Oncological and Functional Outcomes of ExtraperitonealLaparoscopic Radical Prostatectomy: ASingle Surgical Team’s Experience with 1,600 Procedures.
Paolo Verze, Salvatore Scuzzarella, Giorgio R. Martina, Pierluigi Giummelli, Federico Cantoni, Giacomo Caruso, Marco Remotti, Ciro Imbimboand Vincenzo Mirone
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 radicalprostatectomy (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 wasstandardized and recorded into a prospective database. Medianpostoperative 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 performedand 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 <0.2ng/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 andensuresadequateoncologic containment of organ-confined prostate cancer and satisfactory functional results as measured by urinary continence and sexual potency at 1 year follow-up.
Prostate cancer; Laparoscopy; Radical Prostatectomy; Extraperitoneal; Functional outcomes
Laparoscopic radical prostatectomy was first describedby Schuessler et al.and Raboyet al.  in 1997 and proceeded to be more routinelystandardized by Guillonneau et al. in 1999 . The procedure wasreceived with littleinitial enthusiasm by the urologic community becauseof its complexity and prolonged procedural performance times. However, over time it has beenrefined and its popularity has increased exponentially. Preliminaryreports have shown that, in the hands of experienced surgeons, ELRPis safeand yields oncologic and functional resultsequivalent to those ofthe open approach. [4–6]
The technique for ELRP was first described in 2001 by Bollens et al. The extraperitoneal route offers some distinct advantages over the transperitoneal laparoscopic approach: surgical vision and operative steps similar to those of open surgerycombined 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 thetechnical 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 .
PATIENTS AND METHODS
2.1. Patient selection
Between October 2001 and February 2010, 1,600 consecutive menunderwent 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 intervalsfollowing ELRP.
2.2. Surgical procedure
The surgical technique consists of standard extraperitoneal laparoscopic radical prostatectomypractice. 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 ismade and the fascia is incised over the linea alba. The Retziusspace isdelineated by gentlysweepingthe right index finger under the posterior rectusmuscle caudally and laterally and adequate space iscreated by balloon dilation. Four othertrocars (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 trocaris placed at the level of the first incision and used for the 0° telescope whichisheld by a second assistant by way of a specific camera holder device.
Firstly, the pelvic space iscreated laterally until the iliac vessels and vas deferens are visualized. Incasesof patients presenting a Gleason score of >6 and/or PSA level >10 ng/ml, an extended PLNDis performed at this time. Theperiprostatic fat isthen 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 arelowered. The prostate is then dissected from the bladder neck and the urethra identified and subsequently incised. The seminal vesicles and vas deferens oncefreed 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 isdetached and the specimen is removed through the midline incision. The vesicourethralanastomosisis 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 basal-lateral aspect of the gland and favorsthe exclusive use of titanium clips and cold scissors.
Patients’ demographics and pre-operative tumor characteristics are reported in Table 1. Intra-operative and post-operative data are reported in Table 2. Conversion to open surgery was neededin only 4 patients (0.25%) andall of these cases were amongst the first 20 procedures performed. Table 3 describes the results of thepathological 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-upwas available for all patients and mean follow-up was 53.3 months (range 15 to 113). Serum PSA levels were undetectable in 89.1% ofpatients 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 theClavien grading system, are described in Table 7. No intraoperative or perioperative deaths occurred.
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 ourdepartmentin 2001 based upon the conviction that laparoscopy is an important skill for the urologist to have in his armamentarium and the encouraging initial results reportedon 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 extraperitonealradical prostatectomyisa idealprocedural model forhoningindividual laparoscopic skill because it can be applied to a large volume of cases and is performed at both the demolishing and reconstructive stages.
All operations were conducted with the extraperitonealaccess 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. 
Since our report of our initial experience with 114ELRP cases  we have continued torefine and standardize our techniqueso as to improve the feasibility of the procedurewhile, 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 150.9minutes for procedures includingPLND) 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. Thereduced operative time could be explained by the fact that all the surgeonswere trained at the same institution and have adopted someof the same advantageous surgical maneouvressuch 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 thepressure of the balloon without requiring adjunctive, time-consuming haemostatic procedures; 2. placing the trocarsby guiding the tip of the device with the index fingerallowedfor 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 incisionallowedfora perfect maintaining ofthe preperitoneal spaceduring the operation andavoided 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 theoperator and his first assistant’s movements, especially during the suturing steps; 5. performing the uretrovesicalanastomosis 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%)withindifferent oncologic series and this data could be explained by differingsurgical experience, patient selection criteria or the surgical procedures adopted .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 itshould be emphasized that the present study includes the very first patients of our series. Thisdata 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 hospitalwillingly 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 managethe 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 foundwithin the very first cases of our series and were related to inadequate intravesical knotting while performing urethrovesicalanastomosis.Realizing this we immediately modified our suturing technique and no additional cases were observed.
PSA levels resulted <0.2 ng/mL in 96.4% and84.9% of the cases at 3 and 12 months after surgery which confirmed that ELRP was effective in maintaining good oncologicdisease control. The vast majority of PSA recurrence was observed between 6 and 12 mo after ELRP. Patients with biochemical recurrence were treated asfollows: 92 men received external radiation, 128 receivedhormone therapy, and 22 received a combination of radiotherapyand 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 in49% and 93% after 1 and 12 months, respectively. This data can be explained by the fact that the vast majority of our patients werefollowed-upfor a prolonged period at a dedicated outpatient clinicin order to complete an adequate urinary continence rehabilitation course managedby 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 lownumber 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 whoreceived 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 thispatient subgroup whoreceived 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 urologistsspecialized in sexual medicine in order to commencean early sexual rehabilitation courseand optimize functional sexual results.
The advantageous results of oursingle surgical team’s extensive experience on 1,600 cases of ELRP over the course of a 10 year periodare encouraging and confirm thatELRP, as a widely practiced and standardized procedure, combinesthe advantages of both the minimally invasive and extraperitonealapproaches. On the basis of 1-year follow-up data, ourexperienceindicates that adequate oncologic and functional outcomes can be achieved withvery low incidence of complications.
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