International, Multi Centre, Open, Prospective, Randomized Study: Banded Versus Conventional Laparoscopic Roux-en-Y (GABY)
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 384
- 试验地点
- 28
- 主要终点
- postoperative reduction of body mass index (BMI) and maintenance related to used bariatric procedure
研究概览
简要总结
Banded Versus Conventional Laparoscopic Roux-en-Y Gastric Bypass (GABY).
The aim of this novel study is to evaluate, if an additional restrictive silastic ring can avoid dilation of the gastro-entero anastomosis and adjacent small bowel with consecutive better postoperative weight loss and significantly improved long-term weight maintenance.
The study will not investigate the GaBP-Ring as medical product but the effect of the GaBP-Ring on weight loss in comparison to gastric bypass alone.
详细描述
GABY is designed as an international, multi center, open, prospective, randomized study to compare two methods of bariatric surgery: Banded versus conventional laparoscopic Roux-en-Y gastric bypass.
At least 16 international high volume centres of excellence in bariatric surgery and at least 384 patients (24 patients at each center) in total will be included into this study. At least 320 patients must have completed the study after 5 years.
Surgery will be performed according to standardized operating protocol. The group A (control group) will follow the worldwide golden standard of bariatric surgery (gastric bypass). Patients randomised to group B will receive in addition a restrictive silastic ring. The ring is a launched medical product and is registered in the European Community.
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 ≥ 40 kg /m2 to ≤ 50 kg/m2
- •Eating habit: sweet eater and volume eater
- •Signed informed consent
- •Patients with one or more of the following comorbidities: Hypertension, Diabetes mellitus Type 2, Hyperlipidemia, Hyperuricemia, Sleep apnea, Degenerative diseases of: Spine osteochondrosis, hip, knee, feet
排除标准
- •History of obesity surgery
- •History of major abdominal surgery with consecutive malabsorption (no resections of the stomach, small and large bowel (exception: appendectomy)
- •Patients not eligible to implement silastic ring size 6.5 cm
- •History of drug or alcohol abuse
- •History of major psychiatric illness conflicting with patient's compliance
- •History of recent or chronic steroid medication
- •Autoimmune disease
- •Inflammatory bowel disease or malabsorptive disease
- •Liver cirrhosis (CHILD B + C)
- •Active viral or bacterial disease (e.g. HIV, Hepatitis B or C, Tbc etc.)
- •Pregnant women or women with childbearing potential without efficient contraception
- •History of cancer in the last five years
- •Need of long-term anticoagulant medication for any reason
- •Any medication with ingredient ASA
结局指标
主要结局
postoperative reduction of body mass index (BMI) and maintenance related to used bariatric procedure
时间窗: 0, 3, 6, 12 months and 2, 3, 4, 5 years
次要结局
未报告次要终点