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Malnutrition is common in older adults and is associated with functional impairment, reduced quality of life, and increased morbidity and mortality. The aim of this study was to explore the association between health (including depression), physical functioning, disability and cognitive decline, and risk of malnutrition. Participants were recruited from nursing homes in Italy and completed a detailed multidimensional geriatric evaluation. All the data analyses were completed using Stata Version 15.1. The study included 246 participants with an age range of 50 to 102 (80.4 ± 10.5). The sample was characterised by a high degree of cognitive and functional impairment, disability, and poor health and nutritional status (according to Mini Nutritional Assessment (MNA), 38.2% were at risk for malnutrition and 19.5% were malnourished). Using a stepwise linear regression model, age (B = -0.043, SE = 0.016, p = 0.010), depression (B = -0.133, SE = 0.052, p = 0.011), disability (B = 0.517, SE = 0.068, p < 0.001), and physical performance (B = -0.191, SE = 0.095, p = 0.045) remained significantly associated with the malnutrition risk in the final model (adjusted R-squared = 0.298). The logistic regression model incorporating age, depression, disability, and physical performance was found to have high discriminative accuracy (AUC = 0.747; 95%CI: 0.686 to 0.808) for predicting the risk of malnutrition. The results of the study confirm the need to assess nutritional status and to investigate the presence of risk factors associated with malnutrition in order to achieve effective prevention and plan a better intervention strategy. [ABSTRACT FROM AUTHOR]

Introduction: Malnutrition is a frequent condition in the elderly especially in hospitals and in nursing homes, and even among the free-living elders the prevalence is not negligible (5-10%). Awareness towards malnutrition is still limited. The lack of time for nutritional assessment by the overcommitted healthcare personnel, including the general practitioners (GPs), may represent one possible explanation for limited recognition of malnutrition. Therefore, a self-administered instrument could be useful in raising alert on the GPs and allow early detection of malnutrition and early care provision. The aim of the present study was to analyze the validity of the Self-MNA that takes cue from the Mini Nutritional Assessment-Short Form (MNA-SF) and has been adapted to be self-administered by free-living elderly subjects.Methods: Participants were recruited from patients referring to the GP offices in Italy. Nutritional evaluation was performed through the administration of Full-MNA, MNA-SF and Self-MNA. The comorbidity level was assessed through the Cumulative Illness Rating Scale (CIRS). The level of difficulty in filling out the test was reported by the participants, and the time spent to complete the Self-MNA was also registered.Results: A total of 226 subjects, 125 women and 101 men (75.1 ± 8 and 75.3 ± 8 years old, respectively; p=0.89) were enrolled, and 214 (94.7%) of them completed the Self-MNA. According with the Full-MNA test score, 8.4% of women and 3.5% of men were classified as malnourished, whereas 32.7% of women and 31.4% of men were at risk of malnutrition. Agreement between Self-MNA and Full-MNA, and Self-MNA vs. MNA-SF was classified as “moderate” (k = 0.476 and 0.496 respectively; p < 0.001). Self-MNA showed a fair predictive value compared to the Full-MNA and MNA-SF tests (76.6 and 79.9%, respectively) with a barely adequate sensitivity (70.9 and 75.4%, respectively). The analysis of the characteristics of FN (false negative: subjects who were considered at risk of malnutrition or malnourished at Full-MNA but not at Self-MNA) showed that the clinical and functional aspects of these subjects (age, comorbidity and severity, time necessary to complete the Self-MNA, decrease in food intake, severe illness in the past 3 months, dementia and depression, fluid intake, need for feeding assistance, arm and calf circumferences) were very similar to the characteristics of true positive subjects. Patients required 6.7 ± 4.5 minutes to complete the test and 25 subjects (11.7%) needed more than 10 minutes, up to a maximum of 30 minutes. Patients who stated a greater difficulty were older (79.8 ± 7 vs. 73.5 ± 7 years; p< 0.001), they were more «malnourished» at Full-MNA (10.7 vs. 1,7%; p= 0.006) and clinical status was characterized by a higher severity index (1.72 ± 0.6 vs. 1.41 ± 0.4; p= 0.008).Conclusion: In the present study we investigated the validity of the Self-MNA in a sample of free-living elderly subjects. The results obtained confirm the validity of the test that may represent a useful tool for the GPs, although some important limitations need to be considered, limiting its use in clinical practice. [ABSTRACT FROM AUTHOR]

Introduction: In the last decades, dietary supplements consumption has increased in the Western world for all age groups. The long-term potentially dangerous effects related to an indiscriminate consumption of dietary supplements are still unknown and are becoming a matter of public health concern. Therefore, the aims of the present study were: to explore the contribution of dietary supplements to micronutrient daily intake, and to evaluate awareness and knowledge about dietary supplements. Methods: Participants (age ranging from 14 to 18 years) were recruited among students attending 8 high schools in the province of Frosinone (Italy). An anonymous questionnaire, composed of 12 multiple-choice items, was administered to all the participants. T-test and the analysis of variance (ANOVA) were performed to describe differences between means of the groups, while the chi-square test was used to compare observed and expected frequencies. The logistic regression model, aimed at identifying the characteristics of potential consumers of dietary supplements, Results: A total of 686 teenagers (288 males and 398 females, average age: 17,89±0,91 years) participated in the study. The 83,6% of participants affirmed to be aware of dietary supplements. 239 participants consumed dietary supplements: 118 males and 121 females. 49,1% of females consumed dietary supplements less than twice a week, whereas 43,6% of males consumed dietary supplements from 2 to 5 times per week. Statistically significant differences emerged between the genders with respect to the source of information regarding dietary supplements, the perceived indications for their use, and the choice of the store/place to purchase them. Discussion: Findings in the present study provide insight into the consumption of dietary supplements among young Italians, highlighting the need to foster further awareness among adolescents about the correct use of dietary supplements, especially in terms of indications and contraindications. [ABSTRACT FROM AUTHOR]

Objectives To validate the modified Mini Nutritional Assessment ( MNA) short-forms ( MNA- SFs) with respect to agreement with full MNA classification in the target populations of the MNA. Design Prospective analysis. Setting Community, nursing home, rehabilitation. Participants Six hundred fifty-seven individuals aged 65 and older (75.3% female; mean age 82.3 ± 7.4). Measurements Classification agreement between full MNA score and MNA- SF scores. Results Agreement between the full MNA and classification using the MNA- SFs was 84.6% when the MNA- SF using body mass index ( BMI) was applied and 81.4% when the MNA- SF using calf circumference ( CC) was applied. The highest agreement of classification was found in the community setting (90.8% and 90.4%, respectively) and the lowest in the rehabilitation setting (72.4% and 71.4%, respectively). Both MNA- SFs tended to underestimate nutritional status, but that was significant only for the MNA- SF with CC. Conclusion The modified MNA- SFs represent a valuable tool for rapid and reliable nutritional screening. [ABSTRACT FROM AUTHOR]

The article presents a study on daily precipitation covering Emilia-Romagnia, a region of Northern Italy. It outlines the data available for all stations for the period of 1951-2004 and for a selected group of stations located over the Reno hydrological basin for the period 1925-2004. It describes the seasonal values of mean precipitation and computes the frequency of extreme events starting from daily data, which are used to describe the temporal and spatial variability of precipitation over the region. It notes that the analysis allows the identification of the presence on clear decadal periodicity in river discharge, strongly related with decadal variability in both total precipitation and frequency of intense events.

Background: Cholecystoenteric fistula (CF) is a rare complication of cholelithiasis. The aim of this study was to evaluate the safety and risk of complications when the laparoscopic approach is applied in patients with CF.Methods: A questionnaire was mailed to all surgeons with experience of >100 cholecystectomies working in Naples, Italy, and the neighboring area.Results: Between February 1990 and May 1999, 34 patients presented with cholecystoenteric fistula (0.2% of >15,000 laparoscopic cholecystectomies performed in the same period). These patients were allocated into two groups: the LT group (those who underwent laparotomic conversion after the diagnosis of CF), which consisted of 20 patients, four men and 16 women, with a mean age of 66.5 +/- 9.3 years (range, 46-85) and the LS group (laparoscopically treated patients), which consisted of 14 patients, three men and 11 women, with a mean age of 65.6 +/- 8.8 years (range, 51-74). They types of CF observed were as follows: in the former group of patients, cholecystoduodenal fistulas (n = 11, 55%), cholecystocolic fistulas (n = 5, 25%), cholecystojejunal fistulas (n = 3, 15%), and cholecystogastric fistulas (n = 1, 5%); in the latter group, cholecystoduodenal fistulas (n = 8, 5.1%), and cholecystocolic fistulas (n = 4, 28.6) and cholecystojejunal fistulas (n = 2, 14.3%). Stapler closure of CF was done in four LT patients and three LS patients with cholecystoduodenal fistula; it was also done in three LT patients and three LS patients with cholecystocolic fistula. Hand-sutured fistulectomy was performed in six LT patients and three LS patients with cholecystoduodenal fistula, in two LT patients with cholecystocolic fistula, and in all patients with cholecystojejunal or cholecystogastric fistula. There were no deaths or intraoperative complications in either group. One patient in the LT group developed a bronchopneumonia postoperatively. Postoperative hospital stay was significantly longer in LT patients-17 +/- 4 vs 3+/-1 days (p < 0.001).Conclusion: Cholecystoenteric fistula is an occasional intraoperative finding during laparoscopic cholecystectomy. The results of this study, which are based on the collective experiences of 19 surgeons, illustrate the growing success of the laparoscopic approach to this condition, including a decreasing rate of conversion to open surgery over the last 3 years. [ABSTRACT FROM AUTHOR]

Background: Parvovirus B19 (PVB19) is a small, nonenveloped, single-stranded DNA virus commonly causing asymptomatic infections or mild, flu-like symptoms. In children, PVB19 can lead to various clinical conditions, including erythema infectiosum, arthropathy, transient aplastic crisis and papular-purpuric eruptions, among others., Methods: We present 3 pediatric cases treated at Luigi Sacco University Hospital in Milan, Italy, in March 2024, each demonstrating distinct manifestations of PVB19 infection. Case 1 involved a 7-year-old girl with a maculopapular rash and panniculitis-like symptoms. Case 2 described an 8-year-old boy with a maculopapular rash, vasculitis component and mild thrombocytopenia. Case 3 focused on a 7-year-old girl with petechial and purpuric eruptions and a mild decrease in platelets. Serological tests confirmed PVB19 infection in all cases., Results: The discussed cases highlight the heterogeneous clinical spectrum of PVB19 infection and emphasize its potential to cause thrombocytopenia even in healthy children. The recent surge in PVB19 cases in Europe, aligned with known epidemiological cycles, underscores the importance of vigilance in diagnosis, particularly during peak seasons. Additionally, concerning the role of serological testing in the diagnostic process, the potential for cross-reactivity among viral antigens is pointed out., Conclusion: PVB19 is a common infection with a broad range of clinical presentations. Awareness of its potential complications, including thrombocytopenia, even in nonimmunocompromised children, is crucial. Moreover, understanding the epidemiological patterns of PVB19 can aid in anticipating and managing outbreaks, thus minimizing its impact on pediatric health., Competing Interests: The authors have no funding or conflicts of interest to disclose., (Copyright © 2024 Wolters Kluwer Health, Inc. All rights reserved.)

Background/objectives: One of the main culprits of the obesity epidemic is the obesogenic food environment, which promotes the consumption of ultra-processed foods (UPFs) that are highly palatable, have low nutritional quality and a high caloric impact and are economical and ready to use. This monocentric retrospective study explored the association between UPFs, obesity and adiposity measurements among adults living with obesity in Southern Italy., Methods: According to their Body Mass Index (BMI) values, 175 participants (63M) were recruited and stratified into three groups. To evaluate their usual eating habits, PREDIMED and the Nova Food Frequency Questionnaire (NFFQ) were administered to investigate Mediterranean diet (MD) adherence and UPF consumption. Anthropometric and biochemical measurements, body composition, as well as visceral obesity indices were collected., Results: The data showed an increase in UPF consumption as the BMI increased, with a concomitant decrease in MD adherence. Soft drinks were the most representative UPF in all groups, and we observed a significant increase in such consumption as the BMI increased. In addition, in the highest tertile of UPF consumption, there was an increase in adiposity indices., Conclusions: Our data suggest that high UPF consumption correlates with an increased BMI and visceral adiposity, and it is a predictive risk factor for the occurrence of non-communicable diseases.

Aim: This guideline (GL) is aimed at providing a clinical practice reference for the management of adult patients with overweight or obesity associated with metabolic complications who are resistant to lifestyle modification., Methods: Surgeons, endocrinologists, gastroenterologists, psychologists, pharmacologists, a general practitioner, a nutritionist, a nurse and a patients' representative acted as multi-disciplinary panel. This GL has been developed following the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach. A systematic review and network meta-analysis was performed by a methodologic group. For each question, the panel identified potentially relevant outcomes, which were then rated for their impact on therapeutic choices. Only outcomes classified as "critical" and "important" were considered in the systematic review of evidence. Those classified as "critical" were considered for clinical practice recommendations. Consensus on the direction (for or against) and strength (strong or conditional) of recommendations was reached through a majority vote., Results: The present GL provides recommendations about the role of both pharmacological and surgical treatment for the clinical management of the adult patient population with BMI > 27 kg/m 2 and < 40 kg/m 2 associated with weight-related metabolic comorbidities, resistant to lifestyle changes. The panel: suggests the timely implementation of therapeutic interventions in addition to diet and physical activity; recommends the use of semaglutide 2.4 mg/week and suggests liraglutide 3 mg/day in patients with obesity or overweight also affected by diabetes or pre-diabetes; recommends semaglutide 2.4 mg/week in patients with obesity or overweight also affected by non-alcoholic fatty liver disease; recommends semaglutide 2.4 mg/week as first-line drug in patients with obesity or overweight that require a larger weight loss to reduce comorbidities; suggests the use of orlistat in patients with obesity or overweight also affected by hypertriglyceridemia that assume high-calorie and high-fat diet; suggests the use of naltrexone/bupropion combination in patients with obesity or overweight, with emotional eating; recommends surgical intervention (sleeve gastrectomy, Roux-en-Y gastric bypass, or metabolic gastric bypass/gastric bypass with single anastomosis/gastric mini bypass in patients with BMI ≥ 35 kg/m 2 who are suitable for metabolic surgery; and suggests gastric banding as a possible, though less effective, surgical alternative., Conclusion: The present GL is directed to all physicians addressing people with obesity-working in hospitals, territorial services or private practice-and to general practitioners and patients. The recommendations should also consider the patient's preferences and the available resources and expertise., (© 2024. The Author(s), under exclusive licence to Italian Society of Endocrinology (SIE).)

Climate change has significant impacts on marine ecosystems, resulting in disruptions in biological interactions, shifts in community composition, and changes in the physiology of fish and other marine organisms. In this study conducted in the central Mediterranean Sea, the mean temperature of the catch (MTC) was employed as an indicator to investigate the climatological factors influencing the fish community. The MTC, which utilizes species-preferred temperatures, was calculated using bottom temperature (BT) data weighted against scientific catches. The estimated MTC increasing rates were 0.01 °C year -1 for the entire community, 0.017 °C year -1 for the shelf break, and 0.004 °C year -1 for the continental slope assemblage. We found that MTC is increasing at a lower rate compared to BT, suggesting a progressive under-adaptation of the fish community that seems not fully able to keep up with the ongoing pace of warming. The study identified sea surface temperature and bottom temperature as key drivers of changes in fish community composition. Notably, the fish community composition exhibited drastic changes over the studied period, and we suggest that the MTC can be a useful index to monitor such changes within the context of the EU's climate change adaptation strategy., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2023 The Authors. Published by Elsevier Ltd.. All rights reserved.)

This article is about current challenges to evidence-based medicine (EMB) in Italy. The authors, who share a 20-year commitment to the field of clinical research, discuss what they define as a phase of "stagnation" in practicing and teaching methods and research tactics, both in clinical and academic settings. Early success of EBM cultural movement was not persistent. The authors reason about how the teaching of EBM has remained a niche, concerning few professionals compared to the needs of the country. The authors identify some reasons that might have led to inconsistent attention to research methodology and address ways to strengthen the contribution of academic medicine to clinical research.

Background: Obesity is a clinical condition that contributes to the development of related disability in different areas (physical, psychological and social). Multidisciplinary treatment calls for specific instruments able to evaluate all related functional problems. We have developed a tool (an ICF-based assessment instrument, the ICF-OB schedule) to evaluate obesity-related disability, composed of an inventory of 71-items from the WHO International Classification of Functioning, Disability and Health (ICF)., Aim: The aim of the present study was to validate this new tool for the definition of obesity-related disability. We also sought to examine the relationship between obesity disability, an index of multimorbidity (Cumulative Illness Rating Scale [CIRS]) and a well-validated score of perceived obesity-related disability (Italian Obesity Society Test for Obesity-Related Disability [TSD-OC])., Design: Process validation of the ICF-OB schedule., Setting: Baseline conditions of out- and in-patients., Population: A large cohort of obese patients recruited from 9 multidisciplinary centers belonging to the Italian Obesity Society (SIO) network, which provide specialized obesity care., Methods: A total of 353 patients (F: 70%, age: 50.2±12.7yrs, BMI: 41.4±8.3kg/m 2 ) were enrolled between January 2017 and June 2018. The ICF-OB was used to define patients' functioning and disability profiles in order to set and appraise rehabilitation goals., Results: We described the distribution of body functions (BF), body structures (BS) and activities and participations (A&P) categories and the agreement rates were significant for the majority of these. The ICF-OB was more often significantly associated, and with stronger coefficients, with patients' comorbidities as described by the CIRS rather than with Body Mass Index (BMI). The TSD-OC also presented a strong association with A&P indexes., Conclusions: The complexity of clinical condition, that generates disability in obesity might be well identified with the use of this new instrument that appear significant related to the perceived disability for each patients and also with their multimorbidity., Clinical Rehabilitation Impact: The ICF-OB shows great promise as a tool for goal setting in the rehabilitation of obese patients.

Background: Sleeve gastrectomy (SG) leads to esophageal mucosal damage in an elevated percentage of cases, configuring a clinical condition of Barrett's esophagus (BE) in a proportion as high as 15-18.8%. BE may rarely evolve into esophageal adenocarcinoma (EAC)., Objectives: To raise awareness of BE as a precancerous lesion which may progress toward malignancy after this popular bariatric procedure., Setting: Bariatric referral centers, Italy., Methods: All patients referred to our bariatric center who developed an EAC after SG between 2012 and 2019 were reviewed and consecutively included in this study. The available scientific literature regarding this complication is additionally reviewed., Results: The 3 male patients comprised in this case series underwent laparoscopic SG between 2012 and 2015 in different bariatric referral centers. Age and body mass index at baseline ranged from 21-54 years and 43.1-75.6 kg/m 2 , respectively. All patients were lost to follow-up early after surgery (3.7 ± 1.4 months), and were diagnosed with EAC at a mean of 27.3 ± 7.6 months after SG. The 4 reported cases in the scientific literature developed an EAC at a mean of 32.5 ± 23 months from SG. Overall, a diagnosis of EAC was made approximately 30.3 ± 17.1 months postoperatively, which seems relatively and worryingly early after surgery., Conclusion: Although the rate and probability of progression from BE to EAC is still not well defined, assuming that the rising popularity and execution of SG leads to a growth in the BE incidence, then the preoperative identification and stratification of cancer risk factors in this subset of patients is strongly encouraged. Clinical and endoscopic follow-ups are essential to allow for prevention and early diagnosis and for epidemiologic data collection purposes., (Copyright © 2020 American Society for Bariatric Surgery. Published by Elsevier Inc. All rights reserved.)

Objectives: The association between folate insufficiency and congenital neural tube defects has been extensively investigated since the 1990s. To reach an adequate intake of folic acid (FA), improving folate status through periconceptional supplementation with FA, promotion of the consumption of foods rich in natural folates, and appropriate use of fortified foods is recommended. The aim of the present study was to investigate the supplementation of FA in a sample of pregnant women referred to general practice services in Italy, with a focus on the quality of information received by fertile women., Methods: Participants were recruited from patients admitted to 44 general practice offices enrolled in the Italian Society of Preventive Medicine and Lifestyle study and located in Italy throughout the national territory. A questionnaire for the evaluation of FA supplementation was administered by the general practitioners (GPs). The interviewed subjects were asked to provide information about pregnancy characteristics, nutritional habits, lifestyle and risk factors, information sources, and knowledge about FA., Results: This study included 328 participants. The percentage of women who did not take any FA supplements was 16.8%, and 66.4% of women started FA supplementation only after finding out they were pregnant. Only 16.8% of women started FA supplementation 12 wk before the beginning of pregnancy. The lack of supplementation with FA, as well as the incorrect adherence to the existing FA supplementation protocol, is attributable to different social (e.g., immigration, place of residence, job employment) and cultural (e.g., educational level, knowledge about FA) factors, the relatively poor planning of pregnancies, and the lack of information concerning the need for FA supplementation in the prepregnancy period. Finally, GPs and gynecologists are the only sources of information on the importance of FA supplementation., Conclusions: The adherence of women to FA supplementation before pregnancy is still insufficient. The GP role in preconception care, and the promotion of FA supplementation, needs to be emphasized and further promoted., Competing Interests: Conflict of Interest The authors declare that there are no conflicts of interest., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Aging is a risk factor for the development of multiple chronic diseases, including cardiovascular disease, cancer and dementia. Life expectancy has increased in certain countries but this phenomenon is associated with a reduction of years of healthy life. Aging is associated with a number of physical and functional changes, especially sarcopenia. Sarcopenia is a clinical condition associated with a decrease in skeletal muscle and muscle strength, however, sarcopenia is a reversible condition. On the basis of the current scientific literature, sarcopenia could more appropriately capture an individual's vulnerability to negative health-related outcomes since it represents an early form of the chronic diseases. Recognition of this clinical condition can improve the management of older individuals in many different clinical settings. Despite the limitations of the indirect methods used to study body composition, the Italian College of the Academic Nutritionists ME/49 recommends that health authorities and health professionals around the world should make a greater effort to diagnose sarcopenia earlier and to manage it more effectively. In line with the development of cancer screening, the use of two diagnostic tools for sarcopenia (BIA and DXA) should be implemented.

Introduction: Clinical practice guidelines need rigorous and transparent methods for summarizing the evidence, rate its certainty and moving from evidence to recommendations. We describe an intervention to support local efforts to provide optimal and safer care bridging the gap between researchers and local busy clinicians., Methods: A group of methodologists provided a wide range of research services to the medical community of a local non-teaching general hospital in Italy. Methodological support encompassed synthesis of evidence, rating of uncertainty and moving from evidence to recommendations. Local professionals were asked to judge GRADE (Grading of Recommendations Assessment, Development and Evaluation) methodology and its impact on patients' safety, professional liability, and guideline reliability. The research team then reflected on the barriers of implementing GRADE in local settings., Results: Seven clinical recommendations about frequent complex medical conditions were produced. Few local clinicians completed the project. All clinicians found the GRADE methodology a guarantee for defending excellent standards of care. However, we identified a diffuse sense of inability to improve clinical behaviours as negative effects of general poor working conditions, in particular the strained health care workforce., Discussion: Current financial constraints may be impeding the ability of clinicians in improving their clinical practice through adaptation and use of evidence. A successful integration of evidence-based guidelines cannot be separated from an activate promotion by the institutional management.

Importance: Sophisticated evidence-based information resources can filter medical evidence from the literature, integrate it into electronic health records, and generate recommendations tailored to individual patients., Objective: To assess the effectiveness of a computerized clinical decision support system (CDSS) that preappraises evidence and provides health professionals with actionable, patient-specific recommendations at the point of care., Design, Setting, and Participants: Open-label, parallel-group, randomized clinical trial among internal medicine wards of a large Italian general hospital. All analyses in this randomized clinical trial followed the intent-to-treat principle. Between November 1, 2015, and December 31, 2016, patients were randomly assigned to the intervention group, in which CDSS-generated reminders were displayed to physicians, or to the control group, in which reminders were generated but not shown. Data were analyzed between February 1 and July 31, 2018., Interventions: Evidence-Based Medicine Electronic Decision Support (EBMEDS), a commercial CDSS covering a wide array of health conditions across specialties, was integrated into the hospital electronic health records to generate patient-specific recommendations., Main Outcomes and Measures: The primary outcome was the resolution rate, the rate at which medical problems identified and alerted by the CDSS were addressed by a change in practice. Secondary outcomes included the length of hospital stay and in-hospital all-cause mortality., Results: In this randomized clinical trial, 20 563 patients were admitted to the hospital. Of these, 6480 (31.5%) were admitted to the internal medicine wards (study population) and randomized (3242 to CDSS and 3238 to control). The mean (SD) age of patients was 70.5 (17.3) years, and 54.5% were men. In total, 28 394 reminders were generated throughout the course of the trial (median, 3 reminders per patient per hospital stay; interquartile range [IQR], 1-6). These messages led to a change in practice in approximately 4 of 100 patients. The resolution rate was 38.0% (95% CI, 37.2%-38.8%) in the intervention group and 33.7% (95% CI, 32.9%-34.4%) in the control group, corresponding to an odds ratio of 1.21 (95% CI, 1.11-1.32; P < .001). The length of hospital stay did not differ between the groups, with a median time of 8 days (IQR, 5-13 days) for the intervention group and a median time of 8 days (IQR, 5-14 days) for the control group (P = .36). In-hospital all-cause mortality also did not differ between groups (odds ratio, 0.95; 95% CI, 0.77-1.17; P = .59). Alert fatigue did not differ between early and late study periods., Conclusions and Relevance: An international commercial CDSS intervention marginally influenced routine practice in a general hospital, although the change did not statistically significantly affect patient outcomes., Trial Registration: ClinicalTrials.gov identifier: NCT02577198.

Background: The nocebo effect is a negative effect of a pharmacological or nonpharmacological medical treatment that is induced by patients' expectations, and that is unrelated to the physiological action of the treatment. The nocebo effect can negatively affect treatment outcomes., Aim: To develop evidence-based consensus recommendations for the prevention and management of the nocebo effect in biosimilar-treated patients with IBD., Methods: The "NOCE-BIO Consensus Group" was composed of 19 members from five European countries, and with different fields of expertise. A literature review on the nocebo effect, with specific focus on information about its prevention and management in biosimilar-treated IBD patients, was performed. Preliminary statements were formulated and voted on during a consensus group meeting held in Milan, Italy, in July 2018. A statement was accepted if >75% of participants voted 4 ("agree") or 5 ("strongly agree") on a scale of 1-5., Results: Consensus was reached on 11 recommendation statements. Seven statements reached consensus after one voting round and four statements reached consensus after two voting rounds. All statements were supported by very low-quality level of evidence. The panel agreed that patient-health-care provider relationship is a key driver of acceptance of biosimilars, which limits the risk of negative bias and the nocebo effect. Lack of knowledge among patients and health-care providers about the effectiveness and safety of biosimilars should be minimized. Education about biosimilars needs to be tailored to the individual patient, and positive framing is recommended., Conclusions: The nocebo effect is under-recognised in the era of biosimilars, although it may negatively impact on the cost-savings of biosimilars. Future research should focus on the magnitude, the risk factors, the impact, and the management of the nocebo effect in biosimilars-treated IBD patients., (© 2019 John Wiley & Sons Ltd.)

Introduction: The knowledge of principles and methods of Evidence Based Medicine (EBM) and the use of Clinical Practice Guidelines to inform clinical decisions are recognised as key instruments to improve the quality of care. In Italy the Parliament has revised the legal system that rules the responsibilities of health professionals and health care safety, prescribing health professionals to adhere to guidelines and good practice recommendations. The objective of the study was to evaluate guidelines and clinical pathways developed at local level and to assess knowledge and attitudes of healthcare workers toward EBM and guidelines., Methods: At the l'ASL 5 Liguria La Spezia we performed a census of all the documents registered as "guidelines" or "clinical pathways" at the Direzione Generale by the end of May 2016. We assessed their methodological quality by the "Recognition Card for Clinical Pathways Production and Revision Activity" prepared by the Ligurian Region. We conducted semi-structured interviews to assess attitudes and knowledge of healthcare workers., Results: We found 17 clinical pathways, 41% contained organizational/management recommendations, and 59% contained mainly clinical recommendations. 41% was produced by assimilating already existing guidelines. 29% did not describe the method of production. Only one document linked directly each recommendation with scientific evidence. 10 healthcare workers out of 32 invited actually accepted to conduct the interview. Respondents showed a positive attitude toward the EBM and guidelines but a poor knowledge of the methodology of production and the instruments and principles for critical appraising of scientific literature. Nobody knew the GRADE approach. The most relevant barriers identified were: lack of time, poor knowledge of English and statistical methods, poor applicability of the international guidelines to local setting and real patients encountered in clinical practice., Discussion: Despite the initiatives of the legislator toward civil responsibility and safety of care that should increase the use of guidelines, we found an overall poor knowledge of the concepts of EBM and method of guidelines production. Though the attitudes of responders to the interview were positive, barriers to use seemed to be predominant and considered more as obstacles than as a stimulus. In peripheral settings or in hospitals of medium/small size, clinical guidelines could remain confined to a merely juridical role, with weak impact on professional practice.

Purpose: The aim of this study was to evaluate the safety and efficacy of a new intragastric balloon (Elipse™ Balloon, Allurion Technologies, Natick, MA USA) not needing endoscopy., Materials and Methods: The balloon was swallowed under fluoroscopy in 38 consecutive patients (F/M 28/10, mean age 46.4 ± 10.6 years, mean weight 109.7 ± 21.9 kg, and mean body mass index (BMI) 38.6 ± 6.7 kg/m 2 ). After 4 months, the balloon spontaneously emptied and it was excreted through the digestive tract without upper endoscopy., Results: There were no complications during balloon passage. After 16 weeks, the mean weight loss was 12.7 kg, mean percent excess weight loss was 26%, and mean BMI reduction was 4.2 kg/m 2 . Total body weight loss was 11.6%. There was a significant reduction in major co-morbidities related to metabolic syndrome: blood pressure (p < 0.02), waist circumference (p < 0.002), triglycerides (p < 0.0001), blood glucose (p < 0.001), and HOMA-IR index (p < 0.001). At the end of the treatment, 37 balloons were naturally excreted in the stool, and one balloon was endoscopically removed., Conclusions: The results of this study on 38 consecutive patients demonstrate that the Elipse™ Balloon is safe, effective, and very well accepted by patients.

Background: Obesity is a major risk factor for several chronic diseases. The BioEnterics(®) Intragastric Balloon (BIB(®)) is used worldwide as a short-term (6 months) treatment in morbid obese patients. However, removal of BIB(®) past 6 months is a common occurrence in clinical practice often as a result of patient factors. The aim of the present Italian multicentre cohort study was to evaluate the safety and efficacy of the BIB(®) left in situ for more than 6 months., Materials and Methods: A total of eight Italian centres participated in the study. Participating centres received a standardised questionnaire designed to capture safety and efficacy data. Weight loss data, as well as date, and reason for removal of the BIB(®) after 6 months were recorded. Adverse events, including mortality and complications, operators' subjective technical notes and findings, and difficulties during removal procedure were also collected., Results: Six hundred and eleven patients were included. In the majority of cases, patient extended BIB(®) treatment due to satisfactory weight loss (44 %). At 6 months, all patients achieved a BMI statistically lower than the initial BMI (p < 0.001). There was a non-significant trend towards greater BMIL % in patients who underwent removal up to 15 months versus the results achieved up to 6 months. No major complications were recorded., Conclusion: Extending the duration of BIB(®) use up to 14 months safely maintains weight loss and satiety with greater results than that up to 6 months, without complications.

Background: The intragastric balloon has been reported to be a safe and effective tool for temporary weight loss. The aim of this study is the evaluation of the possible predictive role of intragastric balloon when used before laparoscopic adjustable gastric banding., Methods: A longitudinal multicenter study was conducted in patients with body mass index (BMI)>35 kg/m(2) who underwent gastric banding with the BioEnterics Intragastric Balloon (BIB). After balloon removal (6 mo), patients were allocated into 2 group according to their percentage of excess weight loss (%EWL): group>25 (%EWL>25%) and group<25 (%EWL<25%). Patients from both group underwent laparoscopic adjustable gastric banding (LAGB) 1-3 months after BIB removal. The LAP-BAND AP band was placed in all patients via pars flaccida. Weight loss parameters were considered in both groups., Results: From January 2005 to December 2009, 1357 patients were enrolled in this study. Mean BMI at time of BIB positioning was 44.9±8.4 (range 29-82.5). After 6 months, at time of removal, mean BMI was 39.4±7.3. According to the cutoff, patients were allocated into group A (n = 699) and group B (n = 658). At this time the mean BMI was 36.4±6.4 and 42.7±6.9 (P = .001) in groups A and B, respectively. At 1-year follow-up from LAGB, mean BMI was 35.8±6.5 and 40.0±7.4 (P<.001) in groups A and B, respectively. This significant difference was confirmed at 3- and 5-year follow-ups. A similar pattern was observed with the %EWL., Conclusion: Satisfactory results with BIB are predictive of a positive outcome of LASB at 1, 3, and 5 years after the procedure, and poor results do not inevitably indicate a negative outcome for gastric banding., (Copyright © 2014 American Society for Bariatric Surgery. Published by Elsevier Inc. All rights reserved.)

Obesity is the result of a complex interplay among several factors leading to medical, functional and psychosocial consequences that markedly reduce life expectancy and impair quality of life. Is obesity itself a disease? Is obesity a brain disease? Who should treat obesity? This paper is a narrative review aimed to describe and to argue the prevalent position of some major Italian scientific and academic institutions dealing with obesity. According to the recent statements and recommendations published by the Italian Society for Obesity (SIO) and the Italian Society for the Study of Eating Disorders (SISDCA), the management of obese patients should include five main levels of care: (1) primary care, (2) outpatient treatment, (3) intensive outpatient treatment, (4) residential rehabilitative treatment, and (5) hospitalization. Ideally, patients suffering from obesity need a multidimensional evaluation intended to design an individualized treatment plan applying different procedures and therapeutic strategies (diet, physical activity and functional rehabilitation, educational therapy, cognitive-behavior therapy, drug therapy, and bariatric surgery). This thorough approach should address not only weight loss but also quality of weight loss, medical and psychiatric comorbidity, psychosocial problems, and physical disability. Such management of obesity requires an effective multiprofessional team, while health services have to overcome a number of administrative and organizational barriers that do not account for diseases requiring resources and professionals from different areas of medicine. Integrating several competences in a team-based approach demands specific education, skills and expertise. As for other diseases, the principles of complexity theory may offer a model useful to implement both teamwork and care delivery for patients with obesity.

Background: Eating disorders are a group of conditions characterised by abnormal eating habits. Greater than 50 % of patients with eating disorders have an 'eating disorder not otherwise specified' (EDNOS). No specific tools exist to evaluate EDNOS, and patients are identified only with a diagnosis of exclusion from the other eating disorders. The BioEnterics® Intragastric Balloon (BIB®) is used worldwide as a short-term treatment option in obese patients. A new frequency score was used to evaluate the influence of double consecutive BIB® treatment compared with single BIB® treatment followed by diet on four categories of EDNOS (grazing, emotional eating, sweet-eating and after-dinner grazing)., Methods: A prospective study allocated 50 obese patients (age range 25-35, BMI range 40.0-44.9) into two groups: BIB® (6 months) followed by diet therapy (7 months; group A (N = 25)) and BIB® placement for 6 months followed by another BIB® for 6 months, with a 1-month interval between placement (group B (N = 25)). Baseline demographics were similar across both groups., Results: At the time of removal of the first BIB® device, EDNOS scores in both groups were not significantly different, but decreased significantly from baseline. By the end of the study, all EDNOS scores were significantly lower in patients undergoing consecutive BIB®, compared with single BIB® followed by diet therapy., Conclusions: The placement of an intragastric balloon in obese patients allows for a reduction in the intensity of grazing, emotional eating, sweet-eating and after-dinner grazing. A more significant reduction in the EDNOS score was observed with two consecutive BIBs®.

Background: The objective of this study is the comparison of a new intragastric balloon recently introduced, the Adjustable Balloon System (ABS), with the BioEnterics intragastric balloon (BIB) in terms of tolerance, safety, and weight loss parameters., Methods: A case-control study was done: 40 patients were matched with 80 controls. To achieve the same duration therapy (12 months), a single ABS positioning was compared with a BIB followed by another BIB (6 + 6 months). Length of procedure, hospital stay, complications, and weight loss parameters after 6 months (time of first BIB removal) and after 12 months from baseline (time of Spatz and second BIB removal) were considered. Statistical analysis was done by means of Student's t test, χ2 test, or Fisher's test. P < 0.05 was considered significant., Results: Mortality, positioning, and extraction complications were absent. Both the devices were well tolerated with slight duration of post placement symptoms. During this study, the Spatz balloon was adjusted with inflation of 200 cm(3) of saline (total, 800 cm(3)) in 9/40 (22.5 %) patients, for poor weight loss after first 6-months treatment. In the Spatz group, there occurred 7/40 complications linked to the device and in 6/7 patients the balloon was removed. At the end of the study, the weight loss parameters were similar between groups: BMI 31.0 ± 11.8 (Spatz group) vs 31.3 ± 12.3 (BIB group) (p = Ns)., Conclusions: The idea of dynamic balloon therapy needs to be confirmed with wider series. The rate of complication reported is very high, and several studies regarding safety and efficacy are needed.

Background: The request to lose weight is expanding not only in obese and morbidly obese patients but also in overweight patients affected by co-morbidities as diabetes and hypertension and who do not tolerate diet regimen or lifestyle changes. The aim of this study is a multicenter evaluation of outcomes of intragastric balloon in overweight patients., Methods: Patients (BMI 27-30 kg/m2) treated with a BioEnterics Intragastric Balloon (BIB) between 1996 and 2010 were extracted from the database of the participating centres in Rome (Italy), Liège (Belgium) and Madrid (Spain). Primary endpoints were the efficacy and safety at 6 and 42 months from balloon positioning. Secondary endpoints included resolution of co-morbidities., Results: A total of 261 patients were included in this study. The most common indication for balloon placement was a psychological disorder (54%). Mean body mass index (BMI) fell from 28.6 ± 0.4 at baseline to 25.4 ± 2.6 kg/m2 at 6 months and to 27.0 ± 3.1 kg/m2 at 3 years from BIB removal. The mean %EWL was 55.6% at 6 months and 29.1% at 3 years. Forty-seven patients (18%) had complications associated with placement of the intragastric balloon (leak = 28, intolerance = 14, duodenal ulcer = 2, gastritis = 1, oesophagitis = 1, duodenal polyps = 1). The rate of patients with hypertension decreased from 29% at baseline to 16% at 3 years. Diabetes decreased from 15 to 10%, dyslipidaemia decreased from 20 to 18%, hypercholesterolaemia decreased from 32 to 21% and osteoarthropathy decreased from 25 to 13%., Conclusions: The intragastric balloon is safe and effective in overweight patients, helping to reduce progression to obesity and decreasing the prevalence of a number of important co-morbidities.

Unlabelled: Cancer prevalence is the proportion of a population diagnosed with cancer. We present a method for differentiating prevalence into the proportions expected to survive without relapse, die of cancer within a year, and die of cancer within 10 years or survive with relapse at the end of the 10th year., Material and Methods: The method was applied to samples of colorectal cancer cases, randomly extracted from four Italian cancer registries (CRs). The CRs collected data on treatments, local relapses, distant relapses, and causes of death: 1) over the entire follow-up to 31 December 2007 for 601 cases diagnosed in 2002 (cohort approach); 2) over a single year (2007) for five cohorts of cases defined by year of diagnosis (from 1997 to 2001), alive at 1 January 2007 (total 298 cases). The cohorts were combined into a fictitious cohort with 10 years survival experience. For each year j after diagnosis the health status of cases alive at the beginning of j was estimated at the end of the 10th year. From these estimates the 10-year colorectal cancer prevalence was differentiated., Results: We estimated: 74.7% alive without relapse or not undergoing treatment at the end of 10 years; 8.1% had died of colorectal cancer within a year; 11.4% had died of colorectal cancer 1-10 years after diagnosis or had relapsed or were undergoing treatment at the end of the 10th year; and 5.8% had died of other causes., Conclusions: We have introduced a new method for estimating the healthcare and rehabilitation demands of cancer survivors based on CR data plus treatment and relapse data specifically collected for samples of cases archived by CRs.

Purpose: To validate a new obesity-specific disability assessment test: the Obesity-related Disability test (Test SIO Disabilità Obesità Correlata, TSD-OC)., Methods: Adult obese individuals were assessed with the TSD-OC, 36-Item Short-Form Health Survey (SF-36), 6-min walking test (6MWT) and grip strength. The TSD-OC is composed of 36 items divided into seven sections (pain, stiffness, activities of daily living and indoor mobility, housework, outdoor activities, occupational activities and social life). Statistical correlations between the TSD-OC, functional assessment (6MWT and grip strength) and quality of life parameters (SF-36) were analysed. Internal consistency was assessed with Cronbach's α test. Test-retest reliability was evaluated in a subgroup of 30 individuals. A linking exercise between TSD-OC items and categories of the International Classification of Functioning, Disability and Health was performed., Results: Test-retest showed excellent stability (r = 0.90) and excellent internal consistency was reported (Cronbach's α > 0.90). Significant low to moderate correlations between TSD-OC, SF-36 scores, 6MWT and grip strength were observed. A total of 26 ICF categories were linked, mostly related to the area of mobility., Conclusions: The TSD-OC is a reliable and valid instrument for measuring self-reported disability in obese subjects. It may represent an important tool for establishing rehabilitation needs in individuals with obesity-related disability, for planning appropriate rehabilitation programmes and for evaluating their effectiveness.

Objective: Bariatric surgery is not usually recommended in the elderly. The aim of this study is to evaluate the safety and efficacy of laparoscopic adjustable gastric banding (LAGB) in older patients registered in the database of the Italian Group for Lap-Band Gruppo Italiano Lap-Band (GILB)., Methods and Procedures: GILB is a centralized database which collects operative and follow-up data from 26 Italian surgical centers who utilize the Lap-Band System as a restrictive procedure. Patients > or =60 years were selected from the database of the GILB and analyzed according to co-morbidities, conversion, peri-operative complications, and weight loss., Results: Of 5,290 patients, 216 (4.1%; 184F/32M) were > or =60 years old at surgery (mean age 64.1 +/- 4.0 years; range 60-83). Baseline BMI was similar in both sets of patients i.e., > or =60 and <60 years of age (44.2 +/- 7.6 kg/m(2) vs. 44.9 +/- 7.4 kg/m(2)). Patients > or =60 years of age were more frequently affected by co-morbidities than patients <60 years of age. Two cases of operative mortality were observed in patients <60 years old (0.04%) and one in patients > or =60 years old (0.46%). The proportion of patients requiring revision surgery was comparable as well. Weight loss was significantly lower in elderly patients. Despite their lower weight loss, patients > or =60 years of age experienced a significant improvement of obesity-related co-morbidities (they showed improvement 1 year after surgery in 100% of cases of diabetes or sleep apnoea, 67.1% of cases of hypertension, and 34.9% of cases of osteoarthritis)., Discussion: LAGB may be performed safely in patients > or =60 years old. Weight loss in older patients seems unsatisfactory if compared to younger subjects. However, the majority of elderly patients show an improvement in obesity-related co-morbidities.

Background: Little is known about obesity surgery in young and adolescent patients. The aim of this study is to evaluate results of laparoscopic adjustable gastric banding in obese teenagers., Methods: Patients < or = 19 years old selected from the database of the Italian Collaborative Study Group for Lap-Band were analyzed according to mortality, comorbidities, laparotomic conversion, intra- and postoperative complications, body mass index (BMI), and % excess weight loss (EWL) at different times of follow-up. Data were expressed as mean +/- SD., Results: Fifty-eight (1.5%) of 3813 patients who underwent operation with the Lap-Band System were < or = 19 years old: 47F/11M; mean age, 17.96 +/- 0.99 years (range, 15-19); mean BMI, 46.1 +/- 6.31 Kg/m2 (range, 34.9 - 69.25); mean % excess weight, 86.4 +/- 27.1 (range, 34 - 226.53). Sixteen (27.5%) of the 58 patients were superobese (BMI > or = 50). In 27/58 (46.5%) patients, 1 or more comorbidities were diagnosed. Mortality was absent. Laparotomic conversion was necessary in 1 patient with gastric perforation on the anterior wall. Overall postoperative complications occurred in 6/58 (10.3%). The band was removed in 6/58 (10.3%) patients for gastric erosion (3 patients), psychologic, intolerance (2 patients), and in the remaining patient was converted 2 years after surgery (BMI 31) to gastric bypass or gastric pouch dilatation. Patient follow-up at 1, 3, 5, and 7 years was 48/52 (92.3%), 37/42 (88.1%), 25/33 (75.7%), and 10/10, respectively. At these times, mean BMI was 35.9 +/- 8.4, 37.8 +/- 11.27, 34.9 +/- 12.2, and 29.7 +/- 5.2 Kg/m2. Mean %EWL at the same time was 45.6 +/- 29.6, 39.7 +/- 29.8, 43.7 +/- 38.1, and 55.6 +/- 29.2. Five/25 (20%) patients had < or = 25% EWL at 5 years follow-up, while none of the 10 patients subject to follow-up at 7 years had < or = 25% EWL., Conclusions: Lap-Band System is an interesting option for teenagers suffering obesity and its related comorbidities, which deserves further investigation.

Background: The temporary use of the BioEnterics Intragastric Balloon (BIB) in morbidly obesity is increasing worldwide. The aim of this study is the evaluation of the efficacy of this device in a large population, in terms of weight loss and its influence on co-morbidities., Methods: Data were retrospectively recruited from the data-base of the Italian Collaborative Study Group for Lap-Band and BIB (GILB). After diagnostic endoscopy, the BIB was positioned and was filled with saline (500-700 ml) and methylene blue (10 ml). Patients were discharged with diet counselling ( approximately 1000 Kcal) and medical therapy. The BIB was removed after 6 months. Positioning and removal were performed under conscious or unconscious sedation. Mortality, complications, BMI, %EWL, BMI loss and co-morbidities were evaluated., Results: From May 2000 to September 2004, 2,515 patients underwent BIB (722M/1,793F; mean age 38.9+/-14.7, range 12-71; mean BMI 44.4+/-7.8 kg/m(2) ; range 28.0-79.1; and mean excess weight 59.5+/-29.8 kg, range 16-210). BIB positioning was uncomplicated in all but two cases (0.08%) with acute gastric dilation treated conservatively. Overall complication rate was 70/2,515 (2.8%). Gastric perforation occurred in 5 patients (0.19%), 4 of whom had undergone previous gastric surgery: 2 died and 2 were successfully treated by laparoscopic repair after balloon removal. 19 gastric obstructions (0.76%) presented in the first week after positioning and were successfully treated by balloon removal. Balloon rupture (n=9; 0.36%) was not prevalent within any particular period of BIB treatment, and was also treated by BIB removal. Esophagitis (n=32; 1.27%) and gastric ulcer (n=5; 0.2%) presented in patients without a history of peptic disease and were treated conservatively by drugs. Preoperative co-morbidities were diagnosed in 1,394/2,471 patients (56.4%); these resolved in 617/1,394 (44.3%), improved (less pharmacological dosage or shift to other therapies) in 625/1,394 (44.8%), and were unchanged in 152/1,394 (10.9%). After 6 months, mean BMI was 35.4+/-11.8 kg/m(2) (range 24-73) and %EWL was 33.9+/-18.7 (range 0-87). BMI loss was 4.9+/-12.7 kg/m(2) (range 0-25)., Conclusions: BIB is an effective procedure with satisfactory weight loss and improvement in co-morbidities after 6 months. Previous gastric surgery is a contraindication to BIB placement.

Background: The Lap-Band System is the most common bariatric operation world-wide. Current selection criteria do not include patients with BMI < or = 35. We report the Italian multicentre experience with BMI < or = 35 kg/m(2) over the last 5 years., Patients and Methods: Data were obtained from 27 centres involved in the Italian Collaborative Study Group for Lap-Band System. Detailed information was collected on a specially created electronic data sheet (MS Access 2000) on patients operated in Italy since January 1996. Items regarding patients with BMI < or = 35 were selected. Data were expressed as mean +/- SD except as otherwise indicated., Results: 225 (6.8%) out of 3,319 Lap-Band patients were recruited from the data-base. 15 patients, previously submitted to another bariatric procedure (BIB =14; VBG= 1) were excluded. 210 patients were eligible for study (34M/176F, mean age 38.19+/-11.8, range 17-66 years, mean BMI 33.9+/-1.1, range 25.1-35 kg/m(2), mean excess weight 29.5+/-7.1, range 8-41). 199 comorbidities were diagnosed preoperatively in 55/210 patients (26.2%). 1 patient (0.4%) (35 F) died 20 months postoperatively from sepsis following perforation of dilated gastric pouch. There were no conversions to laparotomy. Postoperative complications presented in 17/210 patients (8.1%). Follow-up was obtained at 6, 12, 24, 36, 48 and 60 months. At these time periods, mean BMI was 31.1+/-2.15, 29.7+/-2.19, 28.7+/-3.8, 26.7+/-4.3, 27.9+/-3.2, and 28.2+/-0.9 kg/m(2) respectively. Co-morbidities completely resolved 1 year postoperatively in 49/55 patients (89.1%). At 60 months follow-up, only 1 patient (0.4%) has a BMI >30., Conclusions: Although surgical indications for BMI < or = 35 remain questionable, the Lap-Band in this study demonstrated that all but 1 patient achieved normal weight, and most lost their co-morbidities with a very low mortality rate.

Background: Laparoscopic adjustable gastric banding (LAGB) is the most common bariatric operation. This study is a retrospective analysis of the multicenter Italian experience in patients with BMI > 50 over the last 4 years., Methods: An electronic data sheet made for LAGB-operated patients since January 1996, was mailed and e-mailed to all surgeons involved in this kind of procedure in Italy. Items regarding patients with BMI > 50 were selected. Analysis used Fisher's exact test and logarithmic regression analysis (P < 0.05 significant). Data were expressed as mean +/- SD., Results: 239 patients (13.3%), out of 1,797 Lap-Band operated patients entered the study (179F / 60M), with mean age 37.6 +/- 11.3 years (19-69) and mean BMI 54.6 +/- 4.8 (50.1-83.6). Laparotomic conversion rate was 5.4% (44/239). Postoperative complications occurred in 24 / 239 patients (9.0%). Follow-up was obtained in 218 / 218, 198 / 198, 121 /147, 75 / 93, 30 / 38 LAGB patients at 6,12, 24, 36, and 48 months respectively. At these time periods, mean BMI was 46.7, 43.9, 42.2, 41.9, and 39.3 kg/m2. At the same intervals, mean %EWL was 24.1, 34.1, 38.8, 38.9, and 52.9%. The number of patients with < 25% EWL at 12, 24, 36, and 48 months follow-up were 34, 10, 4, and 0. Serious co-morbidities (189 in 124 of 239, 57%) had completely resolved 1 year postoperatively in 74 / 124 of the patients (59.6%)., Conclusion: Although super-obese patients following the LAGB remain obese with BMI > 35, in the short-term most lose their co-morbidities, with a very low morbidity and mortality rate.

Background: An increasing number of surgeons with different levels of experience with laparoscopic surgery and open obesity surgery have started to perform laparoscopic implantation of the Lap-Band., Methods: An electronic patient data sheet was created and was mailed and e-mailed to all surgeons performing laparoscopic adjustable silicone gastric banding (LASGB) in Italy. Patients were recruited since January 1996. Data on 1,265 Lap-Band System operated patients (258 M/1,007 F; mean BMI 44.1, range 27.0-78.1; mean age 38, range 17-74 years) were collected from 23 surgeons performing this operation., Results: Intra-operative mortality was absent. Post-operative mortality was 0.55% (7 patients) for causes not specifically related to LASGB implantation. The laparotomic conversion rate was 1.7% (22 patients). LASGB related complications occurred in 143 patients (11.3%). Pouch dilatation was diagnosed in 65 (5.2%), and 28 (2.2%) of these underwent re-operation. Band erosion was observed in 24 patients (1.9%). Port or connecting tube-port complications occurred in 54 patients (4.2%), 12 of whom required revision under general anesthesia. Follow-up was obtained at 6, 12, 18, 24, 36 and 48 months, and mean BMI was respectively 38.4, 35.1, 33.1, 30.2, 32.1 and 31.5. The percentage of patients observed at each follow-up was > 60%. There was no intra-operative mortality and no complication-related mortality, with acceptable weight loss., Conclusion: The LASGB operation is safe and effective, and deserves wider use for treatment of morbid obesity.

Background: Laparoscopic adjustable silicone gastric banding (LASGB) is a minimally invasive surgical procedure indicated for the treatment of patients with morbid obesity., Methods: From January 1996, eight patients successfully underwent the video-laparoscopic procedure., Results: Preoperative body mass index was 44.4 +/- 4.7 (range 37.9-53.3). Mean operative time was 255 +/- 73 minutes (range 150-360). Mean hospital stay was 3 +/- 1 days. Intraoperative complications were absent., Conclusion: Preliminary results have been satisfactory, and encourage us to continue with LASGB.