Long or Very Long-Limb Gastric Bypass in Superobese
试验速览
- 阶段
- 3 期
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- weight loss- we will compare percentage of excess body weight loss (%EWL) between groups.
研究概览
简要总结
The goal of this study is to compare the clinical efficacy (weight loss and metabolic changes) of long (150 cm) versus very long (250cm) Roux alimentary limb gastric bypass in superobese (BMI>50) patients.
详细描述
The study is a multicentre trial in which superobese (BMI>50) patients will be randomly assigned (in a 1:1 ratio) for laparoscopic gastric Roux-en-Y gastric bypass with: a) long (150 cm) or b) very long (250cm) alimentary Roux limb. Patients will be included from three hospitals: Kaunas University of Medicine Hospital (Lithuania), Klaipeda District Hospital (Lithuania), Vaasa Central Hospital (Finland) ) where preoperative investigation, the same technique surgical procedures and follow up will be performed acording approved protocol.
Approximate duration of subject participation
Subjects in the study will participate for approximately 5 years:
- Preoperative investigation and surgery 3- 5 days in the hospital;
- First follow up visit: 6 months after surgery;
- Next follow up visits: 12, 24, 36, 48 months after surgery;
- Last follow up visit: 5 years after surgery.
- The interim results after 12, 24 and 36 months will be calculated and presented before end of the study.
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
- Single (Participant)
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
- •Hospitalized male or female subjects 18-65 years of age.
- •Obese subjects with body mass index (BMI= kg/m²)>50
- •Patients without mental or nervous disorders interfering with adequate evaluation of one's health condition.
- •Patients who read the informed consent form and gave a written consent to participate in the study.
排除标准
- •Previous open abdominal surgery, except appendectomy, cholecystectomy and gynaecological procedures.
- •Presence of any significance cardiac, hepatic, renal, blood, alimentary tract disease which may lead to system or organ failure in intraoperative or postoperative period.
- •Pregnant women.
- •Subjects taking immunosuppressive therapy.
- •Any concomitant condition that, in the opinion of the investigator, would preclude an operation and postoperative follow up acording to a protocol
结局指标
主要结局
weight loss- we will compare percentage of excess body weight loss (%EWL) between groups.
时间窗: 7 years
次要结局
- To compare body mass index changes and absolute weight loss. To evaluate obesity-related medical problems. To obtain data about impromvement of metabolic syndrom. To compare quality of life changes between treatment arms.(7 years)