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.

Corrigendum to "Rectal Perforation During Pelvic Surgery" [Eur Urol Open Sci 44 (2022) 54-59].

[This corrects the article DOI: 10.1016/j.euros.2022.04.006.].

The Therapeutic Intensity Score as Predictor of Clinical Outcomes after Total and Partial Adrenalectomy for Unilateral Primary Aldosteronism: Results of a Multicentric Series.

BACKGROUND: To evaluate the ability of therapeutic intensity score (TIS) in predicting the clinical outcomes of partial (PA) and total adrenalectomy (TA) for UPA. METHODS: Between 2011 and 2022, a four-center adrenalectomy dataset was queried for "unilateral adrenal mass" and "UPA" (n = 90). Preoperative TIS of each antihypertensive medication were individually calculated and merged to create a single, cumulative variable. Probability of complete clinical, partial, and absent pooled success rates according to TIS were assessed for the overall cohort by Kaplan-Meier. Cox analyses were used to identify predictors of complete clinical and partial/absent success, respectively. For all analyses, a two-sided p < 0.05 was considered significant. RESULTS: At a median follow-up of 42 months (IQR 27-54) complete partial, and absent clinical success were observed in 60%, 17.7%, and 22.3%, respectively. On Kaplan-Meier analysis, TIS < 1 predicted higher complete success rates (p < 0.001), while TIS ≥ 1 was predictor of either partial and absent clinical success (p = 0.008). On multivariable analysis, TIS < 1 (HR 0.25; 95% CI 0.11-0.57; p = 0.001) and adenoma size (HR 1.11; 95% CI 1-1.23; p = 0.0049) were independent predictors of complete clinical success, while TIS ≥ 1 (HR 2.84; 95% CI 1.32-6.1; p = 0.007) was the only independent predictor of absent clinical success. CONCLUSIONS: TIS score and adenoma size may help to identify patients who are likely to be at risk of persistent hypertension after surgery.

Rectal Perforation During Pelvic Surgery.

Rectal perforations during pelvic surgery are rare but serious complications. The occurrence of rectal involvement is generally lower than that of the involvement of other portions of the bowel. The urologic field is responsible for the majority of iatrogenic rectal injuries from pelvic surgery; general and gynecologic surgeries are prone to the occurrence as well, the latter especially in the case of rectal shaving for deep infiltrating endometriosis. Attention should be posed to the prevention of rectal injuries, especially in case of challenging or salvage procedures; some tricks may be recommended to avoid thermal and mechanical damages and to realize a safe dissection. Intraoperative detection of rectal injuries is of paramount importance; once confirmed, immediate management with the closure of the defect is recommended. In general, rectal injuries diagnosed after surgery are liable to significantly worse outcomes than those detected and managed intraoperatively. Patient summary: Rectal perforation is a rare but possible complication of pelvic surgeries. The more challenging the procedure (ie, surgery for locally advanced tumors or after radiation therapy), the higher the risk of rectal lesion. Intraoperative management of the injury should be attempted, with direct repair of the defect with or without fecal diversion.

Surgical Quality, Antihypertensive Therapy, and Electrolyte Balance: A Novel Trifecta to Assess Long-Term Outcomes of Adrenal Surgery for Unilateral Primary Aldosteronism.

BACKGROUND: To propose a trifecta that summarizes endpoints and predicts their maintenance after adrenalectomy (n = 90) for unilateral primary aldosteronism (UPA). METHODS: Trifecta was defined as coexistence of: ≥50% antihypertensive therapeutic intensity score reduction (∆TIS), no hypokalemia at 3 months, and no Clavien grade 2-5. Logistic regression was used to identify predictors of trifecta. Probability of clinical, biochemical, and simultaneous success according to trifecta were assessed by Kaplan-Meier. Cox regression was used to identify predictors of long-term clinical, biochemical, and simultaneous success. For all analyses, a two-sided p < 0.05 was considered significant. RESULTS: Simultaneous success rate was 50%. On multivariable analysis, TIS was an independent predictor of trifecta achievement (HR 3.28; 95% CI 1.07-10.9; p = 0.03). At Kaplan-Meier, trifecta predicted higher success for all endpoints (each p < 0.03). On multivariable Cox analysis, adenoma size (AS) ≥6 cm and trifecta were independent predictors of biochemical (AS: HR 2.87; 95% CI 1.53-5.36; trifecta: HR 2.1; 95% CI 1.13-3.90; each p < 0.02) and simultaneous success (AS: HR 3.81; 95% CI 1.68-8.65; trifecta: HR 4.29; 95% CI 2.08-8.86; each p < 0.01), while trifecta was an independent predictor of complete clinical success (HR 2.84; 95% CI 1.45-5.58; p < 0.01). CONCLUSIONS: Trifecta and AS are independent predictors of either long-term complete clinical, biochemical, or combined success after adrenalectomy for UPA.

Clinical cure vs a novel trifecta system for evaluating long-term outcomes of minimally-invasive partial or total adrenalectomy for unilateral primary aldosteronism: results of a multicentric series.

Introduction: Several predictive scores to evaluate outcomes of adrenal surgery for unilateral primary aldosteronism (UPA), have been conceived. We compared a novel trifecta that summarizes outcomes of adrenal surgery for UPA with the clinical cure proposed by Vorselaars. Material and methods: Between March 2011 and January 2022, a multi-institutional dataset was queried for UPA. Baseline, perioperative and functional data were collected. Clinical and biochemical complete and partial success rates according to Primary Aldosteronism Surgical Outcome (PASO) criteria were assessed for the overall cohort. Clinical cure was defined either as normotension without antihypertensive medications or normotension with lower or equal use of antihypertensive medications. Trifecta was defined as the coexistence of ≥50% antihypertensive therapeutic intensity score (TIS) reduction (ΔTIS), no electrolyte impairment at 3-months and no Clavien-Dindo (2-5) complications. Cox regression analyses were used to identify predictors of long-term clinical and biochemical success. For all analyses, a two-sided p <0.05 was considered significant. Results: Baseline, perioperative and functional outcomes were analyzed. Out of 90 patients, at a median follow-up of 42 months (IQR 27-54) a complete and partial clinical success was observed in 60% and 17.7% of cases while a complete and partial biochemical success was achieved in 83.3% and 12.3% of cases, respectively. Overall trifecta and clinical cure rates were 21.1% and 58.9%, respectively. On multivariable Cox regression analysis, trifecta achievement (HR 2.87; 95% CI 1.45-5.58; p = 0.02) was the only independent predictor of complete clinical success at long-term follow-up. Conclusions: Despite its complex estimation and more restrictive criteria, trifecta but not clinical cure allows to independently predict composite PASO endpoints on the long run.

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.

Minimally Invasive Partial Versus Total Adrenalectomy for the Treatment of Primary Aldosteronism: Results of a Multicenter Series According to the PASO Criteria.

BACKGROUND: Determination of success after adrenal-sparing surgery for primary aldosteronism (PA) is limited by the lack of standardized definitions of outcomes. OBJECTIVE: To evaluate the safety and effectiveness of minimally invasive partial adrenalectomy (MIPA) for PA by comparing perioperative and functional outcomes with minimally invasive total adrenalectomy (MITA) according to the Primary Aldosteronism Surgical Outcome (PASO) criteria. DESIGN, SETTING, AND PARTICIPANTS: Between March 2011 and April 2020, a multicenter adrenalectomy dataset was queried for "unilateral adrenal mass, PA, MIPA (n = 29), or MITA (n = 61)"at four participating Institutions. INTERVENTION: MITA and MIPA for PA. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Differences between continuous variables were assessed with the Wilcoxon rank sum test, while Pearson's χ2 test was used for categorical data. Complete, partial, and absent clinical success rates were assessed for the overall cohort and compared between groups. RESULTS AND LIMITATIONS: The median tumor size was significantly higher in the MITA group (4.2 vs 2.7 cm; p = 0.001), while preoperative hypertension rate was significantly higher in the MIPA series (82.8% vs 57.4%, p = 0.01). The median length of hospital stay was increased in the MITA cohort (4 vs 3 d; p = 0.038). Overall, at a median follow-up of 42 mo (interquartile range 27-54 mo), complete, partial, and absent clinical success was observed in 60%, 17.7%, and 22.3% of cases, respectively. The complete clinical success rate was higher in the MIPA group (72.4% vs 54.1%), while a partial clinical success was higher in the MITA series (23% vs 6.8%). The absence of clinical success was comparable between groups (MITA 23% vs MIPA 20.7%). CONCLUSIONS: MIPA showed excellent perioperative results with a complete clinical success rate of 72.4%. Owing to the heterogeneity of the PASO criteria in the assessment of partial or absent success, the quest for a univocal definition of satisfactory clinical outcomes in the treatment of PA remains open. PATIENT SUMMARY: We compared minimally invasive partial adrenalectomy (MIPA) and minimally invasive total adrenalectomy for the treatment of unilateral primary aldosteronism, assessing the outcomes with the Primary Aldosteronism Surgical Outcome (PASO) criteria. MIPA seems to provide comparable perioperative outcomes and midterm clinical success rates.

The role of renal biopsy to improve small renal mass diagnosis and management: are there predictive factors for a higher detection rate?. The first Italian study of 100 cases.

BACKGROUND: Incidence of small renal masses (SRMs) has increased over the last decade: in order to reduce overtreatment of benign lesions, renal tumor biopsy (RTB) has been advocated. The primary aim of this study were to establish the rate of diagnostic biopsies and the concordance rate between RTB and surgical pathology with regard to tumor histology. The secondary aim was to identify what predictive factors are associated with an initial diagnostic biopsy. METHODS: We retrospectively analyzed RTB performed in our center in patients with SRMs between 2015 and 2017. We assessed patient demographics and clinical status, lesion characteristics and procedural factors. The categorical variables were tested with the chi-square test. We used univariate and multivariate analysis to identify what factors are indicative of non-diagnostic biopsies. We used the SPSS statistics v. 23. RESULTS: We performed a total of 100 RTBs to management 94 patients. The initial biopsy was diagnostic in 88 patients (67 malignant and 21 benign lesion). The six remaining patients had repeat biopsies, of which four were diagnostic. Complications rate was 5% prevalently local hematoma treated with surveillance. Agreement between biopsy and surgical histology was found in 94% of cases. On contingency analysis and on univariate and multivariate analysis, these factors (age, tumor size, exophytic location, and type of imaging used) were not predictive with diagnostic biopsy. CONCLUSIONS: RTB for SRMs helps establish pre-treatment diagnosis, reduce overtreatment, with a low risk of complications and high diagnostic rate. In our experience, we did not find predictive factors more likely associated with a diagnostic biopsy.

Percutaneous tumor ablation versus partial nephrectomy for small renal mass: the impact of histologic variant and tumor size.

BACKGROUND: The aim, of this study was to investigate recurrence rates in patients with T1 renal cell carcinoma (RCC) undergone partial nephrectomy (PN), radiofrequency ablation (RFA) or cryoablation (Cryo). METHODS: We retrospectively evaluated data from 665 (81.4%), 68 (8.3%) and 83 (10.3%) patients who underwent PN, RFA and Cryo, respectively. Kaplan-Meier curves depict recurrence-free survival (RFS) rates in the overall population and after stratifying according to tumor's histology (namely, clear cell RCC and non-clear RCC) and size (namely <2 cm and 2-4 cm). Multivariable Cox regression model was used to identify predictors of recurrence. Cumulative-incidence plots evaluated disease recurrence and other causes of mortality (OCM). RESULTS: Patients referred to PN experienced higher RFS rate compared to those treated with RFA and Cryo at 60-month in the overall population (96.4% vs. 79.4% vs. 87.8%), in patients with clear cell RCC (93.3% vs. 75% vs. 80.4%) and in those with tumor of 2-4 cm (97.3% vs. 78% and 84.4%; all P≤0.01). In patients with non-clear cell RCC and with tumor <2cm, PN showed higher RFS rate at 60-month as compared to RFA (97.9% vs. 84.4% and 95.1% vs. 78.1%, respectively: all P≤0.02). At multi-variate analysis, ablative techniques (RFA [HR=4.03] and Cryo [HR=3.86]) were independent predictors of recurrence (all P<0.03). At competing risks analysis, recurrence rate and OCM were 7.3% and 1.3% vs. 25% and 7.2% vs. 19.9% and 19.9% for PN, RFA and Cryo, respectively. CONCLUSIONS: PN and Cryo showed similar RFS rates in patients with non-clear cell RCC and with renal mass <2cm.

Fusion US/MRI prostate biopsy using a computer aided diagnostic (CAD) system.

BACKGROUND: The aim of this study was to investigate the impact of computer aided diagnostic (CAD) system on the detection rate of prostate cancer (PCa) in a series of fusion prostate biopsy (FPB). METHODS: Two prospective transperineal FPB series (with or without CAD assistance) were analyzed and PCa detection rates compared with per-patient and per-target analyses. The χ2 and Mann-Whitney test were used to compare categorical and continuous variables, respectively. Univariable and multivariable regression analyses were applied to identify predictors of any and clinically significant (cs) PCa detection. Subgroup analyses were performed after stratifying for PI-RADS Score and lesion location. RESULTS: Out of 183 FPB, 89 were performed with CAD assistance. At per-patient analysis the detection rate of any PCa and of cs PCa were 56.3% and 30.6%, respectively; the aid of CAD was negligible for either any PCa or csPCa detection rates (P=0.45 and P=0.99, respectively). Conversely in a per-target analysis, CAD-assisted biopsy had significantly higher positive predictive value (PPV) for any PCa versus MRI-only group (58% vs. 37.8%, P=0.001). PI-RADS Score was the only independent predictor of any and csPCa, either in per-patient or per-target multivariable regression analysis (all P<0.029). In a subgroup per-patient analysis of anterior/transitional zone lesions, csPCa detection rate was significantly higher in the CAD cohort (54.5%vs.11.1%, respectively; P=0.028), and CAD assistance was the only predictor of csPCa detection (P=0.013). CONCLUSIONS: CAD assistance for FPB seems to improve detection of csPCa located in anterior/transitional zone. Enhanced identification and improved contouring of lesions may justify higher diagnostic performance.

Outcomes of minimally invasive partial nephrectomy among very elderly patients: report from the RESURGE collaborative international database.

The aim of the study was to perform a comprehensive investigation of clinical outcomes of robot-assisted partial nephrectomy (RAPN) or laparoscopic partial nephrectomy (LPN) in elderly patients presenting with a renal mass. The REnal SURGery in Elderly (RESURGE) collaborative database was queried to identify patients aged 75 or older diagnosed with cT1-2 renal mass and treated with RAPN or LPN. Study outcomes were: overall complications (OC); warm ischemia time (WIT) and 6-month estimated glomerular filtration rate (eGFR); positive surgical margins (PSM), disease recurrence (REC), cancer-specific mortality (CSM) and other-cause mortality (OCM). Descriptive statistics, Kaplan-Meier, smoothed Poisson plots and logistic and linear regression models (MVA) were used. Overall, 216 patients were included in this analysis. OC rate was 34%, most of them being of low Clavien grade. Median WIT was 17 minutes and median 6-month eGFR was 54 ml/min/1.73 m2. PSM rate was 5%. After a median follow-up of 20 months, the 5-year rates of REC, CSM and OCM were 4, 4 and 5%, respectively. At MVA predicting perioperative morbidity, RAPN relative to LPN (odds ratio [OR] 0.33; p <0.0001) was associated with lower OC rate. At MVA predicting functional outcomes, RAPN relative to LPN was associated with shorter WIT (estimate [EST] -4.09; p <0.0001), and with higher 6-month eGFR (EST 6.03; p = 0.01). In appropriately selected patients with small renal masses, minimally-invasive PN is associated with acceptable perioperative outcomes. The use of a robotic approach over a standard laparoscopic approach can be advantageous with respect to clinically relevant outcomes, and it should be preferred when available.

Gelatin sponge (Spongostan®) and N-butyl-2-cyanoacrylate: Utility on percutaneous treatment of persistent urinary leakage after partial nephrectomy. Case report and review of the literature.

INTRODUCTION: Percutaneous treatment of persistent urinary fistula after partial nephrectomy using N-butyl-2-cyanoacrylate and gelatin sponge (Spongostan®) is an effective and relatively non-invasive procedure that should be considered when a conservative approach fails. Three successful cases of percutaneous embolization by using N-butyl-2-cyanoacrylate have been reported in the literature. To our knowledge, the use of Spongostan for the treatment of urinary fistula after partial nephrectomy has not been previously described. CASE REPORT: We present the case of an 82-year old man who underwent percutaneous closure of a urinary fistula following partial nephrectomy by using gelatin sponge (Spongostan®) and N-butyl-2-cyanoacrylate. CONCLUSIONS: We encourage the use of this technique in selected cases. Collaboration amongst urologists and skilled interventional radiologist is strongly recommended.

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.

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.

Factors predictive of shockwave lithotripsy failure for ureteral stones: why we need to hurry.

BACKGROUND: The aims of this study are to evaluate the prognostic factors of extracorporeal shockwave lithotripsy in patients with ureteric stones, and to identify which patients might directly benefit of an endoscopic treatment. METHODS: We performed a prospective study from January 2013 and July 2016 on patients with single ureteric stone and undergoing extracorporeal shockwave lithotripsy (SWL). We divided patients into two groups: first group (success group) included cases resolved with SWL only, and a second group (failure group) including patients with stone not resolved by SWL and requiring an endoscopic treatment. We evaluated age, weight, height, body mass index, stone size, hydronephrosis, laterality, location, days elapsed from onset of symptoms to SWL and stone density when computed tomography was performed. In case of stone fragments >4 mm, the procedure was repeated up to a maximum of three times. SWL was considered as failed if patients had a residual stone of any size after a follow-up of 3 months or if a complication occurred. RESULTS: 274 patients completed follow-up and were enrolled in the study. Mean age was 53.22 years (standard deviation: 13.98). SWL overall success rate was 84.3% (231 patients successfully treated with shockwaves) and failure rate was 15.7% (43 patients underwent auxiliary endoscopic procedure). At the univariate analysis, we observed a statistically significant difference for hydronephrosis (P=0.006), time elapsed from symptoms onset (P=0.013), patients' age (P=0.06) and mean stone density (0.023). In the multivariate logistic regression, patients' age (OR: 1.517), and time elapsed from obstruction to SWL (OR: 3.005) were independent predictive factors for SWL failure. Furthermore, moderate and severe hydronephrosis seemed to be independent predictive factors for SWL failure, presenting an OR of 2.451 and 4.207 respectively. High stone density resulted to be a predictive factor for SWL failure (OR: 2.293 if density was higher than 1100 Hounsfield Units). CONCLUSIONS: We report a large series of patients undergone primary SWL for ureteric stones. Our data demonstrated the role of hydronephrosis, time elapsed from obstruction onset to treatment and stone density as independent predictive factors of SWL failure.

Peri-Operative Outcomes after Open and Robot-Assisted Radical Cystectomy by Using an Advanced Bipolar Seal and Cut Technology (Caiman®): A Prospective, Comparative, and Multi-Institutional Study.

OBJECTIVE: To report and compare the peri-operative outcomes of patients undergoing open (ORC) and robotic-assisted radical cystectomy (RARC) for bladder cancer performed with a radiofrequency seal and cut device (Caiman®). MATERIALS AND METHODS: Data of patients undergoing ORC or RARC between January 2015 and March 2016 at 6 Italian institutions were prospectively recorded and analyzed. Thirty-and 90-day complications were stratified according to the Martin's criteria and graded according to the Clavien-Dindo classification. Data on operative time, blood loss, transfusion rate, complications, and length of stay were evaluated and compared between the ORC and RARC groups. RESULTS: Thirty-three (66%) and 17 (34%) patients were treated with ORC and RARC, respectively. The median age was 72 (64-78) years. Overall operative time was longer in RARC compared to ORC (389 ± 80.1 vs. 242 ± 62.2 min, p < 0.001), while the estimated blood loss during cystectomy was higher after ORC (370 ± 126.8 vs. 243.3 ± 201.6 ml, p = 0.03). The transfusion rate was significantly higher in the ORC compared to RARC (24.2 vs. 5.9%, p = 0.04). Eight (19%) and 7 (16.7%) patients experienced 30- and 90-day post-operative complications, with no significant difference between ORC and RARC. Length of stay was significantly shorter in RARC group (median 7 vs. 14 days, p < 0.001). CONCLUSION: Open and robot-assisted procedures were safely performed by using a new advanced bipolar seal and cut technology (Caiman®). RARC demonstrated to be superior to ORC in terms of bleeding, transfusion rates and length of hospital stay, despite longer operative time.