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Background: In patients with asthma, particularly severe asthma, poor adherence to inhaled drugs negatively affects the achievement of disease control. A better adherence rate is expected in the case of injected drugs, such as omalizumab, as they are administered only in a hospital setting. However, adherence to omalizumab has never been systematically investigated. The aim of this study was to review the omalizumab drop-out rate in randomized controlled trials (RCTs) and real-life studies. A comparative analysis was performed between published data and the Italian North East Omalizumab Network (NEONet) database.Results: In RCTs the drop-out rate ranged from 7.1 to 19.4 %. Although the reasons for withdrawal were only occasionally reported, patient decision and adverse events were the most frequently reported causes. In real-life studies the drop-out rate ranged from 0 to 45.5 %. In most cases lack of efficacy was responsible for treatment discontinuation. According to NEONet data, 32 % of treated patients dropped out, with an increasing number of drop outs observed over time. Patient decision and lack of efficacy accounted for most treatment withdrawals.Conclusions: Treatment adherence is particularly crucial in patients with severe asthma considering the clinical impact of the disease and the cost of non-adherence. The risk of treatment discontinuation has to be carefully considered both in the experimental and real-life settings. Increased knowledge regarding the main reasons for patient withdrawal is important to improve adherence in clinical practice. [ABSTRACT FROM AUTHOR]

Aim: To investigate the prevalence of biopsy-proven non-alcoholic steatohepatitis (NASH) in a cohort of patients with morbid obesity and with or without type 2 diabetes (T2D) and to find non-invasive predictors of NASH severity., Methods: We evaluated a cohort of 412 subjects (age 19-67 years, body mass index-BMI: 44.98 kg/m 2 ), who underwent fine-needle liver biopsy during bariatric surgery. Thirty-six percent of the subjects were affected by T2D. Liver biopsies were classified according to the Kleiner's NAFLD Activity Score (NAS). NAFLD Fibrosis Score (NFS), AST/ALT ratio, AST to Platelet ratio (APRI), fibrosis-4 score (FIB4) were calculated. A neural network analysis (NNA) was run to predict NASH severity., Results: The prevalence of biopsy-proven NASH was 63% and 78% in subjects with obesity and without or with T2D, respectively. T2D doubled the risk of NASH [OR 2.079 (95% IC=1.31-3.29)]. The prevalence of NAFL increased with the increase of BMI, while there was an inverse correlation between BMI and NASH (r=-0.145 p=0.003). Only mild liver fibrosis was observed. HOMA-IR was positively associated with hepatocyte ballooning (r=0.208, p<0.0001) and fibrosis (r=0.159, p=0.008). The NNA highlighted a specificity of 77.3% using HDL-cholesterol, BMI, and HOMA-IR as main determinants of NASH., Conclusions: Our data show a higher prevalence of NASH in patients with morbid obesity than reported in the literature and the pivotal role of T2D among the risk factors for NASH development. However, the inverse correlation observed between BMI and biopsy-proven NASH suggests that over a certain threshold adiposity can be somewhat protective against liver damage. Our model predicts NASH presence with high specificity, thus helping identifying subjects who should promptly undergo liver biopsy., (Copyright © 2022 Elsevier Masson SAS. All rights reserved.)

From mid-March 2020, the pandemic caused by COVID 19 has placed health facilities in front of the need to implement a rapid and profound reorganization. However, many hospitals have not had time to organize a rapid and effective response, both for the speed of spread of the virus, and for the lack of previous experience with a pandemic of this magnitude. With the aim of assessing the knowledge and adoption of the procedures and recommendations disseminated by hospitals during the COVID-19 pandemic, in the dialysis and hemodialysis services of Italian centers, a cross-sectional survey was designed by the Society of Nurses in Nephrology (SIAN). The online survey was conducted among nurses who work in the Italian services of dialysis and hemodialysis during the first and second waves. The online survey was completed by 150 nurses. Although hospitals have set up protocols and procedures for patient management during the COVID-19 pandemic, among participants not all were aware of it. With regard to the training of personnel in the use of personal protective equipment, 18.6% declared that they have not received it. The majority implemented specific precautions for patient management, awareness and information., (Copyright by Società Italiana di Nefrologia SIN, Rome,Italy.)

Background and Objectives: Lower extremity lymphedema (LEL) is one of the most relevant chronic and disabling sequelae after gynecological cancer therapy involving pelvic lymphadenectomy (PL). Supermicrosurgical lymphaticovenular anastomosis (LVA) is a safe and effective procedure to treat LEL, particularly indicated in early-stage cases when conservative therapies are insufficient to control the swelling. Usually, preoperative assessment of these patients shows patent and peristaltic lymphatic vessels that can be mapped throughout the limb to plan the sites of skin incision to perform LVA. The aim of this study is to report the efficacy of our approach based on planning LVA in three areas of the lower limb in improving early-stage gynecological cancer-related lymphedema (GCRL) secondary to PL. Materials and Methods: We retrospectively reviewed the data of patients who underwent LVA for the treatment of early-stage GCRL following PL. Patients who had undergone groin dissection were excluded. Our preoperative study based on indocyanine green lymphography (ICG-L) and color doppler ultrasound (CDU) planned three incision sites located in the groin, in the medial surface of the distal third of the thigh, and in the upper half of the leg, to perform LVA. The primary outcome measure was the variation of the mean circumference of the limb after surgery. The changes between preoperative and postoperative limbs’ measures were analyzed by Student’s t-test. p values < 0.05 were considered significant. Results: Thirty-three patients were included. In every patient, three incision sites were employed to perform LVA. A total of 119 LVA were established, with an average of 3.6 for each patient. The mean circumference of the operated limb showed a significant reduction after surgery, decreasing from 37 cm ± 4.1 cm to 36.1 cm ± 4.4 (p < 0.01). Conclusions: Our results suggest that in patients affected by early-stage GCRL secondary to PL, the placement of incision sites in all the anatomical subunits of the lower limb is one of the key factors in achieving good results after LVA.

Introduction: Surgical therapy for vulvar cancer involves wide defects that often require flap-based reconstruction. The goal of the reconstruction is fast wound healing with low donor site morbidity., Materials and Methods: This is a retrospective observational cohort study in which we reviewed all patients who underwent surgery for vulvar cancer followed by reconstruction using the Superficial Circumflex Iliac Artery Perforator (SCIP) flap between 2015 and 2020. The primary outcome measure of this investigation was the incidence of wound complications. The secondary outcomes were the surgical indications in terms of establishing the anatomical subunits involved in the resection that made us choose this flap for reconstruction. This study adheres to the STROBE guidelines., Results: Thirty-two patients were included; in two cases, the flap was performed bilaterally for a total of 34 SCIP flaps. The mean age of patients was 70.6 ± 8.6 years, and the mean BMI was 26.8 ± 4.7. The SCIP flap was always feasible. The mean flap size was 128.8 ± 74.3cm 2 . Three patients showed wound complications. In every patient, the defect involved the vulva, perineum and inguinal area; in 18 patients, the mons pubis was also involved. The mean follow-up was 30 months. During the follow-up, six patients died, and four showed local or nodal cancer relapse., Conclusion: Our results suggest that the advantages of SCIP flap for the reconstruction of vulvoperineal defects secondary to vulvar cancer surgery include low complication rate, minimal donor site morbidity, quick dissection, proximity of donor and recipient sites, possibility to harvest large skin islands of variable thickness and chimeric flaps., Competing Interests: Declaration of Competing Interest None., (Copyright © 2021 Elsevier Ltd. All rights reserved.)

Inguinofemoral lymphadenectomy, frequently performed for vulvar cancer, is burdened with substantial immediate and long-term morbidity. One of the most disabling treatment-related sequelae is lower limb lymphedema (LLL). The present study aims to describe the wound complications and the severity of LLL in patients who have undergone groin dissection for vulvar cancer and immediate inguinal reconstruction with the Lymphatic Superficial Circumflex Iliac Perforator flap (L-SCIP). We retrospectively reviewed the data of patients who underwent bilateral groin dissection and unilateral inguinal reconstruction with the L-SCIP. The presence and severity of postoperative LLL during the follow-up period were assessed by lymphoscintigraphy and limbs' volume measurement. In addition, immediate complications at the level of the inguinal area were registered. The changes between preoperative and postoperative limb volumes were analyzed by Student's t test. p values < 0.05 were considered significant. Thirty-one patients were included. The mean variation of volume was 479 ± 330 cc3 in the side where groin reconstruction had been performed, and 683 ± 425 cc3 in the contralateral side, showing smaller variation in the treated side ( p = 0.022). Lymphoscintigraphy confirmed the clinical findings. Based on our results, inguinal reconstruction with L-SCIP performed at the same time of groin dissection in patients treated for vulvar cancer can provide a significant protective effect on LLL.

Coronavirus disease 2019 is an infectious respiratory syndrome caused by the virus called SARS-CoV-2, belonging to the family of coronaviruses. The first ever cases were detected during the 2019-2020 pandemic. Coronaviruses can cause a common cold or more serious diseases such as Middle Eastern Respiratory Syndromes (MERS) and Severe Acute Respiratory Syndrome (SARS). They can cause respiratory, lung and gastrointestinal infections with a mild to severe course, sometimes causing the death of the infected person. This new strain has no previous identifiers and its epidemic potential is strongly associated with the absence of immune response/reactivity and immunological memory in the world population, which has never been in contact with this strain before. Most at risk are the elderly, people with pre-existing diseases and/or immunodepressed, dialyzed and transplanted patients, pregnant women, people with debilitating chronic diseases. They are advised to avoid contacts with other people, unless strictly necessary, and to stay away from crowded places, also observing scrupulously the recommendations of the Istituto Superiore di Sanità. In this article we detail the recommendations that must be followed by the nursing care staff when dealing with chronic kidney disease patients in dialysis or with kidney transplant patients. We delve into the procedures that are absolutely essential in this context: social distancing of at least one meter, use of PPI, proper dressing and undressing procedures, frequent hand washing and use of gloves, and finally the increase of dedicated and appropriately trained health personnel on ward., (Copyright by Società Italiana di Nefrologia SIN, Rome, Italy.)

Nonalcoholic fatty liver disease (NAFLD) is the most common cause of liver-related mortality. NAFLD is associated with obesity, hepatic fat accumulation, and insulin resistance, all of which contribute to its pathophysiology. Weight-loss is the main therapy for NAFLD, and metabolic surgery is the most effective treatment for morbid obesity and its metabolic comorbidities. Although has been reported that Roux-en-Y gastric bypass can reverse NAFLD, it is unclear whether such effects result from reduced weight, from a lower calorie-intake, or from the direct influence of surgery on mechanisms contributing to NAFLD. We aimed to investigate whether gastrointestinal (GI) bypass surgery could induce direct effects on hepatic fat accumulation and insulin resistance, independently of weight reduction. Twenty Wistar rats on a high-fat diet underwent duodenal-jejunal-bypass (DJB) or sham operation and were pair fed (PF) for 15 wk after surgery to obtain a matched weight. Outcome measures include ectopic fat deposition, expression of genes and proteins involved in fat metabolism, insulin-signaling, and gluconeogenesis in liver and muscle. Despite no differences in body weight and calorie intake, DJB showed lower ectopic fat accumulation, improved peripheral and hepatic insulin sensitivity, and enhanced lipid droplet degradation. In both tissues, DJB increased insulin signaling, whereas hepatic key enzymes involved in gluconeogenesis and de novo lipogenesis were decreased. These findings suggest that DJB can reverse, independently of weight loss, ectopic fat deposition and insulin resistance, two features of NAFLD that share a mutual pathway, in which perilipin-2 (PLIN2) seems to be the main player, supporting further investigation into strategies that target the gut to treat metabolic liver diseases. NEW & NOTEWORTHY Our findings suggest that duodenal-jejunal bypass can reverse, independently of weight loss, ectopic fat deposition and insulin resistance, two features of nonalcoholic fatty liver disease that share a mutual pathway, in which perilipin-2 seems to be the main player. Our study supports further investigation into the role of proximal small intestine exclusion in the pathophysiology of nonalcoholic fatty liver disease to uncover less invasive treatments that mimic the effects of metabolic surgery and aims to prevent and treat metabolic liver disease.

Introduction: Pelvic lymphadenectomy (PL) causes changes to the inguinal lymph nodes with progressive loss of immune and lymphatic pump function. Efferent lymphatic vessel-to-venous anastomosis (ELVA) has been reported to address this problem. The aim of this report was to describe the feasibility of the SPECT/CT combined with ultrasound fusion imaging (UFI) to target the groin efferent lymph node (GELN) for ELVA., Patients and Methods: Twelve patients with lower limb lymphedema after PL were scheduled for peripheric lymphaticovenular anastomosis (LVA) combined with ELVA. All-patients were clinically ISL-stage1, with good visualization of the inguinal lymph nodes at preoperative lymphoscintigraphy. The mean patient age was 55.4 years and the mean BMI was 25.5.The mean limb circumference (MLC) was calculated before surgery and 1 year after surgery. The LymQoL-Leg questionnaire was administered before surgery and 6 months after surgery. Before surgery, the GELN was identified by SPECT/CT and its location was marked on the skin by UFI virtual navigation. Peripheric LVA sites were planned by ultrasound and indocyanine green (ICG) lymphography. Pre and postoperative MLC and LymQoL-Leg scores were compared., Results: In all-patients, the SPECT/CT succeeded at detecting and targeting the GELN. In all-patients, real-time anatomical coregistration with US was feasible, and it was possible to mark on the groin skin the depth and position of the GELN on the skin at the groin. During surgery, in every patient, we found the GELN marked before surgery and performed ELVA. We also performed two or three peripheric LVAs in every patient. The mean value of MLC decreased (38.2 ± 2.13 cm vs. 36.33 ± 2.14 cm; p = .04) and the mean score of the LymQoL-Leg questionnaire improved (9.3 ± 1.7 vs. 7.7 ± 1.1; p = .02)., Conclusion: SPECT/CT combined with UFI is feasible for the preoperative identification of GELN for ELVA., (© 2019 Wiley Periodicals, Inc.)

Several different flaps based on the feeding vessels of sensitive nerves have been described in the limbs. This article reports the case of a neurocutaneous flap based on the lateral femoral cutaneous nerve (LFCN), employed for reconstruction of an inguinal defect. A 61-years-old female patient had undergone vulvectomy and bilateral inguinal lymphadenectomy for vulvar cancer with postoperative left groin wound breakdown. After a 3 weeks negative pressure therapy course, she presented a 10 × 4 cm skin and subcutaneous defect with undermined edges in the left inguinal area. Reconstruction with 14 × 6 cm pedicled left anterolateral thigh flap was planned. After the dissection of the vascular pedicle and of the sensitive nerve, complete thrombosis of both the veins and arterial spasm of perforating pedicle was detected. As the flap color was good, and slow marginal bleeding was present, we inspected the small vessels surrounding the nerve that were pulsating. To confirm the vascularization coming from the neural pedicle, we clamped the perforator and performed intraoperative indocyanine green (ICG) fluorescence angiography that showed a good fluorescence of the flap with a proximal to distal pattern of progression. The flap was transferred on the neural pedicle, survived completely, and wounds healed normally. Three months after surgery, the patient underwent radiotherapy, with uneventful course. In her last follow-up, 2 years after surgery, patient was free of disease and the flap showed normal scarring. This is the first case reported of a pedicled neurocutaneous flap based on the LFCN, indicating that in case of unsuitable perforators it could be an alternative pedicle., (© 2019 Wiley Periodicals, Inc.)

Randomized clinical trials (RCTs) are the gold standard for the assessment of any therapeutic intervention. Real-life (R-L) studies are needed to verify the provided results beyond the experimental setting. This review aims at comparing RCTs and R-L studies on omalizumab in adult severe allergic asthma, in order to highlight the concurring results and the discordant/missing data. The results of a selective literature research, including "omalizumab, controlled studies, randomized trial, real-life studies" as key words are discussed. Though some similarities between RCTs and R-L studies strengthen omalizumab efficacy and safety outcomes, significant differences concerning study population features, follow-up duration, local adverse events and drop-out rate for treatment inefficacy emerge between the two study categories. Furthermore the comparative analysis between RCTs and R-L studies highlights the need for further research, concerning in particular long-term effects of omalizumab and its impact on asthma comorbidities., (Copyright © 2015 Elsevier Ltd. All rights reserved.)

Introduction: Muscles of the nose are active in facial movements both with the other facial muscles. An active depressor septi muscle (DSN) can accentuate a drooping nasal tip and shorten the upper lip on animation, especially during smiling. Paralysis of the DSN allows the tip of the nose to be lifted up., Materials and Methods: Between January and June 2011 a double blinded, randomized study was performed on 40 patients for nasal defects as "plunging" tip. 20 patients underwent to Botulinum toxin injection (B), 20 patients were treated with placebo such as saline solution (S). Both aesthetic and functional results were evaluated using objective and subjective parameters at time 0, after 7, 15 and 30 days and values were compared using t Student test., Results: S group results were not significant from an objective point of view. In botulinum group, patients showed an increase in columellar-lip distance. Satisfaction of the Group B patients was an average of 6.3 on VAS (range from 4 to 9). VAS mean values were studied with t-Student test and were found significant., Discussion: Several authors recommend the incision of DSN muscle during rhinoplasty to correct the plunging tip. In patients with no needs for rhinoplasty this procedure is unnecessary and a quick and targeted injection of Botulinum toxin is the most convenient choice to improve aesthetic of the plunging tip.

Introduction: Metatypical cell carcinoma is a quite rare malignancy (5% of all non melanoma skin cancers), with features of basal cell carcinoma and squamous cell carcinoma. It is described as coexistence of basal cell carcinoma and squamous cell carcinoma with no transition zone between them., Materials and Methods: We performed a retrospective study of 327 consecutive patients, diagnosed for metatypical carcinoma. Statistical analysis was made to determinate most affected areas, gender prevalence, average age, presence of ulceration and infiltration, peripheral clearance rate., Results: A relevant difference came out between two genders. Chi-square test emphasized a relation between females and the presence of carcinoma on the scalp. In addition a strong correlation between mixed subtype and ulceration was evident. A strong relation between intermediate subtype and positive surgical margin was found; this data could identify a more aggressive behavior of intermediate type., Discussion: Differently from melanoma that usually arises on sun exposed areas, no relation was found between sun exposion and this tumor. This characteristic stresses on the importance of other risks factor apart from sun exposition., Conclusions: We identify some correlation between our data that cannot be explained with previous interpretation of sun exposition.