NL-OMON25900已完成4 期
aparoscopic Sleeve Gastrectomy versus laparoscopic Roux-en-Y Gastric bypass trial for Morbid Obesity.
none0 个研究点目标入组 620 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 620
研究概览
简要总结
none
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 64(—)
入选标准
- •All morbidly obese patients who have been approved for bariatric surgery by the preoperative multidisciplinary team can be included in the sleeve versus bypass trial. Informed consent is mandatory. The criteria for bariatric surgery are age 18-60 years , BMI> 40, or > 35 kg/m2 with obesity-related-comorbidity (such as type 2 diabetes, hypertension, hypercholesterolemia, severe arthrosis and OSAS) for more than 3 years, conservative therapy (preferably under the guidance of a physician or self-help group) that has failed or showed only transient results, completion of psychological screening, excluding patients with psychiatric and psychological disorders, written informed consent and willingness to conclude the lifelong follow up program after surgery.
排除标准
- •Exclusion criteria for this study are: diagnosed gastro oesophageal reflux disease (GERD) [16], severe sweet eating [17] prior bariatric surgery, prior major abdominal surgery (such as colonic resection, abdominal sepsis, aortic surgery, which might jeopardise the technical feasibility of LSG or LRYGB) and the inability of reading or understanding the questionnaires.
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