External validation of a nomogram for outcome prediction in management of medium-sized (1-2 cm) kidney stones.

BACKGROUND: Stone nomogram by Micali et al., able topredict treatment failure of shock-wave lithotripsy (SWL), retrograde intrarenal surgery (RIRS) and percutaneous nephrolithotomy (PNL) in the management of single 1-2 cm renal stones, was developed on 2605 patients and showed a high predictive accuracy, with an area under ROC curve of 0.793 at internal validation. The aim of the present study is to externally validate the model to assess whether it displayed a satisfactory predictive performance if applied to different populations. METHODS: External validation was retrospectively performed on 3025 patients who underwent an active stone treatment from December 2010 to June 2021 in 26 centers from four countries (Italy, USA, Spain, Argentina). Collected variables included: age, gender, previous renal surgery, preoperative urine culture, hydronephrosis, stone side, site, density, skin-to-stone distance. Treatment failure was the defined outcome (residual fragments >4 mm at three months CT-scan). RESULTS: Model discrimination in external validation datasets showed an area under ROC curve of 0.66 (95% 0.59-0.68) with adequate calibration. The retrospective fashion of the study and the lack of generalizability of the tool towards populations from Asia, Africa or Oceania represent limitations of the current analysis. CONCLUSIONS: According to the current findings, Micali's nomogram can be used for treatment prediction after SWL, RIRS and PNL; however, a lower discrimination performance than the one at internal validation should be acknowledged, reflecting geographical, temporal and domain limitation of external validation studies. Further prospective evaluation is required to refine and improve the nomogram findings and to validate its clinical value.

Open versus Robot-Assisted Radical Cystectomy for the Treatment of pT4a Bladder Cancer: Comparison of Perioperative Outcomes.

We compared the perioperative outcomes of open (ORC) vs. robot-assisted (RARC) radical cystectomy in the treatment of pT4a MIBC. In total, 212 patients underwent ORC (102 patients, Group A) vs. RARC (110 patients, Group B) for pT4a bladder cancer. Patients were prospectively followed and retrospectively reviewed. We assessed operative time, estimated blood loss (EBL), intraoperative and postoperative complications, length of stay, transfusion rate, and oncological outcomes. Preoperative features were comparable. The mean operative time was 232.8 vs. 189.2 min (p = 0.04), and mean EBL was 832.8 vs. 523.7 mL in Group A vs. B (p = 0.04). An intraoperative transfusion was performed in 32 (31.4%) vs. 11 (10.0%) cases during ORC vs. RARC (p = 0.03). The intraoperative complications rate was comparable. The mean length of stay was shorter after RARC (12.6 vs. 7.2 days, p = 0.02). Postoperative transfusions were performed in 36 (35.3%) vs. 13 (11.8%) cases (p = 0.03), and postoperative complications occurred in 37 (36.3%) vs. 29 (26.4%) patients in Groups A vs. B (p = 0.05). The positive surgical margin (PSM) rate was lower after RARC. No differences were recorded according to the oncological outcomes. ORC and RARC are feasible treatments for the management of pT4a bladder tumors. Minimally invasive surgery provides shorter operative time, bleeding, transfusion rate, postoperative complications, length of stay, and PSM rate.

Patient and Context Factors in the Adoption of Active Surveillance for Low-Risk Prostate Cancer.

Importance: Although active surveillance for patients with low-risk prostate cancer (LRPC) has been recommended for years, its adoption at the population level is often limited. Objective: To make active surveillance available for patients with LRPC using a research framework and to compare patient characteristics and clinical outcomes between those who receive active surveillance vs radical treatments at diagnosis. Design, Setting, and Participants: This population-based, prospective cohort study was designed by a large multidisciplinary group of specialists and patients' representatives. The study was conducted within all 18 urology centers and 7 radiation oncology centers in the Piemonte and Valle d'Aosta Regional Oncology Network in Northwest Italy (approximate population, 4.5 million). Participants included patients with a new diagnosis of LRPC from June 2015 to December 2021. Data were analyzed from January to May 2023. Exposure: At diagnosis, all patients were informed of the available treatment options by the urologist and received an information leaflet describing the benefits and risks of active surveillance compared with active treatments, either radical prostatectomy (RP) or radiation treatment (RT). Patients choosing active surveillance were actively monitored with regular prostate-specific antigen testing, clinical examinations, and a rebiopsy at 12 months. Main Outcomes and Measures: Outcomes of interest were proportion of patients choosing active surveillance or radical treatments, overall survival, and, for patients in active surveillance, treatment-free survival. Comparisons were analyzed with multivariable logistic or Cox models, considering centers as clusters. Results: A total of 852 male patients (median [IQR] age, 70 [64-74] years) were included, and 706 patients (82.9%) chose active surveillance, with an increasing trend over time; 109 patients (12.8%) chose RP, and 37 patients (4.3%) chose RT. Median (IQR) follow-up was 57 (41-76) months. Worse prostate cancer prognostic factors were negatively associated with choosing active surveillance (eg, stage T2a vs T1c: odds ratio [OR], 0.51; 95% CI, 0.28-0.93), while patients who were older (eg, age ≥75 vs <65 years: OR, 4.27; 95% CI, 1.98-9.22), had higher comorbidity (Charlson Comorbidity Index ≥2 vs 0: OR, 1.98; 95% CI, 1.02-3.85), underwent an independent revision of the first prostate biopsy (OR, 2.35; 95% CI, 1.26-4.38) or underwent a multidisciplinary assessment (OR, 2.65; 95% CI, 1.38-5.11) were more likely to choose active surveillance vs active treatment. After adjustment, center at which a patient was treated continued to be an important factor in the choice of treatment (intraclass correlation coefficient, 18.6%). No differences were detected in overall survival between active treatment and active surveillance. Treatment-free survival in the active surveillance cohort was 59.0% (95% CI, 54.8%-62.9%) at 24 months, 54.5% (95% CI, 50.2%-58.6%) at 36 months, and 47.0% (95% CI, 42.2%-51.7%) at 48 months. Conclusions and Relevance: In this population-based cohort study of patients with LRPC, a research framework at system level as well as favorable prognostic factors, a multidisciplinary approach, and an independent review of the first prostate biopsy at patient-level were positively associated with high uptake of active surveillance, a practice largely underused before this study.

Management of osteomyelitis of the pubic symphysis following urinary fistula in patients with radiation-induced urethral strictures after prostate cancer treatment.

Introduction: Osteomyelitis of the pubic symphysis is a rare condition often occurring in patients with radiation therapy-related urethral strictures after prostate cancer treatment. Material and methods: We retrospectively reviewed patients who presented with osteomyelitis of the pubic symphysis from November 2016 to September 2021. We investigated the factors leading to urosymphyseal fistulas, clinical presentation, radiological assessment, treatments, and outcomes. Results: A total 4 cases were collected. All patients underwent surgery and adjuvant or salvage radiotherapy for prostate cancer. Subsequently, they developed stricture of the vesicourethral anastomosis which was initially treated conservatively. Symptoms of pubic bone osteomyelitis included pain in the pubic area, fever, difficulty walking, and recurrent urinary tract infections. In all cases, computed tomography and magnetic resonance imaging showed a urinary fistula arising from the vesicourethral anastomosis with the involvement of the pubic bone, and severe osteomyelitis. Due to the failure of conservative treatment, debridement of the pubic bone with cystectomy and ileal conduit was performed in 3 patients. One patient refused surgery and bilateral percutaneous nephrostomies were placed. Patients regained their original performance status 1 to 6 months after surgery. Conclusions: General recommendations for the best diagnostic and therapeutic approach to osteomyelitis of the pubic symphysis due to urosymphyseal fistula still do not exist. Conservative treatment often fails and a surgical approach with definitive urinary diversion may be required.

The Intraoperative Complications Assessment and Reporting with Universal Standards (ICARUS) Global Surgical Collaboration Project: Development of Criteria for Reporting Adverse Events During Surgical Procedures and Evaluating Their Impact on the Postoperative Course.

BACKGROUND: Intraoperative adverse events (iAEs) are surgical and anesthesiologic complications. Despite the availability of grading criteria, iAEs are infrequently reported in the surgical literature and in cases for which iAEs are reported, these events are described with significant heterogeneity. OBJECTIVE: To develop Intraoperative Complications Assessment and Reporting with Universal Standards (ICARUS) Global Surgical Collaboration criteria to standardize the assessment, reporting, and grading of iAEs. The ultimate aim is to improve our understanding of the nature and frequency of iAEs and our ability to counsel patients regarding surgical procedures. DESIGN, SETTING, AND PARTICIPANTS: The present study involved the following steps: (1) collecting criteria for assessing, reporting, and grading of iAEs via a comprehensive umbrella review; (2) collecting additional criteria via a survey of a panel of experienced surgeons (first round of a modified Delphi survey); (3) creating a comprehensive list of reporting criteria; (4) combining criteria acquired in the first two steps; and (5) establishing a consensus on clinical and quality assessment utility as determined in the second round of the Delphi survey. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Panel inter-rater agreement and consistency were assessed as the overall percentage agreement and Cronbach's α. RESULTS AND LIMITATIONS: The umbrella review led to nine common criteria for assessing, grading, and reporting iAEs, and review of iAE grading systems led to two additional criteria. In the first Delphi round, 35 surgeons responded and two criteria were added. In the second Delphi round, 13 common criteria met the threshold for final guideline inclusion. All 13 criteria achieved the consensus minimum of 70%, with agreement on the usefulness of the criteria for clinical and quality improvement ranging from 74% to 100%. The mean inter-rater agreement was 89.0% for clinical improvement and 88.6% for quality improvement. CONCLUSIONS: The ICARUS Global Collaboration criteria might aid in identifying important criteria when reporting iAEs, which will support all those involved in patient care and scientific publishing. PATIENT SUMMARY: We consulted a panel of experienced surgeons to develop a set of guidelines for academic surgeons to follow when publishing surgical studies. The surgeon panel proposed a list of 13 criteria that may improve global understanding of complications during specific procedures and thus improve the ability to counsel patients on surgical risk.

Perioperative outcomes of patients undergoing urological elective surgery during the COVID-19 pandemic: a national overview across 28 Italian institutions.

INTRODUCTION: The aim of this study was to assess the safety of elective urological surgery performed during the pandemic by estimating the prevalence of COVID-19-like symptoms in the postoperative period and its correlation with perioperative and clinical factors. MATERIAL AND METHODS: In this multicenter, observational study we recorded clinical, surgical and postoperative data of consecutive patients undergoing elective urological surgery in 28 different institutions across Italy during initial stage of the COVID-19 pandemic (between February 24 and March 30, 2020, inclusive). RESULTS: A total of 1943 patients were enrolled. In 12%, 7.1%, 21.3%, 56.7% and 2.6% of cases an open, laparoscopic, robotic, endoscopic or percutaneous surgical approach was performed, respectively. Overall, 166 (8.5%) postoperative complications were registered, 77 (3.9%) surgical and 89 (4.6%) medical. Twenty-eight (1.4%) patients were readmitted to hospital after discharge and 13 (0.7%) died. In the 30 days following discharge, fever and respiratory symptoms were recorded in 101 (5.2%) and 60 (3.1%) patients. At multivariable analysis, not performing nasopharyngeal swab at hospital admission (HR 2.3; CI 95% 1.01-5.19; p = 0.04) was independently associated with risk of developing postoperative medical complications. Number of patients in the facility was confirmed as an independent predictor of experiencing postoperative respiratory symptoms (p = 0.047, HR:1.12; CI95% 1.00-1.05), while COVID-19-free type of hospitalization facility was a strong independent protective factor (p = 0.02, HR:0.23, CI95% 0.07-0.79). CONCLUSIONS: Performing elective surgery during the COVID-19 pandemic does not seem to affect perioperative outcomes as long as proper preventive measures are adopted, including nasopharyngeal swab before hospital admission and hospitalization in dedicated COVID-19-free facilities.

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.

Large bladder diverticula: a comparison between laparoscopic excision and endoscopic fulguration.

OBJECTIVE: The treatment of bladder diverticula consists of diverticulectomy, mainly by a laparoscopic approach or transurethral resection of the diverticular neck and fulguration of the mucosa. The endoscopic approach is generally dedicated to small diverticula. The aim of this study was to compare laparoscopic diverticulectomy versus endoscopic fulguration for bladder diverticula larger than 4 cm. MATERIALS AND METHODS: A retrospective review of the medical records of consecutive patients undergoing endoscopic or laparoscopic treatment for bladder diverticula larger than 4 cm at two tertiary hospitals was performed. Therapeutic success was defined as either complete resolution or a decrease of at least 80% in the size of the diverticulum. Complications were recorded and graded according to the Clavien-Dindo classification. RESULTS: All patients were treated with transurethral resection of the prostate in the same operative session. The endoscopic group included a cohort of 20 male patients. The median age, diverticular diameter and operative time were 65 years, 7 cm and 62.5 min, respectively. No early postoperative complications were observed. Therapeutic success was achieved in 15 cases (75%). The laparoscopic group included a cohort of 13 male patients with a median age of 63 years and median diverticular diameter of 7.0 cm. The median operative time was 185 min (p < 0.0001). Two grade III postoperative complications were observed (15.3%). Therapeutic success was achieved in all patients (100%). CONCLUSIONS: Acquired bladder diverticula larger than 4 cm can be effectively managed either by a laparoscopic approach or by endoscopic fulguration.

Laparoscopic and robotic ureteral stenosis repair: a multi-institutional experience with a long-term follow-up.

The treatment of ureteral strictures represents a challenge due to the variability of aetiology, site and extension of the stricture; it ranges from an end-to-end anastomosis or reimplantation into the bladder with a Boari flap or Psoas Hitch. Traditionally, these procedures have been done using an open access, but minimally invasive approaches have gained acceptance. The aim of this study is to evaluate the safety and feasibility and perioperative results of minimally invasive surgery for the treatment of ureteral stenosis with a long-term follow-up. Data of 62 laparoscopic (n = 36) and robotic (n = 26) treatments for ureteral stenosis in 9 Italian centers were reviewed. Patients were followed according to the referring center's protocol. Laparoscopic and robotic approaches were compared. All the procedures were completed successfully without open conversion. Average estimated blood loss in the two groups was 91.2 ± 71.9 cc for the laparoscopic and 47.2 ± 32.3 cc for the robotic, respectively (p = 0.004). Mean days of hospitalization were 5.9 ± 2.4 for the laparoscopic group and 7.6 ± 3.4 for the robotic group (p = 0.006). No differences were found in terms of operative time and post-operative complications. After a median follow-up of 27 months, the robotic group yielded 2 stenosis recurrence, instead the laparoscopic group shows no cases of recurrence (p = 0.091). Minimally invasive approach for ureteral stenosis is safe and feasible. Both robotic and pure laparoscopic approaches may offer good results in terms of perioperative outcomes, low incidence of complications and recurrence.

Multicenter analysis of pathological outcomes of patients eligible for active surveillance according to PRIAS criteria.

BACKGROUND: The aim of this study was to retrospectively analyze the pathological outcomes of patients meeting the Prostate Cancer Research International Active Surveillance (PRIAS) criteria who had undergone radical prostatectomy (RP). METHODS: Out of 2014 patients recruited for minimally invasive RP between 2008 and 2014 in 7 centers, 226 (11.2%) met the modified PRIAS criteria (clinical stage T1c/T2, PSA<10 ng/mL, 1-2 positive biopsy cores and Gleason Score<6). RESULTS: At pathological evaluation, Gleason Score upgrade was reported in 47.3% of patients; 74 (32.7%), 10 (4.4%), 9 (3.9%) patients showed RP Gleason sum 7, 8 and 9, respectively. Upstaging was reported in 135 patients (59.7%). Twelve (5.3%) and 4 (1.7%) patients had T3a and T3b pathological stage respectively. CONCLUSIONS: Notwithstanding the PRIAS criteria can identify some PCa patients as low-risk, at pathological evaluation some of them harbored intermediate- or high-risk disease. According to our data, patients eligible for AS should be carefully counseled about possible disease understaging.

[Positive surgical margin status after minimally invasive radical prostatectomy: a multicenter study]. / Margini chirurgici positivi dopo prostatectomia radicale mini-invasiva: studio multicentrico.

UNLABELLED: UNLABELLED: The aim of our study is to evaluate the status of positive margins (PSMs) comparing their incidence between aparoscopic radical prostatectomy (LRP) and robot assisted radical prostatectomy (RARP) in centers with medium case-load (50-150 cases/year). We also analyzed the correlations between surgical technique, nerve-sparing approach (NS), and incidence of PSMs, stratifying our results by pathological stage. MATERIALS AND METHODS: We analyzed 1992 patients who underwent RP in various urologic centers. We evaluated the incidence of PSMs, and then we compared the stage-related incidence of PSMs, for both the techniques. RESULTS: We did not find a statistically significant difference between the two surgical modalities in the study regarding the overall incidence of PSMs. CONCLUSIONS: In our retrospective study, we did not find any difference in terms of PSMs in RARP versus LRP. Our PSMs were not negligible, particularly in pT3 stages, compared with high-volume centers; surgical experience and patients' selection can be a possible explanation.

The R.E.N.A.L. nephrometric nomogram cannot accurately predict malignancy or aggressiveness of small renal masses amenable to partial nephrectomy.

INTRODUCTION/BACKGROUND: The prediction of histology of SRM could be essential for their management. The RNN is a statistical tool designed to predict malignancy or high grading of enhancing renal masses. In this study we aimed to perform an external validation of the RNN in a cohort of patients who received a PN for SRM. MATERIALS AND METHODS: This was a multicentric study in which the data of 506 consecutive patients who received a PN for cT1a SRM between January 2010 and January 2013 were analyzed. For each patient, the probabilities of malignancy and aggressiveness were estimated preoperatively using the RNN. The performance of the RNN was evaluated according to receiver operating characteristic (ROC) curve, calibration plot, and decision curve analyses. RESULTS: The area under the ROC curve for malignancy was 0.57 (95% confidence interval [CI], 0.51-0.63; P = .031). The calibration plot showed that the predicted probability of malignancy had a bad concordance with observed frequency (Brier score = 0.17; 95% CI, 0.15-0.19). Decision curve analysis confirmed a poor clinical benefit from use of the system. The estimated area under the ROC curve for high-grade prediction was 0.57 (95% CI, 0.49-0.66; P = .064). The calibration plot evidenced a bad concordance (Brier score = 0.15; 95% CI, 0.13-0.17). Decision curve analysis showed the lack of a remarkable clinical usefulness of the RNN when predicting aggressiveness. CONCLUSIONS: The RNN cannot accurately predict histology in the setting of cT1a SRM amenable to PN.

Open versus robotic-assisted partial nephrectomy: a multicenter comparison study of perioperative results and complications.

PURPOSE: To compare surgical results, morbidity and positive surgical margins rate of patients undergoing robotic partial nephrectomy (RPN) versus open partial nephrectomy (OPN). METHODS: This is an observational multicenter study promoted by the "Associazione GIovani Laparoscopisti Endoscopisti" (AGILE) no-Profit Foundation, which involved six Italian urologic centers. All clinical, surgical, and pathological variables of patients treated with OPN or RPN for renal tumors were gathered in a prospectively maintained database. Tumor nephrometry was measured with PADUA score, and complications were stratified with modified Clavien system. Differences between RPN and OPN group were assessed with univariate analysis. Perioperative variables independently associated with complications were assessed with multivariate analysis. RESULTS: A total of 198 and 105 patients were enrolled in OPN and RPN group, respectively. Both had similar demographics, indications to surgery, tumor nephrometry, renal function, WIT (18.7 vs. 18.2 min; p = NS), positive margin rate (5.6 vs. 5.7%; p = NS), intraoperative complications, and postoperative medical complications. Compared to OPN, RPN group was significantly more morbid (p = 0.04), included tumors with smaller size (p = 0.002), had longer operative time (p < 0.001), lower blood loss, surgical postoperative complications (5.7 vs. 21.2%, p < 0.001), Clavien 3-4 surgical complications (1 vs. 9.1%, p = 0.001), and shorter hospitalization. The surgical approach resulted independently correlated with surgical complications on multivariate analysis. CONCLUSION: In the present series, RPN was associated with a significant reduction of blood loss, surgical complications, including the reintervention rate for urinary fistula and postoperative bleeding, and with a shorter hospitalization.

The prognostic role of preoperative chromogranin A expression in prostate cancer after radical prostatectomy.

PURPOSES: The aim was to analyze the prognostic role of preoperative chromogranin A CgA) as a marker of poor prognosis and recurrence after radical prostatectomy (RP) and to find a correlation with the other well known prognostic variables. MATERIALS AND METHODS: This study comprises 306 patients with prostate cancer prospectively recruited who underwent RP from between 2000 and 2005. A blood sample for the determination of serum preoperative CgA value was obtained in all cases. Spearman correlation test was used to compare CgA to other variables, Kruskal-Wallis test to analyze CgA differences among > or = 3 groups (PSA, GS, Stage), Mann-Whitney test for 2 grouping variables. Survival analysis was estimated by Kaplan-Meier method, log-rank test to estimate differences among the analyzed variables. RESULTS: Median CgA level was 68 ng/ml. Correlation between age and CgA levels was positive and statistically significant (p < 0.001). Patient were divided in 2 groups based on median age.The difference was statistically significant (p = 0.002). Comparison of CgA among patients grouped according to other variables and patient stratified on normal (123 ng/ml) and cut-off value (68 ng/ml) of CgA did not achieve significant risk stratification. CONCLUSION: Studies on a possible prognostic role of CgA have provided conflicting results. In our series we found a significant positive correlation between CgA and age, but no significant statistical correlation with other available variables analyzed.

Is radical prostatectomy feasible in all cases of locally advanced non-bone metastatic prostate cancer? Results of a single-institution study.

OBJECTIVES: Previous prospective studies of the surgical treatment of locally advanced prostate cancer have enrolled patients selected on the basis of a limited T3 disease extension. The aim of the present study was to assess the feasibility and the oncologic outcome of radical prostatectomy administered to a consecutive unselected series of advanced, non-bone metastatic prostate cancers. METHODS: Between March 1998 and February 2003 radical prostatectomy was offered at our institution to any patient diagnosed with prostate cancer with no sign of extranodal metastatic disease. Data on morbidity and survival for 51 clinically advanced cases (any T>/=3, N0-N1, or any N1 or M1a disease according to the TNM 2002 classification system) operated on by a single expert surgeon were compared with a series of 152 radical prostatectomies performed during the same period by the same operator for clinically organ-confined disease. Adjuvant treatment was administered according to current guidelines. RESULTS: The two groups did not differ significantly in surgical morbidity except for blood transfusion, operative time, and lymphoceles, which showed a higher rate in patients with advanced disease. The Kaplan-Meier estimate of overall survival and prostate cancer-specific survival at 7 yr were 76.69% and 90.2% in the advanced disease group and 88.4% and 99.3% in the organ-confined disease group, respectively. CONCLUSIONS: Even in the scenario of extensive surgical indications up to M1a disease, radical prostatectomy proved to be technically feasible and to have an acceptable morbidity rate compared with organ-confined disease. Our initial survival data strengthen the role for surgery as an essential part in the multimodal approach to treating advanced prostate cancer.