Impact of Bariatric Surgery on the Evolution of Nonalcoholic Fatty Liver Disease: a Comparative Clinical Trial Between Sleeve Gastrectomy and Gastric Bypass
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Measure of fatty liver disease by transient hepatic elastography
研究概览
简要总结
Aim: To compare prospectively two bariatric surgery techniques: sleeve gastrectomy (SG) vs gastric bypass (GB) in the evolution of nonalcoholic fatty liver disease (NAFLD) measured by the transient elastography in the first year. Methods: This is a randomized clinical trial with morbidly obese patients, between 18-60 years old from a Federal Hospital, Ministry of Health, Brazil. Patients were divided into 2 groups: group 1 - SG (n = 30) and group 2 - GB (n = 30). The randomization was made by lots. In the GB the investigators created 30 ml pouch, with a pancreatic and an alimentary limb of 1 meter, and a calibrated gastroenterostomy (1.5 cm diameter). In SG the investigators calibrated the gastric tube with a bougie number 32 (70 ml). The variables were compared one week before surgery and in the postoperative time (1, 3, 6 and 12 months). The variables were: patient anthropometry, laboratory tests and the transient liver elastography.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The eligibility criteria was:
- •morbid obesity patient grade II or grade III (BMI > 35) in prepare to bariatric surgery.
排除标准
- •The exclusion criteria were:
- •age under 18 years or greater than 65 years old,
- •chronic diseases (heart failure, chronic liver disease), and
- •alcohol abuse (abuse was considered in those who consume more than 14 drinks per week).
结局指标
主要结局
Measure of fatty liver disease by transient hepatic elastography
时间窗: Participants will be followed an average of 3 months
Tha aim is to compare the evolution of the fatty liver disease between the sleeve gastrectomy and gastric bypass
次要结局
- Transversal study comparing comorbidities and transient hepatic elastography(Participants will be submitted a correlation with comorbidities)
研究者
Fernando de Barros
Fernando de Barros
Ministry of Health, Brazil