key: cord-0079133-vz3ru31p
authors: Carbonara, Umberto; Minafra, Paolo; Papapicco, Giuseppe; De Rienzo, Gaetano; Pagliarulo, Vincenzo; Lucarelli, Giuseppe; Vitarelli, Antonio; Ditonno, Pasquale
title: Xi Nerve-sparing Robotic Radical Perineal Prostatectomy: European Single-center Technique and Outcomes
date: 2022-05-23
journal: Eur Urol Open Sci
DOI: 10.1016/j.euros.2022.04.014
sha: 39c5786e25d8fd84b09d4f2f53771d11a8b6755f
doc_id: 79133
cord_uid: vz3ru31p

BACKGROUND: Radical prostatectomy (RP) represents the standard of care for the treatment of patients with organ-confined prostatic cancer. Historically, perineal RP has been described as the first surgical approach for the complete removal of the prostatic gland. In the past years, robotic techniques provided some technical advantages that allow resuming alternative approaches, such as robotic radical perineal prostatectomy (r-RPP). OBJECTIVE: To present in detail the technique of Xi nerve-sparing r-RPP and to report perioperative, oncological, and functional outcomes from a European tertiary center. DESIGN, SETTING, AND PARTICIPANTS: Patients with low- or intermediate-risk prostatic cancer not suitable for active surveillance and prostate volume up to 60 ml who underwent r-RPP between November 2018 and December 2020 were identified. SURGICAL PROCEDURE: All patients underwent Xi nerve-sparing r-RPP. MEASUREMENTS: Baseline characteristics and intraoperative, pathological, and postoperative data were collected and analyzed. The complications were reported according to the standardized methodology to report complications proposed by European Association of Urology guidelines. RESULTS AND LIMITATIONS: Overall, our series included 26 patients who underwent r-RPP. Patients’ median age was 62.5 yr. Thirteen (50%) and eight (30.7%) patients showed a body mass index (BMI) of 25–30 and >30, respectively. A history of past surgical procedures was present in seven (26.8%) patients. The median prostate volume was 40 (interquartile range [IQR]: 28–52) ml. The median operative time and blood lost were 246 (IQR: 230–268) min and 275 (IQR: 200–400) ml, respectively. Overall, four (15.4%) patients reported intraoperative complications and five (19.2%) reported postoperative complications, with one (3.8%) reporting major complications (Clavien-Dindo ≥3). No patient with biochemical recurrence (BCR) was reported at 1 yr of follow-up. Continence rates were 73.0%, 84.6%, and 92.3%, respectively, at 3, 6, and 12 mo after surgery. Erectile potency recovery rates were 57.1%, 66.6%, and 80.9% at 3, 6, and 12 mo of follow-up, respectively. CONCLUSIONS: Xi r-RPP is a challenging but safe minimally invasive approach for selected patients. No patient reported BCR at 12 mo. The choice of the surgical approach for RP is likely to be based on the patient’s characteristics as well as the surgeon’s preferences. PATIENT SUMMARY: Our study suggests that Xi radical perineal prostatectomy is a safe minimally invasive approach for patients with low- or intermediate-risk prostatic cancer, and complex abdominal surgical history or comorbidities.

Radical prostatectomy (RP) represents the standard of care for the treatment of patients with organ-confined prostatic cancer (PCa) [1] . Historically, perineal RP has been described as the first surgical approach for the complete removal of the prostatic gland [2] . Nevertheless, retropubic RP by Walsh is considered the most common surgical treatment for localized PCa to date [3] . This surgical approach overcame intrinsic technical limitations of the perineal RP, offering more familiar landmarks [3] .

In the past years, robot-assisted RP (RARP) has rapidly become the leading procedure in prostate cancer surgery [4] . RARP is frequently performed transperitoneally for the large working space and familiar anatomy [5, 6] . Overall, the robotic platform provided some technical advantages as seven degrees of freedom, tremor filtration, a threedimensional magnified view, and improved ergonomics that facilitate performing complex surgical steps, allowing to resume alternative approaches such as the perineal RP following the principles described by Young [2, 3, 7, 8] .

To date, few centers reported their early experience with robotic radical perineal prostatectomy (r-RPP), especially using the da Vinci Si platform [9, 10] . More recently, the introduction of the da Vinci Xi surgical system further facilitated this surgical approach, making it more reproducible and safe [11] . Furthermore, no study evaluated the safety of r-RPP in agreement with the standardized methodology to report complications proposed by European Association of Urology guidelines [12] .

The aim of the present study is to present in detail the technique of Xi nerve-sparing r-RPP and to report perioperative, oncological, and functional outcomes from a European tertiary center.

The present work represents a retrospective study from a prospectively [1, 15] . Continence was defined as the use of one pad or saver-pad [16] . Postoperative erectile function assessment was performed using the IIEF-5 questionnaire [17] . Potency was defined as an IIEF-5 score of 17 with or without the use of phosphodiesterase type 5 inhibitors [17] . Questionnaires were provided to patients at each visit.

Surgical technique is described step by step in the accompanying video 

The da Vinci Xi surgical system represents the fourth-generation robot by Intuitive Surgical (Sunnyvale, CA, USA). Compared with the Si system, the Xi system offers higher versatility and flexibility. For the r-RPP procedure, the following robotic instruments can be used, also depending on the surgeon's preference: Figure 2 . After the port placement,

the Xi system is docked, usually on the patient's left side.

Prostate dissection is performed from the apex to the base, progressing mediolaterally. It reduces the risk of damages to the neurovascular bundles (NVBs; Fig. 3A ). The lateral aspects of the prostate are isolated, leaving the endopelvic fascia intact. The dissection can be performed along an inter-or extrafascial plane, according to the Gleason score, clinical staging, prostate disease localization, and preoperative erectile status.

In particular, our video shows complete preservation of the right-sided NVB with an intrafascial nerve-sparing approach plane using small 

Once the Denonvilliers' fascia is open, vas deferens is identified, clipped, and removed, as well as the seminal vesicle. Isolation of the dorsal aspect of the prostate is completed (Fig. 3B ).

The membranous urethra is then gently dissected from the external urinary sphincter. Care is taken to completely isolate the apex of the prostate, while keeping the membranous urethra as long as possible (Fig. 3C ).

In this step, the surgeon needs to carefully mind the localization of NVBs, which run alongside the apex at 5 and 7 o'clock positions, and slightly move towards 3 and 9 o'clock at the junction with the membranous urethra. The urethra is incised with cold scissors, and the catheter is clipped and then cut, keeping the balloon inflated inside the bladder. This is useful for handling during the dissection of the bladder neck (BN).

The anterior aspect of the prostate is isolated by lifting the endopelvic fascia and the dorsal venous complex, preserving the Retzius space and its ligamentous structures. The ventral circular fibers of the BN are identified and incised. After catheter removal, incision of the BN is completed on lateral and dorsal margins.

The robot is undocked, and the specimen can be retrieved by removing the GelPOINT. After robot redocking, anastomosis is carried out with a running suture using V-Loc 90 barbed sutures (Covidien, Mansfield, 

Statistical analysis was conducted according to guidelines [19] . Descriptive statistics was adopted to describe patients' characteristics and surgical outcomes. The median with interquartile range (IQR) and

frequencies were adopted to report continuous and categorical variables, respectively. Kaplan-Meier analyses of recurrence-free and overall survival were performed. All statistical tests were performed with SPSS 25.0 (version 25.0; IBM Corp., Armonk, NY, USA) and statistical significance was set at p < 0.05.

Overall, our series included 26 patients who underwent r-RPP. Baseline characteristics of the study population, and surgical and pathological outcomes are summarized in Tables 1 and 2 Table 2 ).

Oncological and functional outcomes are reported in Table 4 .

Overall, no patient with BCR was shown at 1 yr of follow-up. Kaplan-Meier analyses were shown in Supplementary Figures 1 and 2 . After catheter removal, postoperative continence rate at 1 mo was 47.6%. Continence rates were 73.0%, 84.6%, and 92.3%, respectively, at 3, 6, and 12 mo after surgery. Erectile potency recovery rates were 57.1%, 66.6%, and 80.9% at 3, 6, and 12 mo of follow-up, respectively.

Herein, we provide in detail the surgical technique and present the outcomes of Xi r-RPP with the longest follow-up available to date (Table 5 ). Our analysis relies on a prospectively maintained dataset that includes a granular description of the study population and its outcomes. Indeed, despite the diffusion of robotic surgery, the literature lacks surgical and postoperative details on Xi r-RPP [3] . Port placement represents a key point in performing a perineal approach with a multiport robotic platform, as also described by Tugcu et al [11] . The da Vinci Xi system facilitates this approach by maximizing freedom of movement, minimizing instrument clashing, and providing good ergonomics during the critical steps of the procedure, compared with Si [20] [21] [22] . Moreover, we introduced for the first time the AirSeal system as an assistant port. This type of insufflation system responds immediately to the slightest changes in pressure maintaining continuous smoke evacuation and CO 2 recirculation, and ensuring visibility during the procedure. One of the challenging steps during r-RPP is the management of the nerve-sparing approach. In our series, in all but five cases (all patients with IIEF-5 <17), the nervesparing approach was accomplished. This demonstrates that one of the advantages of using the Xi system is to facil-itate this step, allowing adherence to a key oncological principle, as also pointed out in the guidelines [11] .

In our cohort, 21 (80.7%) patients reported a BMI of >25, as well as a median Charlson comorbidity index of 4. Overall, nine (34.5%) patients showed a past surgical history. One of the benefits of r-RPP is allowing an optimal surgical option in patients with a previous history of surgical procedure and/or obesity, and cardiac and pulmonary comorbidities, which represent a technical challenge during standard RARP [3] . Moreover, the perineal access minimizes the risks of accidental visceral or major vessel injuries, as well as the no steep Trendelenburg position limits the risk of anesthetic complications [3] .

The assessment of surgical outcomes in the present series shows Xi r-RPP to be a safe and effective minimally invasive procedure, providing acceptable OT, acceptable EBL, and a low risk of complications in selected patients. Indeed, we offered r-RPP only to patients with PCa, with prostate volume <60 ml, and without a nodal metastasis risk. In a recent match-paired analysis, the Cleveland Clinic group compared the outcomes of r-RPP performed with a singleport (SP) robotic platform versus Si RARP [23] . The authors reported that SP r-RPP was performed especially in patients with prostate volume <80 cc and who were unfit for the standard surgical approach as well as radiation treatment options. In their study, one and six patients with major complications were reported in the Si RARP and SP r-RPP groups, respectively (p = 0.233) [23] . These findings underline the safety and reproducibility of r-RPP using different new-generation robotic platforms. Notably, at a time when the da Vinci SP platform is not available in Europe, our results showed that Xi r-RPP represents a safe alternative to standard RARP. Moreover, we reported the complications of r-RPP according to European Association of Urology ''ad hoc'' panel guidelines for the first time, which allow to increase the accuracy of the analysis and avoid missing complication reporting [24] [25] [26] [27] .

Regarding perineal lymph node dissection (LND), we selected patients not suitable for LND according to Briganti's nomogram and staging in the present series. More-over, this represents a challenging procedure that raised few concerns on the safety and technical feasibility [3] . However, several series reported the safety and feasibility of robotic LND with the perineal approach, and the use of a single-port robotic platform facilitated this surgically challenging procedure [23] .

Concerning functional outcomes, 24 (92.3%) and 17 (80.9%) patients showed, respectively, recovery of continence and erectile function at 12 mo of follow-up in our cohort. Recently, Egan et al [28] reported the outcomes of 70 patients who underwent Retzius-sparing RARP compared with those of 70 patients undergoing standard RARP. In their cohort, the Retzius-sparing approach showed a significant improvement of continence rate at 12 mo (97.6% vs 81.4%, p = 0.002) with a faster return to continence (zero to one safety pad, 44 vs 131 d, p < 0.001) compared with the standard approach. To note, our functional results are very similar to those reported by Egan et al [28] . The two surgical approaches allowed a high continence rate due to the preservation of anterior ligaments of the bladder as well as prevention of vesical-urethral anastomosis prolapse with the attempt to maintain as much normal pelvic anatomy as possible [29] . Overall, the robotic platform improved functional outcomes of patients undergoing RP compared with the open and laparoscopic approaches [5, 30] .

Regarding oncological outcomes, nine (34.5%) patients reported PSMs in our cohort. In the largest cohort available to date, Tugcu et al [11] analyzed the outcomes of 95 patients who underwent r-RPP between 2016 and 2018. The authors reported that only eight (8.4%) patients presented PSMs after the surgical procedure [11] . These results are dissimilar to other series looking at an open or minimally invasive approach [3, 23, 31] . However, the difference in the study period, as well as the early phase of the r-RPP learning curve, could have influenced our findings. Furthermore, a low prostate weight was significantly associated with high PSM rates [32] . To note, despite a high PSM rate within our cohort, no patients reported BCR at 12 mo of follow-up after surgery. Intuitively, the short follow-up prevents any conclusion on this aspect, and further studies are needed to better address oncological outcomes of r-RPP and confirm oncological efficacy. [1] . b Continence was defined as the use of one pad or saver-pad [13] . c Potency was defined as an IIEF-5 score of 17 with or without the use of phosphodiesterase type 5 inhibitors [14] . Only patients who underwent nerve-sparing approach were considered. Several limitations should be acknowledged. First, the retrospective nature of the study carries intrinsic biases. A selection bias is related to the precise selection criteria of this surgical approach. Second, these outcomes relied on the experience of a high-volume referral center with extensive experience with open and robotic surgery, and therefore the outcomes might be different in other clinical settings [33] . Last, the length of follow-up, as well as the small study cohort, was limited to assess middle-and longer-term oncological and functional outcomes. Further studies with multicenter design and longer follow-up are needed to better address our findings.

The current study provides evidence that Xi r-RPP is a challenging but safe minimally invasive approach, particularly for patients with low-and intermediate-risk PCa and prostate volume up to 60 ml. Notably, r-RPP could represent a valid alternative in patients with a previous history of abdominal surgery, and with cardiac or pulmonary comorbidities, or in whom the transperitoneal approach is not indicated.

Author contributions: Umberto Carbonara 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.

Study concept and design: Carbonara, Minafra, Ditonno.

Acquisition of data: Carbonara, Minafra, Papapicco.

Analysis and interpretation of data: Carbonara, Minafra.

Drafting of the manuscript: Carbonara, Minafra. Other: None.

Financial disclosures: Umberto Carbonara 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: None. 

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Supplementary data to this article can be found online at https://doi.org/10.1016/j.euros.2022.04.014.