The role of warm ischemia time on functional outcomes after robotic partial nephrectomy: a radionuclide renal scan study from the clock randomized trial.

PURPOSE: To evaluate the relationship between warm ischemia time (WIT) duration and renal function after robot-assisted partial nephrectomy (RAPN). METHODS: The CLOCK trial is a phase 3 randomized controlled trial comparing on- vs off-clamp RAPN. All patients underwent pre- and postoperative renal scintigraphy. Six-month absolute variation of eGFR (AV-GFR), rate of relative variation in eGFR over 25% (RV-GFR > 25), absolute variation of split renal function (SRF) at scintigraphy (AV-SRF). The relationships WIT/outcomes were assessed by correlation graphs and then modeled by uni- and multivariable regression. RESULTS: 324 patients were included (206 on-clamp, 118 off-clamp RAPN). Correlation graphs showed a threshold on WIT equal to 10 min. The differences in outcome measures between cases with WIT < vs ≥ 10 min were: AV-GFR - 3.7 vs - 7.5 ml/min (p < 0.001); AV-SRF - 1% vs - 3.6% (p < 0.001); RV-GFR > 25 9.3% vs 17.8% (p = 0.008). Multivariable models found that AV-GFR was related to WIT ≥ 10 min (regression coefficient [RC] - 0.52, p = 0.019), age (RC - 0.35, p = 0.001) and baseline eGFR (RC - 0.30, p < 0.001); RV-GFR > 25 to WIT ≥ 10 min (odds ratio [OR] 1.11, p = 0.007) and acute kidney injury defined as > 50% increase in serum creatinine (OR 19.7, p = 0.009); AV-SRF to WIT ≥ 10 min (RC - 0.30, p = 0.018), baseline SRF (RC - 0.76, p < 0.001) and RENAL score (RC - 0.60. p = 0.028). The main limitation was that the CLOCK trial was designed on a different endpoint and therefore the present analysis could be underpowered. CONCLUSIONS: Up to 10 min WIT had no consequences on functional outcomes. Above the 10-min threshold, a statistically significant, but clinically negligible impact was found.

Learning Curve for Endoscopic Combined Intra-Renal Surgery Using Vacuum-Assisted Device.

INTRODUCTION: The aim of the study was to provide data related to endoscopic combined intra-renal surgery learning curve using minimally invasive techniques with vacuum-assisted devices. Minimal data exist on the learning curve for these techniques. METHODS: We conducted a prospective study monitoring the training of a mentored surgeon learning ECIRS with vacuum assistance. We use varied parameters for improvements. After collection of peri-operative data, tendency lines and CUSUM analysis were used to investigate the learning curves. RESULTS: 111 patients have been included. Guy's Stone Score 3 and 4 stones 51.3% of all cases. The mostly used percutaneous sheath was 16 Fr (87.3%). SFR was 78.4%. 52.3% patients were tubeless, and 38.7% achieved trifecta. High-degree complication rate was 3.6%. Operative time improved after 72 cases. We observed a decrease of complications throughout the case series, with improvement after 17 cases. In terms of trifecta, proficiency was reached after 53 cases. Proficiency seems achievable in a limited number of procedures, but results did not plateau. Higher number of cases might be necessary for excellence. DISCUSSION: A surgeon learning ECIRS with vacuum assistance can obtain proficiency in 17-50 cases. The number of procedures required for excellence remains unclear. Exclusion of more complex cases might positively affect the training, reducing unnecessary complications.

External validation of yonsei nomogram predicting chronic kidney disease development after partial nephrectomy: An international, multicenter study.

OBJECTIVE: To externally validate Yonsei nomogram. METHODS: From 2000 through 2018, 3526 consecutive patients underwent on-clamp PN for cT1 renal masses at 23 centers were included. All patients had two kidneys, preoperative eGFR ≥60 ml/min/1.73 m2, and a minimum follow-up of 12 months. New-onset CKD was defined as upgrading from CKD stage I or II into CKD stage ≥III. We obtained the CKD-free progression probabilities at 1, 3, 5, and 10 years for all patients by applying the nomogram found at https://eservices.ksmc.med.sa/ckd/. Thereafter, external validation of Yonsei nomogram for estimating new-onset CKD stage ≥III was assessed by calibration and discrimination analysis. RESULTS AND LIMITATION: Median values of patients' age, tumor size, eGFR and follow-up period were 47 years (IQR: 47-62), 3.3 cm (IQR: 2.5-4.2), 90.5 ml/min/1.73 m2 (IQR: 82.8-98), and 47 months (IQR: 27-65), respectively. A total of 683 patients (19.4%) developed new-onset CKD. The 5-year CKD-free progression rate was 77.9%. Yonsei nomogram demonstrated an AUC of 0.69, 0.72, 0.77, and 0.78 for the prediction of CKD stage ≥III at 1, 3, 5, and 10 years, respectively. The calibration plots at 1, 3, 5, and 10 years showed that the model was well calibrated with calibration slope values of 0.77, 0.83, 0.76, and 0.75, respectively. Retrospective database collection is a limitation of our study. CONCLUSIONS: The largest external validation of Yonsei nomogram showed good calibration properties. The nomogram can provide an accurate estimate of the individual risk of CKD-free progression on long-term follow-up.

Is off-clamp robot-assisted partial nephrectomy beneficial for renal function? Data from the CLOCK trial.

OBJECTIVES: To compare the functional outcomes of on- vs off-clamp robot-assisted partial nephrectomy (RAPN) within a randomized controlled trial (RCT). MATERIALS AND METHODS: The CLOCK study (CLamp vs Off Clamp the Kidney during robotic partial nephrectomy; NCT02287987) is a multicentre RCT including patients with normal baseline function, two kidneys and masses with RENAL scores ≤ 10. Pre- and postoperative renal scintigraphy was prescribed. Renal defatting and hilum isolation were required in both study arms; in the on-clamp arm, ischaemia was imposed until the completion of medullary renorraphy, while in the off-clamp condition it was not allowed throughout the procedure. The primary endpoint was 6-month absolute variation in estimated glomerular filtration rate (AV-GFR); secondary endpoints were: 12, 18 and 24-month AV-GFR; 6-month estimated glomerular filtration rate variation >25% rate (RV-GFR >25); and absolute variation in ipsilateral split renal function (AV-SRF). The planned sample size was 102 + 102 cases, after taking account crossover of cases to the alternate study arm; a 1:1 randomization was performed. AV-GFR and AV-SRF were compared using analysis of covariation, and RV-GFR >25 was assessed using multivariable logistic regression. Intention-to-treat (ITT) and per-protocol analyses (PP) were performed. RESULTS: A total of 160 and 164 patients were randomly assigned to on- and off-clamp RAPN, respectively; crossover was observed in 14% and 43% of the on- and off-clamp arms, respectively. We were unable to find any statistically significant difference between on- vs off-clamp with regard to the primary endpoint (ITT: 6-month AV-GFR -6.2 vs -5.1 mL/min, mean difference 0.2 mL/min, 95% confidence interval [CI] -3.1 to 3.4 [P = 0.8]; PP: 6-month AV-GFR -6.8 vs -4.2 mL/min, mean difference 1.6 mL/min, 95% CI -2.3 to 5.5 [P = 0.7]) or with regard to the secondary endpoints. The median warm ischaemia time was 14 vs 15 min in the ITT analysis and 14 vs 0 min in the PP analysis. CONCLUSION: In patients with regular baseline function and two kidneys, we found no evidence of differences in functional outcomes for on- vs off-clamp RAPN.

The relationship between obstructive sleep apnoea and erectile dysfunction: An underdiagnosed link? A prospective cross-sectional study.

This cross-sectional study aimed to investigate the prevalence and clinical characteristics of erectile dysfunction in patients with obstructive sleep apnoea. We enrolled 133 male patients with suspected obstructive sleep apnoea. Ear, nose and throat evaluation, laboratory tests, body mass index, Epworth sleepiness scale, 5-international index of erectile function, overnight ambulatory polygraphy and drug-induced sleep endoscopy patterns were assessed. Eighty patients reported obstructive sleep apnoea. 60% (n = 48) reported erectile dysfunction. Statistically significant correlations were found between 5-International Index of Erectile Function and age, hypertension, diabetes, Epworth sleepiness scale, apnoea-hypopnea index score, O2 saturation-nadir, and oxygen desaturation index. Age, diabetes and O2 saturation-nadir were independent predictors of erectile function. Epworth sleepiness scale, apnoea-hypopnea index score, O2 saturation-nadir, oxygen desaturation index and albumin were higher compared to patients without erectile dysfunction. No statistically significant differences were reported for drug-induced sleep endoscopy patterns and erectile dysfunction. Patients with obstructive sleep apnoea were at significant risk of having erectile dysfunction. Males with obstructive sleep apnoea should be investigated for erectile dysfunction.

Percutaneous ablation or minimally invasive partial nephrectomy for cT1a renal masses? A propensity score-matched analysis.

OBJECTIVE: Local tumor ablation to treat small renal mass is increasing. The aim of the present study was to compare oncologic outcomes among patients with T1 renal mass treated with partial nephrectomy and local tumor ablation. METHODS: To reduce the inherent differences between patients undergoing laparoscopic or robot-assisted partial nephrectomy (n = 405) and local tumor ablation (n = 137), we used a 1:1 propensity score-matched analysis. Local tumor ablation consisted of radiofrequency ablation and cryoablation. Disease-free survival, overall survival and other causes mortality-free survival rates were estimated using the Kaplan-Meier method. Multivariable logistic regression and competing-risk regression models were used to identify predictors of complications, recurrence and other causes mortality, respectively. RESULTS: Partial nephrectomy had higher disease-free survival estimates, as compared with local tumor ablation (92.8% vs 80.4% at 5 years, P = 0.02), with no significant difference between radiofrequency ablation and cryoablation (P = 0.9). Ablation showed comparable overall survival estimates to partial nephrectomy (91% vs 95.8% at 5 years, P = 0.6). The 5-year recurrence rates were 7.9% versus 23.8% for patients aged ≤70 years, and 2.5% versus 11.9% for patients aged >70 years treated with partial nephrectomy and ablation, respectively; the 5-year other causes mortality rates were 0% and 2.2% for patients treated with partial nephrectomy and ablation aged ≤70 years, and 3% versus 10.9% for patients aged >70 years treated with partial nephrectomy and ablation, respectively. At multivariable analysis, ablation was associated with fewer complications (odds ratio 0.41; P = 0.01). At competing risks analysis, age (hazard ratio 0.96) and ablation (hazard ratio 4.56) were independent predictors of disease recurrence (all P ≤ 0.008). CONCLUSIONS: Local tumor ablation showed a higher risk of recurrence and lower risk of complications compared with partial nephrectomy, with comparable overall survival rates.

Assessing Trifecta Achievement after Percutaneous Cryoablation of Small Renal Masses: Results from a Multi-Institutional Collaboration.

Background and Objectives: To assess efficacy and safety of Percutaneous Cryoablation (PCA) of small renal masses (SRMs) using Trifecta outcomes in a large cohort of patients who were not eligible for surgery. Materials and methods: All PCAs performed in four different centers between September 2009 and September 2019 were retrospectively evaluated. Patients were divided in two different groups depending on masses dimensional criteria: Group-A: diameter ≤ 25 mm and Group-B: diameter > 25 mm. Complications rates were reported and classified according to the Clavien−Dindo system. The estimate glomerular filtration rate (eGFR) was calculated before PCA and during follow-up schedule. Every patient received a Contrast Enhanced Ultrasound (CEUS) evaluation on the first postoperative day. Radiological follow-up was taken at 3, 6, and 12 months for the first year, then yearly. Radiological recurrence was defined as a contrast enhancement persistence and was reported in the study. Finally, Trifecta outcome, which included complications, RFS, and preservation of eGFR class, was calculated for every procedure at a median follow-up of 32 months. Results: The median age of the patients was 74 years. Group-A included 200 procedures while Group-B included 140. Seventy-eight patients were eligible for Trifecta evaluation. Trifecta was achieved in 69.6% of procedures in Group-A, 40.6% in Group-B (p = 0.02). We observed an increased rate of complication in Group-B (13.0% vs. 28.6; p < 0.001). However, 97.5% were

Deviation from the Protocol of a Randomized Clinical Trial Comparing On-Clamp versus Off-Clamp Laparoscopic Partial Nephrectomy (CLOCK II Laparoscopic Study): A Real-Life Analysis.

PURPOSE: We assess factors/additional morbidities related to the conversion of clamping approach during off-clamp vs on-clamp laparoscopic partial nephrectomy in the setting of a randomized study. MATERIALS AND METHODS: Consecutive candidates for laparoscopic partial nephrectomy from 6 institutions were randomized to on-clamp or off-clamp surgery. The present study analyzed 1) off-clamp arm patients, comparing the procedures finalized per protocol without artery clamping (off-clamp) to those needing renal artery clamping (shift-on-clamp) and 2) on-clamp arm patients, comparing the procedures finalized with artery clamping (on-clamp) to those completed without clamping (shift-off-clamp). RESULTS: A total of 123 patients were randomized to on-clamp and 126 to off-clamp surgery. Of the off-clamp patients 41 (32.5%) converted to on-clamp. Of the on-clamp patients 70 (56.9%) completed surgery without clamping the renal artery due to subjective intraoperative decision of the surgeon. Tumor size was greater in shift-on-clamp vs off-clamp cases (4 vs 3, p=0.002). Conversely, tumor size (3.7 vs 3 cm, p=0.002) and R.E.N.A.L. nephrometry score (6 vs 5, p=0.038) were lower in shift-off-clamp cases. Shift-on-clamp cases had longer operative times and greater changes in estimated glomerular filtration rate on postoperative day 1. Shift-off-clamp cases had shorter operative times. A higher proportion of patients who completed on-clamp surgery per protocol had a greater than 25% drop in estimated glomerular filtration rate on postoperative day 1 (29.4%) compared to smaller changes (10.3%, p=0.009) in estimated glomerular filtration rate. Increasing tumor size and complete endophytic growth pattern predicted shift-on-clamp while preventing shift-off-clamp. Body mass index above 28 predicted shift-off-clamp. CONCLUSIONS: The likelihood of shift-on/off-clamp relies on tumor size/complexity. The intraoperative need to convert the planned strategy seemed harmless on postoperative course. An advantage in terms of early functional outcomes does exist when avoiding artery clamping.

Protocol of the Italian Radical Cystectomy Registry (RIC): a non-randomized, 24-month, multicenter study comparing robotic-assisted, laparoscopic, and open surgery for radical cystectomy in bladder cancer.

BACKGROUND: Bladder cancer is the ninth most common type of cancer worldwide. In the past, radical cystectomy via open surgery has been considered the gold-standard treatment for muscle invasive bladder cancer. However, in recent years there has been a progressive increase in the use of robot-assisted laparoscopic radical cystectomy. The aim of the current project is to investigate the surgical, oncological, and functional outcomes of patients with bladder cancer who undergo radical cystectomy comparing three different surgical techniques (robotic-assisted, laparoscopic, and open surgery). Pre-, peri- and post-operative factors will be examined, and participants will be followed for a period of up to 24 months to identify risks of mortality, oncological outcomes, hospital readmission, sexual performance, and continence. METHODS: We describe a protocol for an observational, prospective, multicenter, cohort study to assess patients affected by bladder neoplasms undergoing radical cystectomy and urinary diversion. The Italian Radical Cystectomy Registry is an electronic registry to prospectively collect the data of patients undergoing radical cystectomy conducted with any technique (open, laparoscopic, robotic-assisted). Twenty-eight urology departments across Italy will provide data for the study, with the recruitment phase between 1st January 2017-31st October 2020. Information is collected from the patients at the moment of surgical intervention and during follow-up (3, 6, 12, and 24 months after radical cystectomy). Peri-operative variables include surgery time, type of urinary diversion, conversion to open surgery, bleeding, nerve sparing and lymphadenectomy. Follow-up data collection includes histological information (e.g., post-op staging, grading, and tumor histology), short- and long-term outcomes (e.g., mortality, post-op complications, hospital readmission, sexual potency, continence etc). DISCUSSION: The current protocol aims to contribute additional data to the field concerning the short- and long-term outcomes of three different radical cystectomy surgical techniques for patients with bladder cancer, including open, laparoscopic, and robot-assisted. This is a comparative-effectiveness trial that takes into account a complex range of factors and decision making by both physicians and patients that affect their choice of surgical technique. TRIAL REGISTRATION: ClinicalTrials.gov , NCT04228198 . Registered 14th January 2020- Retrospectively registered.

The dramatic COVID 19 outbreak in Italy is responsible of a huge drop of urological surgical activity: a multicenter observational study.

OBJECTIVE: To describe the trend in surgical volume in urology in Italy during the coronavirus disease 2019 (COVID-19) outbreak, as a result of the abrupt reorganisation of the Italian national health system to augment care provision to symptomatic patients with COVID-19. METHODS: A total of 33 urological units with physicians affiliated to the AGILE consortium (Italian Group for Advanced Laparo-Endoscopic Surgery; www.agilegroup.it) were surveyed. Urologists were asked to report the amount of surgical elective procedures week-by-week, from the beginning of the emergency to the following month. RESULTS: The 33 hospitals involved in the study account overall for 22 945 beds and are distributed in 13/20 Italian regions. Before the outbreak, the involved urology units performed overall 1213 procedures/week, half of which were oncological. A month later, the number of surgeries had declined by 78%. Lombardy, the first region with positive COVID-19 cases, experienced a 94% reduction. The decrease in oncological and non-oncological surgical activity was 35.9% and 89%, respectively. The trend of the decline showed a delay of roughly 2 weeks for the other regions. CONCLUSION: Italy, a country with a high fatality rate from COVID-19, experienced a sudden decline in surgical activity. This decline was inversely related to the increase in COVID-19 care, with potential harm particularly in the oncological field. The Italian experience may be helpful for future surgical pre-planning in other countries not so drastically affected by the disease to date.

Retroperitoneal versus transepritoneal robot-assisted partial nephrectomy for postero-lateral renal masses: an international multicenter analysis.

PURPOSE: To assess the outcomes of retroperitoneal robot-assisted partial nephrectomy (r-RAPN) in a large cohort of patients with postero-lateral renal masses comparing to those of transperitoneal RAPN (t-RAPN). METHODS: Patients with posterior (R.E.N.A.L. score grading P) or lateral (grading X) renal mass who underwent RAPN in six high-volume US and European centers were identified and stratified into two groups according to surgical approach: r-RAPN ("study group") and t-RAPN ("control group"). Baseline characteristics, intraoperative, and postoperative data were collected and compared. RESULTS: Overall, 447 patients were identified for the analysis. 231 (51.7%) and 216 (48.3%) patients underwent r-RAPN and t-RAPN, respectively. Baseline characteristics were not statistically significantly different between the groups. r-RAPN group reported lower median operative time (140 vs. 170 min, p < 0.001). No difference was found in ischemia time, estimated blood loss, and intraoperative complications. Overall, 47 and 54 postoperative complications were observed in r-RAPN and t-RAPN groups, respectively (20.3 vs. 25.1%, p = 0.9). 1 and 2 patients reported major complications (Clavien-Dindo ≥ III grade) in the retroperitoneal and transperitoneal groups (0.4 vs. 0.9%, p = 0.9). There was no difference in hospital re-admission rate, median length of stay, and PSM rate. Trifecta criteria were achieved in 90.3 and 89.2% of r-RAPN and t-RAPN, respectively (p = 0.7). CONCLUSION: r-RAPN and t-RAPN offer similar postoperative, functional, and oncological outcomes for patients with postero-lateral renal tumors. Our analysis suggests an advantage for r-RAPN in terms of shorter operative time, whereas it does not confirm a difference in terms of length of stay, as suggested by previous reports.

The role of vacuum-assisted closure (VAC) therapy in the management of FOURNIER'S gangrene: a retrospective multi-institutional cohort study.

PURPOSE: To explore the role of vacuum assisted closure (VAC) therapy versus conventional dressings in the Fournier's gangrene wound therapy. PATIENTS AND METHODS: This is a retrospective multi-institutional cohort study. Data of 92 patients from nine centers between 2007 and 2018 were retrospectively analyzed. After surgery, patient having a local or a disseminated FG were managed with VAC therapy or with conventional dressings. The 10-weeks wound closure cumulative rate and OS were analyzed. RESULTS: Of the 92 patients, 62 (67.4%) showed local and 30 (32.6%) a disseminated FG. After surgery, 19 patients (20.7%) with local and 14 (15.2%) with disseminated FG underwent to VAC therapy; 43 (46.7%) with local and 16 (17.4%) with disseminated FG were treated using conventional dressings. The multivariable logistic regression analysis demonstrated that the VAC in patients with disseminated FG led to a higher cumulative rate of wound closure than patients treated with no-VAC (OR = 6.5; 95% CI 1.1-37.4, p = 0.036). The Kaplan-Meier survival curves for the OS showed a significant difference between no-VAC patients with local and disseminated FG (OS rate at 90 days 0.90, 95% CI 0.71-0.97 vs 0.55, 95% CI 0.24-0.78, respectively; p = 0.039). Cox regression confirmed that no-VAC patients with disseminated FG showed the lowest OS (hazard ratio adjusted for sex and age HR = 3.4, 95% CI 1.1-10.4; p = 0.033). CONCLUSIONS: In this large cohort study, VAC therapy in patients with disseminated FG may offer an advantage in terms of 10-weeks wound closure cumulative rate and OS at 90 days after initial surgery.

Safety of on- vs off-clamp robotic partial nephrectomy: per-protocol analysis from the data of the CLOCK randomized trial.

PURPOSE: To compare the safety of on- vs off-clamp robotic partial nephrectomy (RAPN). METHODS: 302 patients with RENAL masses ≤ 10 were randomized to undergo on-clamp (150) vs off-clamp (152) RAPN (CLOCK trial-ClinicalTrials.gov NCT02287987) at seven institutions by one experienced surgeon per institution. Intra-operative data, complications, and positive surgical margins were compared. RESULTS: Due to a relevant rate of shift from the assigned treatment, the per-protocol analysis only was considered and the data from 129 on-clamp vs 91 off-clamp RAPNs analyzed. Tumor size (off-clamp vs on-clamp, 2.2 vs 3.0 cm, p < 0.001) and RENAL score (5 vs 6, p < 0.001) significantly differed. At univariate analysis, no differences were found regarding intra-operative estimated blood loss (off- vs on-clamp, 100 vs 100 ml, p = 0.7), post-operative complications rate (19% vs 26%, p = 0.2), post-operative anemia (Hb decrease > 2.5 g/dl 26% vs 27%, p = 0.9; transfusion rate 3.4% vs 6.3%, p = 0.5; re-intervention due to bleeding 1.1% vs 4%, p = 0.4), acute kidney injury (4% vs 6%, p = 0.8), and positive surgical margins (3.5% vs 8.2%, p = 0.1). At multivariate analysis accounting for tumor diameter and complexity, considering the on-clamp group as the reference category, a significant difference was noted in the off-clamp group exclusively for blood loss (OR 0.3, 95% CI 0.09-0.52, p = 0.008). CONCLUSIONS: The on-clamp and off-clamp approaches for RAPN showed a comparable safety profile.

External validation of Cormio nomogram for predicting all prostate cancers and clinically significant prostate cancers.

PURPOSE: Recently, the Cormio et al. nomogram has been developed to predict prostate cancer (PCa) and clinically significant PCa using benign prostatic obstruction parameters. The aim of the present study was to externally validate the nomogram in a multicentric cohort. METHODS: Between 2013 and 2019, patients scheduled for ultrasound-guided prostate biopsy were prospectively enrolled at 11 Italian institutions. Demographic, clinical and histological data were collected and analysed. Discrimination and calibration of Cormio nomogram were assessed with the receiver operator characteristics (ROC) curve and calibration plots. The clinical net benefit of the nomogram was assessed with decision curve analysis. Clinically significant PCa was defined as ISUP grade group > 1. RESULTS: After accounting for inclusion criteria, 1377 patients were analysed. 816/1377 (59%) had cancer at final pathology (574/816, 70%, clinically significant PCa). Multivariable analysis showed age, prostate volume, DRE and post-voided residual volume as independent predictors of any PCa. Discrimination of the nomogram for cancer was 0.70 on ROC analysis. Calibration of the nomogram was excellent (p = 0.94) and the nomogram presented a net benefit in the 40-80% range of probabilities. Multivariable analysis for predictors of clinically significant PCa found age, PSA, prostate volume and DRE as independent variables. Discrimination of the nomogram was 0.73. Calibration was poor (p = 0.001) and the nomogram presented a net benefit in the 25-75% range of probabilities. CONCLUSION: We confirmed that the Cormio nomogram can be used to predict the risk of PCa in patients at increased risk. Implementation of the nomogram in clinical practice will better define its role in the patient's counselling before prostate biopsy.

Partial versus radical nephrectomy in very elderly patients: a propensity score analysis of surgical, functional and oncologic outcomes (RESURGE project).

PURPOSE: To compare the outcomes of PN to those of RN in very elderly patients treated for clinically localized renal tumor. PATIENTS AND METHODS: A purpose-built multi-institutional international database (RESURGE project) was used for this retrospective analysis. Patients over 75 years old and surgically treated for a suspicious of localized renal with either PN or RN were included in this database. Surgical, renal function and oncological outcomes were analyzed. Propensity scores for the predicted probability to receive PN in each patient were estimated by logistic regression models. Cox proportional hazard models were estimated to determine the relative change in hazard associated with PN vs RN on overall mortality (OM), cancer-specific mortality (CSM) and other-cause mortality (OCM). RESULTS: A total of 613 patients who underwent RN were successfully matched with 613 controls who underwent PN. Higher overall complication rate was recorded in the PN group (33% vs 25%; p = 0.01). Median follow-up for the entire cohort was 35 months (interquartile range [IQR] 13-63 months). There was a significant difference between RN and PN in median decline of eGFR (39% vs 17%; p < 0.01). PN was not correlated with OM (HR = 0.71; p = 0.56), OCM (HR = 0.74; p = 0.5), and showed a protective trend for CSM (HR = 0.19; p = 0.05). PN was found to be a protective factor for surgical CKD (HR = 0.28; p < 0.01) and worsening of eGFR in patients with baseline CKD. Retrospective design represents a limitation of this analysis. CONCLUSIONS: Adoption of PN in very elderly patients with localized renal tumor does not compromise oncological outcomes, and it allows better functional preservation at mid-term (3-year) follow-up, relative to RN. Whether this functional benefit translates into a survival benefit remains to be determined.

Urology in the Time of Coronavirus: Reduced Access to Urgent and Emergent Urological Care during the Coronavirus Disease 2019 Outbreak in Italy.

PURPOSE: The coronavirus disease 2019 (COVID-19) pandemic has put a substantial burden on the Italian healthcare system, resulting in the restructuring of hospitals to care for COVID-19 patients. However, this has likely impacted access to care for patients experiencing other conditions. We aimed to quantify the impact of COVID-19 on access to care for patients with urgent/emergent urological conditions throughout Italy. MATERIALS AND METHODS: A questionnaire was sent to 33 urological units in the AGILE consortium, asking clinicians to report on the number of urgent/emergent urological patients seen and/or undergoing surgery over a 3-week period during the peak of the COVID-19 outbreak and a reference week prior to the outbreak. ANOVA and linear regression models were used to quantify these changes. RESULTS: Data from 27 urological centres in Italy showed a decrease from 956 patients/week seen just prior to the outbreak to 291 patients/week seen by the end of the study period. There was a difference in the number of patients with urgent/emergent urological disease seen within/during the different weeks (all p values < 0.05). A significant decrease in the number of patients presenting with haematuria, urinary retention, urinary tract infection, scrotal pain, renal colic, or trauma and urgent/emergent cases that required surgery was reported (all p values < 0.05). CONCLUSION: In Italy, during the COVID-19 outbreak there has been a decrease in patients seeking help for urgent/emergent urological conditions. Restructuring of hospitals and clinics is mandatory to cope with the COVID-19 pandemic; however, the healthcare system should continue to provide adequate levels of care also to patients with other conditions.

Predictors of the Transition from Off to On Clamp Approach during Ongoing Robotic Partial Nephrectomy: Data from the CLOCK Randomized Clinical Trial.

PURPOSE: We sought to identify predictive factors of the transition from off clamp to on clamp robotic partial nephrectomy following an intraoperative decision. MATERIALS AND METHODS: In the multicenter, randomized, prospective CLOCK (CLamp vs Off Clamp the Kidney during robotic partial nephrectomy) trial 152 and 149 of the 301 patients with a localized renal mass were assigned to undergo off clamp and on clamp robotic partial nephrectomy, respectively. Surgery was done at a total of 7 referral institutions by 1 surgeon per institution. A localized renal mass was defined as having a R.E.N.A.L. (radius, exophytic/endophytic, nearness to collecting system or sinus, anterior/posterior, location relative to polar lines, hilar) score less than 10. Surgeons had similar experience with at least 100 previous robotic partial nephrectomies. All patients underwent a preoperative and a 6-month renal scan. The current study deals with one of the secondary end points of the trial, comparing cases finalized as clampless (off robotic partial nephrectomy group) with those which were converted (shift robotic partial nephrectomy group). RESULTS: Of the 152 patients randomized to off clamp 61 (40%) were shifted to clamp with a median ischemia time of 15 minutes. In the shift robotic partial nephrectomy group the masses were larger (3.5 vs 2.2 cm) and more complex (R.E.N.A.L. score 7 vs 6). A significant association with transition was found for tumor diameter (OR 1.4) and the R.E.N.A.L. score continuously (OR 1.4) and when recoded in groups, including 4-no risk (referent OR 1), 5-6-low risk (OR 1.8), 7-8-intermediate risk (OR 3.6) and 9 or greater-high risk (OR 6.6). The shift robotic partial nephrectomy group had longer operative time, higher blood loss and increased performance of 2-layer renorrhaphy. No significant differences were noted in postoperative complications or renal function after 6 months. CONCLUSIONS: The transition from off to on clamp robotic partial nephrectomy is associated with renal mass diameter and complexity. Under the specific conditions of the current trial no harm was related to this decision.

Saphenous-sparing laparoscopic inguinal lymphadenectomy.

INTRODUCTION: Inguinal lymphadenectomy is an integral part in the management of penile cancer. Video endoscopic in-guinal lymphadenectomy (VEIL) is emerging as a minimally invasive treatment to reduce postoperative complications. MATERIALS AND METHODS: 62 years old man underwent glansectomy for a squamous cell carcinoma (pT1b). At the physical examination one left inguinal lymph node was detectable (cN1). The chest-abdomen-pelvis CT was negative for me-tastasis. A 10-mm optical trocar and two 5mm operating trocar were placed. The optical trocar was placed in the apex of Scarpa's triangle after a skin incision and after the creation of a subcutaneous space by blunt finger dissection. The pCO2 was 8-10mmHg. The surgical technique involved the removal of superficial lymph nodes according to the scheme described by Deseler and of the deep lymph nodes. Sparing main venous structures and closing lymphatic vessels is im-portant to reduce post operative complications. At the end of the procedure, a suction drain was placed per side. RESULTS: Operative time was 90 minutes per side. Drains were removed on the seventh postoperative day. Hospital stay was 8 days and no postoperative complications occurred. The total number of nodes removed was 16 (8 per side) with 2 superficial positive nodes on the left side. CONCLUSION: ILND is burned by a high complication rate. VEIL provides a less invasive approach and a saphenous-sparing technique ensures a lower complication rate, reducing lymphorrhea, skin necrosis and wound complications (1-3). In experienced laparoscopic hands, VEIL is a safe and effective treatment.

Cryotherapy of Renal Lesions: Enhancement on Contrast-Enhanced Sonography on Postoperative Day 1 Does Not Imply Viable Tissue Persistence.

OBJECTIVES: To investigate whether persistent enhancement detected on contrast-enhanced sonography at postoperative day 1 (early contrast-enhanced sonography) after cryoablation of renal tumors implies the presence of residual viable tumor tissue, defined as residual enhancing tissue on reference imaging (computed tomography or magnetic resonance imaging) performed 6 months after the procedure. METHODS: Seventy-four patients with percutaneous cryoablation of renal tumors had early contrast-enhanced sonography from November 2011 to August 2015. Two independent readers evaluated early contrast-enhanced sonographic findings and contrast-enhanced sonographic investigations performed 1 month after cryoablation of lesions that displayed enhancement on early contrast-enhanced sonography. They scored intralesional enhancement in 4 groups: no enhancement, few intralesional vessels, focal enhancing areas, and diffuse enhancement. Inter-reader agreement in evaluating lesion vascularity on early contrast-enhanced sonography was assessed with weighted κ statistics. Computed tomography or magnetic resonance imaging performed 6 months after the treatment was the reference procedure for assessing the absence or presence of residual disease. RESULTS: Inter-reader agreement in assessing intratumoral vascularization on early contrast-enhanced sonography was very good (κ = 0.90). Enhancement was absent for both readers in 33 of 74 cases; only a few intralesional vessels were visible in 21; whereas diffuse or focal enhancement was present in 13. In the remaining 7 patients, there were differences. Four lesions with focal enhancement on early contrast-enhanced sonography and 1 that was considered avascular had residual tumors on reference imaging. Ablation was successful in the remaining 69 of 74 patients (93%). CONCLUSIONS: After cryoablation, intratumoral enhancement on early contrast-enhanced sonography does not imply tumor cell viability.