Laparoscopic Roux-en-Y Gastric Bypass Versus Laparoscopic Mini Gastric Bypass: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Excess Weight Loss
研究概览
简要总结
Several retrospective studies have shown same efficiency in regard to weight loss, with a lower rate of complications for the laparoscopic mini gastric bypass (LMGB) compared to Roux-en-Y gastric bypass (LRYGB). The aim of this double-blinded randomized controlled trial is to compare the two procedures in respect of excess weight loss, complications, operation time, length of stay and the metabolic impact on the hormonal brain-gut-axis.
详细描述
Bariatric surgery, the only effective treatment for morbid obesity, has shown effective long term weight loss and good control of obesity related comorbidities in randomized controlled trials.
Obesity related diseases, such as hypertension, type 2 diabetes, dyslipidemia, osteoarthritis and various tumours, have a significant socio-economic impact, since the cost of the obesity epidemic is 5.7 billion Swiss francs yearly.
According to the current Swiss National Guidelines defined by the Swiss Group for Morbid Obesity surgical therapy is indicated in cases of BMI 35 kg/m2 or higher, showing better weight reduction and control of comorbidties than conservative therapy alone. Obesity reduces quality of life and life expectancy dramatically. Furthermore it has a significant impact on our economy. Bariatric surgery is likely to improve all of these negative impacts on society.
The most commonly performed procedures at present are laparoscopic adjustable gastric banding, laparoscopic Roux-en-Y gastric bypass (LRYGB) and laparoscopic sleeve gastrectomy (LSG).
LRYGB is considered the golden standard in bariatric surgery, although little evidence is available to justify this standpoint. In fact, the choice of the surgical procedure depends more on patient factors such as present comorbidities and operative risk. Therefore, surgeons consult after a work up within a multidisciplinary team of caretakers such as nutritionists, endocrinologists and psychiatrists and chose a patient tailored approach. Recently, the laparoscopic mini gastric bypass (LMGB) has gained worldwide popularity in addition to the standard available procedures for the treatment of morbid obesity. Therefore, it has been added by the Swiss Group for Morbid Obesity as a surgical option, which has to be evaluated in clinical trials.
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
- Double (Participant, 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
- 否
入选标准
- •BMI > 35
- •age > 18
排除标准
- •malignancy
- •lack of compliance
- •BMI > 50
结局指标
主要结局
Excess Weight Loss
时间窗: 1 year postoperative
次要结局
- Early surgical complications(≤ 30 days)
- Length of stay(up to 24 weeks)
- Glucose homeostasis(preoperative, 6 weeks, 1 and 3 years)
- Subjective perception of the appetite and saturation(6 weeks, 1 and 3 years)
- Early non-surgical complications(≤ 30 days)
- Hormonal assay (GLP-1)(preoperative, 6 weeks, 1 and 3 years)
- Hormonal assay (PYY)(preoperative, 6 weeks, 1 and 3 years)
- Operation time(intraoperative)
- Lipid profile(preoperative, 6 weeks, 1 and 3 years)
- Hormonal assay (Ghrelin)(preoperative, 6 weeks, 1 and 3 years)
研究者
Marko Kraljevic, MD
MD
Spital Limmattal Schlieren