Oncological and Functional Outcomes of Extraperitoneal Laparoscopic Radical
Prostatectomy: A Single Surgical Team’s Experience with 1,600 Procedures.
Paolo Verze, Salvatore Scuzzarella, Giorgio R. Martina, Pierluigi Giummelli, Federico Cantoni,
Giacomo Caruso, Marco Remotti, Ciro Imbimbo and Vincenzo Mirone
ABSTRACT
Background: Laparoscopic radical prostatectomy (LRP) is standard procedure for the treatment of
organ confined prostate cancer.
Objective: To determine short-term oncologic and functional outcomes of extraperitoneal
laparoscopic radical prostatectomy (ELRP) on a single team’s large surgical series.
Design, setting, and participants: Between October 2001 and February 2010, data arising from
1600 consecutive patients who underwent ELRP for localized prostate cancer was standardized and
recorded into a prospective database. Median postoperative follow-up was 53.3 mo.
Intervention: All ELRPs were performed at the Department of Urology Sondalo Hospital, Italy.
Measurements: Oncologic (PSA detection) and functional (urinary continence and potency rates)
outcomes were assessed 12 months postoperatively.
Results and limitations: The mean operative time was 125.6 minutes if pelvic lymph node
dissection (PLND) was not performed and 150.9 minutes if this surgical step was required. The
post-operative pathologic stage was pT2a in 362 patients (22.6%), pT2b in 891 patients (55.6%),
pT2c in 2 patients (0.1%), pT3a in 165 patients (10.3%), and pT3b in 180 patients (11.2%). Positive
margins were detected in 7.4% and 24% of pT2 and pT3 tumors, respectively. Overall complication
rate was 4%. PSA level resulted <0.2 ng/mL in 96.4% and 84.9% of the cases at 3 and 12 months
following surgery, respectively. Complete continence rate increased over time and resulted in 49%
at 1 month post-operatively and 93% at 12 months post-operatively. A nerve sparing procedure was
performed in 20% of patients. Overall potency rate at 12 months was 38.67% and 75% for unilateral
and bilateral nerve sparing procedure, respectively. Conversion to open surgery was needed in only
4 patients (0.25%).
Conclusions: Our extensive experience with this procedure confirms that ELRP is safe and
efficient and ensures adequate oncologic containment of organ-confined prostate cancer and
satisfactory functional results as measured by urinary continence and sexual potency at 1 year
follow-up.
Keywords
Prostate cancer; Laparoscopy; Radical Prostatectomy; Extraperitoneal; Functional outcomes
INTRODUCTION
Laparoscopic radical prostatectomy was first described by Schuessler et al.[1] and Raboy et al. [2]
in 1997 and proceeded to be more routinely standardized by Guillonneau et al. in 1999 [3]. The
procedure was received with little initial enthusiasm by the urologic community because of its
complexity and prolonged procedural performance times. However, over time it has been refined
and its popularity has increased exponentially. Preliminary reports have shown that, in the hands of
experienced surgeons, ELRP is safe and yields oncologic and functional results equivalent to those
of the open approach. [4–6]
The technique for ELRP was first described in 2001 by Bollens et al. [7] The extraperitoneal route
offers some distinct advantages over the transperitoneal laparoscopic approach: surgical vision and
operative steps similar to those of open surgery combined with a reduced risk of intraperitoneal
complications such as bleeding, bowel injury, ileus, urine ascites and adhesions. The aim of the
present study is to describe the technical aspects, complications, short-term oncologic and
functional results of a large surgical series of ELRP interventions performed by a single surgical
team over a 10-year period [7].
PATIENTS AND METHODS
2.1. Patient selection
Between October 2001 and February 2010, 1,600 consecutive men underwent ELRP for localized
prostate cancer. A history of previous abdominal surgery, transurethral prostate resection or hernia
repair were not considered contraindications. All patients were scheduled for follow-up visits at our
institution at 1, 3, 6 mo and subsequently at 6-mo intervals following ELRP.
2.2. Surgical procedure
The surgical technique consists of standard extraperitoneal laparoscopic radical prostatectomy
practice. Patients are positioned on the operating table in the supine position with their legs slightly
divaricated and an approximately 10-cm-thick roll is placed under the sacrum. A 1-cm
infraumbilical incision is made and the fascia is incised over the linea alba. The Retzius space is
delineated by gently sweeping the right index finger under the posterior rectus muscle caudally and
laterally and adequate space is created by balloon dilation. Four other trocars (three 12/10 mm
trocars and one 5 mm trocar) are placed in a symmetrical V pattern guided by the index finger. A 12
mm double sealed structural trocar is placed at the level of the first incision and used for the 0°
telescope which is held by a second assistant by way of a specific camera holder device.
Firstly, the pelvic space is created laterally until the iliac vessels and vas deferens are visualized. In
cases of patients presenting a Gleason score of >6 and/or PSA level >10 ng/ml, an extended PLND
is performed at this time. The periprostatic fat is then removed and the superficial dorsal vein
interrupted. The endopelvic fascia is incised and the prostate freed from its surrounding muscular
fibers up to its apex while the puboprostatic ligaments are lowered. The prostate is then dissected
from the bladder neck and the urethra identified and subsequently incised. The seminal vesicles and
vas deferens once freed and are dissected. The dorsal vein complex (DVC) is tied by a 2-0
absorbable suture and then cut. Once the urethra has been sharply cut, the prostatic apex is detached
and the specimen is removed through the midline incision. The vesicourethral anastomosis is then
created using five interrupted 3-0 absorbable, monofilament sutures.
Low-risk patients (primary Gleason grade of 3, clinical T1c stage, PSA level <10 ng/ml) undergo a
conventional nerve-sparing procedure which avoids the use of any cauterization along the basallateral aspect of the gland and favors the exclusive use of titanium clips and cold scissors.
RESULTS
Patients’ demographics and pre-operative tumor characteristics are reported in Table 1. Intraoperative and post-operative data are reported in Table 2. Conversion to open surgery was needed in
only 4 patients (0.25%) and all of these cases were amongst the first 20 procedures performed.
Table 3 describes the results of the pathological assessment of prostate glands. The pathological
assessment of lymph nodes taken from patients who received PLND revealed pN1 disease in 26
patients (5.1%). The rates of positive surgical margins and the tumor grade stratified according to
tumor stage are reported in table 3. Location of positive surgical margins was: 21.8% of the cases
(n=41) in the prostate apex, 71.8% of the cases (n=135) in the postero-lateral aspect and 42.5% of
the cases (n=80) in the prostate base. 23.4% of the cases (n=44) had multiple positive margins.
Follow-up was available for all patients and mean follow-up was 53.3 months (range 15 to 113).
Serum PSA levels were undetectable in 89.1% of patients 3 months after surgery. Table 4
summarizes the biochemical follow-up. Functional results in terms of urinary continence and
erectile function are reported in Tables 5 and 6, respectively, and were assessed through direct
patient questioning by the attending urologists. Sexual potency was defined as the ability to obtain
erection sufficient for intercourse with or without the use of a PDE5 inhibitor. Overall
complications occurred in 65 patients (4.0%). Intraoperative and post-operative complications,
graded according to the Clavien grading system, are described in Table 7. No intraoperative or
perioperative deaths occurred.
DISCUSSION
Radical prostatectomy represents the gold standard treatment for localized cancer prostate. LRP was
introduced to combine the advantages of a minimally invasive approach with the satisfactory
oncologic and functional results of open surgery.
We started routinely performing ELRP in our department in 2001 based upon the conviction that
laparoscopy is an important skill for the urologist to have in his armamentarium and the
encouraging initial results reported on laparoscopic radical prostatectomy. [8-10] In particular, we
decided to embark on a training program to learn the procedure while continuing with the on-going
daily activities of a busy urology clinic, taking into consideration that the extraperitoneal radical
prostatectomy is a ideal procedural model for honing individual laparoscopic skill because it can be
applied to a large volume of cases and is performed at both the demolishing and reconstructive
stages. [11]
All operations were conducted with the extraperitoneal access because of our personal belief that it
is a safe and reproducible approach, avoids potential intraperitoneal complications and allows the
patient to remain in the supine position without requiring any inclination of the surgical bed.
However several published studies show equivalent operative, postoperative, and pathologic results
with the transperitoneal approach. [12]
Since our report of our initial experience with 114 ELRP cases [11] we have continued to refine and
standardize our technique so as to improve the feasibility of the procedure while, at the same time,
optimize our oncological (positive surgical margins, PSA progression) and functional (urinary
continence and erectile function) success rate.
Our results are comparable to those of other large published series on laparoscopic radical
prostatectomy [13-17].
The mean operative time (125.6 minutes for procedure not including PLND and 150.9 minutes for
procedures including PLND) has proven to be substantially shorter than other published series [13,
16, 17], even though patients who received a contextual laparoscopic inguinal hernia repair (36
cases, 2,25%) or underwent prior prostate surgery (119 cases, 7,4%) are included in our study. The
reduced operative time could be explained by the fact that all the surgeons were trained at the same
institution and have adopted some of the same advantageous surgical maneouvres such as: 1.
creating the extraperitoneal space by combining the digital sweep of the muscle plane and the
pneumatic dilation using a dilating balloon. We found this procedure to be fast and safe and any
minor hemorrhaging was immediately prevented by the pressure of the balloon without requiring
adjunctive, time-consuming haemostatic procedures; 2. placing the trocars by guiding the tip of the
device with the index finger allowed for a rapid and safe operative step even in less experienced
hands; 3. using a double-sealed structural trocar at the level of the first infraumbilical incision
allowed for a perfect maintaining of the preperitoneal space during the operation and avoided
fastidious and time-consuming lack of gas. This system also provides an 11 mm diameter working
channel through which the laparoscope or other instruments can be introduced. Furthermore, the
employment of 4 additional trocars allowed the operator and his assistant to simultaneously use 4
different instruments that optimized the exposure of the surgical field and made both demolitive and
reconstructive steps easier; 4. employing a special hand-made camera holder device allowed the
second assistant to maintain optimal visualization of the surgical field without interfering with the
operator and his first assistant’s movements, especially during the suturing steps; 5. performing the
uretrovesical anastomosis using 5 separate monofilament absorbable stitches placed at 12, 2, 5, 7,
10 o’clock positions. In cases of wider bladder wall opening the stitch at the 12 o’clock position
was used to complete a running suture of the bladder wall. All stitches were tied intracorporeally
and adequate preventive training with the simulator was considered the most important requirement
for all surgeons performing the operations.
Some major published series confirm that positive surgical margin rates (PSM) between the open
and laparoscopic approaches do not differ [4, 18]. However wide variabilities in PSM rates have
been reported particularly for pT2 tumors (range: 6.2–27.5%) within different oncologic series and
this data could be explained by differing surgical experience, patient selection criteria or the
surgical procedures adopted [19]. Our results concerning the PSM rate show a lower value for both
pT2 (7,4%) and pT3 tumors (24%) compared to other published series, although it should be
emphasized that the present study includes the very first patients of our series. This data can be
explained by the fact that we chose to perform nerve-sparing surgery in specifically selected
patients based upon our conviction that the risk of detecting a positive surgical margin could expose
the patient to a higher risk of disease recurrence. Furthermore, the rural population that is mostly
served by our hospital willingly accepted the possibility of undergoing non nerve-sparing surgery
in exchange for a higher probability of cancer containment.
The overall complication rate result was very low (4,0%) and, most importantly, we were able to
conservatively manage the vast majority of the intra-operative and early postoperative cases, except
for those patients who required an operative re-intervention due to the presence of symptomatic
lymphocele (laparoscopic peritoneal fenestration) or major postoperative bleeding related to
epigastric vessel injury (laparoscopic or open revision). All cases of bladder stone formation were
found within the very first cases of our series and were related to inadequate intravesical knotting
while performing urethrovesical anastomosis. Realizing this we immediately modified our suturing
technique and no additional cases were observed.
PSA levels resulted <0.2 ng/mL in 96.4% and 84.9% of the cases at 3 and 12 months after surgery
which confirmed that ELRP was effective in maintaining good oncologic disease control. The vast
majority of PSA recurrence was observed between 6 and 12 mo after ELRP. Patients with
biochemical recurrence were treated as follows: 92 men received external radiation, 128 received
hormone therapy, and 22 received a combination of radiotherapy and androgen deprivation therapy.
Data concerning medium and long term recurrence-free rates are not shown in this study as it is part
of an additional analysis that our group is currently conducting.
The urinary continence rate resulted adequate and similar to those of other published large series
[13, 20]. Over time we observed a significant and constant increase in the complete urinary
continence rate that resulted in 49% and 93% after 1 and 12 months, respectively. This data can be
explained by the fact that the vast majority of our patients were followed-up for a prolonged period
at a dedicated outpatient clinic in order to complete an adequate urinary continence rehabilitation
course managed by a combined clinical team (urologist and physiotherapist). All of these patients
received an early postoperative pelvic floor biofeedback and physiotherapist-guided pelvic floor
muscle training.
As previously mentioned, a relatively low number of patients in our series underwent nerve-sparing
procedures (unilateral nerve sparing procedure in 16%, bilateral nerve sparing procedure in 4%).
The overall potency rate at 12 month follow-up was 38.67% for patients who received a unilateral
nerve sparing procedure and 75% for those who received a bilateral nerve sparing procedure. The
percentage of potency recovery resulted age-dependent, with the highest rate achieved in subjects
aged <55 years. In this patient subgroup who received a unilateral or bilateral nerve sparing
procedure the potency rate resulted 45% and 83%, respectively. It is worth mentioning that,
immediately following catheter removal, all patients who underwent a nerve-sparing procedure
were referred to a dedicated outpatient clinic managed by one of our staff urologists specialized in
sexual medicine in order to commence an early sexual rehabilitation course and optimize functional
sexual results.
CONLUSIONS
The advantageous results of our single surgical team’s extensive experience on 1,600 cases of
ELRP over the course of a 10 year period are encouraging and confirm that ELRP, as a widely
practiced and standardized procedure, combines the advantages of both the minimally invasive and
extraperitoneal approaches. On the basis of 1-year follow-up data, our experience indicates that
adequate oncologic and functional outcomes can be achieved with very low incidence of
complications.
Bibliography
[1] Schuessler WW, Shulam PG, Clayman RV, et al: Laparoscopic radical prostatectomy: initial
short term experience. Urology 50: 854–857, 1997.
[2] Raboy A, Ferzli G, Albert P: Initial experience with extraperitoneal endoscopic radical
retropubic prostatectomy. Urology 50: 849–853, 1997.
[3] Guillonneau B, Cathelineau X, Barret E, Rozet F, Vallancien G: Laparoscopic radical
prostatectomy: technical and early oncological assessment of 40 operations. Eur Urol. 1999;
36: 14-20.
[4] Guillonneau B, El-Fettouh H, Baumert H, et al: Laparoscopic radical prostatectomy:
oncological evaluation after 1,000 cases at Montsouris Institute. J Urol 169: 1261–1266,
2003.
[5] Artibani W, Grosso G, Novara G, et al: Is laparoscopic radical prostatectomy better than
traditional retropubic radical prostatectomy? An analysis of perioperative morbidity in two
contemporary series in Italy. Eur Urol 44: 401–406, 2003.
[6] Salomon L, Levrel O, de la Taille A, et al: Radical prostatectomy by the retropubic, perineal
and laparoscopic approach: 12 years of experience in one center. Eur Urol 42: 104–110,
2002.
[7] Bollens R, Vanden Bossche M, Roumeguere T, Damoun A, Ekane S, Hoffmann P, Zlotta
AR, Schulman CC. Extraperitoneal laparoscopic radical prostatectomy. Results after 50
cases. Eur Urol. 2001 Jul;40(1):65-9.
[8] Rassweiler J, Stolzenburg J, Sulser T, Deger S, Zumbé J, Hofmockel G, et al.: Laparoscopic
radical prostatectomy--the experience of the German Laparoscopic Working Group. Eur
Urol. 2006; 49: 113-9.
[9] Touijer K, Guillonneau B. Laparoscopic radical prostatectomy: a critical analysis of surgical
quality. Eur Urol. 2006 Apr;49(4):625-32.
[10]
Hoznek A, Salomon L, Olsson LE, Antiphon P, Saint F, Cicco A, Chopin D, Abbou
CC. Laparoscopic radical prostatectomy. The Créteil experience. Eur Urol. 2001.
Jul;40(1):38-45.
[11]
Martina GR, Giumelli P, Scuzzarella S, Remotti M, Caruso G, Lovisolo J
Laparoscopic extraperitoneal radical prostatectomy--learning curve of a laparoscopy-naive
urologist in a community hospital. Urology. 2005 May;65(5):959-63.
[12]
Rozet F, Galiano M, Cathelineau X, Barret E, Cathala N, Vallancien G.
Extraperitoneal laparoscopic radical prostatectomy: a prospective evaluation of 600 cases. J
Urol 2005;174:908–11.
[13]
Stolzenburg JU, Rabenalt R, Do M, Truss MC, Burchardt M, Herrmann TR,
Schwalenberg T, Kallidonis P, Liatsikos EN. Endoscopic extraperitoneal radical
prostatectomy: the University of Leipzig experience of 1,300 cases. World J Urol. 2007
Mar;25(1):45-51.
[14]
Stolzenburg JU, Rabenalt R, DO M, Ho K, Dorschner W, Waldkirch E, Jonas U,
Schütz A, Horn L, Truss MC. Endoscopic extraperitoneal radical prostatectomy: oncological
and functional results after 700 procedures. J Urol. 2005 Oct;174(4Pt 1):1271-5
[15]
Paul A, Ploussard G, Nicolaiew N, Xylinas E, Gillion N, de la Taille A, Vordos D,
Hoznek A, Yiou R, Abbou CC, Salomon L. Oncologic outcome after extraperitoneal
laparoscopic radical prostatectomy: midterm follow-up of 1115 procedures. Eur Urol. 2010
Feb;57(2):267-72.
[16]
Rassweiler J, Seemann O, Schulze M, Teber D, Hatzinger M, Frede T. Laparoscopic
versus open radical prostatectomy: a comparative study at a single institution. J Urol 2003;
169:1689.
[17]
Guillonneau B, Rozet F, Cathelineau X, Lay F, Barret E, Doublet JD, Baumert H,
Vallancien G. Perioperative complications of laparoscopic radical prostatectomy: the
Montsouris 3-year experience. J Urol 2002; 167:51
[18]
Herrmann TR, Rabenalt R, Stolzenburg JU, et al. Oncological and functional results
of open, robot-assisted and laparoscopic radical prostatectomy: does surgical approach and
surgical experience matter? World J Urol 2007;25:149–60
[19]
Yossepowitch O, Bjartell A, Eastham JA, et al. Positive surgical margins in radical
prostatectomy: outlining the problem and its long-term consequences. Eur Urol 2009; 55:8799
[20]
Anastasiadis AG, Salomon L, Katz R, et al: Radical retropubic versus laparoscopic
prostatectomy: a prospective comparison of functional outcome. Urology 62: 292–297, 2003