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Quality of life (QOL) outcome is an ideal method for determining the efficacy of a surgical treatment. In children operated for pilonidal sinus disease (PSD), open procedures imply prolonged wound care, significant morbidity, and high recurrence rates. Endoscopic treatment (PEPSIT) overcomes these limitations. We report our experience in the management of PSD to evaluate the QOL of patients undergoing open and endoscopic treatment. The records of 177 patients undergoing surgery for PSD from 2008 to 2021 were retrospectively reviewed. Twenty patients were operated with open surgery (G1) and 157 with PEPSIT (G2). We analyzed QOL through the following criteria: hospital stay (HS), healing time (HT), return to sport (RTSp), return to school (RTSc), resumption of social life (RSL), and recurrence rate and reoperation (RRR). Moreover, we used Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q) for a more subjective evaluation of life satisfaction. We found significant differences in all the analyzed criteria: HS varied from 3 to 7 days in G1 and from 1 to 2 days in G2; HT from 40 to 75 days in G1 while from 20 to 41 days in G2; RTSp from 50 to 80 days in G1 while from 7 to 21 days in G2; RTSc from 9 to 15 days in G1 while from 2 to 4 days in G2; RSL from 13 to 20 days in G1 while from 2 to 5 days in G2; RRR was 25% in G1 and 4.4% in G2.Conclusion: Endoscopic treatment (PEPSIT) significantly improves the quality of life of patients operated for PSD. Compared to open surgery, PEPSIT presents shorter hospital stay, faster healing time, return to sport activities, return to school and resumption of a normal social life, and lower rates of recurrence and reoperation. In addition, PQ-LES-Q demonstrated a good overall quality of life and life satisfaction. Further prospective studies should be obtained to consider PEPSIT as the gold standard for the treatment of PSD in pediatric patients. What is Known: • Many techniques have been proposed in the last 20 years for the surgical treatment of PSD. • PEPSIT is showing promising results in terms of safety and long-term efficacy. What is New: • The main impact in QOL of patients operated with PEPSIT is on their daily activity, including a shorter hospital stay, faster healing time, return to sport activities, return to school and resumption of a normal social life, lower rates of recurrence and reoperation. • After PEPSIT, children maintain a satisfactory quality of life according to the analysis of PQ-LES-Q

Locoregional therapies are commonly used as bridging strategies to decrease the drop-out of patients with hepatocellular carcinoma (HCC) awaiting liver transplantation (LT). The present paper aims to assess the outcomes of bridging therapies in patients with HCC considered for LT according to an intention-to-treat (ITT) survival analysis.Medline and Web of Science databases were searched for reports published before May 2021. Papers assessing adult patients with HCC considered for LT and reporting ITT survival outcomes were included. Two reviewers independently identified, extracted the data, and evaluated the papers according to Newcastle-Ottawa criteria. Outcomes analyzed were: drop-out rate; time on the waiting list; 1-, 3-, and 5-year survival after LT and based on an ITT analysis.The search identified 3106 records; six papers (1043 patients) met the inclusion criteria. Patients with HCC, listed for LT and submitted to bridging therapies presented a longer waiting time before LT (MD 3.77, 95% CI 2.07-5.48) in comparison with the non-interventional group. However, they presented a raised post LT after 1-year (OR 2.00, 95% CI 1.18-3.41), 3-years (OR 1.47, 95% CI 1.01-2.15), and 5-years (OR 1.50, 95% CI 1.06-2.13) survival.Patients submitted to bridging procedures, despite having a longer interval on the waiting list, presented better post-LT survival outcomes. Bridging therapies for selected patients at low risk of post-procedural complications and long expected intervals on the waiting list should be encouraged. However, further clinical trials should confirm the survival benefit of bridging therapies in patients with HCC listed for LT.

The study presents the Italian adaptation of the Personal and General Belief in a Just World (P-BJW and G-BJW) Scales. Dalbert and colleagues developed these scales to capture the belief in a just world for oneself and a just world in general. After the translation and back-translation, the P-BJW and G-BJW scales were administered first to a pilot sample of 213 university students and then to a national sample of 2683 Italian people. Results showed that it was necessary to make some revisions to the predicted two correlated factor structure. These changes entailed correlating the error terms for some manifest variables and removing the first item of the P-BJW factor. The final structure of the P-BJW and G-BJW scales presented satisfactory indexes of model fit as well as high reliability and moderate validity values. Additionally, this structure proved to fit the data better than an alternative one-factor or a bi-factor model with two orthogonal-specific factors. As predicted, well-being strongly predicted scores on the BJW, but age and gender did not. Multigroup comparisons among Northern, Central, and Southern Italy respondents indicated that Italian people interpret scale items equivalently, regardless of their geographical location. Introducing the P-BJW and G-BJW scales to the Italian justice scholarship is very useful to unpack the reasons why Italy reports lower levels of social justice than other European countries and also to investigate the link between justice, well-being, and other socio-psychological variables.

Background Surgical techniques for treatment of gynecomastia are increasingly less invasive. We described technical standardization of pediatric endoscopic subcutaneous mastectomy (PESMA) with liposuction. Methods All adolescents with primary gynecomastia, operated using PESMA with liposuction over the period June 2014–July 2021, were included. The video recording of procedures was analyzed to standardize the operative technique. After patient installation, 3 trocars were placed on the mid-axillary line. The technique included 5 steps: (1) subcutaneous injection of lipolysis solution and liposuction; (2) creation of working space using an inflated balloon; (3) gland dissection using 5-mm sealing device; (4) specimen extraction through the largest trocar orifice; and (5) placement of suction drainage tube. Results Twenty-four male adolescents, operated for Simon’s grade 2B and 3 gynecomastia using PESMA with liposuction over the study period, were included. Mean patient age was 16 years (range 15–18). Gynecomastia was bilateral in 19/24 (79.2%) and unilateral in 5/24 (20.8%). One (4.1%) conversion to open was reported. The mean operative time was 87 min (range 98–160) for unilateral and 160 min (range 140–250) for bilateral procedure. The mean length of stay was 2.2 days (range 1–4). Patients wore a thoracic belt for 15 up to 30 days postoperatively. Post-operative complications occurred in 5/24 (20.8%): 2- or 3 mm second-degree burns in 4 (16.7%) and subcutaneous seroma in 1 (4.1%). All complications were Clavien 2 grade and did not require further treatment. Aesthetic outcomes were very good in 21/24 (87.5%). Three (12.5%) boys had persistent minimal breast asymmetry but did never perceive it negatively. Conclusion PESMA combined with liposuction was feasible and safe for surgical treatment of gynecomastia in this selected cohort of patients. Although challenging, this procedure provided good aesthetic results, with no scars on the anterior thoracic wall. Standardization of the operative technique was a key point for successful outcome.

Introduction: Primary focal segmental glomerular sclerosis (FSGS) is a rare, likely immune-mediated disease. Rituximab (RTX) may play a role in management, although data in adults are scanty. Methods: We collected cases of RTX-treated primary FSGS within the Italian Society of Nephrology Immunopathology Working Group and explored response rate (24-hour proteinuria

Background: During COVID-19 pandemic, many restrictions were applied in the field of health care. For this reason, we decided to adopt the laparoscopic simulator Laparo® Analytic to allow the trainees of our pediatric surgery training program to continue their training activity, and we determined its impact on their surgical education. Methods: We used Laparo Analytic Simulator for laparoscopic surgery training among the residents of our center. Fifteen residents from different years of the pediatric surgery program participated in this study. Each participant performed a 2-hour training session per week, consisting of three different exercises: Rubber Bands, Knotting, and Suturing. For each training session, the following parameters were analyzed: training time, economy of movement, smoothness, instrument activity (IA), instrument visibility (IV), and instrument symmetry. Results: Results were collected after the first training session (T0), at 3 months after the beginning of the study (T1) and at 6 months after the beginning of the study (T2). At T2 of training with Laparo Analytic Simulator, residents were able to complete their tasks significantly faster (P = .001) and had a significant improvement in smoothness of movements, IA, IV, and instrument symmetric movements during the tasks analyzed. Conclusion: On the basis of our results, we believe that Laparo analytic is an excellent system to adopt in minimally invasive surgery (MIS) training programs, in particular, during periods of surgical restrictions, as COVID-19 pandemic, or in centers with a limited MIS activity.

Robotic-assisted surgery (RAS) is increasingly adopted in the pediatric population. This retrospective multicenter study aimed to report application of RAS for pediatric gynecological indications. The medical records of all children and adolescents with gynecological pathology, operated in 3 different institutions over a 3-year period, were retrospectively collected. Robot docking time, total operative time, length of stay (LOS), requirement time of pain medication, complication rate, conversion rate, and pathology results were analyzed. Sixteen girls, with median age of 11.7 years (range 0.6-17.9) and median weight of 47.2 kg (range 9-73), received the following RAS procedures: ovarian cystectomy for serous cystoadenoma (n=2), salpingo-oophorectomy for immature teratoma (n=6), bilateral gonadectomy for ovotestis (n=2) and Turner syndrome SRY+ (n=1), salpingectomy for fallopian tube lesion (n=1), Gartner cyst excision (n=1), paravaginal ganglioneuroma resection (n=1), fistula closure in urogenital sinus (n=1) and vaginoplasty using ileal flap in cloaca malformation (n=1). Median operative time was 131.3 minutes (range 65-360), and median docking time was 13.9 min (range 7-20). Conversion to open or laparoscopy was not necessary in any case. Median LOS was 2.3 days (range 1-7), and median analgesic requirement was 1.5 days (range 1-4). One patient needed redo-surgery for recurrent Gartner cyst. This preliminary experience showed that RAS is safe and feasible for surgical management of pediatric gynecological pathology, although no conclusive data are available to confirm its superiority over traditional laparoscopy. Randomized, prospective, comparative studies are needed to confirm these preliminary results and identify the gold standard approach in such patients.

Robotic pyeloplasty has become a natural progression from the development of open, then laparoscopic procedures to treat pediatric patients with ureteropelvic junction obstruction (UPJO). Robotic-assisted pyeloplasty (RALP) is now considered a new gold standard in pediatric MIS. A systematic review of the literature retrieved from PubMed and published in the last 10 years (2012–2022) was performed. This review underlines that in all children except the smallest infants, where the open procedure has benefits in terms of duration of general anesthetic and there are limitations in the size of instruments, robotic pyeloplasty is becoming the preferred procedure to perform in patients with UPJO. Results for the robotic approach are extremely promising, with shorter operative times than laparoscopy and equal success rates, length of stay and complications. In case of redo pyeloplasty, RALP is easier to perform than other open or MIS procedures. By 2009, robotic surgery became the most used modality to treat all UPJO and continues to grow in popularity. Robot-assisted laparoscopic pyeloplasty in children is safe and effective with excellent outcomes, even in redo pyeloplasty or challenging anatomical cases. Moreover, robotic approach shortens the learning curve for junior surgeons, who can readily achieve levels of expertise comparable to senior practitioners. However, there are still concerns regarding the cost associated with this procedure. Further high-quality prospective observational studies and clinical trials, as well as new technologies specific for the pediatric population, are advisable for RALP to reach the level of gold standard.

This study aimed to describe the available dressings and their management in patients undergoing hypospadias repair and compare postoperative outcomes with and without dressing and between the different dressing types. A comprehensive electronic literature search of PubMed, Embase, and Cochrane Library was conducted to obtain studies, published in the period 1990 to 2021, reporting on the dressing used following hypospadias surgery. All information regarding the dressing was considered as primary endpoints, whereas surgical outcomes were assessed as secondary outcomes. Thirty-one studies containing 1,790 subjects undergoing hypospadias repair were included. Dressings were divided into three categories: nonadherent to the wound, adherent to the wound, and glue-based dressings. Most authors preferred to remove/change the dressing in the ward and the median time of removal/change was 6.56 postoperative days. The dressing removal appeared as the most frequent factor generating parental anxiety. The median rate of wound-related complications was 8.18%, of urethroplasty complications 9.08% and of reoperations 8.18%. Meta-analysis of outcomes showed higher risk of reoperations using conventional dressing, with no differences in urethroplasty and wound-related complications rates between conventional and glue-based dressings. Furthermore, the use of dressing reported increased risk of wound-related complications compared with no dressing, without significant differences regarding occurrence of urethroplasty complications and reoperations. The current evidence confirmed that there is no difference in outcomes of hypospadias repair depending on a certain dressing type. To date, surgeon's preference remains the main factor determining the choice for a specific dressing or for no dressing at all.

In the last 20 years, endoscopic injection (EI) has affirmed as a valid alternative to open surgery for management of pediatric vesicoureteral reflux (VUR). This study aimed to investigate and discuss some debated aspects such as indications, bulking agents and comparison, techniques of injection and comparison, predictive factors of success, use in specific situations. EI is minimally invasive, well accepted by patients and families, with short learning curve and low-morbidity profile. It provides reflux resolution rates approaching those of open reimplantation, ranging from 69 to 100%. Obviously, the success rate may be influenced by several factors. Recently, it is adopted as first-line therapy also in high grade reflux or complex anatomy such as duplex, bladder diverticula, ectopic ureters. The two most used materials for injection are Deflux and Vantris. The first is absorbable, easier to inject, has lower risk of obstruction, but can lose efficacy over time. The second is non-absorbable, more difficult to inject, has higher risk of obstruction, but it is potentially more durable. The two main techniques are STING and HIT. To date, the ideal material and technique of injection has not yet clearly established, but the choice remains dependent on surgeon’s preference and experience.

Introduction Glans dehiscence (GD) is reportedly a common complication after proximal hypospadias repairs. However, the need for surgical correction is controversial. The aim of this study was to assess awareness, risk factors, and outcome of GD in post-pubertal patients. The agreement with surgeon assessment was also evaluated. Methods The design was retrospective. All consecutive patients treated for proximal hypospadias between 2000 and 2011 were included. The presence of GD was self-reported, and the participants could optionally upload a photograph for surgeon assessment. Cosmetic and functional outcomes were assessed by validated questionnaires (HOSE, PPPS, KINDL®, IIEF-5). Results were compared between patients with and without GD. Results Of 219 patients, 34 (16%) participated. Fourteen of them (41%) self-reported GD. Eighteen patients (8%) also uploaded a photograph and, in ten of them (56%), the surgeon noted the presence of GD with poor agreement [k = − 0.444 (95 CI − 0.856 to − 0.033)] with patient report. Patients self-reporting GD had had more frequently a penile curvature at diagnosis (12/14 = 86%, p = 0.01), and had undergone a single-staged repair (100% vs. 65%, p = 0.03). No difference was found in cosmetic and functional outcomes. Results were similar also comparing groups with and without GD as assessed by the surgeon. Conclusion GD was a common finding after severe hypospadias repair. It was more common in case of surgeon assessment with poor agreement between patients and surgeons. GD did not prove to have clear clinical implications. Therefore, in our opinion, surgical repair of GD should be recommended only on patients request.

This study aimed to report a multicentric national experience about the outcomes of pediatric endoscopic pilonidal sinus treatment (PEPSiT). The medical records of all pediatric patients, aged up to 18 years, who underwent PEPSiT in the period 2019–2021, were retrospectively reviewed. Patients’ demographics, operative details, and post-operative outcomes were assessed. A total of 294 patients (182 boys), with median age of 14 years (range 10–18), receiving PEPSiT in the study period, were enrolled. Pilonidal sinus disease (PSD) was primary in 258 (87.8%) and recurrent in 36 (12.2%). The median operative time was 36 min (range 11–120). The median VAS pain score was 0.86 (range 0–3) and the median duration of analgesic use was 27 h (range 12–60). The overall success rate was 95.2% (280/294) and the median time to full healing was 23.4 days (range 19–50). Six/294 (2.0%) patients developed Clavien 2 post-operative complications. The recurrence rate was 4.8% (14/294) and all recurrences were re-operated using PEPSiT. Redo-surgery for wound debridement was performed in one (0.3%) patient with late healing. On multivariate analysis, hirsutism and typology of sinus (pits ≥ 2, paramedian and more proximal to the anus) were predictors of PSD recurrence (p = 0.001). To date, this is the largest series of PEPSiT published in the pediatric population. The outcomes reported after a 3 years experience confirm that PEPSiT is a safe, effective, and real minimally invasive procedure to treat adolescents with PSD. It provides patients quick and painless recovery, satisfactory success, and high quality of life. Graphical abstract

Civic engagement behaviors (CEB) refer to the activation of citizens’ resources to face community problems. However, modern local communities are characterized by lower rates of civic engagement, especially among youths. Therefore, this study deepens the role of some individual and community-related assets which could foster citizens’ CEB. It specifically addresses two research questions: (a) which are the social roots of citizens’ feelings of Hope, and (b) what role citizens’ Sense of Responsible Togetherness (SoRT), Community Trust, and Hope play as to their CEB. An online questionnaire was administered to 486 Italian citizens aged between 18 and 30. A multiple mediation model was run with Structural Equation Modelling to test the role of Hope as a mediator in the relationships of SoRT and Community Trust with CEB. The results confirmed all the hypotheses, supporting both (a) the social roots of Hope and (b) its role as a mediator in the considered relationships between community-related assets and CEB. Overall, relying on positive representations of how to live together in one’s community and how the latter is able to meet its members’ needs showed a critical role as to citizens’ civic engagement, both directly and via an enhanced feeling of Hope. This provides Institutions and stakeholders with hints about the dimensions of communities to be fostered and strengthened in order to counteract the pessimistic visions and the lack of civic engagement now characterizing them.

International audience; Introduction: The search for the 'perfect' renal replacement therapy has been paralleled by the search for the perfect biomarkers for assessing dialysis adequacy. Three main families of markers have been assessed: small molecules (prototype: urea); middle molecules (prototype β2-microglobulin); comprehensive and nutritional markers (prototype of the simplified assessment, albumin levels; composite indexes as malnutrition-inflammation score). After an era of standardization of dialysis treatment, personalized dialysis schedules are increasingly proposed, challenging the dogma of thrice-weekly hemodialysis.Areas covered: In this review, we describe the advantages and limitations of the approaches mentioned above, focusing on the open questions regarding personalized schedules and incremental hemodialysis.Expert opinion: In the era of personalized dialysis, the assessment of dialysis adequacy should be likewise personalized, due to the limits of 'one size fits all' approaches. We have tried to summarize some of the relevant issues regarding the determination of dialysis adequacy, attempting to adapt them to an elderly, highly comorbidity population, which would probably benefit from tailor-made dialysis prescriptions. While no single biomarker allows precisely tailoring the dialysis dose, we suggest using a combination of clinical and biological markers to prescribe dialysis according to comorbidity, life expectancy, residual kidney function, and small and medium-size molecule depuration.

We aimed to evaluate the usefulness of C-reactive protein (CRP) and procalcitonin (PCT) as markers of infection, sepsis and as predictors of antibiotic response after non-emergency major abdominal surgery. We enrolled, from June 2015 to June 2019, all patients who underwent surgery due to abdominal infection (peritoneal abscess, peritonitis) or having sepsis episode after surgical procedures (i.e. hepatectomy, bowel perforation, pancreaticoduodenectomy (PD), segmental resection of the duodenum (SRD) or biliary reconstruction in a Tertiary Care Hospital. Serum CRP (cut-off value < 5 mg/L) and PCT (cut-off value < 0.1mcg/L) were measured in the day when fever was present or within 24 h after abdominal surgery. Both markers were assessed every 48 h to follow-up antibiotic response and disease evolution up to disease resolution. We enrolled a total of 260 patients underwent non-emergency major abdominal surgery and being infected or developing infection after surgical procedure with one or more microbes (55% mixed Gram-negative infection including Klebsiella KPC, 35% Gram-positive infection, 10% with Candida infection), 58% of patients had ICU admission for at least 96 h, 42% of patients had fast track ICU (48 h). In our group of patients, we found that PCT had a trend to increase after surgical procedure; particularly, those undergoing liver surgery had higher PCT than those underwent different abdominal surgery (U Mann-Whitney p < 0.05). CRP rapidly increase after surgery in those developing infection and showed a statistical significant decrease within 48 h in those subject being responsive to antibiotic treatment and having a clinical response within 10 days independently form the pathogens (bacterial or fungal). Further we found that those having CRP higher than 250 mg/L had a reduced percentage of success treatment at 10 days compared to those < 250 mg/mL (U Mann-Whitney p < 0.05). PCT did not show any variation according to treatment response. CRP in our cohort seems to be a useful marker to predict antibiotic response in those undergoing non-emergency abdominal surgery, while PCT seem to be increased in those having major liver surgery, probably due to hepatic production of cytokines.

Over decades now, laparoscopic Nissen fundoplication represents the treatment of choice for symptomatic children with gastroesophageal reflux disease (GERD) unresponsive to medication. Although the basic principles of Nissen's technique are still essential today, academic studies of long-Term results, complications, and patients benefits have fostered distinct modifications. Identification of surgical factors for wrap migration, dysphagia, and recurrent GERD led to recommendations for "short and floppy"wraps with minimal dissection of the phrenoesophageal membranes. This report summarizes up-To-date information from experts in the field on "how to wrap it right"followed by a critical discussion about long-Term benefits for children with GERD and future developments of laparoscopic Nissen fundoplication.

The arteriovenous fistula (AVF) has long been considered the optimal vascular access. However, the evolving characteristics of the ageing dialysis population limit the creation of an AVF in all patients. Thus, more patients start hemodialysis (HD) with a central venous catheter (CVC) rather than an AVF, and the supremacy of the AVF has recently been questioned. The aim of this study was to analyze the incidence and rate of access complications in 100 patients between 2010 and 2015. A total of 63 patients started HD with an AVF, while 37 began HD with a CVC. We found no differences in patient survival according to the vascular access in use at the beginning of dialysis, but patients were more likely to die while undergoing dialysis by means of a CVC than an AVF. Patients started on dialysis with a CVC had more cardiovascular disease, while patients who began dialysis with an AVF presented more hypertension. Fistulas presented a longer survival time despite more hospital admissions, but CVCs bore a higher risk of infections. Our results suggest that starting dialysis with a CVC does not confer a greater risk of death.

Introduction Roxadustat is an orally administered hypoxia-inducible factor prolyl hydroxylase inhibitor being developed for the treatment of anemia of chronic kidney disease (CKD). This European, phase 3, randomized, open-label, active-controlled study investigated efficacy and safety of roxadustat in patients with end-stage kidney disease on dialysis for at least 4 months. Methods Patients were randomized to switch from an erythropoiesis-stimulating agent (ESA) (epoetin alfa or darbepoetin alfa) to roxadustat three times/week or to continue their previous ESA. Roxadustat and ESA doses were adjusted to maintain hemoglobin within 10.0–12.0 g/dL during the treatment period (day 1 up to 52–104 weeks). Primary endpoints were hemoglobin change from baseline (CFB) to the average of weeks 28–36 without rescue therapy and hemoglobin CFB to the average of weeks 28–52 regardless of rescue therapy. Treatment-emergent adverse events (TEAEs) were assessed descriptively. Results Of 1081 screened patients, 836 were randomized and received treatment (roxadustat, n = 415; ESA, n = 421). The least squares means (95% CI) of the treatment difference (roxadustat − ESA) for hemoglobin CFB to weeks 28–36 (without rescue therapy) and CFB to weeks 28–52 (regardless of rescue therapy) were 0.235 (0.132, 0.339) g/dL and 0.171 (0.082, 0.261) g/dL, respectively, demonstrating non-inferiority of roxadustat to ESA (non-inferiority margin of − 0.75 g/dL). The proportions of patients who achieved target hemoglobin without rescue therapy during weeks 28–36 were 84.2% (roxadustat) and 82.4% (ESA). Roxadustat was superior to ESA in decreasing LDL cholesterol from baseline to the average of weeks 12–28. Serious TEAEs occurred in 50.7% (roxadustat) and 45.0% (ESA) of patients. Common TEAEs in both treatment groups included hypertension, arteriovenous fistula thrombosis, headache, and diarrhea. Conclusion Roxadustat was non-inferior to ESAs in maintaining hemoglobin levels in this cohort of patients with anemia of CKD on dialysis for at least 4 months who were previously treated with ESAs. Observed TEAEs were consistent with previous studies. Supplementary Information The online version contains supplementary material available at 10.1007/s12325-021-01904-6.

Introduction This integrated phase 3 analysis examined efficacy and cardiovascular safety for roxadustat vs erythropoiesis-stimulating agents (ESAs) in dialysis-dependent patients. Methods Efficacy and safety results from four phase 3, randomized, open-label studies comparing roxadustat to ESAs (PYRENEES, SIERRAS, HIMALAYAS, ROCKIES) in dialysis-dependent patients with anemia of chronic kidney disease (CKD) were evaluated by study, pooled population and in two subgroups: incident dialysis and stable dialysis. The primary efficacy endpoint per study was hemoglobin change from baseline (CFB) to weeks 28–36 using least-squares mean difference (LSMD) without rescue therapy. Pooled safety endpoints included time to major adverse cardiovascular event (MACE; myocardial infarction, stroke, and all-cause mortality [ACM]) and MACE+ (MACE plus congestive heart failure or unstable angina requiring hospitalization), ACM, and treatment-emergent adverse events (TEAEs). MACE and MACE+ were evaluated for non-inferiority at 1.8 and 1.3 margins using hazard ratios (HRs) and 95% confidence intervals (CIs). TEAEs were descriptively summarized. Results In total, 4714 patients were randomized (2354 roxadustat; 2360 ESA). Hemoglobin CFB to weeks 28–36 achieved non-inferiority for roxadustat vs ESA in each study. Roxadustat was non-inferior to ESA for risks for MACE and MACE+ in the entire cohort (MACE: HR 1.09, 95% CI 0.95–1.26; MACE+ : HR 0.98, 95% CI 0.86–1.11) and similar to the incident dialysis and stable dialysis subgroups; ACM results were consistent with MACE and MACE+ (HR 1.13, 95% CI 0.95–1.34). TEAEs were generally comparable between groups. Conclusion Roxadustat improved hemoglobin similarly to ESA while demonstrating comparable cardiovascular and overall safety profiles in a wide spectrum of dialysis-dependent patients with anemia of CKD. Roxadustat represents an oral alternative to ESAs for achieving a target hemoglobin for anemia of CKD in dialysis-dependent patients. Supplementary Information The online version contains supplementary material available at 10.1007/s12325-021-01903-7.

Enteric duplication cysts (EDCs) are rare congenital malformations of the children and can develop everywhere along the gastrointestinal (GI) tract, being the ileum the most frequent localization. We herein present an unusual case of duplication cyst of ileal origin who show a tubular morphology and doesn't communicate with GI lumen. A 2-month-old boy was admitted to our hospital for investigation of an anechoic formation of the lower right abdomen for the surgical planning. The patient was asymptomatic. Ultrasound (US) and magnetic resonance imaging (MRI) showed features of a cystic lesion. Laparoscopic surgery was performed and the cyst excised. Macroscopic examination and histologic findings confirmed the diagnosis of a enteric duplication cyst arising from the ileum. In a patient with an abdominal cystic mass, although asymptomatic, it's worth assessing the nature of the lesion and planning a surgery in order to avoid future complications. A correct use of diagnostic it's fundamental to identify the etiology and the characteristics of a cystic mass.

Background: This study aimed to review our 25-year experience with pediatric laparoscopic splenectomy (LS) and describe tips, tricks, and technical considerations. Methods: The records of 121 children, undergoing minimally invasive splenectomy in the last 25 years (1996-2021), were retrospectively reviewed. Median patient age was 10.2 years (range 7-17). The patients were grouped according to the period: G1 (1996-2005) included 31 patients undergoing open splenectomy using left subcostal minilaparotomy (G1a) and 28 receiving LS using supine position (G1b); G2 (2006-2021) included 62 patients undergoing LS using lateral decubitus. A five-trocar technique was adopted in G1b, with the spleen removed through a Pfannenstiel incision. In G2, we preferred to use lateral decubitus, 10-mm 30° optic, only four trocars, and sealing devices. In such cases, the spleen was placed in an endobag, finger-fragmented, and extracted through the umbilicus. Furthermore, indocyanine green (ICG) fluorescence was used in the last 4 G2 patients to clearly identify the vascular anatomy. Results: The median operative time was 65 minutes in G1a, 125 in G1b, and 95 in G2. Complications occurred intraoperatively in 14 cases (11.5%): 5 bleedings during dissection (G1b), 4 endobag breakages during spleen removal (G2); 3 spleen capsule breakages during removal (G1a); and 2 instrumentation failures (G2). No conversions to open occurred. Median hospital stay was 6 days in G1a and 4 days in G1b and G2. Conclusions: LS is a standardized and effective procedure in children and is preferable to mini- or conventional open splenectomy. Our 25-year experience showed that major complications may occur even in expert hands, mainly during hilar dissection or spleen extraction. Technically, sealing devices and ICG fluorescence were helpful to perform a safer and faster procedure. We believe that lateral decubitus and 30° optic should be considered technical key points to provide excellent organ exposure and easier dissection of hilar structures.

Kidney international 103(2), 391-402 (2022). doi:10.1016/j.kint.2022.09.017, Published by Elsevier, New York, NY

Background: This study aimed to report a European multi-institutional experience about thoracoscopic management of children with congenital lung malformations. Methods: The records of 102 patients (49 girls and 53 boys) with median age at surgery of 1 year (range 6 months-1.5 years), who underwent thoracoscopic lobectomy in five European Pediatric Surgery units, were retrospectively collected. Indications for surgery included congenital pulmonary airway malformation (CPAM) (n = 47), intra- and extralobar pulmonary sequestration (n = 34), hybrid lesion (CPAM/intralobar sequestration) (n = 2), severe bronchiectasis (n = 9), congenital lobar emphysema (n = 8), and others (n = 2). The condition was asymptomatic in 77/102 (75.5%), whereas symptoms such as recurrent pneumonia and/or respiratory distress were present in 25/102 (24.5%). Results: Surgical procedures included 18 upper, 20 middle, and 64 lower lobe resections. No conversions to open were reported. A 3 mm sealing device and 5 mm stapler were adopted in the last 48/102 patients (47%). The median operative time was 92.2 minutes (range 74-141). The median operative time significantly decreased in patients in whom the vessel division and bronchial sealing were performed using sealing devices (75.5 minutes) compared with suture ligations (118.9 minutes) (P = .001). The median hospital stay was 3.7 days (range 2-6.2). Three/102 patients (2.9%) developed postoperative complications, including air leakage requiring pleural drainage (n = 1) (Clavien IIIb) and respiratory infection (n = 2) (Clavien II). A reoperation was required in one patient with residual pleuropulmonary blastoma (0.9%). All symptomatic patients reported resolution of symptoms postoperatively. Conclusions: Thoracoscopic lobectomy is a safe and effective procedure with excellent cosmetic outcome, in expert hands. Based upon our experience, we strongly recommend surgery in patients with congenital lung malformations by the first year of life, to reduce the risk of infection and make the procedure technically easier, despite the small patients' size. Surgeon's experience and use of miniaturized instruments and sealing devices remain key factors for successful outcome.

Background Roxadustat is an orally active hypoxia-inducible factor prolyl hydroxylase inhibitor for the treatment of chronic kidney disease (CKD) anemia. Methods This Phase 3, multicenter, randomized, double-blind, placebo-controlled study examined patients with Stages 3–5 CKD, not on dialysis (NCT01887600). Patients were randomized (2:1) to oral roxadustat or placebo three times weekly for 52–104 weeks. This study examined two primary efficacy endpoints: European Union (European Medicines Agency)—hemoglobin (Hb) response, defined as Hb ≥11.0 g/dL that increased from baseline (BL) by ≥1.0 g/dL in patients with Hb >8.0 g/dL or ≥2.0 g/dL in patients with BL Hb ≤8.0 g/dL, without rescue therapy, during the first 24 weeks of treatment; US Food and Drug Administration—change in Hb from BL to the average Hb level during Weeks 28–52, regardless of rescue therapy. Secondary efficacy endpoints and safety were examined. Results A total of 594 patients were analyzed (roxadustat: 391; placebo: 203). Superiority of roxadustat versus placebo was demonstrated for both primary efficacy endpoints: Hb response [odds ratio = 34.74, 95% confidence interval (CI) 20.48–58.93] and change in Hb from BL [roxadustat – placebo: +1.692 (95% CI 1.52–1.86); both P, Graphical Abstract

This study investigated the social and cultural representations that employees of the Municipality of Naples hold concerning violence against women. The aim of this research was to explore if and how they attribute blame for gender-based violence and their perception of the effectiveness of resolution strategies focused on either preventing or actively combating violence against women. Their results showed that when respondents attribute violence to sociocultural factors, they recognize the importance of implementing effective resolution strategies. Conversely, those who primarily place the blame for violence against women on male individual characteristics generally do not support and propose strategies to stop this kind of violence. Moreover, violence perpetrators not resulting in the work context or in the neighborhood of the respondents and implications of these data will be further discussed.

BACKGROUND AND AIMS Despite World Health Organisation recommends a salt intake of METHOD We conducted a single centre, cross-sectional, observational study enrolling patients older than 18, with a diagnosis of chronic kidney disease stage 3 to 5, who underwent a regular visit at the outpatient clinic of our Unit, from 12 March 2021 to 10 October 2021. Clinical data, including medical history, treatments and sociodemographic information were collected from patients’ records. Anthropometric measurements were performed during the visit. Every patient was asked to provide a random urine sample, to perform a 24-h urine collection and filled a questionnaire on Knowledge, Attitude and Practice toward salt that we adapted from other studies[1,2]; a section was focused on Mediterranean Diet adherence. Salt intake was assessed by means of 24-h sodium excretion and using three equations (namely Tanaka, Nerbass and Kawasaki) to estimate it from spot urine. Adequacy of 24-h urine collection was defined upon values of creatininuria. We evaluated whether there was a correlation between sodium intake with demographic and clinical data and with the scores from various sections of the questionnaire. RESULTS We enrolled 90 patients, 55 males and 35 females, aged 73.7 ± 8.7 years; mean BMI was 29.1 ± 5.5. Of 90 patients, 78 provided the 24-h urine collection; however, 30 out of 78 were not included due to inadequacy. Twenty-four hours sodium excretion of remaining 48 was compared with the estimates obtained from spot urine. Bland Altman test revealed best performance for Tanaka equation (bias 0.99 ± 62.5 mEq/d, 95% LoA from -121.6 to 123.6); thus, this was used for subsequent analysis. Mean sodium intake in our population was 156.2 ± 50.5 mEq/d. We found no difference in sodium intake according to gender, age, stage of CKD, blood pressure, education, smoking habits or residency; however, we found higher intake in overweight (148.5 ± 38.9 mEq/d) and obese (179.5 ± 62.4 mEq/d) people when compared with normal weight subjects (142.2 ± 43.1 mEq/d; P = 0.0301). Patients on diuretic treatment were found to have higher sodium intake (173.6 ± 58.6 versus 137.9 ± 30.7 mEq/d, P = 0.0018), but there was no association of sodium intake with number of antihypertensive medications. Although 63.3% of patients thought of consuming a diet with the right amount of salt, less than 10% of them knew exactly the recommended daily salt intake. We found no correlation between the questionnaire scores and clinical and sociodemographic data, even if female patients showed a trend toward better performance in Knowledge (P = 0.0756) and Mediterranean Diet adherence (P = 0.0632). A positive correlation between Knowledge and Practice scores was found (r = 0.3506, P = 0.0007). CONCLUSION Our study shows that the mean salt intake in chronic kidney disease patient is much higher than recommended, despite the importance of a low salt diet. Obese patients showed the highest sodium intake, possibly due to the elevate intake of processed food. The questionnaire showed a lack of knowledge that encompasses every sociodemographic category. Also, the high number of inadequate 24-h urine collections points out the critical role of the assessment method, which may need to be reconsidered.

Robot-assisted extravesical ureteral reimplantation (REVUR) is a well established approach for surgical treatment of pediatric vesicoureteral reflux (VUR). However, further evidence is needed to confirm its efficacy even in case of complex anatomy.This study aimed to further confirm the evidence that REVUR is safe and effective in both simple and complex ureter anatomy.The charts of all patients with VUR, who received REVUR in 6 different institutions over a 5-year period, were retrospectively reviewed. Patients with both simple and complex ureter anatomy were included. Patient demographics, surgical variables, and post-operative results were assessed. VUR resolution was defined as either being resolved VUR on voiding cystourethrogram (VCUG) or clinically without symptoms during the follow-up.Fifty-seven patients with median age of 6.9 years (range 4.5-12), receiving REVUR in the study period, were included. Eighteen (31.6%) patients had complex anatomy and included prior failed endoscopic injection (n = 13), complete ureteral duplication (n = 2), periureteral diverticulum (n = 2), ectopic megaureter requiring dismembering (n = 1). The median operative time was 155 min for unilateral and 211.5 min for bilateral repairs. The clinical + radiographic VUR resolution rate was 96.5%. Post-operative complications (Clavien 2) included urinary retention following bilateral repair (n = 5, 8.7%), febrile urinary tract infection (UTI) (n = 6, 10.5%) and gross hematuria (n = 3, 5.2%). Comparative analysis between simple and complex cases showed that REVUR was faster in simple cases in both unilateral [p = 0.002] and bilateral repair [p = 0.001] and post-operative urinary retention was more frequent in simple cases [p = 0.004] and in patients with pre-operative bowel and bladder dysfunction (BBD) [p = 0.001] (Table).This series confirmed that the robot-assisted technique was feasible even in cases with complex anatomy using some technical refinements, that justified the longer operative times in both unilateral and bilateral cases. An interesting finding of this study was the correlation emerged between BBD and risk of post-operative urinary retention and VUR persistence. Our results also excluded any significant correlation between complex cases and risk of post-operative urinary retention. The main study limitations included the retrospective and nonrandomized design, the small number of cases and the arbitrary definition of complex anatomy.REVUR was safe and effective for management of VUR in both simple and complex ureter anatomy. Complex REVUR required slightly longer operative times, without significant differences in post-operative mordidity and success rates. Aside from complex anatomy, BBD emerged as the main risk factor associated with surgical failure and post-operative morbidity.

High altitude can be a hostile environment and a paradigm of how environmental factors can determine illness when human biological adaptability is exceeded. This paper aims to provide a comprehensive review of high-altitude sickness, including its epidemiology, pathophysiology, and treatments. The first section of our work defines high altitude and considers the mechanisms of adaptation to it and the associated risk factors for low adaptability. The second section discusses the main high-altitude diseases, highlighting how environmental factors can lead to the loss of homeostasis, compromising important vital functions. Early recognition of clinical symptoms is important for the establishment of the correct therapy. The third section focuses on high-altitude pulmonary edema, which is one of the main high-altitude diseases. With a deeper understanding of the pathogenesis of high-altitude diseases, as well as a reasoned approach to environmental or physical factors, we examine the main high-altitude diseases. Such an approach is critical for the effective treatment of patients in a hostile environment, or treatment in the emergency room after exposure to extreme physical or environmental factors.

Purpose This multi-institutional study aimed to assess the outcomes of laparoscopic ureterocalicostomy (LUC) and robot-assisted laparoscopic ureterocalicostomy (RALUC) and compare them with laparoscopic pyeloplasty (LP) and robot-assisted laparoscopic pyeloplasty (RALP) in children with pelvi-ureteric junction obstruction (PUJO). Methods The data of 130 patients (80 boys), with median age 7.6 years and median weight 33.8 kg, receiving minimally invasive treatment of PUJO over a 6-year period, were retrospectively analyzed. Patients were grouped according to the operative approach: G1 included 15 patients, receiving LUC (n = 9) and RALUC (n = 6), and G2 included 115 patients, receiving LP (n = 30) and RALP (n = 85). Patient characteristics and operative outcomes were compared in both groups. Results The median patient age and weight were significantly higher in G1 than in G2 [p = 0.001]. The median operative time was similar in both groups (157.6 vs 150.1 min) [p = 0.66] whereas the median anastomotic time was shorter in G1 than in G2 (59.5 vs 83.1 min) [p = 0.03]. The surgical success rate was similar in both groups (100% vs 97.4%) [p = 0.33]. Post-operative complications rate was higher in G1 than in G2 (20% vs 6.1%) but all G1 complications were Clavien 2 and did not require re-intervention. Conclusion LUC/RALUC can be considered safe and effective alternative approaches to LP/RALP for PUJO repair and reported excellent outcomes as primary and salvage procedures. Robot-assisted technique was the preferred option to treat most patients with recurrent PUJO in both groups.

Objectives To present a technical tip to be incorporated in the first stage of a 2-stage graft repair of proximal hypospadias associated with curvature, aiming at widening the graft bed and enhancing mobility of the lateral portions of the graft for subsequent urethroplasty. Methods After penile straightening, the dorsal dartos layer, carefully preserved attached to the dorsal penile skin used for penile coverage, is anchored to the lateral edges of the denuded corpora cavernosa with 3 to 4 interrupted 6-0 resorbable stiches on each side. The dartos creates a sort of hammock in-between the corpora, on which the central portion of the graft is quilted as in standard staged graft repair, and the skin margins laterally. Therefore, it widens the graft bed by 3-4 mm on each side. The lateral portions of the graft, laying on dartos, also remain supple for subsequent tabularization. Results Between 2017 and 2019, the technique was used in 16 cases (range 10-19 months). None of these patients required re-grafting because of severe longitudinal graft shrinkage. Conclusion The described modification seems a simple tip to be incorporate in staged graft urethroplasty. Putative advantages include that a wider graft can compensate for some graft shrinkage occurring in-between stages; during the second stage, it can facilitate dissection and improve mobility of the lateral graft portions for tubularization, and make retrieval of a dartos flap for urethroplasty coverage easier. Prospective evaluation and comparative data are needed.

Background: The injection of tissue adhesives has been proposed as an alternative to standard laparoscopic inguinal hernia repair but no evidence is available in the pediatric population. This study aimed to evaluate safety, efficacy, and feasibility of injection of tissue adhesives for inguinal hernia repair in a rabbit model. Materials and Methods: Thirty-six New Zealand White male rabbits underwent laparoscopic inguinal hernia repair. In each animal, the hernia defect was repaired using glue on the right side and purse-string suture on the left side. The animals were divided in 3 groups, each 1 of 12 animals, according to the glue used: Glubran 2® (cyanoacrylate), Histoacryl® (cyanoacrylate), and BioGlue® (bovine serum albumin-based). For each group, 6 animals were sacrificed at 7 days postoperatively, and 6 animals at 90 days postoperatively. Histopathological exam of testis and spermatic bundle was performed. Results: The hernia defect was successfully closed on both sides in all cases. The injection of glue was faster than suture repair (P = .001). Postoperative complications (epiploon-parietal adhesions, spermatic vessel ectasia, and hydrocele) rate was significantly higher on the right side compared to the left side at both short- and long-term follow-up (P = .001). Furthermore, a lower maturity of testicles treated by adhesive compared with suture was histologically demonstrated at both short- and long-term follow-up (P = .001). Conclusions: The present experimental study confirmed the feasibility and efficacy of inguinal hernia repair by injection of tissue adhesive. However, several critical issues emerged about the safety of this technique. The use of glue was associated with higher incidence of postoperative complications and significant decrease of testicular maturity compared with standard suture repair. Based upon these preliminary results, repair using suture remains the standard of care for inguinal hernia in children. Further experimental studies are needed to assess the safety of injection of tissue adhesives for pediatric inguinal hernia repair.

The increased prevalence of chronic kidney disease (CKD) in elderly patients recognizes, as main cause, the long-term exposure to atherosclerosis and hypertension. Chronic ischemic damage due to critical renal arterial stenosis induces oxidative stress and intra-renal inflammation, resulting in fibrosis and microvascular remodelling, that is the histological picture of atherosclerotic renal vascular disease (ARVD). The concomitant presence of a long history of hypertension may generate intimal thickening and luminal narrowing of renal arteries and arterioles, glomerulosclerosis, interstitial fibrosis and tubular atrophy, more typically expression of hypertensive nephropathy. These complex mechanisms contribute to the development of CKD and the progression to End Stage Kidney Disease. In elderly CKD patients, the distinction among these nephropathies may be problematic; therefore, ischemic and hypertensive nephropathies can be joined in a unique clinical syndrome defined as atherosclerotic nephropathy. The availability of novel diagnostic procedures, such as intra-vascular ultrasound and BOLD-MRI, in addition to traditional imaging, have opened new scenarios, because these tools allow to identify ischemic lesions responsive to renal revascularization. Indeed, although trials have deflated the role of renal revascularization on the renal outcomes, it should be still used to avoid dialysis initiation and/or to reduce blood pressure in selected elderly patients at high risk. Nonetheless, lifestyle modifications (smoking cessation, increased physical activity), statins and antiplatelet use, as well as cautious use of renin-angiotensin system inhibitors, remain the main therapeutic approach aimed at slowing the renal damage progression. Mesenchymal stem cells and Micro-RNA are promising target of anti-fibrotic therapy, which might provide potential benefit in ARVD patients, though safety and efficacy profile in humans is unknown too.

Purpose: To present the outcomes of the laparoscopic and robotic treatment of pediatric simple renal cysts with two novel modifications: the indocyanine green (ICG) fluorescence and the perirenal f...

Gut microbiota is emerging as a key regulator of many disease conditions and its dysregulation is implicated in the pathogenesis of several gastrointestinal and extraintestinal disorders. More recently, gut microbiome alterations have been linked to neurodegeneration through the increasingly defined gut microbiota brain axis, opening the possibility for new microbiota-based therapeutic options. Although several studies have been conducted to unravel the possible relationship between Alzheimer’s Disease (AD) pathogenesis and progression, the diagnostic and therapeutic potential of approaches aiming at restoring gut microbiota eubiosis remain to be fully addressed. In this narrative review, we briefly summarize the role of gut microbiota homeostasis in brain health and disease, and we present evidence for its dysregulation in AD patients. Based on these observations, we then discuss how dysbiosis might be exploited as a new diagnostic tool in early and advanced disease stages, and we examine the potential of prebiotics, probiotics, fecal microbiota transplantation, and diets as complementary therapeutic interventions on disease pathogenesis and progression, thus offering new insights into the diagnosis and treatment of this devastating and progressive disease.