Robot-Assisted Extraperitoneal Radical Prostatectomy,Single Site Plus Two Model

Abstract

Purpose:

To demonstrate a feasible procedure of robot-assisted extraperitoneal radical prostatectomy single site plus two model to overcome the limitation of traditional single-port laparoscopic surgery.

Materials and Methods:

All consecutive cases of robot-assisted extraperitoneal radical prostatectomy single site plus two model between November 2015 and April 2016 in our institution were included. We analyze the surgical and continence outcome.

Results:

Twenty cases were included in the analysis. All cases successfully completed without any necessity for conversion to a standard laparoscopic approach or open surgery. The average age is 64.3 ± 8.2 years and average body mass index is 24.3 ± 2.9 kg/m². Eight focal positive margins (40%) (5 in T2 and 3 in T3a disease) were encountered and all occurred at the apex. For continence outcomes, 9 (45%) patients need average 0–1 pads/day and 2 (10%) patients need average 3 pads/day after surgery, but most recover after several months. No intraoperative complications or major postoperative complications were recorded, excluding blood transfusion in one case.

Conclusions:

Robot-assisted extraperitoneal radical prostatectomy single site plus two model is technically feasible and safe in our experience. It can also be performed in patients that have previously received intraperitoneal abdominal surgery using the extraperitoneal approach. We can take this procedure into account for minimal invasive surgical option.

Introduction

At present, there are several definitive surgical options for managing clinically localized prostate cancer, including radical retropubic prostatectomy (RP), laparoscopic RP (LRP), and robot-assisted RP (RALP). While multiple port laparoendoscopic radical prostatectomy is standard practice, efforts have been focused in reducing the number of ports, even a single abdominal incision, for minimizing postoperative pain and expediting postoperative recovery.¹

Early clinical experiences with laparoendoscopic single-site surgery (LESS) have been applied to various urologic surgeries, including adrenalectomy, radical nephrectomy, nephroureterectomy, living donor nephrectomy, pyeloplasty, and radical prostatectomy.² However, there are still several limitations related to technical constraints, including lack of triangulation, clashing of instruments, and limited operating space. Nevertheless, even with the use of laparoscopic curved or articulating instruments, significant “clashing” with both the camera and other instruments can increase operative times and require significant laparoscopic skills, especially for intracorporeal suturing. To overcome these constraints, it has been postulated that robotic technology could be applied to LESS.^3,4

In 2009, Kaouk et al. reported the first successful series of single-incision robotic procedures in humans, and they noted the improved facility for intracorporeal dissecting and suturing because of robotic instrument articulation and stability.⁵

The da Vinci surgical system (Intuitive Surgical, Inc., Sunnyvale, CA) was the first robotic system cleared by the U.S. Food and Drug Administration for use in general and urologic laparoscopic surgery. Some of its benefits over conventional laparoscopy include superior ergonomics, optical magnification of the operative field, enhanced dexterity, and greater precision.⁶ Although the da Vinci systems are shown to be valuable tools in LESS, it is not what they were specifically designed for and five to seven ports for one 4–5 cm wound is necessary. A novel set of instrumentation, da Vinci Single Site, specifically dedicated to LESS, was recently introduced and its use in urology was reported in both laboratory^7,8 and clinical^9,10 settings.

The single-site instruments and accessories are used with the da Vinci Si surgical system and are of similar construction to existing EndoWrist instruments, except they do not have a wrist at the distal end of the instrument. Nevertheless, even with the use of robotic platform, significant collision against the robotic arms was experienced by the assistant, which at times restricted retraction and suction, and limited intra-abdominal triangulation for precise maneuvers and strength for reliable tissue retraction due to lack of utilization of the fourth robotic arm. To overcome the problems, we have therefore focused on reduced port surgery, introducing the robot-assisted radical prostatectomy-single site plus two model to urologic procedures for clinically localized prostate carcinoma. The aim of this study was to describe the feasibility of the surgical technique and report the early outcomes of robot-assisted radical prostatectomy-single site plus two model.

Materials and Methods

Study design

Data were analyzed retrospectively with an institutional review board-approved database. Demographic data included patient age, body mass index (BMI), preoperative prostate-specific antigen (PSA) level, Gleason score, biopsy characteristics, and preoperative clinical stage. The preoperative evaluation included standard history and physical examination, basic laboratory blood work, metastatic staging, and further cardiac/pulmonary workup when indicated. Perioperative data, including the operative time, estimated blood loss, lymphadenectomy, prostate specimen volume, postoperative Gleason score, postoperative (1 month after operation) PSA and clinical stage, conversion to standard robot-assisted laparoscopy or open surgery, intraoperative complications, positive surgical margins, and length of stay, were recorded. Patients were followed with cystography 1 week after surgery and urethral catheter was removed if no contrast leakage, at 4 weeks, every 3 months for 1 year, and every 6 months thereafter for continence assessment (pads daily), and PSA level assessment. According to guidelines after radical prostatectomy, the definition of biochemical recurrence was PSA >0.2 ng/mL followed by a successive rise.¹¹

Surgical technique

The Si system (Intuitive Surgical, Sunnyvale, CA) was preferable because of its enhanced visualization and ability to customize the console settings ergonomically.

A 3.0-cm lower umbilical “U” incision is created intraumbilically (3.0 cm in length) with extraperitoneum procedure. A multichannel single-site port was inserted and the patient placed in a steep Trendelenburg position. The da Vinci Si system in a four-arm approach was docked and the robotic 12-mm scope introduced through the single-site port, an 8-mm robotic port is placed at the right lower abdominal quadrant for the first arm with EndoWrist and the two curved cannulas for second and third arm with semirigid, nonwristed standard da Vinci instrument tips instruments, and finally a 12 mm port is placed at the left lower abdominal quadrant for assistance, so as to have an adequate working angle for facilitation of all surgical procedures and be able to insert needles. (Fig. 1) A standard radical prostatectomy, lymph node dissection, and urethrovesical anastomosis are performed in an identical manner to the multiport RALP technique.¹²

FIG. 1.

Single-site model and port placement.

Results

This single site plus two model could be successfully completed in all cases, without any necessity for conversion to a standard laparoscopic approach or open surgery. The operations were performed without active complications, including tearing of the multichannel port, gas leakage, or injuries to organs or vessels. The working space was not problematic for the surgeon, and no significant collision against the robotic arms was experienced by the assistant.

Demographics and preoperative data

From March 2015 to April 2016, a total of 20 male patients with clinically diagnosed localized prostate cancer were scheduled to undergo radical prostatectomy with robot-assisted radical prostatectomy-single site plus two model at our institution. The patient demographics and preoperative parameters are shown in Table 1. The average age is 64.3 ± 8.2 years and average BMI is 24.3 ± 2.9 kg/m². Average preoperative PSA level is 16.3 ± 12.9 ng/mL. The preoperative Gleason score of prostate cancer was obtained by transrectal prostate biopsy pathology reports. All patients received magnetic resonance image for clinical staging before operation.

Table 1.

Demographic and Preoperative Data

No. of patients (n)	20
Age, year (mean ± SD)	64.3 ± 8.2
BMI, kg/m² (mean ± SD)	24.3 ± 2.9
Preoperative Gleason score, n (%)
<7	11 (55)
7	4 (20)
>7	5 (25)
Preoperative clinical stage, n (%)
T2a	6 (30)
T2b	2 (10)
T2c	8 (40)
T3a	1 (5)
T3b	3 (15)
Preoperative PSA, ng/mL (mean ± SD)	16.3 ± 12.9

BMI, body mass index; PSA, prostate-specific antigen; SD, standard deviation.

Perioperative and postoperative outcomes

Table 2 summarizes the perioperative and postoperative outcomes for radical prostatectomy. Lymphadenectomy was performed in 15 of the 20 patients. The mean operative time was recorded from skin incision to skin closure. Eight focal positive margins (40%) (five in T2 and three in T3a disease) were encountered and all occurred at the apex. There was one patient need for transfusion due to postoperational anemia.

Table 2.

Perioperative and Postoperative Outcomes

Operative time, minutes (mean ± SD)	294.3 ± 38.9
Estimated blood loss (including urine), mL	577.5 ± 368
Lymphadenectomy, n (%)	15 (75)
Prostate specimen volume, g (mean ± SD)	44 ± 14.4
Postoperative Gleason score, n (%)
<7	3 (15)
7	10 (50)
>7	7 (35)
Postoperative clinical stage, n (%)
T0	1 (5)
T2a	2 (10)
T2c	11 (55)
T3a	4 (20)
T3b	2 (10)
Positive surgical margins, n (%)	8 (40)
Length of stay, days (mean ± SD)	12.7 ± 4.4
Postoperative (1 month) PSA, ng/mL (mean ± SD)	0.19 ± 0.3
Continence, n (%)
0–1 pads/day	9 (45)
≥2 pads/day	2 (10)

PSA, prostate-specific antigen; SD, standard deviation.

Average 1 month after surgery, the PSA level was 0.19 ± 0.3 ng/mL. For continence outcomes, 9 (45%) patients need average 0–1 pads/day and 2 (10%) patients need average 3 pads/day after surgery. However, a trend toward improved urinary continence was observed during follow-up. Most patients recover within 4 months and only one still suffered from persistent incontinence until the end of research. Our experience with this reduced port approach showed the procedure to be as feasible as conventional LRP, with significant cosmetic advantages. Cosmesis as evaluated by the surgical team was excellent. The skin incision measured 3 cm and was mostly concealed within the umbilicus (Fig. 2).

FIG. 2.

Postoperation umbilical single-site wound.

Discussion

An increasing number of hospitals worldwide have adopted LESS, and a wide range of urologic procedures have been performed with this approach.¹³ However, LESS technique has unique challenges to the surgeon, given some inherent limitations including the lack of triangulation, the instrument clashing, and the unfavorable ergonomics. Thus, the application of current da Vinci robotic system to LESS was proposed to address some of these issues. The advantages of robotic platform include reducing instrument crossing, superior ergonomics, and restoring instrument triangulation for significantly facilitating suturing.^3,14

The role of robot-assisted radical prostatectomy in management of prostate cancer patients has grown exponentially over the last decade.¹⁵ Interest among surgeons and patients toward reducing number of incisions used for a minimally invasive surgical procedure is based on the rationale this might translate into pain reduction and better cosmetics. Other practical advantages include decreased intra-abdominal adhesions.¹ A combination of articulating and bent instruments can allow the surgeon to partially overcome the loss of triangulation and “clashing” of instruments. In White et al. study, they report their experience about robotic LESS radical prostatectomy through intraperitoneal approach. The result indicated feasibility of this procedure with safety outcomes.¹⁶ However, robot-assisted LESS RP is a challenging surgical procedure. Considerable instrument clashing limits precise tissue handling and retraction. Despite representing a step forward in the field of robotic single-site surgery, the lack of EndoWrist technology at the instrument tips has represented a major drawback of this novel set.^7–10 Consequently, the current robotic platform is suboptimal for this purpose and other solutions should be investigated. The recent introduction of a purpose-built instrumentation is likely to further foster the application of robotics to LESS. However, we are still far from the ideal robotic platform, as the currently available robot is bulky and not specific for what is necessary in single-site surgery. Significant improvements are needed before this technique might reach a widespread adoption beyond selected centers. Further advances in the field of robotic technology are expected to overcome current limitations and provide optimal interface to facilitate LESS.

Some features of LESS represent significant challenges compared with standard laparoscopy. Novel systems have been tested to offer intuitive instrument maneuverability and restored triangulation without external instrument clashing, but their use remains experimental.¹⁷ Previous articles reviewed recent trend of laparoscopic or robotic single port radical prostatectomy. With improvement of robotic LESS device and platform called plate spring mechanism or flexible robotic platform, this advanced minimal invasive technique is still anticipated and will gain a more acceptable approach.^18,19 We propose the robot-assisted radical prostatectomy-single site plus two model and through this, refinement of the traditional technique of five to seven port laparoendoscopic radical prostatectomy, improved retraction, and reduced external part collision.

All urologic procedures were successfully completed without conversions, and mostly only minor complications were observed, including blood transfusion. That demonstrates the feasibility and safety of the da Vinci Si Surgical System for this application. The mean operative time was slightly higher than the one reported for the standard robotic procedure, which can be easily explained by the expected learning curve.²⁰ Thus data from this investigation suggest that the robot-assisted radical prostatectomy-single site plus two model does not increase new risks to patient safety.

At 1-year follow-up, two patients experienced biochemical recurrence of >1 ng/mL. A 63-year-old man underwent bilateral nerve-sparing radical prostatectomy, with minimal blood loss and an uneventful postoperative course. There was neither positive surgical margin nor seminal vesicle invasion. The pathologic staging of the tumor was pT2c with Gleason score 8. The other patient is a 56-year-old man who underwent a radical prostatectomy and bilateral lymph node dissection. According to pathology report, there were no positive surgical margins, seminal vesicle invasion, and lymph node metastasis. The pathologic staging is pT2c with Gleason score 9. As the above description, even without a positive surgical margin after surgery, they still suffered from a shorter biochemical recurrence period compared to those with a positive surgical margin. It presents various types of prostate cancer with various prognosis and progression fate. The genomic complexity of prostate cancer was discussed in previous studies arousing researchers' attention to the importance of precision medicine.²¹ From our data, 12 patients revealed Gleason score upgrade between initial prostate biopsy and radical prostatectomy, seven patients remained the same grade, and only one downgraded. It is in accordance with previous studies that demonstrated upgrading is highly prevalent.²² Because upgrading is a risk factor for early biochemical recurrence and presents a more aggressive pattern, it is important to monitor patients more actively.²³

In regard to the functional outcome, the continence rate was within the range of most series of multiport robotic prostatectomy.¹² Most patients suffered from mild incontinence (0–1 pad/day) and they all resolved symptoms after several months. In our experience, we will prescribe biofeedback with electrical stimulation or antimuscarinic agent treatment. In addition, our procedure can be performed for previous intraperitoneal abdominal surgery patients as an extraperitoneal approach was utilized and it can easily be changed to conventional LRP for experienced surgeons.

A few limitations to this study should be mentioned, including limited sample, patient selection bias, and lack of a RALP comparative cohort.

Currently this is unavoidable because this is a new approach, and feasibility must first be established before embarking on a prospective comparative analysis.

In addition, we cannot draw conclusions regarding erectile function outcomes because most patients had no erectile function evaluation preoperatively.

Another important limitation is the short follow-up, which limits conclusions about oncologic and functional outcomes.

Conclusions

We describe the first clinical application of a new model of robot-assisted single site plus two radical prostatectomy. In conclusion, from this study, it demonstrated feasibility of the procedure. This procedure reduces some of the difficulties encountered with conventional LESS RP and can be readily performed safely and may become one of the standard laparoendoscopic surgeries for prostate cancer in the future. Additional investigations are now needed to further evaluate the longer term safety and oncologic adequacy of this approach.

Authors' Contributions

I.-S.L., article writing and data analysis. H.-Y.L., data collection, data analysis, and article editing. Y.-H. C., C.-N.H., and W.-J.W., protocol development. H.-C.Y., K.F.Y., and C.H.L., data collection. C.-C.L., protocol development and data collection.

Ethical Standards

This study was approved by the appropriate Institutional Review Board at Kaohsiung medical university hospital and performed according to the ethical standard laid down by the 1964 Declaration of Helsinki.

Footnotes

Disclosure Statement

No competing financial interests exist.

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