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.

Assessment of predictors of renal cell carcinoma progression after nephrectomy at short- and medium-term follow-up and implication on surveillance protocols.

BACKGROUND: Prediction of risk of RCC progression after surgery is important for follow-up planning. We identified predictors of progression-free survival (PFS) and cancer-specific survival (CSS) in a large single institutional cohort and investigated patterns and sites of progression according to stage and grade. METHODS: Node-negative non-metastatic clear-cell RCC (ccRCC) patients treated with radical or partial nephrectomy from 2000 to 2020 were included. Sites of progression were defined as thoracic, abdominal and others (bone/brain). Kaplan-Meier curves and multivariable Cox regression (MCR) models tested for PFS and CSS. RESULTS: Of 384 clear cell RCC N0M0 patients, 301 (78.4%) vs. 83 (21.6%) were pT1-2 vs. pT3-4, respectively; 253 (65.9%) vs. 130 (33.9%) were G1-G2 vs. G3-G4. Thoracic progressions occurred in 2.7% pT1-T2 vs. 21.7% pT3-T4 and 2.8% G1-G2 vs. 14.6% G3-G4 tumors. Abdominal progressions occurred in 4.0% pT1-T2 vs. 13.3% pT3-T4 and 4.3% G1-G2 vs. 9.2% G3-G4. Other progressions occurred in 0.3% pT1-T2 vs. 9.6% pT3-T4 and 0.8% G1-G2 vs. 5.4% G3-G4 (5.4%). Five-year PFS and CSS were 81.7 and 90.6%, respectively. At MCR models, pT3-4 (HR 9.1, P<0.001), G3-G4 (HR 2.7, P=0.003) and PSMs (HR 6.1, P<0.001) independently predicted PFS. Similarly, pT3-4 (HR 10.1, P<0.001), G3-G4 (HR 4.1, P=0.02), and PSMs (HR 5.2, P=0.04) independently predicted CSS. CONCLUSIONS: In ccRCC N0M0 patients, G3-G4, pT3-4, PSMs were independent predictors of progression after surgery. Lower stage and grade ccRCCs progress predominantly in the abdominal sites and may be followed with less frequent extra-abdominal imaging compared to more advanced/aggressive tumors.

Low-Wage Agricultural Migrant Workers in Apulian Ghettos, Italy: General Health Conditions Assessment and HIV Screening.

BACKGROUND: Approximately 500,000 migrants work in the agricultural sector in Italy. Many of them live in shantytowns, wrongly called "ghettos", far away from city centers, with no water, proper hygienic conditions or health services. The aim of this study is to assess general health conditions and HIV prevalence by giving hygienic and sanitary sustenance. METHODS: Between June 2019 and February 2020, we performed a screening campaign for HIV-diabetes-hypertension, involving migrants living in three Apulian establishments: ghetto Pista, "Sankara House" and "Arena House". RESULTS: Overall, 321 migrants were enrolled in the study. In the medical screening, one HIV test resulted positive. Hypertension was found in 12% of the migrants visited, diabetes in 2% and TB symptoms in 17%. Among others symptoms explored, muscle and joint pain/fatigue resulted in being the most frequent, and was reported by 34% of the migrants, followed by cough (10%). Significant predictors of muscle and joint pain/fatigue were: low BMI values (OR = 1.32; 95% CI 1.19-1.99), the absence of education (OR = 1.85; 95% CI 1.02-2.95), being employed with a regular contract (OR = 2.64; 95% CI 2.39-2.83) and living in the ghettos since >12 months (OR = 1.74; 95% CI 1.24-2.21). CONCLUSIONS: Our experience suggests that, in this population, the health condition is mainly linked to the specific working activities in the agricultural fields, as well as to the hygienic and living conditions, and that all of this is due to the lack of social protection in their life and job.

How uro-oncology has been affected by COVID-19 emergency? Data from Piedmont/Valle d'Aosta Oncological Network, Italy.

INTRODUCTION: Coronavirus disease 2019 (COVID-19) pandemic has dramatically hit all Europe and Northern Italy in particular. The reallocation of medical resources has caused a sharp reduction in the activity of many medical disciplines, including urology. The restricted availability of resources is expected to cause a delay in the treatment of urological cancers and to negatively influence the clinical history of many cancer patients. In this study, we describe COVID-19 impact on uro-oncological management in Piedmont/Valle d'Aosta, estimating its future impact. METHODS: We performed an online survey in 12 urological centers, belonging to the Oncological Network of Piedmont/Valle d'Aosta, to estimate the impact of COVID-19 emergency on their practice. On this basis, we then estimated the medical working capacity needed to absorb all postponed uro-oncological procedures. RESULTS: Most centers (77%) declared to be "much"/"very much" affected by COVID-19 emergency. If uro-oncological consultations for newly diagnosed cancers were often maintained, follow-up consultations were more than halved or even suspended in around two out of three centers. In-office and day-hospital procedures were generally only mildly reduced, whereas major uro-oncological procedures were more than halved or even suspended in 60% of centers. To clear waiting list backlog, the urological working capacity should dramatically increase in the next months; delays greater than 1 month are expected for more than 50% of uro-oncological procedures. CONCLUSIONS: COVID-19 emergency has dramatically slowed down uro-oncological activity in Piedmont and Valle d'Aosta. Ideally, uro-oncological patients should be referred to COVID-19-free tertiary urological centers to ensure a timely management.

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.

Assessment of volume preservation performed before or after partial nephrectomy accurately predicts postoperative renal function: Results from a prospective multicenter study.

PURPOSE: Partial nephrectomy (PN) is standard for small renal masses, improving renal function by preserving renal parenchyma compared with radical nephrectomy. Recent work demonstrated that postoperative surgeon assessment of volume preservation (SAVP) and 3D imaging measurements agree and correlate with postoperative function. We hypothesize preoperative assessment of volume preservation (PAVP) with PN based on preoperative imaging will reliably indicate postoperative renal function. MATERIALS AND METHODS: Data were collected from 336 patients undergoing PN for suspected renal cancer by 40 surgeons at 12 centers in Europe and the United States within the Surface-Intermediate-Base International Consortium. Surgeons recorded PAVP and SAVP for individual patients; pre- and postoperative glomerular filtration rate (GFR) was estimated by Chronic Kidney Disease Epidemiology Collaboration equations. Correlations between PAVP, SAVP, and postoperative GFR were assessed with linear regression models. Bland-Altman analysis was used to assess agreement between PAVP and SAVP with a significant cutoff of 5%. RESULTS: Median PAVP was 90% (interquartile range [IQR] 85%-100%) and SAVP was 90% (IQR: 80%-94%). PAVP and SAVP were moderately correlated (R2 = 0.67, P < 0.0001) and deemed "interchangeable" by Bland-Altman analysis at a 5% acceptable rate of difference (95% CI: -5.4, -3.1). Median postoperative GFR was 77.3 (IQR: 56.2, 92.0). Both PAVP (R2 = 0.82, P < 0.0001) and SAVP (R2 = 0.83, P < 0.0001) were correlated with postoperative GFR. Multivariable models utilizing volume-adjusted GFR based on PAVP or SAVP significantly and similarly predicted postoperative GFR (R2 = 0.72 for each). CONCLUSION: Renal function is closely linked to the amount of parenchymal volume preservation, whether estimated prior to surgery (PAVP) or afterward (SAVP). PAVP provides reasonably accurate information for decision-making in patients considering PN.

Multidisciplinary teams for the proper management of patients with genitourinary tumors: When topics set scientific societies' agenda.

INTRODUCTION: The multidisciplinary management of oncologic patients is identified as the bottom line element of quality in tumor care. METHODS: In 2015, 7 Italian scientific societies representing the specialists involved in the diagnosis and treatment of genitourinary tumors joined efforts in the Italian uro-oncologic multidisciplinary teams (MDTs) project. The aims were to promote the reorganization of genitourinary cancer care, switching to a multidisciplinary approach, reach a consensus on the core elements for the setup of MDTs in genitourinary oncology, and support health policy makers and managers in remodeling of the assistance and care of uro-oncologic patients on a national level. RESULTS: The first activity was the setup of 5 working groups, given the task of exploring selected topics: general principles, organization of MDTs, minimal requirements, economic evaluation, and relations with authorities. The groups participated in the writing of a document that was approved by the scientific societies and published on their web sites. Moreover, a few items summarizing the extensive document were approved in the first MDT Consensus Conference held in Milan in December 2015. CONCLUSIONS: The experience of this initial phase led to the opening of the team to other professionals and societies, in line with a correct management of patients with genitourinary tumors, which need a multidisciplinary as well as a multiprofessional approach with emerging techniques and procedures, and with a new project work package on genitourinary paths of care and indicators.

Assessment of risk factors for complications of laparoscopic partial nephrectomy.

OBJECTIVE: Laparoscopic partial nephrectomy (LPN) is a technique that is emerging as an attractive option for the treatment of renal tumors