requires a learning curve [4,5]. These difficulties and the
emergence of robotic assistance that improves precision led
laparoscopic urologists to develop the technique of robot-
assisted radical prostatectomy (RALP) [6–8]. One of the
purposes of the robotic assistance was to reduce the learning
curve, even in laparoscopically naive surgeons, without
sacrificing the oncologic standards established by the open
approach [8,9].
Recent reviews and meta-analyses of the literature
recently highlighted the potential benefit of RALP regard-
ing the functional outcomes [10,11]. In a recent meta-
analysis, Tewari et al. also found that total perioperative
complication rates were higher for LRP than for RALP [12].
Authors highlighted that the lack of randomised controlled
trials were drawbacks in all published studies. The two
first controlled trials comparing LRP and RALP were
recently published using a transperitoneal approach
[13,14]. Authors reported better functional results in
terms of potency favouring RALP in both series and only
in terms of continence recovery in one series. However,
only a few patients were included, limiting the power of
analysis in comparing low events rates such as positive
margins, operative complications, and severe inconti-
nence. Most of these series reported short-term experience
with the transperitoneal (but not the extraperitoneal)
approach.
The aim of our study was to compare the perioperative
parameters and the functional and oncologic outcomes
between pure LRP and RALP using an extraperitoneal
approach and performed in a high-volume laparoscopy
reference centre.
2. Patients and methods
2.1. Patient selection
Between July 2001 and December 2011, 2386 consecutive men
underwent a LRP including 1377 pure LRPs and 1009 RALPs. Indications
of surgery were identical in the cases of pure LRP or RALP. We performed
the first LRP and the first RALP in our department in 2001, and we have
been performing RALP routinely since 2006. The respective rates of LRP
and RALP procedures for RP were 95.6% and 4.4% before 2006, 55.9% and
44.1% during the period 2007–2009, and have been 4.6% and 95.4% since
2010. Most of the LRPs were performed by three senior surgeons (L.S.,
C.C.A., A.D.L.T.), and the total number of RALPs by two senior surgeons
(C.C.A., A.D.L.T.) who had performed >100 LRPs before starting the RALP
learning curve. Mean follow-up in our cohort was 50.4 mo (1–138 mo).
Mean follow-up was 39 and 15.4 mo in the LRP and RALP groups,
respectively. The study was carried out in accordance with our local good
clinical practice rules.
2.2. Surgical procedure
The da Vinci system including three robot arms and a single console (first
generation) was used for all RALPs. We described the surgical technique
and the different steps of the surgery previously [15]. The bladder neck was
incised circumferentially with an attempt to spare the it except for high-
risk prostate cancers at risk of seminal vesicle invasion (assessed by
preoperative magnetic resonance imaging [MRI]). A standard
lymphadenectomy was performed prior to the completion of the
vesicourethral anastomosis in patients whose Gleason score was >6
and/or prostate-specific antigen (PSA) was >10 ng/ml. A running
vesicourethral anastomosis was then performed. At the beginning of
the experience, a 3-0 polyglactin suture on a 5/8 circle tapered needle was
used. For 2 yr we used a bidirectional barbed suture to perform the running
anastomosis. The anastomosis started with a posterior reconstruction of
the rhabdosphincter as described by Rocco. An anterior reconstruction was
performed suspending the anastomosis to the Santorini plexus.
Preoperatively, potent low- or intermediate-risk patients underwent
a nerve-sparing procedure. An intrafascial dissection as a nerve-sparing
procedure could be proposed to very low-risk patients who were potent
preoperatively. Very low-risk prostate cancer was defined by a clinical
T1c cancer with favourable factors including a PSA < 10 ng/ml, a
moderate extent of cancer on positive cores, few cores involved with
cancer, and favourable MRI findings (iT1 or small iT2 cancer). The
urethral catheter was usually removed on postoperative day 7 with no
cystogram.
2.3. Database and statistical analysis
Data were collected prospectively into a database by a clinical research
assistant (MM) including preoperative clinical and biologic character-
istics, surgical data, and postoperative parameters. Pathologic assess-
ments of RP specimens by a senior pathologist were recorded. After
fixation, the apex and base (3-mm-thick slices) were removed from each
specimen and examined by the cone method. The prostate body was
step-sectioned at 3-mm intervals perpendicular to the long axis (apical-
basal) of the gland. Positive surgical margins were defined by the
presence of tumour tissue on the inked surface of the specimen. All
patients prospectively completed self-administered questionnaires
concerning their quality of life (European Organisation for Research
and Treatment of Cancer QLQ-C30) and their voiding and sexual
disorders (International Index of Erectile Function [IIEF]-5), preopera-
tively and at 1, 3, 6, 12, and 24 mo after RP. Potency was defined as the
ability to achieve an erection sufficient for penetration (full erections
or diminished erections are routinely sufficient for intercourse) with or
without the use of a phosphodiesterase type 5 enzyme inhibitor
(excluding cases with intracavernous injection of prostaglandin E
or vacuum). Urinary continence was assessed by questionnaires and
defined as the absence of pads (strict urinary continence). Continence
and potency results were studied in the overall cohort regardless of the
continence and potency status before surgery. Phosphodiesterase type 5
enzyme inhibitors were systematically proposed at patient discretion.
The use of oral erectogenic medications was not statistically different
between LRP and RALP groups. Biochemical recurrence was defined as
any detectable serum PSA (>0.2 ng/ml). Perioperative complications
were noted and reported according to the updated Clavien classification
[16]. The qualitative data were tested using the chi-square or the
Fisher test as appropriate. The quantitative data were analysed by the
Mann-Whitney test. Multivariable analyses used a regression logistic
model. In these multivariable analyses, we have only included the
patients operated beyond the 100 first cases of each procedure and
Table 1 – Preoperative characteristics of the overall cohort andcomparisons between laparoscopic radical prostatectomy androbot-assisted radical prostatectomy subgroups
Overall cohortn = 2386
LRPn = 1377
RALPn = 1009
p value
Age, yr, mean (IQR) 62.7 (9.9) 62.7 62.7 1.00
BMI, kg/m2, mean (IQR) 26.5 (4.6) 26.6 26.5 0.648
PSA, ng/ml, mean (IQR) 9.6 (4.8) 9.8 9.2 0.123
No. of positive
cores, mean (IQR)
4.1 (3.0) 3.9 4.5 <0.001
Clinical stage, %
T1c 81.3 81.0 81.8
T2a–b 15.9 16.2 15.6
T2c–T3 2.7 2.8 2.6
>T1c 18.6 19.0 18.1 0.764
Biopsy GS, % <0.001
6 63.4 65.7 60.1
7 30.9 29.4 33.0
8–10 5.7 4.9 6.9
BMI = body mass index; GS = Gleason score; LRP = laparoscopic radical
prostatectomy; RALP = robot-assisted radical prostatectomy;
IQR = interquartile range.
E U R O P E A N U R O L O G Y 6 5 ( 2 0 1 4 ) 6 1 0 – 6 1 9612
operated on by the two surgeons performing both LRP and RALP (A.D.L.T.
and C.C.A.). Time-dependent variables were compared using the
Kaplan-Meier method and a log-rank test. A double-sided p value
<0.05 was considered statistically significant. All data were analysed
using SPSS v.13.0 software (IBM Corp., Armonk, NY, USA).
3. Results
3.1. Perioperative parameters
Table 1 shows the preoperative characteristics of the
patient’s cohort according to the surgical approach. The
two groups (LRP vs RALP) were comparable in terms of PSA,
body mass index, age, and clinical stage. High-grade
prostate cancers involving a greater number of cores were
more frequently reported in the RALP cohort ( p < 0.001).
Shorter durations of operative time (129 vs 175 min) and
of hospital stay (4.0 vs 5.7 d) were reported in the RALP
group compared with the LRP group ( p < 0.001) even
beyond the 100 first cases of each procedure (Table 2). Mean
blood loss was significantly lower in the RALP group (515 vs
800 ml; p < 0.001). However, bladder catheterisation was
longer in the RALP group (8.0 vs 7.2 d).
The overall rate and the severity (defined by the Clavien
classification) of complications did not differ between the
two groups (Table 2). Detailed complications in each group
are listed in Table 3.
3.2. Pathologic findings, surgical margins, and follow-up data
The results of pathologic findings are listed in Table 4.
Findings in RP specimens did not differ between the two
Table 2 – Comparisons of intraoperative and postoperative data, compassisted radical prostatectomy groups
Overall cohortn = 2386
LRPn = 137
Perioperative data
Operative time, min, mean (IQR) 155.8 (60.0) 175.5
Blood loss, ml, mean (IQR) 680.3 (695.0) 800.3
Bladder catheterization, d, mean (IQR) 7.5 (4.0) 7.2
Hospital stay, d, mean (IQR) 5.0 (3.0) 5.7
Transfusion rate, % 3.9 4.7
Lymph node excision, % 44.4 43.8
Nerve-sparing procedure, %
No 22.4 24.1
Unilateral 11.4 13.1
Bilateral 66.1 62.9
Complications
Clavien
0 95.7 96.0
1 0.7 0.6
2 3.3 3.1
3 0.0 0.0
4 0.2 0.2
5 0.0 0.0
Anastomosis leakage, % 6.5 9.7
Anastomosis stenosis, % 1.3 1.7
LRP = laparoscopic radical prostatectomy; RALP = robot-assisted radical prostatec
Comparisons were made among the overall cohort and after excluding patientsy After excluding the first 100 LRPs and the first 100 RALPs of each surgeon.
groups in terms of Gleason score and pTNM stage ( p = 0.488
and 0.788, respectively). Patients operated on by RALP have
smaller glands compared with their counterparts operated
on by LRP (47.5 vs 53.0 g; p < 0.001). Overall, in univariable
analysis, the rate of positive surgical margins was signifi-
cantly higher in the RALP group (31.3 vs 26.6%; p = 0.038),
especially in the case of pT3 cancer ( p = 0.030). Multivari-
able analysis is shown in Table 5.
Classical prognostic factors were significantly associated
with positive margins: PSA, pTNM stage, and Gleason score.
The prostate volume was inversely correlated with the risk
lications between the laparoscopic radical prostatectomy and robot-
7RALP
n = 1009p value Beyond the learning curvey
p value
128.9 <0.001 <0.001
515.4 <0.001 <0.001
8.0 <0.001 <0.001
4.0 <0.001 <0.001
2.9 0.084 0.235
45.4 0.488 0.441
20.3 0.002 0.249
9.2
70.5
95.3 0.756 0.797
0.7
3.6
0.0
0.2
0.1
2.3 <0.001 <0.001
0.7 0.081 0.036
tomy; IQR = interquartile range.
operated on during the 100 first cases of each procedure.
Table 3 – Detailed surgical and medical complications in the twolaparoscopic radical prostatectomy and robot-assisted radicalprostatectomy groups
LRPn = 1377
RALPn = 1009
Medical complications
Death – 1
Urinary infection 32 32
Fever 1 8
Phlebitis 2
Pulmonary embolus 1 2
Atelectasia 1
Pneumonia 6 4
Ill-being 5 3
Angor 1 1
Threat syndrome 3 1
Myocardial infarction 2 3
Renal insufficiency 2 3
Retina detachment 1 –
Overall, % 4.1 5.9
Surgical complications
Haemorrhage 6 4
Rectal injury 11 3
Epigastric injury 4 3
Wound complications
Haematoma 9 14
Abscess 3 9
Retzius collection 20 23
Lymphorrhea 1 2
Lymphocele 5 9
Haematuria 13 19
Anastomosis leakage 22 14
Ileus 2 4
Neurapraxia 1 1
Bowel injury 1
Overall, % 6.8 10.5
LRP = laparoscopic radical prostatectomy; RALP = robot-assisted radical
prostatectomy.
E U R O P E A N U R O L O G Y 6 5 ( 2 0 1 4 ) 6 1 0 – 6 1 9 613
of positive margins ( p = 0.004). The rate of positive surgical
margins increased over time and was 1.9-fold higher in the
period 2010–2011 compared with the earlier period
( p = 0.045). Surgical experience continuously improved
the margin status even beyond the 100 first cases of each
procedure. The rate of surgical margins decreased by 2.6-
fold after 500 procedures ( p < 0.001).
In multivariable analysis, RALP was not associated with
an increased rate of positive margins. On the contrary, we
observed a trend toward lower rates of positive margins in
the RALP group compared with LRP, but differences did not
reach significance.
This difference was significant in the subgroup of pT2
cancers revealing RALP as the favourable factor indepen-
dently associated with better oncologic control of margins in
organ-confined disease ( p = 0.030; odds ratio [OR]: 0.396).
In pT3 cancers, the type of procedure (LRP vs RALP) did
not affect the rate of surgical margins in multivariable
analysis ( p = 0.619). Only the PSA level and surgical
experience were independent predictors of positive mar-
gins in pT3 cancers ( p < 0.001 and p < 0.001, respectively).
Survival curves stratified by the surgical approach were
not significantly different in the overall cohort and in pT2,
pT3a, or pT3b subgroups (log-rank tests in Table 4) showing
an equal short-term oncologic control. According to the
D’Amico preoperative risk groups (Fig. 1), biochemical
recurrence–free survival curves were not significantly
different between the two procedures in the low-risk
(log-rank test: p = 0.672), intermediate-risk ( p = 0.928), and
high-risk groups ( p = 0.413). The surgical volume had a
significant impact on the recurrence-free survival in the LRP
group with better oncologic outcomes after 300 procedures
compared with the 300 first LRP procedures ( p = 0.027;
Fig. 2). No difference was reported in the RALP group
( p = 0.132). Overall, 221 and 92 salvage treatments were
reported in the LRP (16.0%) and RALP (9.1%) groups,
respectively.
3.3. Continence
In univariable analysis, the rate of continence was
significantly in favour of RALP at each postoperative visit
((Fig. 3; p < 0.001). Results of continence recovery in the
overall cohort are shown in Figure 3. When considering only
patients operated on beyond the learning curve of each
surgeon, differences remained significant; after 6 and 12
mo, the rate of continence was 59% and 48.8% in the cases of
LRP as compared with 72% and 83.6% in the cases of RALP.
In the multivariable analysis shown in Table 6, the only
factor independently associated with a better continence
recovery was age ( p = 0.002) at each time point. Table 6
illustrates the multivariable analysis at the 12-mo visit.
Surgical experience, nerve-sparing surgery, and surgical
approach (LRP vs RALP) were not independent predictors
for short-term (at 1, 3, and 6 mo) or long-term (at 12 and
24 mo) continence recovery. Surgical treatment for persis-
tent incontinence was more frequent in the LRP group as
compared with the RALP group ( p < 0.001). Use of the
Macroplastique injection, adjustable continence therapy
balloon, suburethral sling, and artificial sphincter were
reported in 3, 10, 17, and 13 cases in the LRP group versus 0,
2, 5, and 0 cases in the RALP group.
3.4. Potency
In univariable analysis, the rate of potency was significantly
in favour of RALP at each postoperative visit. This difference
remained significant in a subgroup of patients undergoing a
bilateral nerve-sparing preservation (Fig. 4; p < 0.001).
After 6 and 12 mo, 20% and 31.6% of patients were potent
after LRP compared with 42% and 57.7% after RALP,
respectively.
In the multivariable analysis shown in Table 6, age
( p = 0.001), nerve-sparing surgery ( p = 0.033; OR: 3.9), and
RALP ( p = 0.045; OR: 5.9) were significant independent
predictors of potency recovery 12 mo after surgery. These
factors were also associated with potency at each medical
visit during follow-up. Surgical experience, the surgeon, and
the date of intervention were not associated with this
functional outcome.
The evolution of IIEF-5 over time is reported in Table 7.
Only scores from patients undergoing a bilateral nerve-
sparing surgery were reported. The scores at baseline were
comparable in the two groups. After surgery, scores were
Table 4 – Comparisons of pathological features and follow-up data between the two groups (LRP versus RALP). Comparisons have been madeamong the overall cohort and after excluding patients operated on during the 100 first cases of each procedure. Biochemical recurrence hasbeen tested using a log-rank test
Overall cohortn = 2386
LRPn = 1377
RALPn = 1009
p value Beyond the learning curve*
p value
Pathologic findings
Prostate weight, g, mean (IQR) 50.7 (24.0) 53.0 47.5 <0.001 <0.001
Specimen GS, %
6 28.0 27.0 29.2 0.488 0.997
7 61.4 62.2 60.4
8–10 10.6 10.8 10.4
Pathologic stage, %
pT0 0.7 0.5 0.8 0.788 0.208
pT2a 10.5 10.2 10.9
pT2b 2.0 2.5 1.4
pT2c 45.4 45.8 44.8
pT3a 31.1 30.3 32.2
pT3b–pT4 10.2 10.5 9.8
Positive surgical margins, %
Overall 28.6 26.6 31.3 0.038 0.013
pT2 17.9 16.8 19.6 0.513 0.391
pT3 43.7 41.1 47.4 0.030 0.048
Follow-up data
PSA failure, % <0.001
Overall 14.7 18.0 10.3 0.753y 0.820y
pT2 6.2 7.9 3.7 0.794y 0.502y
pT3 27.5 33.5 19.7 0.663y 0.979y
Follow-up, mo, mean (IQR) 29.1 (36.6) 39.0 15.4 <0.001 <0.001
GS = Gleason score; LRP = laparoscopic radical prostatectomy; PSA = prostate-specific antigen; RALP = robot-assisted laparoscopic prostatectomy;
IQR = interquartile range.* After excluding the first 100 LRPs and the first 100 RALPs of each surgeon.y Log-rank test.
E U R O P E A N U R O L O G Y 6 5 ( 2 0 1 4 ) 6 1 0 – 6 1 9614
higher in the RALP group as compared with those reported
in the LRP at each time point. In the overall cohort,
comparisons confirmed this significant difference at each
time point favouring RALP.
4. Discussion
The use of the robotic system reduces both the difficulty in
performing complex laparoscopic techniques and the
learning curve compared with the pure laparoscopic
procedure. As noted earlier, the practice of the pure LRP
requires a steep learning curve [17,18]. Experience can
improve pathologic and operative outcomes well beyond
the initial learning curve with a plateau at 200–250
procedures [19]. The learning curve for RALP was thor-
oughly studied, and surgical teams were able to accomplish
comparable operative times after 12 or 18 cases [20,21].
Some studies comparing pure LRP and RALP were also
published and show interesting postoperative results for
RALP [22–24]. It is interesting to notice that each of the
parameters—operative, pathologic, or functional—requires
a different learning curve that should be assessed separately
in LRP and RALP procedures. The operative time should not
be the single variable evaluated to define the learning curve
and the surgeon’s expertise. However, due to a lack of large
randomised controlled trials, differences in patient char-
acteristics or surgical experience might explain differences
in outcomes between the surgical approaches. The two first
controlled trials comparing LRP and RALP using a transper-
itoneal approach were recently published [13,14]. Authors
reported better functional results in terms of potency
favouring RALP in both series, and only in terms of
continence recovery in one series. However, few patients
were included, limiting the power of analysis in comparing
low events rates such as positive margins, operative
complications, and severe incontinence. Most of these
series reported the midterm experience of the transper-
itoneal (but not extraperitoneal) approach. Concerning the
extraperitoneal LRP, Rozet et al. showed equivalent opera-
tive, postoperative, and pathologic results when comparing
the extraperitoneal and the transperitoneal approach [24].
Stolzenburg and co-workers also reported interesting
results regarding extraperitoneal LRP in terms of operative
parameters and surgical margin rate [23]. The extraperito-
neal approach proved to be a safe and reproducible
procedure, with a fast recovery after surgery [25].
Our results were in line with those published by
‘‘transperitoneal’’ surgeons. RALP offered advantages con-
cerning the perioperative parameters in terms of hospital
stay, operative time, and blood loss, even beyond the 100
first cases of each surgeon. The overall rate and the severity
of complications did not differ between the two groups.
However, there was a trend towards lower rates of
anastomotic complications in favour of RALP even beyond
the 100 first cases of each procedure. Robotic assistance
offers technical parameters that may improve the anasto-
motic procedure: a magnified three-dimensional (3D)
visual field, a greater range of instrument motion, and a
minimisation of tremor. Advantages of RALP regarding
decreased adverse events and severity of complications
Table 5 – Predictive factors for positive surgical margins inmultivariable analysis: overall cohort and pT2 subgroup
Surgical margins p value OR 95% CI
Overall cohort
Age 0.497 – – –
PSA <0.001 – – –
Prostate volume 0.004 – – –
pT2 disease <0.001 0.478 0.37 0.62
GS
6 – Ref. 1 – –
7 <0.001 2.176 1.56 3.04
8–10 <0.001 3.665 2.29 5.86
Date of intervention
Before 2006 – Ref. 1 – –
2007–2009 0.169 1.355 0.88 2.09
2010–2011 0.045 1.887 1.02 3.51
Surgeon experience beyond the learning curve
100–300 – Ref. 1 – –
300–500 0.035 0.724 0.54 0.98
>500 <0.001 0.382 0.26 0.57
Nerve preservation 0.130 1.254 0.94 1.68
Surgeon 0.407 0.878 0.65 1.19
Procedure
Pure laparoscopy – Ref. 1 – –
Robot assisted 0.057 0.559 0.31 1.02
pT2 cancers
Age 0.283 – – –
PSA 0.063 – – –
Prostate volume <0.001 – – –
GS
6 – Ref. 1 – –
7 <0.001 2.722 1.85 4.01
8–10 0.657 1.340 0.37 4.88
Date of intervention
Before 2006 – Ref. 1 – –
2007–2009 0.253 1.426 0.78 2.62
2010–2011 0.026 2.715 1.13 6.54
Surgeon experience beyond the learning curve
100–300 – Ref. 1 – –
300–500 0.121 0.709 0.46 1.10
>500 0.001 0.387 0.22 0.68
Nerve preservation 0.137 1.484 0.88 2.50
Surgeon 0.692 0.917 0.60 1.41
Procedure
Pure laparoscopy – Ref. 1 – –
Robot assisted 0.030 0.396 0.17 0.91
CI = confidence interval; GS = Gleason score; PSA = prostate-specific
antigen.
[(Fig._1)TD$FIG]
Fig. 1 – Biochemical recurrence–free survival (RFS) curves stratified by theprocedure (laparoscopic radical prostatectomy [LRP] vs robot-assistedradical prostatectomy [RALP]) according to the preoperative D’Amicorisk group: low risk (log-rank test: p = 0.672), intermediate risk( p = 0.928), and high risk ( p = 0.413).
E U R O P E A N U R O L O G Y 6 5 ( 2 0 1 4 ) 6 1 0 – 6 1 9 615
were not found. No significant difference in rectal injuries
was detected. Nevertheless, RALP demonstrated a signifi-
cant improvement of perioperative parameters, shortening
the duration of hospitalisation.
Regarding the continence rate and the time to conti-
nence, RALP performed better than LRP in univariable
models as highlighted by the recent meta-analysis from
Ficarra et al. [11]. Nevertheless, the prevalence of urinary
incontinence after prostatectomy is highly influenced by
numerous parameters such as patient characteristics,
surgeon experience, or continence definitions (no pad vs
safety pad). Drawbacks of a systematic analysis must be
taken into consideration such as the impossibility of
controlling surgical skills and individual surgeon factors
[11]. The integration of all potential predictive factors for
continence recovery is mandatory before drawing major
conclusions. Thus, in line with the prospective trial
[(Fig._2)TD$FIG]
Fig. 2 – Biochemical recurrence–free survival (RFS) curves stratified by thesurgical volume of each surgeon (100–300, 300–500, >500 procedures)for the laparoscopic radical prostatectomy (LRP) and the robot-assistedradical prostatectomy (RALP) groups. Curves were significantly differentafter 300 procedures in the LRP group (log-rank test: p = 0.027) but not inthe RALP group ( p = 0.132).
[(Fig._3)TD$FIG]
Fig. 3 – Continence recovery rates at each medical visit in the laparoscopicradical prostatectomy and the robot-assisted prostatectomy groups(overall cohort). The p values at each time point were preoperative( p = 0.213), 1 mo ( p = 0.191), 3 mo ( p = 0.019), 6 mo ( p = 0.018), 12 mo( p = 0.177), and 24 mo ( p = 0.024).
E U R O P E A N U R O L O G Y 6 5 ( 2 0 1 4 ) 6 1 0 – 6 1 9616
published by Asimakopoulos et al., we did not find any
significant improvement of continence recovery in favour of
RALP after integrating all potential confounding factors in
multivariable analysis [14]. The impact of anterior or
posterior reconstruction on functional outcomes could
not be studied in our database. However, a recent review
did not find a benefit of such reconstructions on shortening
the time to continence recovery [26].
A recent meta-analysis based on four studies compar-
ing potency recovery after LRP and RALP only reported a
nonstatistical trend in favour of RALP [11,27,28]. The only
two prospective studies highlighted better functional
results in terms of potency favouring RALP. However, the
limited number of patients included did not allow
definitive conclusions. Comparisons are also subject to
debate because the incidence of potency recovery is
influenced by numerous factors. Our multivariable results
were in line with those published in the two level 2
studies [13,14]. The use of the robot was significantly
linked with a better recovery independently of surgical
experience, the surgeon, the date of the intervention, and
the practice of neurovascular preservation. After 6 and 12
mo, 20% and 31.6% of patients were potent after LRP
compared with 42% and 57.7% after RALP, respectively.
This difference remained significant after a 2-mo follow-
up. Our surgical technique is based on a retrograde
dissection using low-intensity bipolar cautery and clips.
We did not perform a strict athermal dissection that
might improve potency recovery [29]. However, the use of
a cautery-free technique has not definitively proved its
superiority and needs further evaluation. The fourth robot
arm potentially provides an adequate exposition avoiding
tractions of the bundles that may hinder potency outcomes.
We used a three-arm robot, and our experience with the four-
arm one is limited. However, the extraperitoneal approach is
surely not the best approach to use this fourth arm
extensively due to the limited space of the retroperitoneum.
Limitations of our report on functional outcomes were that
continence and potency require a short-term follow-up. Our
findings from the RALP cohort need to be confirmed. Another
drawback of the study is that our evaluation of the plane of
neurovascular bundle dissection is subjective and not based
on the pathologic outcome. Obtaining the intrafascial plane
may become more frequent and easier with the robotic
approach.
The first statistical analysis found higher positive
margin rates in the RALP cohort compared with those
reported in the LRP, especially in non–organ-confined
disease. Several factors with an impact on the risk of
margins might explain these differences. The RALP cohort
included patients at higher risk of positive margins. Those
patients had a significantly smaller volume of gland,
frequently showed an aggressive cancer on biopsy cores,
and were more often operated on using nerve-sparing
techniques. When all factors potentially linked with the
risk of margins were taken into account in a multivariable
Table 6 – Predictive factors for urinary continence and potency inmultivariable analysis: logistic regression model assessing thefactors predictive for continence and potency recovery 12 mo aftersurgery
p value OR 95% CI
Continence
Age 0.002 – – –
PSA 0.746 – – –
Prostate volume 0.524 – – –
pT2 disease 0.393 0.782 0.44 1.37
GS
6 – Ref. 1 – –
7 0.751 0.915 0.53 1.60
8–10 0.699 1.239 0.42 3.68
Date of intervention
Before 2006 – Ref. 1 – –
2007–2009 0.981 0.991 0.47 2.08
2010–2011 0.387 0.572 0.16 2.03
Surgeon experience beyond the learning curve
100–300 – Ref. 1 – –
300–500 0.230 0.678 0.36 1.28
>500 0.108 0.532 0.25 1.15
Nerve preservation 0.983 0.993 0.54 1.81
Surgeon 0.514 1.295 0.60 2.82
Procedure
Pure laparoscopy – Ref. 1 – –
Robot assisted 0.253 2.079 0.59 7.29
Potency
Age 0.001 – – –
PSA 0.085 – – –
Prostate volume 0.943 – – –
pT2 disease 0.630 0.802 0.33 1.97
GS
6 – Ref. 1 – –
7 0.489 1.358 0.57 3.24
8–10 0.817 1.246 0.19 7.98
Date of intervention
Before 2006 – Ref. 1 – –
2007–2009 0.976 1.021 0.25 4.10
2010–2011 0.467 0.497 0.08 3.27
Surgeon experience beyond the learning curve
100–300 – Ref. 1 – –
300–500 0.085 3.029 0.86 10.71
>500 0.903 0.913 0.21 3.89
Nerve preservation 0.033 3.925 1.11 13.84
Surgeon 0.308 0.556 0.18 1.72
Procedure
Pure laparoscopy – Ref. 1 – –
Robot assisted 0.045 5.933 1.04 33.82
CI = confidence interval; GS = Gleason score; OR = odds ratio;
PSA = prostate-specific antigen.
[(Fig._4)TD$FIG]
Fig. 4 – Potency recovery rates at each medical visit in the laparoscopicradical prostatectomy and in the robot-assisted prostatectomy groupsafter bilateral nerve-sparing surgery (overall cohort). The p values ateach time point were preoperative ( p = 0.716), 1 mo ( p < 0.001), 3 mo( p = 0.001), 6 mo ( p < 0.001), 12 mo ( p < 0.001) and 24 mo ( p < 0.001).
Table 7 – Evolution of International Index of Erectile Function-5 scoreprostatectomy and robot-assisted radical prostatectomy*
IIEF-5 scores Baseline Month 1 Mo
Bilateral preservation
LRP 17.6 3.3
RALP 17.7 5.2
p values 0.847 <0.001
Overall cohort
p values 0.800 <0.001 <
IIEF = International Index of Erectile Function; LRP = laparoscopic radical prostate* Overall cohort and subgroups of patients undergoing bilateral nerve-sparing su
E U R O P E A N U R O L O G Y 6 5 ( 2 0 1 4 ) 6 1 0 – 6 1 9 617
model, the pT3 margin rates were not statistically different
for each surgical modality. We found lower positive
surgical margin rates in pT2 disease for RALP compared
with LRP in line with recent reviews [12,30]. Potential
factors explaining this significant difference could be the
traumatic manipulation of the gland during the neurovas-
cular dissection in LRP and the magnified 3D vision
improving the capsular preservation provided by robotic
assistance. However, urologists performing RALP tend to
expand indications of nerve preservation, exposing
patients selected on nonstringent criteria to an increased
risk of positive margins. Due to the widespread acceptance
of active surveillance in low-risk prostate cancers, we have
observed an important stage migration towards more
aggressive and larger prostate cancers (pT3 and/or Gleason
8–10) in our surgical cohort for the past 5 yr. However,
when strict indications of nerve-sparing techniques are
respected, RALP performs better than LRP in terms of
surgical margins in pathologically organ-confined disease
and does not increase the rate of positive margins in non–
organ-confined cancers.
Positive surgical margins and perioperative parameters
are early outcome measures of importance in comparing
surgical modalities. Our findings showed equivalent bio-
chemical recurrence rates for RALP and LRP. Surgeon
volume did not have an impact on the biochemical
s over time and their comparisons after laparoscopic radical
nth 3 Month 6 Month 12 Month 24
6.1 7.0 8.2 8.1
8.8 10.6 11.5 13.5
0.001 <0.001 <0.001 <0.001
0.001 <0.001 <0.001 <0.001
ctomy; RALP = robot-assisted radical prostatectomy.
rgery.
E U R O P E A N U R O L O G Y 6 5 ( 2 0 1 4 ) 6 1 0 – 6 1 9618
recurrence survival in our series. However, this lack of
difference based on surgeon volume might reflect a low
power effect and be related to the short follow-up.
Sooriakumaran et al. previously reported that lower
surgeon volume was associated with an increased risk of
recurrence after >5-yr follow-up [31]. Biochemical recur-
rences, metastases, and survival statistics require long-term
follow-up to assess [9]. Although we previously reported
the oncologic safety of extraperitoneal LRP, a longer follow-
up is warranted to confirm it in RALP [25]. We would also
like to emphasise that data were collected prospectively but
reviewed in a retrospective manner that introduced an
interpretation bias.
Our statistical analyses highlighted that several factors
must be taken into account when determining functional
outcomes after RP. Many published studies did not include
all these factors with impact, thus limiting the power of
their conclusions. Level of surgical experience, changes of
surgical details over time, cancer characteristics, patient
characteristics, or extension of nerve-sparing surgery could
play a part in differential outcomes and introduce
interpretation biases when comparing surgical techniques.
Systematic reviews and meta-analyses are also limited by
multiple designs, and methodological factors have to be
considered too. The strength of our series was that we chose
to control all these potential confounding factors in
multivariable analyses.
5. Conclusions
Robotic assistance using an extraperitoneal approach
confers better results than the pure laparoscopic procedure
in terms of operative time, blood loss, and hospital
stay. There was no independent impact on continence
by surgical approach. The robotic approach improves
potency recovery at short-term follow-up compared with
pure laparoscopy. Urologists performing RALP tend to
expand indications of nerve preservation exposing
patients selected on nonstringent criteria to an increased
risk of positive margins. However, when strict indications
of nerve-sparing techniques are respected, RALP does not
increase the rate of positive margins. This study did not
lead us to a definitive recommendation for the robot
assistance approach, but it does suggests improved
perioperative parameters and potency recovery without
compromising oncologic control.
Author contributions: Guillaume Ploussard had full access to all the data
in the study and takes responsibility for the integrity of the data and the
accuracy of the data analysis.
Study concept and design: Ploussard, de la Taille, Salomon.
Acquisition of data: Ploussard, de la Taille, Moulin, Salomon.
Analysis and interpretation of data: Ploussard, de la Taille, Salomon.
Drafting of the manuscript: Ploussard.
Critical revision of the manuscript for important intellectual content:
Ploussard, de la Taille, Moulin, Vordos, Hoznek, Abbou, Salomon.
Statistical analysis: Ploussard.
Obtaining funding: None.
Administrative, technical, or material support: None.
Supervision: de la Taille, Abbou, Salomon.
Other (specify): None.
Financial disclosures: Guillaume Ploussard certifies that all conflicts of
interest, including specific financial interests and relationships and
affiliations relevant to the subject matter or materials discussed in the
manuscript (eg, employment/affiliation, grants or funding, consultan-
cies, honoraria, stock ownership or options, expert testimony, royalties,
or patents filed, received, or pending), are the following: None.
Funding/Support and role of the sponsor: None.
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