A Multicentre Randomized Controlled Trial Comparing Outcome of Laparoscopic One-anastomosis Gastric Bypass and Laparoscopic Long Biliopancreatic Limb Roux Gastric Bypass for Treatment of Morbid Obesity.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 2
- 主要终点
- Impact on total cholesterol
研究概览
简要总结
A prospective multicenter randomized controlled trial to compare the outcomes of one-anastomosis gastric bypass to long biliary limb Roux gastric bypass.
We plan to enroll up to 500 patients from three different clinics in Estonia. Outcomes are excess weight loss %, impact on type 2 diabetes, hypertension, hyperlipidemia and obstructive sleep apnea.
Other outcomes are nutritional deficiencies, occurrence of reflux disease and impact on quality of life.
There are planned outpatient visits 1, 5 and 10 years after the surgery to measure the impacts.
There are a lot of studies comparing OAGB to standard Roux gastric bypass but non comparing it to long biliary limb gastric bypass.
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
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •BMI over 35 and obesity related disease
- •BMI over 40
- •age between 18-60 years
- •agrees to participate in the study
排除标准
- •age under 18 years or over 60 years
- •abundant adhesions discovered during the surgery
- •active upper gastrointestinal ulcer disease
- •prior bariatric surgery
- •active symptomatic reflux disease
- •active psychiatric disease (eg psychosis)
结局指标
主要结局
Impact on total cholesterol
时间窗: 10 years
Outcome of hyperlipidemias after the surgery, measured in change in levels of total cholesterol (mmol/L).
Impact on hypertensive disease
时间窗: 10 years
Outcome of hypertensive disease after the surgery; measured in antihypertensive drug usage (same, decrease, ended)
Impact on hyperlipidemias
时间窗: 10 years
Outcome of hyperlipidemias after the surgery, measured in change in levels of total cholesterol, HDL,LDL and triglycerides
Excess weight loss %
时间窗: 10 years
Calculated loss of the excess weight
Impact on type 2 diabetes mellitus
时间窗: 10 years
Outcome of type 2 diabetes mellitus after the surgery, measured in change in HbA1c %
Impact on hyperlipidemia
时间窗: 10 years
Outcome of hyperlipidemias after the surgery, measured in change in levels of HDL (mmol/L)
次要结局
- Nutritional deficiencies: anemia(10 years)
- GERD(10 years)
- Nutritional deficiencies(10 years)
研究者
Eva-Maria Kikkas
Doctor and Teaching staff
Tartu University Hospital