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PURPOSE: With the global epidemic of obesity, the importance of metabolic and bariatric surgery (MBS) is greater than ever before. Performing these surgeries requires academic training and the completion of a dedicated fellowship training program. This study aimed to develop guidelines based on expert consensus using a modified Delphi method to create the criteria for metabolic and bariatric surgeons that must be mastered before obtaining privileges to perform MBS. METHODS: Eighty-nine recognized MBS surgeons from 42 countries participated in the Modified Delphi consensus to vote on 30 statements in two rounds. An agreement/disagreement among ≥ 70.0% of the experts was regarded to indicate a consensus. RESULTS: Consensus was reached on 29 out of 30 statements. Most experts agreed that before getting privileges to perform MBS, surgeons must hold a general surgery degree and complete or have completed a dedicated fellowship training program. The experts agreed that the learning curves for the various operative procedures are approximately 25-50 operations for the LSG, 50-75 for the OAGB, and 75-100 for the RYGB. 93.1% of experts agreed that MBS surgeons should diligently record patients' data in their National or Global database. CONCLUSION: MBS surgeons should have a degree in general surgery and have been enrolled in a dedicated fellowship training program with a structured curriculum. The learning curve of MBS procedures is procedure dependent. MBS surgeons must demonstrate proficiency in managing postoperative complications, collaborate within a multidisciplinary team, commit to a minimum 2-year patient follow-up, and actively engage in national and international MBS societies.
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Policy Points Opioid treatment agreements (OTAs) are controversial because of the lack of evidence that their use reduces opioid-related harms and the potential risks they pose of stigmatizing patients and undermining the clinician-patient relationship. Even so, their use is now required in most jurisdictions, and their use is influencing the outcomes of civil and criminal lawsuits. More research is needed to evaluate how OTAs are implemented given existing requirements. If additional research does not resolve the current level of uncertainty regarding OTA benefits, then policymakers in jurisdictions where they are required should consider eliminating OTA mandates or providing flexibility in the legal requirements to make room for clinicians and health care institutions to implement best practices. CONTEXT: Opioid treatment agreements (OTAs) are documents that clinicians present to patients when prescribing opioids that describe the risks of opioids and specify requirements that patients must meet to receive their medication. Notwithstanding a lack of evidence that OTAs effectively mitigate opioids' risks, professional organizations recommend that they be implemented, and jurisdictions increasingly require them. We sought to identify the jurisdictions that require OTAs, how OTAs might affect the outcomes of lawsuits that arise when things go wrong, and instances in which the law permits flexibility for clinicians and health care institutions to adopt best practices. METHODS: We surveyed the laws and regulations of all 50 states and the District of Columbia to identify which jurisdictions require the use of OTAs, the circumstances in which OTA use is mandatory, and the terms OTAs must include (if any). We also surveyed criminal and civil judicial decisions in which OTAs were discussed as evidence on which a court relied to make its decision to determine how OTA use influences litigation outcomes. FINDINGS: Results show that a slight majority (27) of jurisdictions now require OTAs. With one exception, the jurisdictions' requirements for OTA use are triggered at least in part by long-term prescribing. There is otherwise substantial variation and flexibility within OTA requirements. Results also show that even in jurisdictions where OTA use is not required by statute or regulation, OTA use can inform courts' reasoning in lawsuits involving patients or clinicians. Sometimes, but not always, OTA use legally protects clinicians from liability. CONCLUSIONS: Our results show that OTA use is entwined with legal obligations in various ways. Clinicians and health care institutions should identify ways for OTAs to enhance clinician-patient relationships and patient care within the bounds of relevant legal requirements and risks.
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BACKGROUND: Public libraries in the United States have experienced increases in opioid-related substance use in their communities and on their premises. This includes fatal and non-fatal overdose events. Some libraries have adopted response measures in their branches to deter substance use or prevent overdose. A small number of libraries around the nation have decided to stock the opioid antagonist naloxone (Narcan) for staff to administer to patrons who experience overdose. This response measure has generated extensive media attention. Although Ohio ranks fourth in age-adjusted drug mortality rate in the United States, there has been no investigation of whether Ohio libraries are observing opioid-related transactions, consumption, and/or overdose events, or which measures they have adopted in response to these activities. We conducted a multimethod survey with Ohio public library directors to identify the response measures they have adopted. We present descriptive findings from the quantitative and qualitative items in our survey. METHODS: We conducted a cross-sectional 54-item multimethod survey of public library system directors (one per system) in Ohio. Directors of each of Ohio's public library systems were invited to participate via email. RESULTS: Of 251 library systems, 56 responded (22.3% response rate), with 34 respondents (60.7%) indicating awareness of opioid-related transactions, consumption, and/or overdose on their premises. Most (n = 43, 76.8%) did not stock naloxone in their buildings. Over half (n = 34, 60.7%) reported implementing one or more non-naloxone response measures. These measures focus on improving security for staff and patrons, deterring opioid-related transactions (purchases and exchanges) and consumption, and providing educational events on substance use. Nearly half (n = 25, 47.2%) partner with community organizations to provide opioid response measures. A similar proportion reported adequate funding to respond to opioid-related substance use (n = 23, 45.1%), and most (n = 38, 74.5%) reported adequate support from their boards and communities. Few respondents have implemented evaluations of their response measures. CONCLUSIONS: Ohio public libraries are responding to evidence of opioid-related transactions, consumption, and/or overdose on their premises with a range of measures that focus on substance use prevention and deterrence. Most Ohio library systems do not stock naloxone. Respondents indicated they prefer to call 911 and let first responders handle overdose events. The majority of respondents indicated their library systems have political capacity to respond to evidence of opioid-related substance use on their premises, but have limited operational and functional capacity. Findings suggest the need to revisit assumptions that public libraries are willing to stock naloxone to respond to overdose events, and that libraries have the resources to respond robustly to opioid-related transactions, consumption, and/or overdose on their premises.
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Naloxona , Transtornos Relacionados ao Uso de Opioides , Humanos , Ohio , Estudos Transversais , Naloxona/uso terapêutico , Antagonistas de Entorpecentes/uso terapêutico , Bibliotecas , Inquéritos e Questionários , Feminino , Masculino , Overdose de Drogas/prevenção & controle , AdultoRESUMO
BACKGROUND: Opioids are a first-line treatment for severe cancer pain. However, clinicians may be reluctant to prescribe opioids for patients with concurrent substance use disorders (SUD) or clinical concerns about non-prescribed substance use. MEASURES: Patient volume, 60-day retention rate, and use of sublingual buprenorphine to treat opioid use disorder. INTERVENTION: We created the Palliative Harm Reduction and Resiliency Clinic, a palliative care clinic founded on harm reduction principles and including formal collaboration with addiction psychiatry. OUTCOMES: During the first 18 months, patient volume increased steadily; 70% of patients had at least one subsequent visit within 60 days of the initial appointment; and buprenorphine was prescribed for 55% of patients with opioid use disorder. CONCLUSIONS/LESSONS LEARNED: The formal collaboration with addiction psychiatry and the integration of harm reduction principles and practices into ambulatory palliative care improved our ability to provide treatment to a previously underserved patient population with high symptom burden.
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Analgésicos Opioides , Dor do Câncer , Cuidados Paliativos , Humanos , Cuidados Paliativos/métodos , Dor do Câncer/tratamento farmacológico , Dor do Câncer/terapia , Masculino , Analgésicos Opioides/uso terapêutico , Feminino , Buprenorfina/uso terapêutico , Pessoa de Meia-Idade , Transtornos Relacionados ao Uso de Opioides/terapia , Redução do Dano , IdosoRESUMO
BACKGROUND: Patients with chronic pain face significant barriers in finding clinicians to manage long-term opioid therapy (LTOT). For patients on LTOT, it is increasingly common to have them sign opioid treatment agreements (OTAs). OTAs enumerate the risks of opioids, as informed consent documents would, but also the requirements that patients must meet to receive LTOT. While there has been an ongoing scholarly discussion about the practical and ethical implications of OTA use in the abstract, little is known about how clinicians use them and if OTAs themselves modify clinician prescribing practices. OBJECTIVE: To determine how clinicians use OTAs and the potential impacts of OTAs on opioid prescribing. DESIGN: We conducted qualitative analysis of four focus groups of clinicians from a large Midwestern academic medical center. Groups were organized according to self-identified prescribing patterns: two groups for clinicians who identified as prescribers of LTOT, and two who did not. PARTICIPANTS: 17 clinicians from General Internal Medicine, Family Medicine, and Palliative Care were recruited using purposive, convenience sampling. APPROACH: Discussions were recorded, transcribed, and analyzed for themes using reflexive thematic analysis by a multidisciplinary team. KEY RESULTS: Our analysis identified three main themes: (1) OTAs did not influence clinicians' decisions whether to use LTOT generally but did shape clinical decision-making for individual patients; (2) clinicians feel OTAs intensify the power they have over patients, though this was not uniformly judged as harmful; (3) there is a potential misalignment between the intended purposes of OTAs and their implementation. CONCLUSION: This study reveals a complicated relationship between OTAs and access to pain management. While OTAs seem not to impact the clinicians' decisions about whether to use LTOT generally, they do sometimes influence prescribing decisions for individual patients. Clinicians shared complex views about OTAs' purposes, which shows the need for more clarity about how OTAs could be used to promote shared decision-making, joint accountability, informed consent, and patient education.
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The increasing prevalence of obesity and its associated complications leads to the need to intensify its prevention and treatment. The treatment of obesity is currently based on lifestyle modification, which often fails in the long term. For the next decade, the long-term administration of anti-obesity drugs, i.e. drugs that have a positive effect not only on the reduction of excess weight but also on the health risks associated with obesity, seems to be a necessary part of obesity treatment, along with surgical approaches. This text provides an overview of the current options for the pharmacotherapy of obesity, including their indications, appropriate patient selection and adverse effects of treatment. It also provides an overview of studies that demonstrate the long-term efficacy and safety of these treatments. Although effective and safe anti-obesity drugs are currently available, it is not even partially covered by general health insurance. However, the cost of treatment is unaffordable in the long term for a large proportion of the obese. The virtual unavailability of effective antiobesity drugs for indicated patients has serious health-economic consequences. Failure to take advantage of effective therapeutic options, confirmed by evidence-based medicine, results in a high prevalence of obesity-related diseases, which are even more costly to treat economically and, in the case of type 2 diabetes, even less effective. We consider at least partial reimbursement of antiobesity drugs from general health insurance for cooperating patients under clearly defined conditions to be a necessary step towards improving the situation, and clearly cost-effective in its consequences.
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Fármacos Antiobesidade , Diabetes Mellitus Tipo 2 , Humanos , Diabetes Mellitus Tipo 2/tratamento farmacológico , Obesidade/tratamento farmacológico , Fármacos Antiobesidade/uso terapêuticoRESUMO
BACKGROUND: Dysfunctional adipose tissue (AT) is known to contribute to the pathophysiology of metabolic disease, including type 2 diabetes mellitus (T2DM). This dysfunction may occur, in part, as a consequence of gut-derived endotoxaemia inducing changes in adipocyte mitochondrial function and reducing the proportion of BRITE (brown-in-white) adipocytes. Therefore, the present study investigated whether endotoxin (lipopolysaccharide; LPS) directly contributes to impaired human adipocyte mitochondrial function and browning in human adipocytes, and the relevant impact of obesity status pre and post bariatric surgery. METHODS: Human differentiated abdominal subcutaneous (AbdSc) adipocytes from participants with obesity and normal-weight participants were treated with endotoxin to assess in vitro changes in mitochondrial function and BRITE phenotype. Ex vivo human AbdSc AT from different groups of participants (normal-weight, obesity, pre- and 6 months post-bariatric surgery) were assessed for similar analyses including circulating endotoxin levels. RESULTS: Ex vivo AT analysis (lean & obese, weight loss post-bariatric surgery) identified that systemic endotoxin negatively correlated with BAT gene expression (p < 0.05). In vitro endotoxin treatment of AbdSc adipocytes (lean & obese) reduced mitochondrial dynamics (74.6% reduction; p < 0.0001), biogenesis (81.2% reduction; p < 0.0001) and the BRITE phenotype (93.8% reduction; p < 0.0001). Lean AbdSc adipocytes were more responsive to adrenergic signalling than obese AbdSc adipocytes; although endotoxin mitigated this response (92.6% reduction; p < 0.0001). CONCLUSIONS: Taken together, these data suggest that systemic gut-derived endotoxaemia contributes to both individual adipocyte dysfunction and reduced browning capacity of the adipocyte cell population, exacerbating metabolic consequences. As bariatric surgery reduces endotoxin levels and is associated with improving adipocyte functionality, this may provide further evidence regarding the metabolic benefits of such surgical interventions.
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Diabetes Mellitus Tipo 2 , Endotoxemia , Humanos , Endotoxemia/metabolismo , Adipócitos/metabolismo , Obesidade/metabolismo , Lipopolissacarídeos , Endotoxinas/metabolismoRESUMO
Obesity as a chronic, serious, and progressive lifelong disease requires an active approach to treatment. Treatment means necessary adjustment of lifestyle with suitable regular physical activity, including pharmacological or bariatric support. Current pharmacological treatment can be an effective helper in the preparation for the surgical treatment of obesity (bariatric and metabolic operations), and in greater adherence of the patient to the necessary regime changes in life and in preoperative weight reduction. With the lapse of time after surgical treatment, in many cases we indicate the start of pharmacological treatment if the weight increases again. We do not yet know the appropriate types of patients and the exact indications for specific therapeutic modalities - a suitable antiobesity drug or type of bariatric surgery. The best long-term results come from a combination of at least two of these options, along with a lifestyle change. Among modern antiobesity drugs, there are naltrexone-bupropion and liraglutide. Orlistat can be mentioned from older ones.
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Fármacos Antiobesidade , Cirurgia Bariátrica , Fármacos Antiobesidade/uso terapêutico , Humanos , Obesidade/tratamento farmacológico , Obesidade/cirurgia , Orlistate/uso terapêutico , Redução de PesoRESUMO
BACKGROUND: The European Association for Endoscopic Surgery Bariatric Guidelines Group identified a gap in bariatric surgery recommendations with a structured, contextualized consideration of multiple bariatric interventions. OBJECTIVE: To provide evidence-informed, transparent and trustworthy recommendations on the use of sleeve gastrectomy, Roux-en-Y gastric bypass, adjustable gastric banding, gastric plication, biliopancreatic diversion with duodenal switch, one anastomosis gastric bypass, and single anastomosis duodeno-ileal bypass with sleeve gastrectomy in patients with severe obesity and metabolic diseases. Only laparoscopic procedures in adults were considered. METHODS: A European interdisciplinary panel including general surgeons, obesity physicians, anesthetists, a psychologist and a patient representative informed outcome importance and minimal important differences. We conducted a systematic review and frequentist fixed and random-effects network meta-analysis of randomized-controlled trials (RCTs) using the graph theory approach for each outcome. We calculated the odds ratio or the (standardized) mean differences with 95% confidence intervals for binary and continuous outcomes, respectively. We assessed the certainty of evidence using the CINeMA and GRADE methodologies. We considered the risk/benefit outcomes within a GRADE evidence to decision framework to arrive at recommendations, which were validated through an anonymous Delphi process of the panel. RESULTS: We identified 43 records reporting on 24 RCTs. Most network information surrounded sleeve gastrectomy and Roux-en-Y gastric bypass. Under consideration of the certainty of the evidence and evidence to decision parameters, we suggest sleeve gastrectomy or laparoscopic Roux-en-Y gastric bypass over adjustable gastric banding, biliopancreatic diversion with duodenal switch and gastric plication for the management of severe obesity and associated metabolic diseases. One anastomosis gastric bypass and single anastomosis duodeno-ileal bypass with sleeve gastrectomy are suggested as alternatives, although evidence on benefits and harms, and specific selection criteria is limited compared to sleeve gastrectomy and Roux-en-Y gastric bypass. The guideline, with recommendations, evidence summaries and decision aids in user friendly formats can also be accessed in MAGICapp: https://app.magicapp.org/#/guideline/Lpv2kE CONCLUSIONS: This rapid guideline provides evidence-informed, pertinent recommendations on the use of bariatric and metabolic surgery for the management of severe obesity and metabolic diseases. The guideline replaces relevant recommendations published in the EAES Bariatric Guidelines 2020.
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Cirurgia Bariátrica , Derivação Gástrica , Laparoscopia , Obesidade Mórbida , Adulto , Humanos , Cirurgia Bariátrica/métodos , Consenso , Gastrectomia/métodos , Derivação Gástrica/métodos , Abordagem GRADE , Laparoscopia/métodos , Filmes Cinematográficos , Metanálise em Rede , Obesidade Mórbida/cirurgia , Resultado do TratamentoRESUMO
Objectives: Medication for opioid use disorder (MOUD) has gained significant momentum as an evidence-based intervention for treating opioid use disorder (OUD). The purpose of this study was to characterize MOUD initiations for buprenorphine and extended release (ER) naltrexone across all care sites at a major health system in the Midwest and determine whether MOUD initiation was associated with inpatient outcomes. Methods: The study population comprised patients with OUD in the health system between 2018 and 2021. First, we described characteristics of all MOUD initiations for the study population within the health system. Second, we compared inpatient length of stay (LOS) and unplanned readmission rates between patients prescribed MOUD and patients not prescribed MOUD, including a pre-post comparison of patients prescribed MOUD before versus after initiation. Results: The 3,831 patients receiving MOUD were mostly white, non-Hispanic and generally received buprenorphine over ER naltrexone. 65.5% of most recent initiations occurred in an inpatient setting. Compared to those not prescribed MOUD, inpatient encounters where patients received MOUD on or before the admission date were significantly less likely to be unplanned readmissions (13% vs. 20%, p < 0.001) and their LOS was 0.14 days shorter (p = 0.278). Among patients prescribed MOUD, there was a significant reduction in the readmission rate after initiation compared to before (13% vs. 22%, p < 0.001). Conclusions: This study is the first to examine MOUD initiations for thousands of patients across multiple care sites in a health system, finding that receiving MOUD is associated with clinically meaningful reductions in readmission rates.
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COVID-19 , Obesidade Mórbida , Vacinas contra COVID-19 , Humanos , Obesidade Mórbida/cirurgia , SARS-CoV-2RESUMO
Phenomenon: Physician shortages in low- and middle-income countries (LMIC) have led to increased interest in using e-learning tools for training. Organic digital education (ODE)-digital scholarship largely created outside of formal medical curricula-has increased in popularity over the past decade. Medical podcasting has become one of the most prominent asynchronous ODE sources for learners in high-income (HI) countries; there have been no previous attempts to characterize their use in LMIC. Approach: Listener data from a 2-year period from three major internal medicine podcasts-Bedside Rounds, Core IM, and The Curbsiders-were aggregated, 188 episodes in total. These data were subdivided into country by top-level domain, normalized by population, and grouped together by World Bank income levels and English-speaking status. This methodology was also repeated to compare individual episodes on topics more versus less relevant to learners in LMIC. Findings: Over a 2-year period, the three podcasts had a total of 2.3 million unique downloads and were listened to in 192 of 207 countries worldwide. Overall, 91.5% of downloads were in HI countries, with 8.2% in LMIC. A total of 86.1% of listens were in countries with English as an official or unofficial listed language, whereas 13.8% were in countries without. Normalized for population, listeners in HI countries represented 970.5 listens per million population compared with 12.4 per million in LMIC. An analysis of individual episodes by topic showed that material more relevant to learners in LMIC had significantly more listeners from these countries. Insights: Compared with other forms of ODE, medical podcasting has much lower uptake in LMIC. However, there are considerable opportunities for growth. Medical podcasters in HI countries should be aware of a potential global audience and should take concrete steps to ensure a diversity of content and to periodically audit their data. Medical educators in LMIC should consider podcasting as a potentially powerful form of teaching. International medical educational organizations as well as podcasting organizations should provide resources for educators in these countries.
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Currículo , Países em Desenvolvimento , Humanos , Aprendizagem , Avaliação das NecessidadesRESUMO
INTRODUCTION: Sleeve gastrectomy (SG) is the commonest bariatric procedure worldwide. Yet there is significant variation in practice concerning its various aspects. This paper report results from the first modified Delphi consensus-building exercise on SG. METHODS: We established a committee of 54 globally recognized opinion makers in this field. The committee agreed to vote on several statements concerning SG. An agreement or disagreement amongst ≥ 70.0% experts was construed as a consensus. RESULTS: The committee achieved a consensus of agreement (n = 71) or disagreement (n = 7) for 78 out of 97 proposed statements after two rounds of voting. The committee agreed with 96.3% consensus that the characterization of SG as a purely restrictive procedure was inaccurate and there was 88.7% consensus that SG was not a suitable standalone, primary, surgical weight loss option for patients with Barrett's esophagus (BE) without dysplasia. There was an overwhelming consensus of 92.5% that the sleeve should be fashioned over an orogastric tube of 36-40 Fr and a 90.7% consensus that surgeons should stay at least 1 cm away from the angle of His. Remarkably, the committee agreed with 81.1% consensus that SG patients should undergo a screening endoscopy every 5 years after surgery to screen for BE. CONCLUSION: A multinational team of experts achieved consensus on several aspects of SG. The findings of this exercise should help improve the outcomes of SG, the commonest bariatric procedure worldwide, and guide future research on this topic.
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Derivação Gástrica , Obesidade Mórbida , Consenso , Técnica Delphi , Gastrectomia , Humanos , Obesidade Mórbida/cirurgia , Estudos Retrospectivos , Resultado do Tratamento , Redução de PesoRESUMO
Overweight and obesity prevalence in middle aged subjects in the Czech Republic is more than 50 per cent, obesity is found in around 26 per cent of population. Obesity management is a long-term and time-consuming process. Early start of the treatment can prevent continuous weight gain and development of co-morbidities. General practitioners see obese patients usually as the first and they represent the first point of contact for adults with obesity. The basis of obesity management is a change of the lifestyle with added pharmacotherapy and/or bariatric/metabolic surgery. The paper presents overview of methods in obesity diagnostics and management and possibilities of their use in GPs daily practice.
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Obesidade , Sobrepeso , Adulto , República Tcheca/epidemiologia , Humanos , Pessoa de Meia-Idade , Obesidade/complicações , Obesidade/diagnóstico , Obesidade/epidemiologia , Atenção Primária à Saúde , Aumento de PesoRESUMO
Bariatric and metabolic surgery underwent substantial changes in its history. In the early nineties of the last century, the most important was introduction of laparoscopic procedures. Laparoscopic operations lead to worldwide adoption of bariatric surgery. Shift from bariatric to metabolic surgery represents another substantial change in treatment philosophy. In metabolic surgery, it is improvement/remission of metabolic parameters, such as type 2 diabetes mellitus and others, rather than weight loss what is the most important measure of success. Despite undoubtful success of surgical treatments, only a small proportion of the potentially eligible patients undergoes the operation. There are often fears of both patients and referring physicians of excessive invasiveness, risks and irreversible anatomical changes, mistrust in treatment results. Ongoing research targets these points, the goal is to master less invasive options than standard laparoscopic operations. Direct involvement of other medical specialties, such as gastroenterology or invasive radiology, in patient treatment is essential as well. Gastroenterology and endoscopic gastric plication, partial jejunal bypass and others may serve as the examples. Invasive radiology may offer potentially effective treatment modalities, such as embolization of left gastric artery. There's a trend in patients' preferences, towards less invasive treatment, even though it may result in moderate effectivity, rather than vice versa, choosing highly invasive, more risky treatment, regardless its expected higher efficacy.
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Cirurgia Bariátrica , Diabetes Mellitus Tipo 2 , Laparoscopia , República Tcheca , Diabetes Mellitus Tipo 2/cirurgia , Humanos , Redução de PesoRESUMO
Laparoscopic gastric plication (LGCP) is a newer metabolic/bariatric surgical operation that requires no resection, no implantable device or bypass. We report outcomes in a cohort of LGCP patients at 10-year follow-up. Body mass index (BMI, kg/m2) evolution, total weight loss (%), and comorbidities were recorded. Repeated measures analysis of variance (ANOVA) was used to asses BMI change over 10 years. We have completed data of 86,9 % (109/125) of patients entering the study between 2009 and 2010, 21,6 % of all the patients were men. Mean age was 45,8 ±10,9 years, and mean baseline BMI was 42,1± 5,4 kg/m2. We observed still some weight reduction at 10 years. Hypertension and diabetes were the most frequent comorbidities. Incidence of diabetes decreased within ten years after the procedure, as well as the medication for diabetes decreased, on the other hand we observed no change in hyperlipoproteinemia. There were 16,8 % elective reoperations due to insufficient weight loss, out of that 19 % decided for malabsorptive procedure. There was no mortality or emergencies. At ten years follow-up, LGCP proved to be safe and effective method for obesity treatment.
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Laparoscopia , Doenças Metabólicas , Obesidade Mórbida , Adulto , Criança , Humanos , Masculino , Pessoa de Meia-Idade , Obesidade/epidemiologia , Obesidade Mórbida/cirurgia , Redução de PesoRESUMO
BACKGROUND: Obesity is well-appreciated to result in poor cardiovascular and metabolic outcomes. Dietary and medical weight loss strategies are frequently unsuccessful and unsustainable. Bariatric surgery is quite effective, but is reserved for the most obese patients because of the associated intraoperative/post-operative risks. In preclinical and early clinical case series, a novel therapy, transcatheter bariatric embolotherapy (TBE) of the left gastric artery, has been reported to promote weight loss by reducing ghrelin, an appetite-stimulating hormone secreted from the gastric fundus. OBJECTIVES: The purpose of this study was to examine TBE in a single-blind, sham procedure randomized trial. METHODS: Obese subjects (body mass index 35 to 55 kg/m2) were randomized 1:1 to either sham or TBE targeting the left gastric artery using an occlusion balloon microcatheter to administer 300- to 500-µm embolic beads. All patients entered a lifestyle counseling program. Patients and physicians performing follow-up were blind to the allocated therapy. Endoscopy was performed at baseline and 1-week post-procedure. The primary endpoint was 6-month total body weight loss (TBWL). RESULTS: Eligible subjects (n = 44; age 45.5 ± 9.4 years; 8 men/36 women; body mass index 39.6 ± 3.8 kg/m2) were randomized to undergo the sham or TBE procedure with no device-related complications and 1 vascular complication. Patients reported mild nausea and vomiting, and endoscopy revealed only minor self-limiting ulcers in 5 patients. At 6 months, in both the intention-to-treat and per-protocol populations, the TBWL was greater with TBE (7.4 kg/6.4% and 9.4 kg/8.3% loss, respectively) than sham (3.0 kg/2.8% and 1.9 kg/1.8%, respectively; p = 0.034/0.052 and p = 0.0002/0.0011, respectively). The TBWL was maintained with TBE at 12 months (intention-to-treat 7.8 kg/6.5% loss, per-protocol 9.3 kg/9.3% loss; p = 0.0011/0.0008, p = 0.0005/0.0005, respectively). CONCLUSIONS: In this randomized pilot trial, we have established the proof-of-principle that transcatheter bariatric embolotherapy of the left gastric artery is well-tolerated and promotes clinically significant weight loss over a sham procedure.(The Lowering Weight in Severe Obesity by Embolization of the Gastric Artery Trial [LOSEIT]; NCT03185949).
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Embolização Terapêutica/estatística & dados numéricos , Obesidade/terapia , Adulto , Embolização Terapêutica/efeitos adversos , Embolização Terapêutica/métodos , Feminino , Artéria Gástrica , Grelina/sangue , Humanos , Fome , Hipertensão/etiologia , Hipertensão/terapia , Masculino , Pessoa de Meia-Idade , Obesidade/sangue , Obesidade/complicações , Obesidade/psicologia , Qualidade de Vida , Resposta de SaciedadeRESUMO
BACKGROUND: Surgery for obesity and metabolic diseases has been evolved in the light of new scientific evidence, long-term outcomes and accumulated experience. EAES has sponsored an update of previous guidelines on bariatric surgery. METHODS: A multidisciplinary group of bariatric surgeons, obesity physicians, nutritional experts, psychologists, anesthetists and a patient representative comprised the guideline development panel. Development and reporting conformed to GRADE guidelines and AGREE II standards. RESULTS: Systematic review of databases, record selection, data extraction and synthesis, evidence appraisal and evidence-to-decision frameworks were developed for 42 key questions in the domains Indication; Preoperative work-up; Perioperative management; Non-bypass, bypass and one-anastomosis procedures; Revisional surgery; Postoperative care; and Investigational procedures. A total of 36 recommendations and position statements were formed through a modified Delphi procedure. CONCLUSION: This document summarizes the latest evidence on bariatric surgery through state-of-the art guideline development, aiming to facilitate evidence-based clinical decisions.
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Cirurgia Bariátrica/métodos , Endoscopia/métodos , Guias de Prática Clínica como Assunto , Europa (Continente) , Humanos , Obesidade Mórbida/cirurgia , Sociedades MédicasRESUMO
INTRODUCTION: The study investigates the association between circadian phenotype (CP), its stability (interdaily stability - IS) and physical activity (PA) in a weight loss (WL) programme. METHODS: Seventy-five women in WL conservative treatment (BMI ≥ 25 kg/m2) were measured (for about 3 months in between 2016 and 2018) by actigraphy. RESULTS: We observed a difference in time of acrophase (p = 0.049), but no difference in IS (p = 0.533) between women who lost and did not lose weight. There was a difference in PA (mesor) between groups of women who lost weight compared to those who gained weight (p = 0.007). There was a relationship between IS and PA parametres mesor: p0.001; and the most active 10 h of a day (M10): p < 0.001 - the more stable were women in their rhythm, the more PA they have. Besides confirming a relationship between PA and WL, we also found a relation between WL and CP based on acrophase. Although no direct relationship was found for the indicators of rhythm stability (IS), they can be considered very important variables because of their close connection to PA - a main factor that contributes to the success of the WL programme. DISCUSSION: According to the results of the study, screening of the CP and its stability may be beneficial in the creation of an individualized WL plan.