ACTRN12605000113651已完成4 期
The optimal treatment of obesity: a prospective randomized controlled comparison of best practice medical management versus placement of the Lap-Band System to effect weight loss.
Centre for Obesity Research and Education (CORE)0 个研究点目标入组 80 人开始时间: 2005年8月9日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 80
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 20 Years 至 45 Years（—）
- 性别
- All
入选标准
- •BMI 30-35, have identifiable problems either medical, physical or psychosocial with this level of obesity, be able to understand the options, the potential benefits and risks, and be able to comply with the requirements of each program.
排除标准
- •Lack of acceptance of the randomization process, history of previous abdominal surgery which would potentially preclude the laparoscopic placement of the band, medical issues which contra-indicated either arm of the study including acute myocardial infarction within the past 6 months, dementia, active psychosis, concurrent experimental drug use, autoimmune disease, pregnancy, lactation, illicit drug use, excessive alcohol intake, use of drugs known to affect body composition, cytotoxic drugs, internal malignancy or major organ failure, inability to understand the risks, unrealistic expectation of benefits or likelihood of failure to comply with the follow up requirements of either program.
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