Surgical outcomes of novel retroperitoneal low anterior vs posterior and transperitoneal access in single-port partial nephrectomy.

PURPOSE: Single-Port Robot-Assisted Partial Nephrectomy (SP-RAPN) can be performed by transperitoneal and retroperitoneal approaches. However, there is a lack of surgical outcomes for novel Retroperitoneal Low Anterior Access (LAA) in SP-RAPN. The study compared outcomes of the standard approach (SA), considering transperitoneal (TP) and posterior retroperitoneal (RP) access vs LAA in SP-RAPN series. METHODS: 102 consecutive patients underwent SP-RAPN between 2019 and 2023 at a tertiary referral robotic center were identified. Baseline characteristics, peri- and post-operative outcomes were collected. Patients were stratified according to surgical approach into standard (RP or TP) vs LAA and, subsequently, RP vs LAA. Multivariable logistic regression analysis was used to test the probability of the same-day discharge adjusting for comorbidity indexes. RESULTS: Overall, 102 consecutive patients were included in this study (68 SA - 26 TP and 42 posterior RP vs 34 LAA). Median age was 60 (IQR 51.5-66) years and median BMI was 31 (IQR 26.3-37.6). No baseline differences were observed. LAA exhibited significantly shorter length of stay (LOS) (median 10 [IQR 8-12] vs 24 [IQR 12-30.2.] hours, p < .0001), reduced post-operative pain (p < .0001) and decreased narcotic use on 0-1 PO Day (p < .001) compared to SA and RP only. Multivariate analysis, adjusting for comorbidities, identified LAA as a strong predictor for Same-Day Discharge. CONCLUSION: LAA is an effective approach as well as RP and TP, regardless of the renal mass location, whether it is anterior or posterior, upper/mid or lower pole, yielding favorable outcomes in LOS, post-operative pain and decreased narcotics use compared to SA in SP-RAPN.

Defining the optimal target-to-background ratio to identify positive lymph nodes in prostate cancer patients undergoing robot-assisted [99mTc]Tc-PSMA radioguided surgery: updated results and ad interim analyses of a prospective phase II study.

INTRODUCTION: Prostate-specific membrane antigen radioguided surgery (PSMA-RGS) might identify lymph node invasion (LNI) in prostate cancer (PCa) patients undergoing extended pelvic lymph node dissection (ePLND). The optimal target-to-background (TtB) ratio to define RGS positivity is still unknown. MATERIALS & METHODS: Ad interim analyses which focused on 30 patients with available pathological information were conducted. All patients underwent preoperative PSMA positron emission tomography (PET). 99m-Technetium-PSMA imaging and surgery ([99mTc]Tc-PSMA-I&S) was administered the day before surgery. In vivo measurements were conducted using an intraoperative gamma probe. Performance characteristics and implications associated with different TtB ratios were assessed. RESULTS: Overall, 9 (30%) patients had LNI, with 22 (13%) and 80 (11%) positive regions and lymph nodes, respectively. PSMA-RGS showed uptakes in 12 (40%) vs. 7 (23%) vs. 6 (20%) patients for a TtB ratio ≥ 2 vs. ≥ 3 vs. ≥ 4. At a per-region level, sensitivity, specificity and accuracy for a TtB ratio ≥ 2 vs. ≥ 3 vs. ≥ 4 were 72%, 88% and 87% vs. 54%, 98% and 92% vs. 36%, 99% and 91%. Performing ePLND only in patients with suspicious spots at PSMA PET (n = 7) would have spared 77% ePLNDs at the cost of missing 13% (n = 3) pN1 patients. A TtB ratio ≥ 2 at RGS identified 8 (24%) suspicious areas not detected by PSMA PET, of these 5 (63%) harbored LNI, with one pN1 patient (11%) that would have been missed by PSMA PET. Adoption of a TtB ratio ≥ 2 vs. ≥ 3 vs. ≥ 4, would have allowed to spare 18 (60%) vs. 23 (77%) vs. 24 (80%) ePLNDs missing 2 (11%) vs. 3 (13%) vs. 4 (17%) pN1 patients. CONCLUSIONS: PSMA-RGS using a TtB ratio ≥ 2 to identify suspicious nodes, could allow to spare > 50% ePLNDs and would identify additional pN1 patients compared to PSMA PET and higher TtB ratios.

Single-Port Transvesical Vesico-Vaginal Fistula Repair: An Initial Experience.

INTRODUCTION: Vesicovaginal fistula (VVF) is the most common urogenital fistula due to iatrogenic cause, primarily associated with gynecologic surgery (1). Although both conservative and surgical management may be considered, the optimal treatment is still uncertain and several studies were published using different techniques (open, laparoscopic or robotic) and approaches (extravesical, transvesical or transvaginal) (2-5). In this context, we aim to report our initial experience repairing VVF with Single-Port (SP) Transvesical (TV) access. MATERIALS AND METHODS: Four patients with a diagnosis of VVF underwent SP-TV VVF repair between May 2022 and December 2023. Diagnosis was confirmed by cystoscopy, cystogram and in two cases by CT Urogram. Under general anesthesia, before robotic time, patients were placed in lithotomy position and a preliminary cystoscopy was performed. Fistula was noted and a 5fr stent was placed through the fistulous tract. Two ureteral stents were placed. Then, with patient supine, a transverse suprapubic 3cm incision and 2cm cystotomy were made for SP access. First step was to mark and remove fistula tract to the vagina. The edges of the vagina and bladder were dissected in order to have a closure free of tension and to create three different layers to close: vagina, muscularis layer of the bladder and mucosal layer of the bladder. A bladder catheter was placed, and the two ureteral stents were removed at the end of procedure. RESULTS: Mean age was 53 years old and three out of 4 patients developed VVF after gynecologic surgery. Two patients underwent VVF repair 6 and 8 months after total hysterectomy. One patient developed VVF after total hysterectomy and oophorectomy followed by radiation therapy. Last patient developed VVF after previous urological procedure. Fistula diameter was between 11 and 15mm. Operative time was 211 min, including preliminary cystoscopy, stents placement and SP-access. All patients were discharged on the same day with a bladder catheter, successfully removed between post-operative day 14-18 after negative cystogram. Only in one case a ureteral stent was left because the fistula was closed to the ureteral orifice and we reported one case of UTI twelve days after surgery, treated with outpatient antibiotics. Mean follow-up was 8 months, patients were scheduled for regular follow-up visits and no recurrence was reported. All patients have at least 3 months of post-operative follow-up. CONCLUSIONS: Our experience suggests that SP Transvesical VVF repair may be considered as a safe and feasible minimally invasive treatment for small/medium fistulae (10-15mm).

Versatility of Single Port Retroperitoneal Low Anterior Access: Early Outcomes in Multiple Procedures.

Purpose: This study aimed to assess early outcomes of the single port (SP) robotic low anterior access (LAA) for all upper urinary tract surgeries. In addition, it aimed to explore the impact of clinical factors, notably Body Mass Index (BMI), on post-operative outcomes and length of hospital stay. Materials and Methods: Overall, 76 consecutive patients underwent SP robotic surgery with LAA involving all upper urinary tract pathologies, with data collected prospectively. Baseline characteristics, intra- and post-operative outcomes, pain levels, and opioid use were analyzed. Statistical methods, including logistic regression and locally weighted scatterplot smoothing analysis, were used to assess same-day discharge (SDD) predictors and the association between BMI and SDD probability. According to the Institutional Review Board (IRB) protocol, only data recorded in our electronic medical record system was included. Results: Ten different procedures were performed with LAA, with no need for conversion to open surgery and complication rates in line with the literature (30 days: 5%, 90 days: 6.6%). Notably, 77.6% of patients were discharged on the same day. A significant association was found between BMI and prolonged hospital stay, particularly in obese patients (BMI ≥30 kg/m2). Post-operative pain was generally low (median VAS: 4), with over 70% discharged without opioid prescriptions. Conclusions: The novel LAA is a versatile approach for various upper urinary tract surgeries, including in obese patients. While achieving satisfactory post-operative outcomes, increased BMI correlated with a reduced likelihood of SDD. Further studies, including larger cohorts and multicenter collaborations, are warranted to explore anesthesiologic management and validate these findings.

Outpatient vs Inpatient Single-Port Robotic Urologic Surgery: Perioperative Outcomes and Complications.

INTRODUCTION: The da Vinci Single Port (SP) robotic surgical system has minimized the impact of surgery on patients. Hence, outpatient robotic procedures are being explored to reduce costs and improve patient experience. Here, we evaluate the perioperative outcomes and safety of same-day discharge (SDD) after surgery compared to inpatient procedures using the SP. METHODS: A total of 374 patients underwent surgery with the da Vinci SP system between January 2019 and February 2023. Surgeries were performed in a single high-volume center. Patients were either managed with a standardized outpatient or inpatient protocol. SDD clinical pathway was implemented in June 2021. Patients were assessed for discharge eligibility based on specific guidelines. Detailed instructions were provided at discharge, and patients were followed postoperatively. Baseline characteristics, perioperative data, complications, time to complication, and readmissions were assessed. RESULTS: Two hundred eight patients underwent outpatient surgery and 166 underwent inpatient surgery (total = 374). Outpatient surgery was not associated with increased postoperative complications and readmission compared to inpatient surgery. Ninety percent and 74.6% of patients experienced no complications in the outpatient and inpatient populations, respectively (P =< .001). Time to first complication was also comparable between the 2 groups (3 days [IQR 1-8] vs 10 days [IQR 4-30] for outpatient vs inpatient; P = .3). The proportion of successful SDDs increased over time, reaching 88% in October 2022. CONCLUSIONS: Outpatient surgery using the da Vinci SP is safe and feasible, without increasing postoperative complications compared to standard inpatient surgery.

Single port robot-assisted radical and simple prostatectomy: a systematic review and meta-analysis.

BACKGROUND: Aim of our study was to review the current evidence on single port robot-assisted radical prostatectomy (SP-RARP) and SP robot-assisted simple prostatectomy (SP-RASP) procedures. METHODS: A comprehensive bibliographic search on multiple databases was conducted in July 2023. Studies were included if they assessed patients with non-metastatic prostate cancer or candidate for benign prostatic hyperplasia surgery (P) who underwent SP-RARP or SP-RASP, respectively, (I), compared or not with other surgical techniques (C), evaluating perioperative, oncological, or functional outcomes (O). Prospective and retrospective original articles were included (S). A meta-analysis of comparative studies between SP-RARP and MP-RARP was performed. RESULTS: A total of 21 studies investigating 1400 patients were included in our systematic review, 18 were related to SP-RARP while 3 to SP-RASP. Only 8 comparative studies were eligible for meta-analysis. Mean follow-up was 8.1 (±5.8) months. Similar outcomes were observed for SP-RARP and MP-RARP in terms of operative time, catheterization time, pain score, complications rate, continence and potency rates, positive surgical margin, and biochemical recurrence. Length of hospital stay was shorter in the SP group after sensitivity analysis (WMD -0.58, 95% IC -1.17 to -0.9, p < 0.05). Subgroup analysis by extraperitoneal approach did not show any statistical difference, except for a lower positive margins rate in the SP extraperitoneal technique compared to MP-RARP. Overall, SP-RASP exhibited shorter hospital stay and lower rate of de novo urinary incontinence when compared to other techniques, while no differences were reported in terms of postoperative International Prostate Symptom Score, post void residual and maximum flow. CONCLUSIONS: Overall comparable oncological, functional, and perioperative outcomes can be achieved with SP platform. Subgroup analysis by different approaches did not reveal significant variations in outcomes. However, the retrospective nature of the studies, the limited follow-up, and the relatively small sample size of selected Centers may impact these results.

Application of the single-port robotic platform during radical nephroureterectomy for upper tract urothelial carcinoma: feasibility of the single-port robot in the multi-quadrant setting.

Urothelial carcinoma of the upper tract (UTUC) is a malignancy that accounts for 5-10% of all urothelial carcinomas. Radical surgery is the primary treatment option due to the high rate of invasive stages at the time of diagnosis. Nephroureterectomy (NU) with bladder cuff excision is the current standard of care. While laparoscopic NU has been established since 1991, many centres still perform open surgery due to the complexity of laparoscopic instrumentation and the steep learning curve for excising the bladder cuff. With the increasing adoption of the multi-port (MP) robotic surgery, NU has increasingly been performed using this platform. The use of MP robotic systems for NU has been challenged by the need for patient repositioning and/or redocking of the robot, which can consume valuable operative time. The transition from the daVinci Si to the daVinci Xi system has seen a noticeable reduction in redocking and patient repositioning. However, owing to the multi-quadrant nature of the surgery in question, the use of multiple ports and external instrument clashing are still persistent problems. Moreover, there is a growing interest in utilizing a retroperitoneal approach for robot-assisted NU due to its potential benefits such as improved control of hilar structures, reduction of blood loss, shorter operative time and hospital stay, reduced complications and decreased postoperative discomfort. The application of the daVinci single-port (SP) robotic platform during radical NU for UTUC is feasible and has the potential to improve the current surgical approach. Indeed, the use of a SP platform may solve the problem of patient repositioning and redocking of the robot, improve superficial aesthetic outcome and minimize external instrument clashing. While maintaining an optimal oncological control, the retroperitoneal approach, which has been difficult to replicate and adopt using the MP approach, may become standard practice. However, more studies are needed to confirm the benefit of this approach and ultimately determine the impact of the daVinci SP on the management of UTUC.

Robot-assisted Surgery in the Field of Urology: The Most Pioneering Approaches 2015-2023.

Robot-assisted surgery has emerged as a transformative technology, revolutionizing surgical approaches and techniques that decades ago could barely be imagined. The field of urology has taken charge in pioneering a new era of minimally invasive surgery with the ascent of robotic systems which offer enhanced visualization, precision, dexterity, and enabling surgeons to perform intricate maneuvers with improved accuracy. This has led to improved surgical outcomes, including reduced blood loss, lower complication rates, and faster patient recovery. The aim of our review is to present an evidence-based critical analysis on the most pioneering robotic urologic approaches described over the last eight years (2015-2023).

Oncological and perioperative outcomes of surgery with or without metastasis-directed therapy as part of a multimodal treatment in men with de-novo oligometastatic prostate cancer.

PURPOSE: To investigate the feasibility, safety, and oncological outcomes of Radical Prostatectomy (RP; either Robot-Assisted [RARP] or Open RP [ORP]) in oligometastatic prostate cancer (omPCa). Additionally, we assessed whether there was an added benefit of metastasis-directed therapy (MDT) in these patients in the adjuvant setting. METHODS: Overall, 68 patients with omPCa (≤ 5 skeletal lesions at conventional imaging) treated with RP and pelvic lymph node dissection between 2006 and 2022 were included. Additional therapies (androgen deprivation therapy [ADT] and MDT) were administered according to the treating physicians' judgment. MDT was defined as metastasis surgery/radiotherapy within 6 months of RP. We assessed Clinical Progression (CP), Biochemical Recurrence (BCR), post-operative complications and overall mortality (OM) of RP and the impact of adjuvant MDT + ADT versus RP + ADT alone. RESULTS: Median follow-up was 73 months (IQR 62-89). RARP reduced the risk of severe complications after adjusting for age and CCI (OR 0.15; p = 0.02). After RP, 68% patients were continent. Median 90-days PSA after RP was 0.12 ng/dL. CP and OM-free survival at 7 years were 50% and 79%, respectively. The 7-years OM-free survival rates were 93 vs. 75% for men treated with vs. without MDT (p = 0.04). At regression analyses, MDT after surgery was associated with a 70% decreased mortality rate (HR 0.27, p = 0.04). CONCLUSIONS: RP appeared to represent a safe and feasible option in omPCa. RARP reduced the risk of severe complications. Integrating MDT with surgery in the context of a multimodal treatment might improve survival in selected omPCa patients.

Simplifying Retroperitoneal Robotic Single-port Surgery: Novel Supine Anterior Retroperitoneal Access.

BACKGROUND: Multiport robotic surgery in the retroperitoneum is limited by the bulky robotic frame and clashing of instruments. Moreover, patients are placed in the lateral decubitus position, which has been linked to complications. OBJECTIVE: To assess the feasibility and safety of a supine anterior retroperitoneal access (SARA) technique with the da Vinci Single-Port (SP) robotic platform. DESIGN, SETTING, AND PARTICIPANTS: Between October 2022 and January 2023, 18 patients underwent surgery using the SARA technique for renal cancer, urothelial cancer, or ureteral stenosis. Perioperative variables were prospectively collected and outcomes were assessed. SURGICAL PROCEDURE: With the patient in a supine position, a 3-cm incision is made at the McBurney point and the abdominal muscles are dissected. Finger dissection is used to develop the retroperitoneal space for the da Vinci SP access port. After docking, the first step is to dissect retroperitoneal tissue to reveal the psoas muscle. This allows identification of the ureter, the inferior renal pole, and the hilum. MEASUREMENTS: A descriptive statistical analysis was performed. Data collected included demographics, operative time, warm ischemia time (WIT), surgical margin status, complications, length of hospital stay, 30-d Clavien-Dindo complications, and postoperative narcotic use. RESULTS AND LIMITATIONS: Twelve patients underwent partial nephrectomy (PN) and two each underwent pyeloplasty, radical nephroureterectomy, and radical nephrectomy. In the PN group, mean age was 57 yr (interquartile range [IQR] 30-73), median body mass index was 32 kg/m2 (IQR 17-58), and 25% had stage ≥3 chronic kidney disease. The median Charlson comorbidity index was 3 (IQR 0-7) and 75% of PN patients had an American Society of Anesthesiologists score ≥3. The median RENAL score was 5 (IQR 4-7). The median WIT was 25 min (IQR 16-48) and the median tumor size was 35 mm (IQR 16-50). The median estimated blood loss was 105 ml (IQR 20-400) and the median operative time was 160 min (IQR 110-200). Positive surgical margins were found in one patient. In the overall cohort, one patient was readmitted and managed conservatively; 83% of the PN group were discharged on the same day as their surgery, with the remainder discharged the next day. At 7 d after surgery, no patients reported narcotic use. CONCLUSIONS: The SARA approach is feasible and safe. Larger studies are needed to confirm this approach as a one-step solution for upper urinary tract surgery. PATIENT SUMMARY: We assessed initial outcomes of a novel approach for accessing the retroperitoneum (the space behind the abdominal cavity and in front of the back muscles and spine) during robot-assisted surgery in the upper urinary tract. The patient is placed on their back and surgery is performed with a single-port robot. Our results show that this approach was feasible and safe, with low complication rates, less postoperative pain, and earlier discharge. This is a promising start, but larger studies are needed to confirm our findings.

Single-Port Robot-Assisted Radical Prostatectomy: Where Do We Stand?

In 2018, the da Vinci Single Port (SP) robotic system was approved by the US Food and Drug Administration for urologic procedures. Available studies for the application of SP to prostate cancer surgery are limited. The aim of our study is to summarize the current evidence on the techniques and outcomes of SP robot-assisted radical prostatectomy (SP-RARLP) procedures. A narrative review of the literature was performed in January 2023. Preliminary results suggest that SP-RALP is safe and feasible, and it can offer comparable outcomes to the standard multiport RALP. Extraperitoneal and transvesical SP-RALP appear to be the two most promising approaches, as they offer decreased invasiveness, potentially shorter length of stay, and better pain control. Long-term, high-quality data are missing and further validation with prospective studies across different sites is required.

Focal therapy for prostate cancer: what is really needed to move from investigational to valid therapeutic alternative?-a narrative review.

Background and Objective: The most widely accepted therapeutic alternatives for men with intermediate risk prostate cancer (PCa) are mainly represented by whole gland therapies such as surgery or radiotherapy. However, these treatments can carry in some cases profound functional side effects. With the improvement of risk assessment tools and imaging modalities, in particular with the introduction of multiparametric magnetic resonance imaging of the prostate, a fine topographic characterisation of PCa lesions within the prostatic gland is now possible. This has allowed the development of gland-sparing therapies such as focal therapy (FT) as a means to provide an even more tailored approach in order to safely reduce, where feasible, the harms carried by whole gland therapies. Unfortunately, adoption of FT has been considered so far investigational due to some unsolved issues that currently hamper the use of FT as a valid alternative. Here, we aim to identify the main aspects needed to move FT forward from investigational to a valid therapeutic alternative for clinically localized PCa. Methods: The literature discussing the evolution of focal therapy in the years and its current landscape was broadly searched to identify the factors hindering FT adoption and possible solutions. Key Content and Findings: There are three broad areas hindering FT as a valid therapeutic alternative: (I) Correct patient selection; (II) harmonising the different FT technologies; (III) the lack of oncological outcomes. Conclusions: By targeting the three aforementioned weaknesses of FT, greater adoption is expected, finally making FT a valid therapeutic alternative, potentially reshaping prostate cancer treatment and functional outcomes.

The key role of levator ani thickness for early urinary continence recovery in patients undergoing robot-assisted radical prostatectomy: A multi-institutional study.

BACKGROUND: Urinary continence (UC) recovery dramatically affects quality of life after robot-assisted radical prostatectomy (RARP). Membranous urethral length (MUL) has been the most studied anatomical variable associated with UC recovery. OBJECTIVE: To investigate whether levator ani thickness (LAT), assessed with multi-parametric magnetic resonance imaging (mpMRI), correlates with UC recovery after RARP. DESIGN, SETTING, AND PARTICIPANTS: The study included 209 patients treated with RARP by expert surgeons with extensive robotic experience from 2017 to 2019. All patients had complete, clinical, mpMRI, pathological, and postoperative data including pelvic floor muscle training (PFMT) protocols. INTERVENTION: After a radiologist-specific training, two urologists independently examined the files, blinded to clinical and pathological findings as well as to postoperative continence status. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: On mpMRI, LAT, bladder neck (BN) shape, MUL, and apex overlapping (AO) were measured. UC recovery was defined as use of 0 or 1 safety pad at follow-up. Multivariable models were used to assess the association between variables and UC recovery. RESULTS AND LIMITATIONS: Overall, 173 (82.8%) patients were continent after a median follow-up of 23 months (interquartile range [IQR]: 17-28). Of these, 98 (46.9%) recovered within 3 months after surgery, 42 (20.1%) from 3 to 6 months, and 33 (15.8%) from 6 months onwards. A significant higher rate of patients with LAT > 10 mm (88.1 vs.75.8%; p = 0.03) experienced UC recovery, compared to those with LAT < 10 mm. This difference was observed in the first 3 months after surgery. At multivariable analysis, LAT (odds ratio [OR]: 1.18, 95% confidence interval [CI]: 1.02-1.37; p = 0.02), Preoperative ICIQ score (OR: 0.91, 95% CI: 0.82-0.98, p = 0.03) and PFMT (OR: 1.98, 95% CI: 1.01-3.93; p = 0.04) independently predict higher UC recovery within 3 months, after accounting for age, BMI, preoperative PSA, D'Amico risk group, MUL, BN shape and AO. CONCLUSIONS: LAT greater than 1 cm was associated with greater UC recovery. Specifically, LAT greater than 1 cm seems to be associated with higher UC rate at 3 months after RARP, compared to those with LAT < 1 cm. PATIENT SUMMARY: Magnetic resonance features can help in predicting the risk of incontinence after robot-assisted radical prostatectomy and should be taken into account when counseling patients before surgery.

Prostate-specific membrane antigen Radioguided Surgery to Detect Nodal Metastases in Primary Prostate Cancer Patients Undergoing Robot-assisted Radical Prostatectomy and Extended Pelvic Lymph Node Dissection: Results of a Planned Interim Analysis of a Prospective Phase 2 Study.

BACKGROUND: Extended pelvic nodal dissection (ePLND) represents the gold standard for nodal staging in prostate cancer (PCa). Prostate-specific membrane antigen (PSMA) radioguided surgery (RGS) could identify lymph node invasion (LNI) during robot-assisted radical prostatectomy (RARP). OBJECTIVE: To report the planned interim analyses of a phase 2 prospective study (NCT04832958) aimed at describing PSMA-RGS during RARP. DESIGN, SETTING, AND PARTICIPANTS: A phase 2 trial aimed at enrolling 100 patients with intermediate- or high-risk cN0cM0 PCa at conventional imaging with a risk of LNI of >5% was conducted. Overall, 18 patients were enrolled between June 2021 and March 2022. Among them, 12 patients underwent PSMA-RGS and represented the study cohort. SURGICAL PROCEDURE: All patients received 68Ga-PSMA positron emission tomography (PET)/magnetic resonance imaging; 99mTc-PSMA-I&S was synthesised and administered intravenously the day before surgery, followed by single-photon emission computed tomography/computed tomography. A Drop-In gamma probe was used for in vivo measurements. All positive lesions (count rate ≥2 compared with background) were excised and ePLND was performed. MEASUREMENTS: Side effects, perioperative outcomes, and performance characteristics of robot-assisted PSMA-RGS for LNI were measured. RESULTS AND LIMITATIONS: Overall, four (33%), six (50%), and two (17%) patients had intermediate-risk, high-risk, and locally advanced PCa. Overall, two (17%) patients had pathologic nodal uptake at PSMA PET. The median operative time, blood loss, and length of stay were 230 min, 100 ml, and 5 d, respectively. No adverse events and intraoperative complications were recorded. One patient experienced a 30-d complication (Clavien-Dindo 2; 8.3%). Overall, three (25%) patients had LNI at ePLND. At per-region analyses on 96 nodal areas, sensitivity, specificity, positive predictive value, and negative predictive value of PSMA-RGS were 63%, 99%, 83%, and 96%, respectively. On a per-patient level, sensitivity, specificity, positive predictive value, and negative predictive values of PSMA-RGS were 67%, 100%, 100%, and 90%, respectively. CONCLUSIONS: Robot-assisted PSMA-RGS in primary staging is a safe and feasible procedure characterised by acceptable specificity but suboptimal sensitivity, missing micrometastatic nodal disease. PATIENT SUMMARY: Prostate-specific membrane antigen radioguided robot-assisted surgery is a safe and feasible procedure for the intraoperative identification of nodal metastases in cN0cM0 prostate cancer patients undergoing robot-assisted radical prostatectomy with extended pelvic lymph node dissection. However, this approach might still miss micrometastatic nodal dissemination.

Multidisciplinary team referral at diagnosis for patients with non-metastatic renal cell carcinoma.

BACKGROUND: To date, multidisciplinary team (MDT) evaluation, enrollment in trials evaluating the role of perioperative therapies and deferred active treatments represent accepted strategies for patients with Renal Cell Carcinoma (RCC), which are under investigation to maximize cancer control and implement health care policies and value-based care. Here, we aimed to identify subgroups of patients with RCC who may benefit from early referral for MDT evaluation at diagnosis in light of an increased risk of recurrence relative to the risk of dying of other causes. METHODS: We relied on a prospective dataset including patients diagnosed with RCC from 1998 to 2019 and treated by means of surgery alone at a tertiary referral center. The risk of other cause mortality (OCM) was evaluated against the risk of distant metastasis over time by means of the Weibull regression. Patients were stratified based on clinical stage (cT1a; cT1b; cT2; cT3-4), age (<60; 60-70; >70) and comorbidities [Charlson comorbidity index (CCI) 0 vs. ≥1]. For each combination of cT stage, age, and CCI, the potential need for an MDT referral was defined when the risk of recurrence exceeded the risk of OCM within the lower limit of the 95% CI of the meantime to recurrence. MAIN FINDINGS: Overall, 1,162 (51%) patients had no comorbidities. Median follow-up was 7 years. Patients who would benefit most from an MDT evaluation are those diagnosed with A) cT3-4 disease (any age or comorbidity) or B) cT2 cancers if healthy and younger than 70 years or younger than 60 years with at least 1 comorbidity or C) cT1b if younger than 60 years and without comorbidities. CONCLUSIONS: Our findings can help selecting the optimal candidates for multidisciplinary evaluations and to consider RCC patients for clinical trials, deferred treatment, and treatment policy improvement. Also, our findings can be useful in the case of major healthcare disruptions, such as pandemics.

Metastasis Within Three Years from Radical Nephroureterectomy as a Potential Surrogate for Overall Survival.

INTRODUCTION: The only phase III trial that evaluated the role of adjuvant chemotherapy following radical nephroureterectomy (RNU) for upper tract urothelial carcinoma (UTUC) was terminated early. Thus, eventual overall survival (OS) surrogacy, as per Prentice, cannot be assessed in this setting. We aimed to identify an intermediate clinical endpoint (ICE) that could serve as an OS surrogate after RNU for UTUC. PATIENTS AND METHODS: We retrospectively analyzed 823 high-grade UTUC patients treated with RNU at 8 tertiary referral centers. We explored the role of any recurrence (aR), defined as recurrence in the urinary tract or in the resection bed as well the presence of distant metastasis (DM), defined as metastatic disease outside the urinary tract and regional lymph nodes, on OS through a time-varying Cox regression analyses fitted at the landmark points of 1, 2, 3, and 4 years from RNU. Models' discrimination was assessed using Harrell's c index, after internal validation. RESULTS: Median follow-up for survivors was 5.6 years (interquartile range: 2.0-8.8). Overall, 391 and 212 patients experienced aR and DM, respectively. In a time-varying model, aR and DM were predictors of OS: hazard ratio [HR]:1.20, 95% confidence interval [CI]: 1.13-1.28 (P < .001) and HR:1.26, 95% CI: 1.18-1.34 (P < .001), respectively. Progression to DM within 3 years from RNU was the most informative ICE for predicting OS (c index: 0.81; HR: 4.40; 95%CI: 2.45-7.92; P < .001), compared to DM within 1, 2, and 4 years (c indexes: 0.74, 0.76, and 0.78, respectively). Progression to DM within 3 years from RNU was further found superior for predicting OS compared to aR at any landmark points. CONCLUSIONS: Progression to DM within 3 years represents a potential OS surrogate for surgically-treated UTUC. This information could help in patient counseling, future study design and expedite results release of ongoing randomized controlled trials.

Reducing the Risk of Postoperative Complications After Robot-assisted Radical Prostatectomy in Prostate Cancer Patients: Results of an Audit and Feedback Intervention Following the Implementation of Prospective Data Collection.

BACKGROUND: Prospective data collection for perioperative outcomes might increase awareness of surgical results obtained for patients with prostate cancer (PCa) undergoing robot-assisted radical prostatectomy (RARP). This would prompt the implementation of measures aimed at reducing the risk of adverse outcomes. OBJECTIVE: To assess the efficacy of an audit and feedback process aimed at identifying the most common complications after RARP and at implementing measures to improve outcomes. DESIGN, SETTING, AND PARTICIPANTS: Overall, 415 patients treated with RARP by a high-volume surgeon were included. Perioperative outcomes for 187 patients treated between September 2016 and December 2017 were prospectively collected at 30 d according to the European Association of Urology guideline recommendations (group 1). An audit and feedback process was implemented in January 2018 whereby the most common complication (anastomotic leak) was identified and measures aimed at improving outcomes (changes in the anastomotic technique) were implemented. The outcomes for group 1 were then compared to 228 patients treated after implementation of the modified surgical technique (group 2). SURGICAL PROCEDURE: A novel technique for posterior reconstruction and urethrovesical anastomosis was introduced. MEASUREMENTS: Perioperative outcomes included blood loss, operative time, length of stay, and 30-d postoperative complications. Logistic regression models tested the effect of the novel surgical technique on anastomotic leaks. RESULTS AND LIMITATIONS: Overall, 97 patients (23%) experienced postoperative complications at 30 d. The rate of anastomotic leaks was significantly lower in group 2 compared to group 1 (3.1% vs 9.6%; p < 0.01). Similarly, overall and Clavien-Dindo grade ≥2 complication rates were lower in group 2 versus group 1 (17% vs 31%, and 6% vs 20%; both p ≤ 0.001). In multivariable analyses, treatment after implementation of changes in the anastomotic technique independently predicted a lower risk of complications (odds ratio [OR] 0.58, 95% confidence interval [CI] 0.38-0.89) and of anastomotic leaks (OR 0.43, 95% CI 0.17-0.97). The lack of randomization represents the main limitation. CONCLUSIONS: Implementation of changes in the urethrovesical anastomosis technique arising from increased awareness of surgical outcomes reduced the risk of anastomotic leaks. These findings highlight the importance of audit and feedback processes using a standardized method for reporting surgical morbidity. PATIENT SUMMARY: Increased awareness of surgical outcomes prompted us to change our technique for connecting the bladder to the urethra during robot-assisted surgery to remove the prostate in patients with prostate cancer. These changes resulted in significant improvements in surgical outcomes.

Can Negative Prostate-specific Membrane Antigen Positron Emission Tomography/Computed Tomography Avoid the Need for Pelvic Lymph Node Dissection in Newly Diagnosed Prostate Cancer Patients? A Systematic Review and Meta-analysis with Backup Histology as Reference Standard.

CONTEXT: The role of positron emission tomography/computed tomography (PET/CT) with prostate-specific membrane antigen (PSMA) in the primary staging for patients with prostate cancer (PCa) is still debated. OBJECTIVE: To analyze published studies reporting the accuracy of PSMA PET/CT for detecting lymph node invasion (LNI) at pelvic lymph node dissection (PLND). EVIDENCE ACQUISITION: A search of PubMed/MEDLINE, Cochrane library's Central, EMBASE and Scopus databases, from inception to May 2021, was conducted. The primary outcome was to evaluate the sensitivity, specificity, positive (PPV) and negative (NPV) predictive values of PSMA PET/CT in detecting LNI on a per-patient level. As a secondary outcome, NPV of PET PSMA was tested on a per-node-level analysis. Detection rates were pooled using random-effect models. Preplanned subgroup analyses tested the diagnostic accuracy after stratification for the preoperative risk group. PPV and NPV variation over LNI prevalence was evaluated. Only studies including extended PLND (ePLND) as the reference standard test were included. EVIDENCE SYNTHESIS: Twenty-seven studies, with a total of 2832 participants, were included in quantitative synthesis. The sensitivity, specificity, PPV, and NPV of PSMA PET/CT for LNI were, respectively, 58% (95% confidence interval [CI] 50-66%), 95% (95% CI 93-97%), 79% (95% CI 72-85%), and 87% (95% CI 84-89%), with overall moderate heterogeneity between studies. At bivariate analysis, the diagnostic accuracy of PSMA PET/CT estimated through summary receiver operating characteristic-derived area under the curve was 84% (95% CI 81-87%). On a per-node level, NPV of PET PSMA was 97% (95% CI 96-99%). At subgroup analyses, according to preoperative risk groups, sensitivity, specificity, PPV, and NPV were 51%, 93%, 73%, and 81%, respectively, in high-risk patients. Over the LNI prevalence range of 5-40%, PPV increased from 59% to 91%, while NPV decreased from 99% to 84%. CONCLUSIONS: PSMA PET/CT scan provides promising accuracy in the field of primary nodal staging for PCa. The high NPV in men with a lower risk of LNI might be clinically useful to reduce the number of unnecessary PLND procedures performed. Conversely, in high-risk patients, negative PSMA PET/CT cannot replace staging ePLND. PATIENT SUMMARY: In this systematic review and meta-analysis, we demonstrated that prostate-specific membrane antigen (PSMA) positron emission tomography/computed tomography (PET/CT) scan may optimize the primary nodal staging and surgical management of prostate cancer patients candidate to radical prostatectomy. The high negative predictive value in men with a lower risk of lymph node invasion might be clinically useful for reducing the number of useless pelvic lymph node dissection (PLND) procedures performed. Conversely, in high-risk patients, negative PSMA PET/CT cannot allow avoiding of PLND.