Laparoscopic Adjustable Gastric Banding Versus Open Vertical Banded Gastroplasty: 7-Year Results of a Prospective Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- weight loss
研究概览
简要总结
The study aims to investigate the long term results of a randomized clinical single-centre trial comparing two standard operative techniques in bariatric surgery; laparoscopic adjustable gastric banding and vertical banded gastroplasty.
详细描述
One hundred morbidly obese patients were included in the study. Randomization between the two operative techniques was performed using a computer model. Fifty patients were included in both groups. Weight loss, obesity-related comorbidity, long term complications, re-operations and conversions were all prospectively investigated for a mean period of 84 months.
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
- None
入排标准
- 年龄范围
- 19 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •BMI of > 40 kg/m2 or > 35 kg/m2 with obesity-related comorbidities
- •Failure to achieve sustainable weight loss with proven conservative measures
排除标准
- •severe psychiatric and / or eating disorders
- •unable to keep to a prescribed postoperative diet
- •< 18 or > 60 years
- •not eligible to bariatric surgery according to a member of the multidisciplinary team (psychologist, dietician, nurse practitioner, general practitioner and surgeon)
研究组 & 干预措施
1
Laparoscopic adjustable gastric banding
干预措施: Laparoscopic adjustable gastric banding (Procedure)
2
vertical banded gastroplasty
干预措施: vertical banded gastroplasty (Procedure)
结局指标
主要结局
weight loss
时间窗: 84 months
次要结局
- co-morbidity(84 months)
- complications(84 months)
- reoperations / revisions / conversions(84 months)
- Quality of life(84 months)