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[PMID]:29362796
[Au] Autor:Bouillon K; Bertrand M; Bader G; Lucot JP; Dray-Spira R; Zureik M
[Ad] Endereço:Department of Epidemiology of Health Products, French National Agency for Medicines and Health Products Safety (ANSM), Saint-Denis, France.
[Ti] Título:Association of Hysteroscopic vs Laparoscopic Sterilization With Procedural, Gynecological, and Medical Outcomes.
[So] Source:JAMA;319(4):375-387, 2018 01 23.
[Is] ISSN:1538-3598
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:Importance: Safety of hysteroscopic sterilization has been recently questioned following reports of general symptoms such as allergy, tiredness, and depression in addition to associated gynecological results such as pelvic pain, perforation of fallopian tubes or uterus, and unwanted pregnancy. Objective: To compare the risk of reported adverse events between hysteroscopic and laparoscopic sterilization. Design, Setting, and Participants: French nationwide cohort study using the national hospital discharge database linked to the health insurance claims database. Women aged 30 to 54 years receiving a first hysteroscopic or laparoscopic sterilization between 2010 and 2014 were included and were followed up through December 2015. Exposures: Hysteroscopic sterilization vs laparoscopic sterilization. Main Outcomes and Measures: Risks of procedural complications (surgical and medical) and of gynecological (sterilization failure that includes salpingectomy, second sterilization procedure, or pregnancy; pregnancy; reoperation) and medical outcomes (all types of allergy; autoimmune diseases; thyroid disorder; use of analgesics, antimigraines, antidepressants, benzodiazepines; outpatient visits; sickness absence; suicide attempts; death) that occurred within 1 and 3 years after sterilization were compared using inverse probability of treatment-weighted Cox models. Results: Of the 105 357 women included (95.5% of eligible participants; mean age, 41.3 years [SD, 3.7 years]), 71 303 (67.7% ) underwent hysteroscopic sterilization, and 34 054 (32.3%) underwent laparoscopic sterilization. During the hospitalization for sterilization, risk of surgical complications for hysteroscopic sterilization was lower: 0.13% for hysteroscopic sterilization vs 0.78% for laparoscopic sterilization (adjusted risk difference [RD], -0.64; 95% CI, -0.67 to -0.60) and was lower for medical complications: 0.06% vs 0.11% (adjusted RD, -0.05; 95% CI, -0.08 to -0.01). During the first year after sterilization, 4.83% of women who underwent hysteroscopic sterilization had a higher risk of sterilization failure than the 0.69% who underwent laparoscopic sterilization (adjusted hazard ratio [HR], 7.11; 95% CI, 5.92 to 8.54; adjusted RD, 4.23 per 100 person-years; 95% CI, 3.40 to 5.22). Additionally, 5.65% of women who underwent hysteroscopic sterilization required gynecological reoperation vs 1.76% of women who underwent laparoscopic sterilization (adjusted HR, 3.26; 95% CI, 2.90 to 3.67; adjusted RD, 4.63 per 100 person-years; 95% CI, 3.38 to 4.75); these differences persisted after 3 years, although attenuated. Hysteroscopic sterilization was associated with a lower risk of pregnancy within the first year of the procedure but was not significantly associated with a difference in risk of pregnancy by the third year (adjusted HR, 1.04; 95% CI, 0.83-1.30; adjusted RD, 0.01 per 100 person-years; 95% CI, -0.04 to 0.07). Risks of medical outcomes were not significantly increased with hysteroscopic sterilization compared with laparoscopic sterilization. Conclusions and Relevance: Among women undergoing first sterilization, the use of hysteroscopic sterilization was significantly associated with higher risk of gynecological complications over 1 year and over 3 years than was laparoscopic sterilization. Risk of medical outcomes was not significantly increased over 1 year or over 3 years. These findings do not support increased medical risks associated with hysteroscopic sterilization.
[Mh] Termos MeSH primário: Histeroscopia/efeitos adversos
Laparoscopia/efeitos adversos
Complicações Pós-Operatórias/etiologia
Esterilização Tubária/métodos
[Mh] Termos MeSH secundário: Adulto
Estudos de Coortes
Feminino
França
Seres Humanos
Meia-Idade
Complicações Pós-Operatórias/epidemiologia
Gravidez
Gravidez não Planejada
Reoperação/estatística & dados numéricos
Esterilização Tubária/efeitos adversos
Falha de Tratamento
[Pt] Tipo de publicação:COMPARATIVE STUDY; JOURNAL ARTICLE; OBSERVATIONAL STUDY
[Em] Mês de entrada:1801
[Cu] Atualização por classe:180311
[Lr] Data última revisão:
180311
[Sb] Subgrupo de revista:AIM; IM
[Da] Data de entrada para processamento:180125
[St] Status:MEDLINE
[do] DOI:10.1001/jama.2017.21269


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[PMID]:29340680
[Au] Autor:Jakobsen GS; Småstuen MC; Sandbu R; Nordstrand N; Hofsø D; Lindberg M; Hertel JK; Hjelmesæth J
[Ad] Endereço:Morbid Obesity Centre, Vestfold Hospital Trust, Tønsberg, Norway.
[Ti] Título:Association of Bariatric Surgery vs Medical Obesity Treatment With Long-term Medical Complications and Obesity-Related Comorbidities.
[So] Source:JAMA;319(3):291-301, 2018 01 16.
[Is] ISSN:1538-3598
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:Importance: The association of bariatric surgery and specialized medical obesity treatment with beneficial and detrimental outcomes remains uncertain. Objective: To compare changes in obesity-related comorbidities in patients with severe obesity (body mass index ≥40 or ≥35 and at least 1 comorbidity) undergoing bariatric surgery or specialized medical treatment. Design, Setting, and Participants: Cohort study with baseline data of exposures from November 2005 through July 2010 and follow-up data from 2006 until death or through December 2015 at a tertiary care outpatient center, Vestfold Hospital Trust, Norway. Consecutive treatment-seeking adult patients (n = 2109) with severe obesity assessed (221 patients excluded and 1888 patients included). Exposures: Bariatric surgery (n = 932, 92% gastric bypass) or specialized medical treatment (n = 956) including individual or group-based lifestyle intervention programs. Main Outcomes and Measures: Primary outcomes included remission and new onset of hypertension based on drugs dispensed according to the Norwegian Prescription Database. Prespecified secondary outcomes included changes in comorbidities. Adverse events included complications retrieved from the Norwegian Patient Registry and a local laboratory database. Results: Among 1888 patients included in the study, the mean (SD) age was 43.5 (12.3) years (1249 women [66%]; mean [SD] baseline BMI, 44.2 [6.1]; 100% completed follow-up at a median of 6.5 years [range, 0.2-10.1]). Surgically treated patients had a greater likelihood of remission and lesser likelihood for new onset of hypertension (remission: absolute risk [AR], 31.9% vs 12.4%); risk difference [RD], 19.5% [95% CI, 15.8%-23.2%], relative risk [RR], 2.1 [95% CI, 2.0-2.2]; new onset: AR, 3.5% vs 12.2%, RD, 8.7% [95% CI, 6.7%-10.7%], RR, 0.4 [95% CI, 0.3-0.5]; greater likelihood of diabetes remission: AR, 57.5% vs 14.8%; RD, 42.7% [95% CI, 35.8%-49.7%], RR, 3.9 [95% CI, 2.8-5.4]; greater risk of new-onset depression: AR, 8.9% vs 6.5%; RD, 2.4% [95% CI, 1.3%-3.5%], RR, 1.5 [95% CI, 1.4-1.7]; and treatment with opioids: AR, 19.4% vs 15.8%, RD, 3.6% [95% CI, 2.3%-4.9%], RR, 1.3 [95% CI, 1.2-1.4]). Surgical patients had a greater risk for undergoing at least 1 additional gastrointestinal surgical procedure (AR, 31.3% vs 15.5%; RD, 15.8% [95% CI, 13.1%-18.5%]; RR, 2.0 [95% CI, 1.7-2.4]). The proportion of patients with low ferritin levels was significantly greater in the surgical group (26% vs 12%, P < .001). Conclusions and Relevance: Among patients with severe obesity followed up for a median of 6.5 years, bariatric surgery compared with medical treatment was associated with a clinically important increased risk for complications, as well as lower risks of obesity-related comorbidities. The risk for complications should be considered in the decision-making process.
[Mh] Termos MeSH primário: Cirurgia Bariátrica
Obesidade Mórbida/complicações
[Mh] Termos MeSH secundário: Adulto
Cirurgia Bariátrica/efeitos adversos
Índice de Massa Corporal
Estudos de Coortes
Comorbidade
Depressão/complicações
Diabetes Mellitus Tipo 2/complicações
Feminino
Ferritinas/sangue
Seres Humanos
Hipertensão/complicações
Masculino
Meia-Idade
Obesidade Mórbida/tratamento farmacológico
Obesidade Mórbida/cirurgia
Indução de Remissão
Resultado do Tratamento
[Pt] Tipo de publicação:COMPARATIVE STUDY; JOURNAL ARTICLE
[Nm] Nome de substância:
9007-73-2 (Ferritins)
[Em] Mês de entrada:1801
[Cu] Atualização por classe:180311
[Lr] Data última revisão:
180311
[Sb] Subgrupo de revista:AIM; IM
[Da] Data de entrada para processamento:180118
[St] Status:MEDLINE
[do] DOI:10.1001/jama.2017.21055


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[PMID]:29340679
[Au] Autor:Peterli R; Wölnerhanssen BK; Peters T; Vetter D; Kröll D; Borbély Y; Schultes B; Beglinger C; Drewe J; Schiesser M; Nett P; Bueter M
[Ad] Endereço:Department of Surgery, St Claraspital, Basel, Switzerland.
[Ti] Título:Effect of Laparoscopic Sleeve Gastrectomy vs Laparoscopic Roux-en-Y Gastric Bypass on Weight Loss in Patients With Morbid Obesity: The SM-BOSS Randomized Clinical Trial.
[So] Source:JAMA;319(3):255-265, 2018 01 16.
[Is] ISSN:1538-3598
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:Importance: Sleeve gastrectomy is increasingly used in the treatment of morbid obesity, but its long-term outcome vs the standard Roux-en-Y gastric bypass procedure is unknown. Objective: To determine whether there are differences between sleeve gastrectomy and Roux-en-Y gastric bypass in terms of weight loss, changes in comorbidities, increase in quality of life, and adverse events. Design, Setting, and Participants: The Swiss Multicenter Bypass or Sleeve Study (SM-BOSS), a 2-group randomized trial, was conducted from January 2007 until November 2011 (last follow-up in March 2017). Of 3971 morbidly obese patients evaluated for bariatric surgery at 4 Swiss bariatric centers, 217 patients were enrolled and randomly assigned to sleeve gastrectomy or Roux-en-Y gastric bypass with a 5-year follow-up period. Interventions: Patients were randomly assigned to undergo laparoscopic sleeve gastrectomy (n = 107) or laparoscopic Roux-en-Y gastric bypass (n = 110). Main Outcomes and Measures: The primary end point was weight loss, expressed as percentage excess body mass index (BMI) loss. Exploratory end points were changes in comorbidities and adverse events. Results: Among the 217 patients (mean age, 45.5 years; 72% women; mean BMI, 43.9) 205 (94.5%) completed the trial. Excess BMI loss was not significantly different at 5 years: for sleeve gastrectomy, 61.1%, vs Roux-en-Y gastric bypass, 68.3% (absolute difference, -7.18%; 95% CI, -14.30% to -0.06%; P = .22 after adjustment for multiple comparisons). Gastric reflux remission was observed more frequently after Roux-en-Y gastric bypass (60.4%) than after sleeve gastrectomy (25.0%). Gastric reflux worsened (more symptoms or increase in therapy) more often after sleeve gastrectomy (31.8%) than after Roux-en-Y gastric bypass (6.3%). The number of patients with reoperations or interventions was 16/101 (15.8%) after sleeve gastrectomy and 23/104 (22.1%) after Roux-en-Y gastric bypass. Conclusions and Relevance: Among patients with morbid obesity, there was no significant difference in excess BMI loss between laparoscopic sleeve gastrectomy and laparoscopic Roux-en-Y gastric bypass at 5 years of follow-up after surgery. Trial Registration: clinicaltrials.gov Identifier: NCT00356213.
[Mh] Termos MeSH primário: Gastrectomia
Derivação Gástrica
Laparoscopia
Obesidade Mórbida/cirurgia
Perda de Peso
[Mh] Termos MeSH secundário: Adulto
Índice de Massa Corporal
Feminino
Seguimentos
Gastrectomia/efeitos adversos
Gastrectomia/métodos
Derivação Gástrica/efeitos adversos
Derivação Gástrica/métodos
Refluxo Gastroesofágico/etiologia
Seres Humanos
Masculino
Meia-Idade
Obesidade Mórbida/complicações
Obesidade Mórbida/fisiopatologia
Complicações Pós-Operatórias
Qualidade de Vida
[Pt] Tipo de publicação:COMPARATIVE STUDY; JOURNAL ARTICLE; MULTICENTER STUDY; RANDOMIZED CONTROLLED TRIAL
[Em] Mês de entrada:1801
[Cu] Atualização por classe:180311
[Lr] Data última revisão:
180311
[Sb] Subgrupo de revista:AIM; IM
[Da] Data de entrada para processamento:180118
[Cl] Clinical Trial:ClinicalTrial
[St] Status:MEDLINE
[do] DOI:10.1001/jama.2017.20897


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[PMID]:29340678
[Au] Autor:Ikramuddin S; Korner J; Lee WJ; Thomas AJ; Connett JE; Bantle JP; Leslie DB; Wang Q; Inabnet WB; Jeffery RW; Chong K; Chuang LM; Jensen MD; Vella A; Ahmed L; Belani K; Billington CJ
[Ad] Endereço:Department of Surgery, University of Minnesota, Minneapolis.
[Ti] Título:Lifestyle Intervention and Medical Management With vs Without Roux-en-Y Gastric Bypass and Control of Hemoglobin A1c, LDL Cholesterol, and Systolic Blood Pressure at 5 Years in the Diabetes Surgery Study.
[So] Source:JAMA;319(3):266-278, 2018 01 16.
[Is] ISSN:1538-3598
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:Importance: The Roux-en-Y gastric bypass is effective in achieving established diabetes treatment targets, but durability is unknown. Objective: To compare durability of Roux-en-Y gastric bypass added to intensive lifestyle and medical management in achieving diabetes control targets. Design, Setting, and Participants: Observational follow-up of a randomized clinical trial at 4 sites in the United States and Taiwan, involving 120 participants who had a hemoglobin A1c (HbA1c) level of 8.0% or higher and a body mass index between 30.0 and 39.9 (enrolled between April 2008 and December 2011) were followed up for 5 years, ending in November 2016. Interventions: Lifestyle-intensive medical management intervention based on the Diabetes Prevention Program and LookAHEAD trials for 2 years, with and without (60 participants each) Roux-en-Y gastric bypass surgery followed by observation to year 5. Main Outcomes and Measures: The American Diabetes Association composite triple end point of hemoglobin A1c less than 7.0%, low-density lipoprotein cholesterol less than 100 mg/dL, and systolic blood pressure less than 130 mm Hg at 5 years. Results: Of 120 participants who were initially randomized (mean age, 49 years [SD, 8 years], 72 women [60%]), 98 (82%) completed 5 years of follow-up. Baseline characteristics were similar between groups: mean (SD) body mass index 34.4 (3.2) for the lifestyle-medical management group and 34.9 (3.0) for the gastric bypass group and had hemoglobin A1c levels of 9.6% (1.2) and 9.6% (1.0), respectively. At 5 years, 13 participants (23%) in the gastric bypass group and 2 (4%) in the lifestyle-intensive medical management group had achieved the composite triple end point (difference, 19%; 95% CI, 4%-34%; P = .01). In the fifth year, 31 patients (55%) in the gastric bypass group vs 8 (14%) in the lifestyle-medical management group achieved an HbA1c level of less than 7.0% (difference, 41%; 95% CI, 19%-63%; P = .002). Gastric bypass had more serious adverse events than did the lifestyle-medical management intervention, 66 events vs 38 events, most frequently gastrointestinal events and surgical complications such as strictures, small bowel obstructions, and leaks. Gastric bypass had more parathyroid hormone elevation but no difference in B12 deficiency. Conclusions and Relevance: In extended follow-up of obese adults with type 2 diabetes randomized to adding gastric bypass compared with lifestyle and intensive medical management alone, there remained a significantly better composite triple end point in the surgical group at 5 years. However, because the effect size diminished over 5 years, further follow-up is needed to understand the durability of the improvement. Trial Registration: clinicaltrials.gov Identifier: NCT00641251.
[Mh] Termos MeSH primário: Derivação Gástrica
Hemoglobina A Glicada/análise
[Mh] Termos MeSH secundário: LDL-Colesterol/sangue
Diabetes Mellitus Tipo 2/sangue
Feminino
Seres Humanos
Hipoglicemiantes
Estilo de Vida
Meia-Idade
Taiwan
Resultado do Tratamento
[Pt] Tipo de publicação:JOURNAL ARTICLE; RESEARCH SUPPORT, N.I.H., EXTRAMURAL; COMMENT
[Nm] Nome de substância:
0 (Cholesterol, LDL); 0 (Glycated Hemoglobin A); 0 (Hypoglycemic Agents)
[Em] Mês de entrada:1801
[Cu] Atualização por classe:180311
[Lr] Data última revisão:
180311
[Sb] Subgrupo de revista:AIM; IM
[Da] Data de entrada para processamento:180118
[Cl] Clinical Trial:ClinicalTrial
[St] Status:MEDLINE
[do] DOI:10.1001/jama.2017.20813


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[PMID]:29340676
[Au] Autor:Salminen P; Helmiö M; Ovaska J; Juuti A; Leivonen M; Peromaa-Haavisto P; Hurme S; Soinio M; Nuutila P; Victorzon M
[Ad] Endereço:Division of Digestive Surgery and Urology, Turku University Hospital, Turku, Finland.
[Ti] Título:Effect of Laparoscopic Sleeve Gastrectomy vs Laparoscopic Roux-en-Y Gastric Bypass on Weight Loss at 5 Years Among Patients With Morbid Obesity: The SLEEVEPASS Randomized Clinical Trial.
[So] Source:JAMA;319(3):241-254, 2018 01 16.
[Is] ISSN:1538-3598
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:Importance: Laparoscopic sleeve gastrectomy for treatment of morbid obesity has increased substantially despite the lack of long-term results compared with laparoscopic Roux-en-Y gastric bypass. Objective: To determine whether laparoscopic sleeve gastrectomy and laparoscopic Roux-en-Y gastric bypass are equivalent for weight loss at 5 years in patients with morbid obesity. Design, Setting, and Participants: The Sleeve vs Bypass (SLEEVEPASS) multicenter, multisurgeon, open-label, randomized clinical equivalence trial was conducted from March 2008 until June 2010 in Finland. The trial enrolled 240 morbidly obese patients aged 18 to 60 years, who were randomly assigned to sleeve gastrectomy or gastric bypass with a 5-year follow-up period (last follow-up, October 14, 2015). Interventions: Laparoscopic sleeve gastrectomy (n = 121) or laparoscopic Roux-en-Y gastric bypass (n = 119). Main Outcomes and Measures: The primary end point was weight loss evaluated by percentage excess weight loss. Prespecified equivalence margins for the clinical significance of weight loss differences between gastric bypass and sleeve gastrectomy were -9% to +9% excess weight loss. Secondary end points included resolution of comorbidities, improvement of quality of life (QOL), all adverse events (overall morbidity), and mortality. Results: Among 240 patients randomized (mean age, 48 [SD, 9] years; mean baseline body mass index, 45.9, [SD, 6.0]; 69.6% women), 80.4% completed the 5-year follow-up. At baseline, 42.1% had type 2 diabetes, 34.6% dyslipidemia, and 70.8% hypertension. The estimated mean percentage excess weight loss at 5 years was 49% (95% CI, 45%-52%) after sleeve gastrectomy and 57% (95% CI, 53%-61%) after gastric bypass (difference, 8.2 percentage units [95% CI, 3.2%-13.2%], higher in the gastric bypass group) and did not meet criteria for equivalence. Complete or partial remission of type 2 diabetes was seen in 37% (n = 15/41) after sleeve gastrectomy and in 45% (n = 18/40) after gastric bypass (P > .99). Medication for dyslipidemia was discontinued in 47% (n = 14/30) after sleeve gastrectomy and 60% (n = 24/40) after gastric bypass (P = .15) and for hypertension in 29% (n = 20/68) and 51% (n = 37/73) (P = .02), respectively. There was no statistically significant difference in QOL between groups (P = .85) and no treatment-related mortality. At 5 years the overall morbidity rate was 19% (n = 23) for sleeve gastrectomy and 26% (n = 31) for gastric bypass (P = .19). Conclusions and Relevance: Among patients with morbid obesity, use of laparoscopic sleeve gastrectomy compared with use of laparoscopic Roux-en-Y gastric bypass did not meet criteria for equivalence in terms of percentage excess weight loss at 5 years. Although gastric bypass compared with sleeve gastrectomy was associated with greater percentage excess weight loss at 5 years, the difference was not statistically significant, based on the prespecified equivalence margins. Trial Registration: clinicaltrials.gov Identifier: NCT00793143.
[Mh] Termos MeSH primário: Gastrectomia
Derivação Gástrica
Laparoscopia
Obesidade Mórbida/cirurgia
Perda de Peso
[Mh] Termos MeSH secundário: Adolescente
Adulto
Diabetes Mellitus Tipo 2/complicações
Feminino
Seguimentos
Gastrectomia/efeitos adversos
Gastrectomia/métodos
Derivação Gástrica/efeitos adversos
Derivação Gástrica/métodos
Seres Humanos
Hiperlipidemias/complicações
Hipertensão/complicações
Masculino
Meia-Idade
Obesidade Mórbida/complicações
Obesidade Mórbida/fisiopatologia
Complicações Pós-Operatórias
Qualidade de Vida
Resultado do Tratamento
Adulto Jovem
[Pt] Tipo de publicação:COMPARATIVE STUDY; EQUIVALENCE TRIAL; JOURNAL ARTICLE; MULTICENTER STUDY; RANDOMIZED CONTROLLED TRIAL
[Em] Mês de entrada:1801
[Cu] Atualização por classe:180311
[Lr] Data última revisão:
180311
[Sb] Subgrupo de revista:AIM; IM
[Da] Data de entrada para processamento:180118
[Cl] Clinical Trial:ClinicalTrial
[St] Status:MEDLINE
[do] DOI:10.1001/jama.2017.20313


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[PMID]:29340677
[Au] Autor:Reges O; Greenland P; Dicker D; Leibowitz M; Hoshen M; Gofer I; Rasmussen-Torvik LJ; Balicer RD
[Ad] Endereço:Clalit Research Institute, Clalit Health Services, Tel Aviv, Israel.
[Ti] Título:Association of Bariatric Surgery Using Laparoscopic Banding, Roux-en-Y Gastric Bypass, or Laparoscopic Sleeve Gastrectomy vs Usual Care Obesity Management With All-Cause Mortality.
[So] Source:JAMA;319(3):279-290, 2018 01 16.
[Is] ISSN:1538-3598
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:Importance: Bariatric surgery is an effective and safe approach for weight loss and short-term improvement in metabolic disorders such as diabetes. However, studies have been limited in most settings by lack of a nonsurgical group, losses to follow-up, missing data, and small sample sizes in clinical trials and observational studies. Objective: To assess the association of 3 common types of bariatric surgery compared with nonsurgical treatment with mortality and other clinical outcomes among obese patients. Design, Setting, and Participants: Retrospective cohort study in a large Israeli integrated health fund covering 54% of Israeli citizens with less than 1% turnover of members annually. Obese adult patients who underwent bariatric surgery between January 1, 2005, and December 31, 2014, were selected and compared with obese nonsurgical patients matched on age, sex, body mass index (BMI), and diabetes, with a final follow-up date of December 31, 2015. A total of 33 540 patients were included in this study. Exposures: Bariatric surgery (laparoscopic banding, Roux-en-Y gastric bypass, or laparoscopic sleeve gastrectomy) or usual care obesity management only (provided by a primary care physician and which may include dietary counseling and behavior modification). Main Outcomes and Measures: The primary outcome, all-cause mortality, matched and adjusted for BMI prior to surgery, age, sex, socioeconomic status, diabetes, hyperlipidemia, hypertension, cardiovascular disease, and smoking. Results: The study population included 8385 patients who underwent bariatric surgery (median age, 46 [IQR, 37-54] years; 5490 [65.5%] women; baseline median BMI, 40.6 [IQR, 38.5-43.7]; laparoscopic banding [n = 3635], gastric bypass [n = 1388], laparoscopic sleeve gastrectomy [n = 3362], and 25 155 nonsurgical matched patients (median age, 46 [IQR, 37-54] years; 16 470 [65.5%] women; baseline median BMI, 40.5 [IQR, 37.0-43.5]). The availability of follow-up data was 100% for all-cause mortality. There were 105 deaths (1.3%) among surgical patients during a median follow-up of 4.3 (IQR, 2.8-6.6) years (including 61 [1.7%] who underwent laparoscopic banding, 18 [1.3%] gastric bypass, and 26 [0.8%] sleeve gastrectomy), and 583 deaths (2.3%) among nonsurgical patients during a median follow-up of 4.0 (IQR, 2.6-6.2) years. The absolute difference was 2.51 (95% CI, 1.86-3.15) fewer deaths/1000 person-years in the surgical vs nonsurgical group. Adjusted hazard ratios (HRs) for mortality among nonsurgical vs surgical patients were 2.02 (95% CI, 1.63-2.52) for the entire study population; by surgical type, HRs were 2.01 (95% CI, 1.50-2.69) for laparoscopic banding, 2.65 (95% CI, 1.55-4.52) for gastric bypass, and 1.60 (95% CI, 1.02-2.51) for laparoscopic sleeve gastrectomy. Conclusions and Relevance: Among obese patients in a large integrated health fund in Israel, bariatric surgery using laparoscopic banding, gastric bypass, or laparoscopic sleeve gastrectomy, compared with usual care nonsurgical obesity management, was associated with lower all-cause mortality over a median follow-up of approximately 4.5 years. The evidence of this association adds to the limited literature describing beneficial outcomes of these 3 types of bariatric surgery compared with usual care obesity management alone.
[Mh] Termos MeSH primário: Gastrectomia/mortalidade
Derivação Gástrica/mortalidade
Gastroplastia/mortalidade
Laparoscopia
Obesidade Mórbida/mortalidade
Obesidade Mórbida/terapia
[Mh] Termos MeSH secundário: Adulto
Feminino
Gastrectomia/métodos
Seres Humanos
Estimativa de Kaplan-Meier
Masculino
Meia-Idade
Obesidade Mórbida/cirurgia
Modelos de Riscos Proporcionais
Estudos Retrospectivos
Perda de Peso
[Pt] Tipo de publicação:COMPARATIVE STUDY; JOURNAL ARTICLE
[Em] Mês de entrada:1801
[Cu] Atualização por classe:180311
[Lr] Data última revisão:
180311
[Sb] Subgrupo de revista:AIM; IM
[Da] Data de entrada para processamento:180118
[St] Status:MEDLINE
[do] DOI:10.1001/jama.2017.20513


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[PMID]:29318278
[Au] Autor:Atri A; Frölich L; Ballard C; Tariot PN; Molinuevo JL; Boneva N; Windfeld K; Raket LL; Cummings JL
[Ad] Endereço:Ray Dolby Brain Health Center, California Pacific Medical Center, San Francisco.
[Ti] Título:Effect of Idalopirdine as Adjunct to Cholinesterase Inhibitors on Change in Cognition in Patients With Alzheimer Disease: Three Randomized Clinical Trials.
[So] Source:JAMA;319(2):130-142, 2018 01 09.
[Is] ISSN:1538-3598
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:Importance: New therapeutic approaches for Alzheimer disease (AD) are needed. Objective: To assess whether idalopirdine, a selective 5-hydroxytryptamine-6 receptor antagonist, is effective for symptomatic treatment of mild to moderate AD. Design, Setting, and Participants: Three randomized clinical trials that included 2525 patients aged 50 years or older with mild to moderate AD (study 1: n = 933 patients at 119 sites; study 2: n = 858 at 158 sites; and study 3: n = 734 at 126 sites). The 24-week studies were conducted from October 2013 to January 2017; final follow-up on January 12, 2017. Interventions: Idalopirdine (10, 30, or 60 mg/d) or placebo added to cholinesterase inhibitor treatment (donepezil in studies 1 and 2; donepezil, rivastigmine, or galantamine in study 3). Main Outcomes and Measures: Primary end point in all 3 studies: change in cognition total score (range, 0-70; a lower score indicates less impairment) from baseline to 24 weeks measured by the 11-item cognitive subscale of the Alzheimer's Disease Assessment Scale (ADAS-Cog); key secondary end points: Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change Scale and 23-item Activities of Daily Living Inventory scores. Dose group efficacy required a significant benefit over placebo for the primary end point and 1 or more key secondary end points. Safety data and adverse event profiles were recorded. Results: Among 2525 patients randomized in the 3 trials (mean age, 74 years; mean baseline ADAS-Cog total score, 26; between 62% and 65% of participants were women), 2254 (89%) completed the studies. In study 1, the mean change in ADAS-Cog total score between baseline and 24 weeks was 0.37 for the 60-mg dose of idalopirdine group, 0.61 for the 30-mg dose group, and 0.41 for the placebo group (adjusted mean difference vs placebo, 0.05 [95% CI, -0.88 to 0.98] for the 60-mg dose group and 0.33 [95% CI, -0.59 to 1.26] for the 30-mg dose group). In study 2, the mean change in ADAS-Cog total score between baseline and 24 weeks was 1.01 for the 30-mg dose of idalopirdine group, 0.53 for the 10-mg dose group, and 0.56 for the placebo group (adjusted mean difference vs placebo, 0.63 [95% CI, -0.38 to 1.65] for the 30-mg dose group; given the gated testing strategy and the null findings at the 30-mg dose, statistical comparison of the 10-mg dose was not performed). In study 3, the mean change in ADAS-Cog total score between baseline and 24 weeks was 0.38 for the 60-mg dose of idalopirdine group and 0.82 for the placebo group (adjusted mean difference vs placebo, -0.55 [95% CI, -1.45 to 0.36]). Treatment-emergent adverse events occurred in between 55.4% and 69.7% of participants in the idalopirdine groups vs between 56.7% and 61.4% of participants in the placebo groups. Conclusions and Relevance: In patients with mild to moderate AD, the use of idalopirdine compared with placebo did not improve cognition over 24 weeks of treatment. These findings do not support the use of idalopirdine for the treatment of AD. Trial Registration: clinicaltrials.gov Identifiers: NCT01955161, NCT02006641, and NCT02006654.
[Mh] Termos MeSH primário: Doença de Alzheimer/tratamento farmacológico
Benzilaminas/uso terapêutico
Inibidores da Colinesterase/uso terapêutico
Indóis/uso terapêutico
Antagonistas da Serotonina/uso terapêutico
[Mh] Termos MeSH secundário: Acidentes por Quedas
Idoso
Idoso de 80 Anos ou mais
Doença de Alzheimer/psicologia
Benzilaminas/administração & dosagem
Benzilaminas/efeitos adversos
Inibidores da Colinesterase/efeitos adversos
Cognição/efeitos dos fármacos
Relação Dose-Resposta a Droga
Método Duplo-Cego
Quimioterapia Combinada
Feminino
Galantamina/uso terapêutico
Seres Humanos
Indanos/uso terapêutico
Indóis/administração & dosagem
Indóis/efeitos adversos
Masculino
Meia-Idade
Piperidinas/uso terapêutico
Rivastigmina/uso terapêutico
Antagonistas da Serotonina/administração & dosagem
Antagonistas da Serotonina/efeitos adversos
Falha de Tratamento
[Pt] Tipo de publicação:JOURNAL ARTICLE; MULTICENTER STUDY; RANDOMIZED CONTROLLED TRIAL
[Nm] Nome de substância:
0 ((2-(6-fluoro-1H-indol-3-yl)-ethyl)-(3-(2,2,3,3-tetrafluoropropoxy)benzyl)amine); 0 (Benzylamines); 0 (Cholinesterase Inhibitors); 0 (Indans); 0 (Indoles); 0 (Piperidines); 0 (Serotonin Antagonists); 0D3Q044KCA (Galantamine); 8SSC91326P (donepezil); PKI06M3IW0 (Rivastigmine)
[Em] Mês de entrada:1801
[Cu] Atualização por classe:180311
[Lr] Data última revisão:
180311
[Sb] Subgrupo de revista:AIM; IM
[Da] Data de entrada para processamento:180111
[Cl] Clinical Trial:ClinicalTrial
[St] Status:MEDLINE
[do] DOI:10.1001/jama.2017.20373


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[PMID]:29318277
[Au] Autor:Jones PM; Cherry RA; Allen BN; Jenkyn KMB; Shariff SZ; Flier S; Vogt KN; Wijeysundera DN
[Ad] Endereço:Department of Anesthesia and Perioperative Medicine, University of Western Ontario, London, Ontario, Canada.
[Ti] Título:Association Between Handover of Anesthesia Care and Adverse Postoperative Outcomes Among Patients Undergoing Major Surgery.
[So] Source:JAMA;319(2):143-153, 2018 01 09.
[Is] ISSN:1538-3598
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:Importance: Handing over the care of a patient from one anesthesiologist to another occurs during some surgeries and might increase the risk of adverse outcomes. Objective: To assess whether complete handover of intraoperative anesthesia care is associated with higher likelihood of mortality or major complications compared with no handover of care. Design, Setting, and Participants: A retrospective population-based cohort study (April 1, 2009-March 31, 2015 set in the Canadian province of Ontario) of adult patients aged 18 years and older undergoing major surgeries expected to last at least 2 hours and requiring a hospital stay of at least 1 night. Exposure: Complete intraoperative handover of anesthesia care from one physician anesthesiologist to another compared with no handover of anesthesia care. Main Outcomes and Measures: The primary outcome was a composite of all-cause death, hospital readmission, or major postoperative complications, all within 30 postoperative days. Secondary outcomes were the individual components of the primary outcome. Inverse probability of exposure weighting based on the propensity score was used to estimate adjusted exposure effects. Results: Of the 313 066 patients in the cohort, 56% were women; the mean (SD) age was 60 (16) years; 49% of surgeries were performed in academic centers; 72% of surgeries were elective; and the median duration of surgery was 182 minutes (interquartile [IQR] range, 124-255). A total of 5941 (1.9%) patients underwent surgery with complete handover of anesthesia care. The percentage of patients undergoing surgery with a handover of anesthesiology care progressively increased each year of the study, reaching 2.9% in 2015. In the unweighted sample, the primary outcome occurred in 44% of the complete handover group compared with 29% of the no handover group. After adjustment, complete handovers were statistically significantly associated with an increased risk of the primary outcome (adjusted risk difference [aRD], 6.8% [95% CI, 4.5% to 9.1%]; P < .001), all-cause death (aRD, 1.2% [95% CI, 0.5% to 2%]; P = .002), and major complications (aRD, 5.8% [95% CI, 3.6% to 7.9%]; P < .001), but not with hospital readmission within 30 days of surgery (aRD, 1.2% [95% CI, -0.3% to 2.7%]; P = .11). Conclusions and Relevance: Among adults undergoing major surgery, complete handover of intraoperative anesthesia care compared with no handover was associated with a higher risk of adverse postoperative outcomes. These findings may support limiting complete anesthesia handovers.
[Mh] Termos MeSH primário: Anestesiologia/organização & administração
Cuidados Intraoperatórios/efeitos adversos
Transferência da Responsabilidade pelo Paciente
Complicações Pós-Operatórias/etiologia
[Mh] Termos MeSH secundário: Adulto
Idoso
Feminino
Seres Humanos
Masculino
Meia-Idade
Readmissão do Paciente/estatística & dados numéricos
Estudos Retrospectivos
Procedimentos Cirúrgicos Operatórios/mortalidade
[Pt] Tipo de publicação:COMPARATIVE STUDY; JOURNAL ARTICLE; RESEARCH SUPPORT, NON-U.S. GOV'T
[Em] Mês de entrada:1801
[Cu] Atualização por classe:180311
[Lr] Data última revisão:
180311
[Sb] Subgrupo de revista:AIM; IM
[Da] Data de entrada para processamento:180111
[St] Status:MEDLINE
[do] DOI:10.1001/jama.2017.20040


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[PMID]:29305450
[Au] Autor:Kono K; Tomita T; Futai K; Yamazaki T; Tanaka S; Yoshikawa H; Sugamoto K
[Ad] Endereço:Graduate School of Medicine, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo 113-0033, Japan and Department of Orthopaedic Biomaterial Science, Osaka University Graduate School of Medicine, 2-2 Yamada-oka, Suita, Osaka 565-0871, Japan.
[Ti] Título: three-dimensional kinematics of normal knees during different high-flexion activities.
[So] Source:Bone Joint J;100-B(1):50-55, 2018 Jan.
[Is] ISSN:2049-4408
[Cp] País de publicação:England
[La] Idioma:eng
[Ab] Resumo:AIMS: In Asia and the Middle-East, people often flex their knees deeply in order to perform activities of daily living. The purpose of this study was to investigate the 3D kinematics of normal knees during high-flexion activities. Our hypothesis was that the femorotibial rotation, varus-valgus angle, translations, and kinematic pathway of normal knees during high-flexion activities, varied according to activity. MATERIALS AND METHODS: We investigated the kinematics of eight normal knees in four male volunteers (mean age 41.8 years; 37 to 53) using 2D and 3D registration technique, and modelled the knees with a computer aided design program. Each subject squatted, kneeled, and sat cross-legged. We evaluated the femoral rotation and varus-valgus angle relative to the tibia and anteroposterior translation of the medial and lateral side, using the transepicodylar axis as our femoral reference relative to the perpendicular projection on to the tibial plateau. This method evaluates the femur medially from what has elsewhere been described as the extension facet centre, and differs from the method classically applied. RESULTS: During squatting and kneeling, the knees displayed femoral external rotation. When sitting cross-legged, femurs displayed internal rotation from 10° to 100°. From 100°, femoral external rotation was observed. No significant difference in varus-valgus angle was seen between squatting and kneeling, whereas a varus position was observed from 140° when sitting cross-legged. The measure kinematic pathway using our methodology found during squatting a medial pivoting pattern from 0° to 40° and bicondylar rollback from 40° to 150°. During kneeling, a medial pivot pattern was evident. When sitting cross-legged, a lateral pivot pattern was seen from 0° to 100°, and a medial pivot pattern beyond 100°. CONCLUSION: The kinematics of normal knees during high flexion are variable according to activity. Nevertheless, our study was limited to a small number of male patients using a different technique to report the kinematics than previous publications. Accordingly, caution should be observed in generalizing our findings. Cite this article: 2018;100-B:50-5.
[Mh] Termos MeSH primário: Fenômenos Biomecânicos/fisiologia
Articulação do Joelho/fisiologia
[Mh] Termos MeSH secundário: Atividades Cotidianas
Adulto
Simulação por Computador
Projeto Auxiliado por Computador
Fluoroscopia
Seres Humanos
Imagem Tridimensional/métodos
Articulação do Joelho/diagnóstico por imagem
Masculino
Meia-Idade
Modelos Anatômicos
Amplitude de Movimento Articular/fisiologia
Rotação
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Em] Mês de entrada:1801
[Cu] Atualização por classe:180311
[Lr] Data última revisão:
180311
[Sb] Subgrupo de revista:AIM; IM
[Da] Data de entrada para processamento:180107
[St] Status:MEDLINE
[do] DOI:10.1302/0301-620X.100B1.BJJ-2017-0553.R2


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[PMID]:29297077
[Au] Autor:Purnell TS; Luo X; Cooper LA; Massie AB; Kucirka LM; Henderson ML; Gordon EJ; Crews DC; Boulware LE; Segev DL
[Ad] Endereço:Division of Transplantation, Department of Surgery, Johns Hopkins School of Medicine, Baltimore, Maryland.
[Ti] Título:Association of Race and Ethnicity With Live Donor Kidney Transplantation in the United States From 1995 to 2014.
[So] Source:JAMA;319(1):49-61, 2018 01 02.
[Is] ISSN:1538-3598
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:Importance: Over the past 2 decades, there has been increased attention and effort to reduce disparities in live donor kidney transplantation (LDKT) for black, Hispanic, and Asian patients with end-stage kidney disease. The goal of this study was to investigate whether these efforts have been successful. Objective: To estimate changes over time in racial/ethnic disparities in LDKT in the United States, accounting for differences in death and deceased donor kidney transplantation. Design, Setting, and Participants: A secondary analysis of a prospectively maintained cohort study conducted in the United States of 453 162 adult first-time kidney transplantation candidates included in the Scientific Registry of Transplant Recipients between January 1, 1995, and December 31, 2014, with follow-up through December 31, 2016. Exposures: Race/ethnicity. Main Outcomes and Measures: The primary study outcome was time to LDKT. Multivariable Cox proportional hazards and competing risk models were constructed to assess changes in racial/ethnic disparities in LDKT among adults on the deceased donor kidney transplantation waiting list and interaction terms were used to test the statistical significance of temporal changes in racial/ethnic differences in receipt of LDKT. The adjusted subhazard ratios are estimates derived from the multivariable competing risk models. Data were categorized into 5-year increments (1995-1999, 2000-2004, 2005-2009, 2010-2014) to allow for an adequate sample size in each analytical cell. Results: Among 453 162 adult kidney transplantation candidates (mean [SD] age, 50.9 [13.1] years; 39% were women; 48% were white; 30%, black; 16%, Hispanic; and 6%, Asian), 59 516 (13.1%) received LDKT. Overall, there were 39 509 LDKTs among white patients, 8926 among black patients, 8357 among Hispanic patients, and 2724 among Asian patients. In 1995, the cumulative incidence of LDKT at 2 years after appearing on the waiting list was 7.0% among white patients, 3.4% among black patients, 6.8% among Hispanic patients, and 5.1% among Asian patients. In 2014, the cumulative incidence of LDKT was 11.4% among white patients, 2.9% among black patients, 5.9% among Hispanic patients, and 5.6% among Asian patients. From 1995-1999 to 2010-2014, racial/ethnic disparities in the receipt of LDKT increased (P < .001 for all statistical interaction terms in adjusted models comparing white patients vs black, Hispanic, and Asian patients). In 1995-1999, compared with receipt of LDKT among white patients, the adjusted subhazard ratio was 0.45 (95% CI, 0.42-0.48) among black patients, 0.83 (95% CI, 0.77-0.88) among Hispanic patients, and 0.56 (95% CI, 0.50-0.63) among Asian patients. In 2010-2014, compared with receipt of LDKT among white patients, the adjusted subhazard ratio was 0.27 (95% CI, 0.26-0.28) among black patients, 0.52 (95% CI, 0.50-0.54) among Hispanic patients, and 0.42 (95% CI, 0.39-0.45) among Asian patients. Conclusions and Relevance: Among adult first-time kidney transplantation candidates in the United States who were added to the deceased donor kidney transplantation waiting list between 1995 and 2014, disparities in the receipt of live donor kidney transplantation increased from 1995-1999 to 2010-2014. These findings suggest that national strategies for addressing disparities in receipt of live donor kidney transplantation should be revisited.
[Mh] Termos MeSH primário: Disparidades em Assistência à Saúde/etnologia
Falência Renal Crônica/etnologia
Transplante de Rim/tendências
Doadores Vivos
[Mh] Termos MeSH secundário: Adulto
Afroamericanos
Americanos Asiáticos
Estudos de Coortes
Grupo com Ancestrais do Continente Europeu
Feminino
Disparidades em Assistência à Saúde/tendências
Hispano-Americanos
Seres Humanos
Estimativa de Kaplan-Meier
Falência Renal Crônica/cirurgia
Transplante de Rim/mortalidade
Masculino
Meia-Idade
Estados Unidos/epidemiologia
Listas de Espera
[Pt] Tipo de publicação:JOURNAL ARTICLE; RESEARCH SUPPORT, N.I.H., EXTRAMURAL
[Em] Mês de entrada:1801
[Cu] Atualização por classe:180311
[Lr] Data última revisão:
180311
[Sb] Subgrupo de revista:AIM; IM
[Da] Data de entrada para processamento:180104
[St] Status:MEDLINE
[do] DOI:10.1001/jama.2017.19152



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