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OBJECTIVE: To assess short-term outcomes after minimally invasive (laparoscopic, robot-assisted, and hybrid) pancreatoduodenectomy (MIPD) versus open pancreatoduodenectomy (OPD) among European centers. BACKGROUND: Current evidence on MIPD is based on national registries or single expert centers. International, matched studies comparing outcomes for MIPD and OPD are lacking. METHODS: Retrospective propensity score matched study comparing MIPD in 14 centers (7 countries) performing ≥10 MIPDs annually (2012-2017) versus OPD in 53 German/Dutch surgical registry centers performing ≥10 OPDs annually (2014-2017). Primary outcome was 30-day major morbidity (Clavien-Dindo ≥3). RESULTS: Of 4220 patients, 729/730 MIPDs (412 laparoscopic, 184 robot-assisted, and 130 hybrid) were matched to 729 OPDs. Median annual case-volume was 19 MIPDs (interquartile range, IQR 13-22), including the first MIPDs performed in 10/14 centers, and 31 OPDs (IQR 21-38). Major morbidity (28% vs 30%, P = 0.526), mortality (4.0% vs 3.3%, P = 0.576), percutaneous drainage (12% vs 12%, P = 0.809), reoperation (11% vs 13%, P = 0.329), and hospital stay (mean 17 vs 17 days, P > 0.99) were comparable between MIPD and OPD. Grade-B/C postoperative pancreatic fistula (POPF) (23% vs 13%, P < 0.001) occurred more frequently after MIPD. Single-row pancreatojejunostomy was associated with POPF in MIPD (odds ratio, OR 2.95, P < 0.001), but not in OPD. Laparoscopic, robot-assisted, and hybrid MIPD had comparable major morbidity (27% vs 27% vs 35%), POPF (24% vs 19% vs 25%), and mortality (2.9% vs 5.2% vs 5.4%), with a fewer conversions in robot-assisted- versus laparoscopic MIPD (5% vs 26%, P < 0.001). CONCLUSIONS: In the early experience of 14 European centers performing ≥10 MIPDs annually, no differences were found in major morbidity, mortality, and hospital stay between MIPD and OPD. The high rates of POPF and conversion, and the lack of superior outcomes (ie, hospital stay, morbidity) could indicate that more experience and higher annual MIPD volumes are needed.

Background Hypersensitivity to acetylsalicylic acid (ASA) constitutes a serious problem for subjects with coronary artery disease. In such subjects, physicians have to choose the more appropriate procedure between challenge and desensitization. As the literature on this issue is sparse, the present study aims to establish in these subjects clinical criteria for eligibility for an ASA challenge and/or desensitization. Methods Collection and analysis of data on ASA challenges and desensitizations from 10 allergy centers, as well as consensus among the related physicians and an expert panel. Results Altogether, 310 subjects were assessed; 217 had histories of urticaria/angioedema, 50 of anaphylaxis, 26 of non-immediate cutaneous eruptions, and 17 of bronchospasm related to ASA/NSAID intake. Specifically, 119 subjects had index reactions to ASA doses lower than 300 mg. Of the 310 subjects, 138 had an acute coronary syndrome (ACS), 101 of whom underwent desensitizations, whereas 172 suffered from a chronic ischemic heart disease (CIHD), 126 of whom underwent challenges. Overall, 163 subjects underwent challenges and 147 desensitizations; 86 of the latter had index reactions to ASA doses of 300 mg or less. Ten subjects reacted to challenges, 7 at doses up to 500 mg, 3 at a cumulative dose of 110 mg. The desensitization failure rate was 1.4%. Conclusions In patients with stable CIHD and histories of non-severe hypersensitivity reactions to ASA/NSAIDs, an ASA challenge is advisable. Patients with an ACS and histories of hypersensitivity reactions to ASA, especially following doses lower than 100 mg, should directly undergo desensitization. This article is protected by copyright. All rights reserved.

Sleep promotes health, well-being, recovery and athletic performance. As a consequence, sleep problems in athletes may have detrimental effects. Previous investigations showed that professional athletes often reported to suffer of poor sleep quality and insomnia (e.g. difficulties falling asleep and/or maintaining sleep). However, psychological variables exacerbating and maintaining insomnia in professional athletes as well as its mechanistic pathways are still largely unknown. Available literature mostly focused on effects of sport-related variables, such as evening training and stimulant consumption on athletes’ sleep. Instead, the contribution of cognitive and emotional variables globally associated with insomnia in athletes in clinical models has been largely neglected. To address these limitations, this study explored the associations between emotional experience, pre-sleep arousal, pre-sleep worry and rumination and insomnia severity in a sample of 210 (25.93 ± 6.68 years) male professional soccer players. Bivariate correlations, multiple regression, and structural equation modelling with manifest variables (path analysis) were computed. Results showed that insomnia severity was associated with stimulants consumption, pre-sleep arousal, negative emotions, positive emotions, and pre-sleep worry/rumination (all p

Management for HCV has undergone a notable change using direct-acting antiviral drugs (DAAs), which are safe and effective even in elderly. Here, we define impact of comorbidities, concomitant medication and drug–drug interactions in elder patients with HCV related disease before starting DAAs regimen. We analyzed data of 814 patients prospectively enrolled at our Unit within the web based model HCV Sicily Network. Out of 814, 590 were treated with DAAs and 414 of them were older than 65 years. We divided those 414 in two groups, one including 215 patients, aged between 65 and 74 years, and another with 199 patients, aged of 75 years and over. Charlson Comorbidity Index (CCI) was assessed for each patient; drug–drug interactions (DDI) and de-prescribing process were carried out appropriately. Within 414 patients included, percentage rates of women treated was higher than males, BMI was lower and cirrhosis was frequently reported in patients older than 75 years. Hypertension, diabetes mellitus, dyslipidemia (p p p p

Objective/BackgroundPoor sleep hygiene is considered an exacerbating and perpetuating factor of sleep disturbances and is also associated with poor mental health. The Sleep Hygiene Index (SHI) is a self-report measure assessing adherence to sleep hygiene practices. The aim of this study was to estimate the psychometric properties of the SHI in an Italian representative sample of the general population, following a formative measurement approach.Patients/MethodsParticipants (n=6276; M=33.62, SD=13.45) completed the SHI alongside measures of sleep disturbance, depression, anxiety, and stress. To consider the item formative nature, sets of item-composites weighted by means of canonical correlation analysis was created and a confirmatory factor analysis (CFA) was implemented. Factorial invariance tests were computed considering both presence of sleep problems and presence of emotional distress symptoms as grouping variables.Results and ConclusionsCFA confirmed the unidimensional structure of SHI. Internal consistency was acceptable (ω=0.752). Test-retest reliability at 8-10 months presented an ICC of 0.666. SHI significantly correlated with sleep, depression, anxiety and stress symptoms (r range from 0.358 to 0.500). Configural and metric invariance were reached for both grouping variables. Partial scalar invariance was obtained only across emotional distress groups. People with emotional symptoms reported higher latent means on the sleep hygiene dimension. Findings support the validity and reliability of the Italian version of the SHI. Importantly, the SHI showed robust psychometric properties both in healthy individuals and in individual reporting mental health symptoms. Thus, it is advisable to use this version of the SHI in both research and clinical practice.

MacroH2A1 has two splice isoforms, macroH2A1.1 and macroH2A1.2, that have been studied in several form of cancer. In the literature there are not many scientific papers dealing with the role of macroH2A1 in breast cancer. Breast cancer is the most frequent form of malignancy in females. It tend to metastasize to the bone in ~70% of patients. Despite treatment, new bone metastases will still occur in 30–50% of cases with advanced disease. Overall 5-year survival after the diagnosis of bone metastasis is ~20%. Osteoclasts and osteoblasts of the bone microenvironment are engaged by soluble factors released by neoplastic cells, resulting in bone matrix breakdown. This malfunction enhances the proliferation of the cancer cells, creating a vicious cycle. We investigated immunohistochemical expression of macroH2A1 in primitive breast cancer, focusing on the comparison of metastatic and non-metastatic cases. Furthermore, the immunohistochemical expression of macroH2A1 has been evaluated both in all cases of nodal metastases and in distant metastases. Our data demonstrated that macroH2A1 expression was higher expressed in metastatic breast cancer (77%) vs. non-metastatic breast cancer (32%). Also in analyzed metastases cases, a high macroH2A1 expression was detected: 85 and 80% in nodal and distant metastases cases, respectively. These results supported the fact that macroH2A1 is more highly expressed in breast cancer with worst prognosis.

Summary Repetitive negative thinking (RNT), i.e., worry, rumination, and transdiagnostic repetitive thinking, is thought to exacerbate and perpetuate insomnia in cognitive models. Moreover, RNT is a longitudinal precursor of depression and anxiety, which are often co-present alongside insomnia. Whilst accumulating evidence supports the efficacy of cognitive behavioural therapy for insomnia (CBT-I) in reducing depression and anxiety symptoms, the literature on the effects of CBT-I on RNT has never been systematically appraised. Importantly, preliminary evidence suggests that reduction of RNT following CBT-I may be associated with reduction of depression and anxiety. Therefore, we aimed to conduct a systematic review and meta-analysis on the effects of CBT-I on RNT. Seven databases were searched, and 15 randomised controlled trials were included. Results showed moderate-to-large effects of CBT-I on worry (Hedge's g range: −0.41 to g = −0.71) but small and non-reliable effects on rumination (g = −0.13). No clear evidence was found for an association between post-treatment reduction in RNT and post-treatment reduction in depression and anxiety. Although the literature is small and still developing, CBT-I seems to have a stronger impact on sleep-related versus general measures of RNT. We discuss a research agenda aimed at advancing the study of RNT in CBT-I trials.

Sleep problems during pregnancy are prevalent and could be linked to negative outcomes during pregnancy or post-partum. However, these complaints are often underdiagnosed and undertreated. This review aimed to systematically assess the effectiveness of different interventions to ameliorate poor sleep quality and insomnia during pregnancy. Pubmed, PsycINFO and Medline databases were systematically searched without publication period restriction until 3rd May 2019. Eligible studies had to: include pregnant women of any age and gestational age; use clinical intervention designs targeted at improving sleep outcome; report pre- and post-treatment data for one or more sleep-related outcomes; be published in English, Italian, German, Spanish, or French. Sixteen studies were selected including 1252 expecting mothers. Studies evaluated the efficacy of various interventions: cognitive behavioral interventions for insomnia (4); pharmacotherapy (1); acupuncture (1); mindfulness and yoga (3); relaxation (5) and herbal medication (2). Only six were randomized controlled trials, and only four evaluated longitudinal outcomes. Preliminary support was found for all interventions, but our knowledge is still too limited by lack of evidence. There is an utmost urgency to perform high-quality randomized controlled trials for insomnia interventions during pregnancy and to implement effective programs in standard gynecological care.

Short and long sleep duration have been associated with risk of obesity in children and adolescents. Evidence in adults is more mixed, with biological and psychosocial factors underlying these relationships mostly unknown. This review aimed at qualitatively and quantitatively summarizing previous studies on sleep duration as a predictor of obesity in adults in order to provide an update of the state of art in this field and clarify these relationships. Odds ratios at 95% Confidence Intervals (CI) were estimated using random-effects models. Heterogeneity of effects distribution and publication bias were tested. Twelve articles were selected for short sleep (n = 154,936) and eight for long sleep duration (n = 152,192). Results indicated that short sleep duration (OR: 1.412; 95% CI: 1.177–1.694) was significantly associated with the risk of future obesity, and that long sleep duration (OR: 0.995; 95% CI: 0.889–1.114) was not associated. Heterogeneity was high and lowered to non-significant values when considering gender and extremes of short/long sleep duration. Results seem to confirm a potential role of short sleep duration in predicting but results on long sleep are still mixed. Future investigations on potential mediators of such relationships are needed.

International audience; OBJECTIVE: The aim of this study was to compare oncological outcomes after minimally invasive distal pancreatectomy (MIDP) with open distal pancreatectomy (ODP) in patients with pancreatic ductal adenocarcinoma (PDAC). BACKGROUND: Cohort studies have suggested superior short-term outcomes of MIDP vs. ODP. Recent international surveys, however, revealed that surgeons have concerns about the oncological outcomes of MIDP for PDAC. METHODS: This is a pan-European propensity score matched study including patients who underwent MIDP (laparoscopic or robot-assisted) or ODP for PDAC between January 1, 2007 and July 1, 2015. MIDP patients were matched to ODP patients in a 1:1 ratio. Main outcomes were radical (R0) resection, lymph node retrieval, and survival. RESULTS: In total, 1212 patients were included from 34 centers in 11 countries. Of 356 (29%) MIDP patients, 340 could be matched. After matching, the MIDP conversion rate was 19% (n = 62). Median blood loss [200?mL (60-400) vs 300?mL (150-500), P = 0.001] and hospital stay [8 (6-12) vs 9 (7-14) days, P \textless 0.001] were lower after MIDP. Clavien-Dindo grade >=3 complications (18% vs 21%, P = 0.431) and 90-day mortality (2% vs 3%, P \textgreater 0.99) were comparable for MIDP and ODP, respectively. R0 resection rate was higher (67% vs 58%, P = 0.019), whereas Gerota's fascia resection (31% vs 60%, P \textless 0.001) and lymph node retrieval [14 (8-22) vs 22 (14-31), P \textless 0.001] were lower after MIDP. Median overall survival was 28 [95% confidence interval (CI), 22-34] versus 31 (95% CI, 26-36) months (P = 0.929). CONCLUSIONS: Comparable survival was seen after MIDP and ODP for PDAC, but the opposing differences in R0 resection rate, resection of Gerota's fascia, and lymph node retrieval strengthen the need for a randomized trial to confirm the oncological safety of MIDP.

Purpose The aim of this study was to demonstrate the effectiveness of a new kind of disposable surgical retractor in arteriovenous fistula (AVF) procedures in order to achieve an easier, faster and safer surgical intervention. Methods Between January and June 2008, 22 AVF procedures were performed using the 3PAWS ReeTrakttrade; (Insightra Inc. - Irvine, Ca., USA) a self-retaining, low profile retractor. An equivalent patient sample, in which an AVF was performed using conventional retraction devices, was considered for comparison of the intra- and post-operative results. Results In all of the 22 AVF procedures performed, the ReeTrakt™ system has simplified the performance of the surgical team. The retractors were very easy to place. The view of the operating field was always optimal. The introduction of the surgical instruments was at all times extremely easy and unrestricted. We also noted a reduction in the operating time (from an average of 67 min in controls to 43 min). There were no intraoperative complications. No post-operative complications related to the use of this kind of device occurred. Conversely, the amount of intra- and post-operative complications in the control group managed with conventional retraction devices was marginally higher than in the ReeTrakt™ patient group. Conclusion The ReeTrakt™ system is a very simple and useful low profile retractor for AVF procedures. Its ultra low profile allows a much improved view of the operating field, an unhindered insertion of the surgical instruments and a shortening of intervention time, avoiding the problems which arise as a result of standard retractors typically used during this kind of procedure. Due to absolute perpendicular retraction it offers a highly atraumatic performance, avoiding swelling and marks on the insertion sites. Therefore, in our opinion, it has the potential to reduce the risk of wound oedema, hematomas or infection associated with the AVF procedure. This is important as many patients are elderly with fragile tissues.