- To report a novel technique for performing single-port transvesical laparoscopic radical prostatectomy (STLRP) and to evaluate the oncological and functional outcomes in 16 patients with organ-confined prostate cancer.
laparoscopic radical prostatectomy
single-port transvesical laparoscopic radical prostatectomy
International Index of Erectile Function
dorsal vein complex
Laparoscopic radical prostatectomy (LRP) has become the standard approach to the treatment of organ-confined prostate cancer; however, outcomes can include incontinence and loss of sexual function, which can have significant adverse effects on quality of life. Although some modifications, including preservation of the bladder neck , sparing neurovascular bundles and apical modified dissection , have been implemented to improve outcomes with regard to postoperative continence and sexual function, achieving the rapid recovery of continence and sexual function remains a huge challenge.
Recently, Wilt et al.  reported that among men with localized prostate cancer (PSA < 10 ng/ml, low risk) detected early by PSA testing, radical prostatectomy (RP) did not significantly reduce all-cause or prostate-cancer mortality, as compared with observation, through at least 12 years of follow-up. Nevertheless, in men with low-risk organ-confined prostate cancer who present with significant obstructive symptoms, RP should be recommended rather than TURP to resolve the obstruction as well as control the prostate cancer. Regaining a high quality of life after RP should therefore be a priority as well as cancer control.
Researchers are striving to identify a novel approach for RP that maximizes the functional outcome of the procedure without compromising the oncological efficacy. It has been shown that the early recovery of continence and sexual function after RP is closely related to the preservation of the external striated urethral sphincter complex and its innervations . Current evidence regarding the anatomical structure suggests that the neurovascular bundles are not confined to a single dorsolateral bundle but consist of nerves of variable distribution, including perivesical, periprostatic and peri-urethral tissue or fascia [5, 6]. Laparoendoscopic single-site (LESS) RP is an attractive, minimally invasive operating procedure for the treatment of prostate cancer. With the aid of the specialized multichannel single-port access device and pre-curved flexible-articulating laparoscopic instruments, RP has been performed with less morbidity and improved cosmetic outcomes through a single abdominal incision concealed within the umbilicus . Desai et al.  expanded the concept of LESS-RP and first reported the initial feasibility of performing single-port transvesical LRP (STLRP) in two cadavers. They suggested that an insufflated bladder might supply an optimum portal to the prostate in RP by eliminating contact with the peritoneal cavity and its contents, thus providing direct in-line access to the prostate and relevant periprostatic anatomy. Most importantly, the transvesical approach also excludes the need for dissecting the prevesical space and conveniently introduces an intrafascial nerve-sparing procedure, further reducing dissection injury to the nerves distributed around the prostate, bladder neck and urethra, which play an important role in urinary control and sexual function. Nevertheless, the steps required for the transvesical approach by Desai et al.  were performed in two cadavers and aspects for clinical use, particularly reducing the undue tension on the vesico-urethral anastomotic suture, remain to be validated.
In the present study, we report our initial clinical experience with STLRP in 16 consecutive patients with organ-confined prostate cancer, with particular emphasis on technical procedures and functional outcomes.
The present prospective study was conducted in accordance with the guidelines of the Ethics Committee of the Third Affiliated Hospital of Sun Yat-sen University. Between November 2010 and November 2011, a total of 16 consecutive patients with low-risk organ-confined prostate cancer (PSA ≤ 10 ng/mL, Gleason score <7, and clinical stage T1-T2aN0M0) were recruited for the study and considered suitable for STLRP, with a minimum follow-up of 12 months postoperatively. All patients provided written informed consent. All data were prospectively entered into an institutional review board-approved database and queried retrospectively.
All patients had a baseline clinical evaluation, including patient age, body mass index, preoperative PSA level, prostate volume measured by preoperative TRUS, International Index of Erectile Function (IIEF)-6 score, pelvic MRI, biopsy Gleason score, metastatic staging when indicated and clinical TNM stage. Exclusion criteria included previous radiotherapy for the prostate and conventional contraindications to laparoscopic procedures.
Peri-operative data, including estimated blood loss, operating time, additional ports or conversion to conventional laparoscopy, incidence of complications graded according to the modified Clavien system [9, 10], and length of stay, were recorded. Patients were evaluated at 9 days postoperatively with cystography. If satisfactory, the catheter was removed. If there was leakage from the anastomosis, the catheter remained in place for an additional 5 days, and cystography was repeated. Patients were followed up every 3 months for 1 year and every 6 months thereafter for postoperative complications, PSA level, continence assessment (pads daily), erectile function (IIEF-6 score), requirement for additional interventions and biochemical recurrence (diagnosed as PSA > 0.2 ng/mL). Continence and potency were evaluated using the ICS questionnaire and IIEF diaries, respectively. Continence was defined as achieving 0-pad use or a liner used for security reasons only . The requirement for 2–3 pads daily by patients with normal physical activity was considered ‘mild incontinence’, and >3 pads daily was considered ‘incontinence’. Potency was defined as an IIEF-6 score ≥ 18 without pharmacological or mechanical support . The questions concerning continence and potency were asked by a special interviewer in a double-blinded fashion. The vesico-urethral stricture was determined by urethrography when indicated.
All procedures were performed with the patient under general anaesthesia and in a slight Trendelenburg tilt position. The major surgical techniques included the following.
From November 2010 to November 2011, 16 patients with low-risk prostate cancer were scheduled for STLRP at our institution. The baseline characteristics of the patients are shown in Table 1. The mean (range) estimated prostate volume was 42 (32–65) mL, and the mean (range) baseline PSA level was 7.5 ng/mL. The mean (range) body mass index was 22.5 (20–26) kg/m2. No patient had preoperative incontinence on urodynamic examination. All cases were identified as potent before the operation.
|No. of patients||16|
|Mean (range) age, years||62 (47–70)|
|Body mass index, kg/m2||22.5 (20–26)|
|Mean (range) preoperative PSA level, ng/mL,||7.5 (0.6–10.8)|
|Prostate volume, mL||42 (32–65)|
|IIEF-6 ≥ 18, n||16|
|Clinical TNM stage, n|
|Biopsy Gleason score, n|
|2 + 2||6/16|
|3 + 2||4/16|
|3 + 3||6/16|
Table 2 provides the operative and postoperative data. All 16 procedures were technically successful, and no conversion to standard laparoscopic approach or open surgery was noted. The mean operating time was 105 min, recorded from bladder incision to bladder closure. No intra-operative complications, including severe retropubic vascular haemorrhage or ureter/rectum injury, were observed.
|No. of patients||16|
|Mean (range) EBL, mL,||130 (75–500)|
|Mean (range) operative time, min||105.0 (75–180)|
|Conversion to traditional LRP||0|
|Intra-operative complications*, n||0|
|Pathological T stage, n|
|Pathological Gleason score, n|
|2 + 2||3/16|
|3 + 2||7/16|
|3 + 3||6/16|
|Positive margins, n||0|
|Postoperative complications, grade II*, n||5/16|
|Mean (range) catheterization time, days||11.2 (9–14)|
|Mean (range) in-hospital stay, days||12.7 (10–15)|
|Continent when the catheter was removed|
|0 pads/day, n||13/16|
|2–3 pads/day, n||3/16|
|Postoperative IIEF-6 score|
|6 months, IIEF-6 ≥ 18||10/16|
|12 months, IIEF-6 ≥ 18||12/16|
|Mean (range) follow-up, months||17.5 (12–24)|
|Mean (range) postoperative PSA level, ng/mL|
|3 months||0.015 (0.001–0.058)|
|6 months||0.017 (0.001–0.093)|
|12 months||0.016 (0–0.099)|
The mean (range) duration of Foley catheter use was 11.2 (9–14) days postoperatively. No patients required prolonged catheterization for >14 days. Of the 16 patients, 13 were immediately continent (0 pads/day), and three had mild incontinence (2–3 pads/day) at the removal of the catheter. All of the 16 patients were recorded as continent at 3 months postoperatively. All patients demonstrated continence (0 pad use or a liner used for security reasons only) at 6 and 12 months postoperatively. In total, 10 and 12 of the 16 patients achieved a satisfactory erection at 6 and 12 months postoperatively, respectively, with an IIEF-6 score ≥ 18. Three patients developed a urinary infection (elevated urine white blood cell count; urine culture: Pseudomonas, n = 1 and Escherichia coli, n = 2) and required antibiotic intervention (grade II). Two patients had haematuria. To prevent the obstruction of the catheter, the variable-rate continuous bladder irrigation was used. The haematuria was treated by i.v. administration of haemostatic agents (grade II). No patient needed transfusion, re-exploration or bilateral internal iliac embolization owing to haematuria. No patient was found to have vesico-urethral stricture on urethrography during follow-up at 12–24 months postoperatively.
The pathological stages and Gleason scores are shown in Table 2. No patient had a higher stage than pT2b. The Gleason scores of all patients were <7. The seminal vesicles were completely excised. The prostate capsule was intact in every specimen and no patient had positive surgical margins. The mean postoperative PSA levels at 3, 6 and 12 months were 0.015, 0.017 and 0.016 ng/mL, respectively. No patient was identified as having biochemical recurrence during the mean follow-up of 17.5 months in this series.
Encouraging results have been reported for LRP as an alternative to open RP for treating organ-confined prostate cancer. Urinary incontinence and erectile dysfunction are major drawbacks after RP and adversely affect the quality of life. Although the LRP technique has undergone various refinements, the number of patients who have early urinary incontinence after RP cannot be ignored . Intrafascial nerve-sparing endoscopic extraperitoneal RP is recognized as a novel technique for limiting trauma to the surrounding fascias and the enclosed neurovascular bundles, but the early continence rate (3 months postoperatively) is only 72.7% . Incontinence is typically long-lasting, compromising quality of life. Moreover, potency with or without the help of phosphodiesterase 5 inhibitors was reported by 61.2% of patients who underwent bilateral nerve-sparing endoscopic extraperitoneal RP at 6 months postoperatively (data available for 129 cases) . Currently, efforts are ongoing to further improve the quality of life and cosmetic outcomes of LRP. More recently, the introduction of novel single-site devices has enabled the performance of LRP procedures in a virtually scarless fashion through a solitary intra-umbilical incision. The evidence shows that this technique has been proven to be technically feasible [14, 15], but it is important to remember the underpinnings of this technique and its inherent difficulties; limited operating space and considerable instrument clashing limit precise tissue handling and retraction.
To solve the technical drawbacks and improve the surgical outcomes of LESS-RP, we performed 16 STLRP procedures through a solitary suprapubic incision using a single access port inserted directly into the bladder. There are several advantages to this approach. The bladder lumen is a natural entry point and offers adequate space after being inflated with CO2, which can act as a self-retaining retractor to reduce the need for the additional instruments and ports that are typically required for LRP. The pneumovesicum confines CO2 within the deep bony pelvis and eliminates its influence on the bowel and peritoneal contents. Moreover, the transvesical approach provides direct access to the prostate, and the working space confers freedom of movement, thus reducing instrument clashing and technical challenges during dissection. Most importantly, this approach does not require mobilizing the bladder and dissecting the perivesical space. Recent studies have shown that continence-relevant nerves are abundant in the periprostatic and perivesical space, particularly in the tissue between the periprostatic fascia and the endopelvic fascia [16-19]. It has been proven that careful dissection of the prostate laterally from its thin surrounding fascia (periprostatic fascia) could improve functional outcomes, although the role of these nerves in continence and erectile function is unclear . However, conventional LRP inevitably dissects the perivesical, periprostatic and peri-urethric space and damages the nerves around them. Desai et al.  performed single-port transvesical enucleation of the prostate in 34 patients with large-volume BPH and found that no patient developed urinary incontinence. Thus, the hypothesis is that if we could identify a novel approach to minimize the dissection of the tissue around the bladder neck, prostate and urethra, better continence and erectile function could be achieved. The transvesical approach excludes the need for dissecting the perivesical space, and the intrafascial nerve-sparing procedure preserves the periprostatic fascia and nerves by dissecting as close to the prostatic capsule as possible, which could minimize dissecting injury during RP and reduce the risk of incontinence and erectile dysfunction after surgery. We did not incise the endopelvic fascia, which covers the prostate and bladder and is attached to the pubic bone, therefore, little urine extravasated into the extraperitoneal space during surgery, which facilitated the recovery. In addition, a urethral catheter connected to a suction apparatus was introduced into the bladder, which further reduced the number of instruments and facilitated removing urine, blood and smoke. At the conclusion of the procedure, the transvesical approach enabled single-site RP to be performed effectively and efficiently . In our 16 consecutive cases with STLRP, the mean operation time was 105 min, all the patients were continent at 3 months, and 12/16 patients achieved potency at 12 months postoperatively.
To improve the performance of STLRP, our experience highlights several technical points. 1) To facilitate the intrafascial nerve-sparing procedure, we modified the lateral prostatic dissection described by Desai et al  and introduced two lateral incisions encircling the prostate (Fig. 2). 2) To reduce bleeding of the DVC, attention was paid to identify the correct plane between the prostate apex and the DVC. Then, the DVC was easily removed and controlled. The underlying prostate apex and urethra were exposed. 3) A major challenge arising from this approach is the vesico-urethral anastomosis. Because the endopelvic fascia covering the prostate and bladder is intact, tension is present between the bladder neck and urethra during vesicourethral anastomosis. To solve this technical limitation, three circumferential intravesical mucosa-muscle incisions were made at 2 cm proximal from the bladder neck margin for a tension-reduced suture. In our experience, the site of vesico-urethral anastomosis will heal well owing to the fine vicinal mucosa, while the additional mucosa-muscle incisions will close similar to the transurethral resection of bladder tumours perioperatively. Notably, we used barbed polydioxanone [22, 23] sutures to achieve good vesico-urethral anastomosis in LESS. For all cases, the vesico-urethral anastomoses were well performed. Although the first three patients undergoing STLRP had urinary infections and another two patients developed haematuria, with the improvement of the suture technique, these complications were not observed in later cases.
We should note that staging lymphadenectomy cannot be performed with this approach. Indeed, some researchers have demonstrated that the preoperative clinical stage of prostate cancer is under-evaluated in some patients during surgery, and those patients required lymph node dissection . The oncological data from 1000 LRPs at the Montsouris Institute showed positive surgical margin rates of ∼ 6.9% for pT2a . In this situation, the bladder incision is closed, and the port is re-inserted into the extraperitoneal space to perform standard lymph node resection when the intravesical procedure is finished. Concerns about improving functional outcomes at the expense of cancer control have also been expressed. In the present study, all 16 patients were defined as having low-risk prostate cancer and were indicated for intrafascial RP. The pathological study showed that no patient was diagnosed with a higher stage than pT2b or had a positive surgical margin after operation. No patient was identified with biochemical recurrence during the mean follow-up of 17.5 months in this series.
We emphasize that STLRP must be performed by surgeons who have experience in LRP. Longer follow-up data and a higher number of patients are required to provide solid data on this issue. The next step is to conduct randomized controlled trials to compare the oncological and functional results of different approaches for RP and thus establish evidence-based guidelines.
In conclusion, STLRP is technically feasible for patients with organ-confined prostate cancer, with promising functional results. Longer survival and functional data and randomized prospective studies in a larger cohort of patients are necessary to determine the appropriate role of STLRP in patients with low-risk organ-confined prostate cancer.
This study was funded by the 5010 Program (2007028), Cultivation Project of Scientific Research Innovation Team of Sun Yat-sen University, and a Key Project of the Chinese Ministry of Health.