NCT01479452已完成不适用
Effects of Bariatric Surgery in Swedish Obese Subjects
Göteborg University2 个研究点 分布在 1 个国家目标入组 4,047 人开始时间: 2011年11月24日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 4,047
- 试验地点
- 2
- 主要终点
- Overall mortality
研究概览
简要总结
The purpose of the Swedish Obese Subjects (SOS) study is to examine the long-term effects of bariatric surgery on overall mortality and obesity-related co-morbidities.
详细描述
The Swedish Obese Subjects (SOS) study is a prospective non-randomized controlled intervention study designed to examine the long-term effects of bariatric surgery compared to usual care in obese subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 37 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 37-60 years and BMI ≥34 kg/m2 in men and ≥38 kg/m2 in women.
排除标准
- •Exclusion criteria of both groups were: earlier operation for gastric or duodenal ulcer; earlier bariatric surgery
- •Gastric ulcer during the past 6 months; ongoing malignancy
- •Active malignancy during the past 5 years
- •Myocardial infarction during the past 6 months
- •Bulimic eating pattern; drug or alcohol (>0·75 L 40% liquor per week or corresponding amount of ethanol) abuse
- •Psychiatric or cooperative problems contraindicating bariatric surgery
- •Other contraindicating conditions (such as continuous glucocorticoid or anti-inflammatory treatment).
结局指标
主要结局
Overall mortality
时间窗: 10 years
The SOS study was started in 1987 and effect of bariatric surgery on overall mortality (primary endpoint) was reported in 2007. Cut off date for the analysis was November 1, 2005.
次要结局
未报告次要终点
研究者
研究点 (2)
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