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Robotic Transvesical Partial Prostatectomy Using a Purpose-Built Single Port. Robotic ..... Anesthetic challenges in Robotic-assisted urologic surgery. Rev Urol.
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DR. JUAN GARISTO (Orcid ID : 0000-0001-9530-4039)

Article type

: Step-by-Step

Robotic Transvesical Partial Prostatectomy Using a Purpose-Built Single Port Robotic System Jihad Kaouk, Daniel Sagalovich, Juan Garisto Glickman Urological & Kidney Institute, Cleveland Clinic, Cleveland OH, USA

*Corresponding

author:

Jihad H. Kaouk, MD Glickman Urology and Kidney Institute, Cleveland Clinic 9500 Euclid Ave, Q10 Cleveland, OH 44195, USA Tel: (216) 444-2976 Email ID: [email protected]

Key words: single port, partial prostatectomy, transvesical approach

INTRODUCTION Prostate cancer (PCa) is the most common malignancy among men in the western world.1 Organ confined PCa treatment relies on a precise evaluation of the primary disease site. With the evolution of technology, prostate imaging modalities such as magnetic resonance imaging (MRI) are being used to localize PCa lesions dramatically impacting the management of this urologic malignancy2. MRI studies have shown that anterior prostate cancer (APCs) account for around 21% of all prostate malignancies3,4. A standard treatment for these lesions includes radical

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whole-gland surgery or radiotherapy creating substantial side effects such as urinary incontinence (5-20%) and erectile dysfunction (30-70%). Robotic-assisted laparoscopic surgery and energy-based ablation therapy for localized PCa do not necessarily offer improvements in patient morbidity and health related quality of life outcomes. Surgical removal of the APCs, such as partial prostatectomy, has been proposed as an alternative treatment for energy-based ablation of localized prostate cancer. In a recent study, Villers et al5,6. reported on a case series of low- and intermediate risk PCa patients that underwent robotic assisted anterior partial prostatectomy (APP) showing excellent functional outcomes. The modern era of prostate cancer surgery has been mainly driven by the development of novel minimally invasive techniques such as laparoendoscpic single-site surgery (LESS) and natural orifice transluminal endoscopic surgery (NOTES)7. Improvement of this surgical techniques boost the evolution of novel robotic platforms, such as the SP1098 (Intuitive Surgical, Sunnyvale, CA) that may potentially facilitate earlier postoperative recovery, reduced pain, and improved cosmesis. This surgical platform merges the concept LESS with robotics, providing the basis for performing intraluminal reconstructive, ablative and extirpative procedures using single port (SP) access. Robotic LESS opens the possibility of new surgical approaches, such as transvesical, that were technically challenging in prostate cancer surgery with standard robotic platforms. The objective of our study was to evaluate the feasibility of a single port transvesical robotic approach for partial prostatectomy (SP-TVPP) using a novel purpose-built single port surgical platform (SP1098) in a pre-clinical model.

MATERIALS AND METHODS Features of the Da Vinci SP1098 surgical system The new da Vinci SP1098 consists of a surgeon console, vision cart, and patient side cart, similar to da Vinci’s previous surgical platforms (SP999). A single arm is connected to the patient side cart and consists of four instruments -- including three robotic instruments and an articulating camera -- which are inserted through a 25-mm SP multichannel port. Additional characteristics include the SP1098 EndoWrist instruments (maintaining the 7 degrees of freedom with an additional “elbow” joint to facilitate SP intracorporeal triangulation), high-definition threedimensional optics, an instrument guidance system, and enhanced instrument arm control. The console is similar to the previous generations of da Vinci systems with an integrated separate foot clutch allowing simultaneous movements of the instruments and cameras.

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Surgical technique The cadavers were placed in lithotomy position. A 3-cm midline incision was made in the suprapubic area 4-cm from the symphisis pubis. After opening the Retzius space, the bladder was distended via a catheter and a GelPOINT (Rancho Margarita, CA, USA) was introduced percutaneously into the bladder (Fig.1). A SP multichannel port was inserted through the gelport to accommodate an oval articulating camera (12mm x 10mm) and three 6-mm doublejointed articulating instruments (Fig.2). An 8-mm accessory port was used for introduction of sutures and suctioning. The operating table was placed in a 0 degree and the SP robotic platform was side-docked (Fig.3). Pneumovesicum was obtained providing an adequate space for robotic arm mobilization. After docking the da Vinci robotic system, all steps of SP-TVPP were similar in the three cadavers.

Step 1- Antegrade Dissection at the BN An incision was made distal to the trigone to expose the peripheral zone (PZ) of the prostate and avoid the ureteral orifices. Dissection was performed circumferentially around the bladder neck (BN).

After exposing the transition zone (TZ) of the prostate, a combination of blunt and sharp dissection was continued; the plane between the seminal vesicles and Denonvilliers fascia was developed. Dissection was carried anteriorly through the anterior commissure of the prostate. The dorsal venous complex marked the anterior limit of resection. In the cadaver model, a hypothetical clinical scenario was created of a unifocal anterior tumor localized to the medial prostate-requiring wedge resection. The anterior prostate was divided along the prostatic urethra. Resection of the tumor was started at the 10 and 2 o’clock positions with cold scissors using an anterograde approach and incising the TZ up to the verumontanum (VM). VM and the posterior half of the urethra were preserved completing the resection of the anterior tumor from our hypothetical case.

Step 2- Bladder reconstruction to the urethra Vesico-prostato-urethra anastomosis was made by approximating the edges of the BN and advancing the anterior bladder flap to the urethral stump. Reconstruction was started by suturing the urethral stump to the prostatic urethral plate using a 3/0 V-lock 12” running

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suture. Then, the proximal prostatic urethral plate was advanced to the anterior BN. Once half of the urethra was approximated, suturing the anterior urethral stump to BN followed. Lastly, the posterior bladder flap was sutured to the edge of the initial bladder neck incision obtaining a watertight anastomosis.

The SP robot was undocked, the gelseal was opened and the specimen was extracted from the incision (Fig.4). A single layer watertight closure was used to approximate the bladder (3/0 VLock 6”). In this pre-clinical study, the primary outcomes were completion of SP-TVPP without conversion, total robotic operative time, and intraoperative complications (considered as any accidental puncture or laceration to an organ, hollow viscus, or blood vessel).

RESULTS Three procedures were technically successful through the transvesical route. The mean total operative duration was 49.3 mins, the mean time to obtain transvesical access was 16 mins, and the anastomotic suturing mean time was 14.3 min. There appeared to be no undue tension on the vesico-prostatic-urethral anastomotic suture-line. There was no need for conversion to standard techniques or for additional ports. On this pre-clinical model, there were no intraoperative complications. A summary of the steps and operative times are listed in Table 1.

DISCUSSION Over the past years, there has been an enormous expansion in the use of minimally invasive surgery for treating organ-confined PCa. Robot-assisted urologic surgery has demonstrated to be a safe surgical system for numerous urologic procedures.

In our study, we have shown the feasibility of a purpose built, novel robotic platform in performing a transvesical partial prostatectomy. This technique proposes an alternative to standard treatment on a very selective population for removal of single APC’s lesions with the potential of preserving functional and oncological outcomes. Although PCa is predominantly found in the peripheral zone (PZ), histopathological studies have shown that approximately 2030% of PCa occurs anteriorly. APC’s is defined as a tumor in which more than 50% of the malignant tissue is located anterior to the urethra. These tumors are generally lower Gleason grade compared to conventional posterior PCa. For APC’s tumors, depending on the nature of

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the disease, radical treatments represent a standard of care. Recently, focal ablative therapy (focal high-intensity focal ultrasound, cryotherapy or laser ablation) has been proposed as an alternative therapy for particular PCa lesions aiming to preserve quality of life for the patient. To the best of our knowledge, there is no current data supporting the safe utilization of focal therapy specifically in APCs. Robotic partial prostatectomy is a surgical concept initially proposed by Villers et al5, 6. on a careful chosen group of patients with APCs. The technique was feasible in 17 consecutive patients with low-to intermediate-risk APCs that were enrolled in a well-designed prospective single-arm phase study. Short-term oncologic outcomes showed an APC recurrence free-survival at 2 years of 0.86 (95% confidence interval, 0.55-0.96) with rates of continence and potency rates of 100% and 83%, respectively6.

With advances in robotic surgery, a new SP1098 robotic platform was developed to enhance the LESS approach. Fusion of robotic technology into the LESS space was initially assessed by Kaouk et al8. describing the first series of clinically applicable single-port (SP) robotic surgery with favorable outcomes.

The unique aspects of this SP platform prompted us to further extend the scope of minimally invasive surgery and explore the possibility of performing partial prostatectomy via transvesical appraoch.

During the cadaver procedure, we recognized several advantages of the SP-transvesical approach compared with a conventional 3-arms transperitoneal robotic approach. Achieving access through a suprapubic incision with the mini advance access platform (gelport) is technically simple and avoids the risks inherent to intraperitoneal access such as accidental visceral puncture. In addition, transvesical access avoided the need for steep Trendelemburg, which after extended periods of time is associated with rhabdomyolysis, positioning injuries, and facial/laryngeal edema9,10. After the SP system is docked, the SP cannula is positioned inside the bladder providing an acceptable pneumovesicum due to the effective seal from the multiaccess platform. With sufficient bladder distention and the ergonomic design of the SP1098 endowrist instruments, there is an ideal surgical space for intracorporeal triangulation making anterior resection of the prostate feasible. Moreover, pneumoperitoneum is bypassed with the transvesical approach excluding the possible deleterious effects of CO2 absorption on the cardiopulmonary physiology of patients.

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Additionally, the SP three-dimensional high definition magnified vision allows the surgeon to differentiate the surgical planes to achieve resection of an anterior lesion. An adequate urethroprostato-vesical anastomosis can satisfactorily be completed with triangulation of the robotic instruments and precise EndoWrist movement facilitated by an “elbow” joint.

Limitations include the preclinical model and lack of a control group. Additionally, certain technical aspects of the SP-TVPP still need to be considered given that this was a cadaver model and the ability to perform haemostasis was not feasible. The ability to increase pneumovesicum without an impact on cardiopulmonary parameters may in fact facilitate haemostasis especially if suture ligation of the dorsal venous complex is required. Moreover, this is a proof concept study conducted by an experienced robotic surgery team with a small sample size making intraoperative complications difficult to assess. As other surgical procedure, SP-TVPP is not innocuous and the occurrence of complications will be mandatory to be evaluated in human beings.

CONCLUSION We demonstrated the technical feasibility of SP-TVPP in human cadavers. The clinical applicability of this novel approach in selected patients with low-intermediate risk organconfined anterior prostate cancer is imminent.

REFERENCE 1. Sanda MG, Dunn RL , Michlaski J, et al. Quality of life and satisfaction with outcome among prostate cancer survivor. N Engl J Med 2008; 358:1250-61. 2. Johnson DC, Reiter RE. Multi-parametric magnetic resonance imaging as a management decision tool. Transl Androl Urol 2017 Jun;6(3):472-482. 3. Bott SR, Young MP, Kellet MJ., et al Anterior prostate cancer: is it more difficult to diagnose? BJU Int, 89 (2002):886-889. 4. Ouzzane A, Puech P, Lemaitre L. et al. Combined multiparametric MRI and targeted biopsies improve anterior prostate cancer detection, staging and grading. Urology 2011 Dec;78(6):1356-1362. 5. Villers A, Flamand V, Arquimedes RC. Et al. Robot-assisted partial prostatectomy for anterior prostate cancer: a step-by-step guide. BJU Int. 2017 Jun; 119(6): 968-974.

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6. Villers A, Puech P, Flamand V, et al. Partial Prostatectomy for Anterior Cancer: ShortTerm Oncologic and Functional Outcomes. Eur Urol. 2017 Sep; 72(3): 333-342. 7. Humphreys MR, Krambeck AE, Andrews PE, et al Natural orifice translumenal endoscopic surgical radical prostatectomy: proof of concept. J ENdourol. 2009; 23(4):669-75. 8. Kaouk JH, Goel RK, Haber GP, Crouzet S, Stein R. Robotic laparoendoscopic transumbilical surgery in humans: initial report. BJU Int 2009; 103:366-9. 9. Hsu RL, Kaye AD, Urman RD. Anesthetic challenges in Robotic-assisted urologic surgery. Rev Urol. 2013;15(4):178-84 10. Cockcroft JO, Berry CB, McGrath JS. Anesthesia for major urologic surgery. Anesthesiol Clin. 2015 Mar; 33(1):165-72.

ACKNOWLEDGEMENTS None.

Author contributions: Jihad H. Kaouk 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.

FINANCIAL DISCLOSURES This study was conducted with financial and logistical support from Intuitive Surgical, Inc (Sunnyvale, CA, USA). Jihad H. Kaouk 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, consultancies, honoraria, stock ownership or options, expert testimony, royalties, or patents filed, received, or pending), are the following: Endocare, Inc, Intuitive. - J.H. Kaouk (consultant). The remaining author (Juan Garisto, Daniel Sagalovich) has no industrial relationship to disclose.

Funding/Support and role of the sponsor: This research project was supported by Intuitive Surgical (Sunnyvale, CA, USA) who provided financial and material support. The sponsor played a role in the design and conduct of the study.

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Correspondence: Jihad H. Kaouk, Department of Urology, Glickman Urological and Kidney Institute, Cleveland Clinic, 9500 Euclid Ave., Q10-1, Cleveland, Ohio 44195, USA. Email: [email protected]

SUPPORTING INFORMATION Additional Supporting information may be found in the online version of this article:

Video S1. Robotic Transvesical Partial Prostatectomy Using a Purpose-Built Single Port Robotic System – link: https://www.dropbox.com/s/mblqd4e8tu62wau/SPKaoukTransvesical.m4v?dl=0

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Table No.1. Procedure Data for Single Port Transvesical Partial Prostatectomy Variable

Cadaver 1

Cadaver 2

Cadaver 3

Mean Time

Setup time (Port placement + Docking) (min)

18

14

16

16

Time for bladder neck and specimen extraction

20

19

18

19

a) Time for BN posterior dissection (min)

5

8

3

5.3

15

11

15

11

Time for vesicourethral anastomosis (min)

13

14

16

14.3

Total operative time (min)

51

47

50

49.3

b) Time for apical dissection and section of the urethra (min)

BN= bladder neck; min= minutes

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Figure 1. Placement of the Alexis® perrcutaneously into the bladder.

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Figure 2. A SP multichannel port was inserted through the gelport to accommodate the caamera nstruments. An accessory port was used for introdu uction and three double-jointed articulating in of sutures and suctioning.

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Figure 3. The operating table was placced in a 0 degree and the SP robotic platform was sidedocked

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Figure 4. A) An incision was made distal to the trigone to expose the peripheral zone (PZ) of the prostate and avoid the ureteral orifices, B) Resection of the tumor was started at the 10 and 2 o’clock positions with cold scissors using an anterograde approach and incising the TZ up to the verumontanum (VM), C) Completion of the prostate lesion resected, D) Vesico-prostato-urethra anastomosis, the posterior bladder flap was sutured to the edge of the initial bladder neck incision obtaining a watertight anastomosis

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Figure 5. The SP robot was undocked, the gelseal was opened and the specimen was extraacted from the incision