The Evidence of One-anastomosis Gastric Bypass/Mini-Gastric Bypass Versus Roux-en Y Gastric Bypass in Metabolic Surgery - a Prospective Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- complications
研究概览
简要总结
The aim of this prospective randomized controlled trial is to compare the two procedures One-anastomosis gastric Bypass/Mini-gastric Bypass (OAGB/MGB) and Roux-en Y gastric bypass (RYGB) in relation to intraoperative and postoperative complications (classification of Clavien-Dindo), mortality, metabolic impact (remission of type 2 diabetes mellitus, hypertonus, gastro-esophageal reflux disease, sleep apnea, dyslipidemia, quality of life, operation time, postoperative excess weight loss, malnutrition and re-do/revisonal surgery.
详细描述
OAGB/MGB is gaining popularity as a primary surgical treatment for morbid obesity due to reduced operation time, a shorter learning curve, better weight loss, higher metabolic impact and fewer major complications compared to RYGB.
In this prospective randomized controlled trial we want to compare OAGB/MGB and RYGB with a FU of up to 24 month.
Patients with indication for gastric bypass get randomized in group A (RYGB, n = 50) or B (OAGB/MGB, n = 50). FU is performed 1, 3, 6, 12 and 24 month after surgery.
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 (Investigator)
盲法说明
envelope randomization
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
- 是
入选标准
- •primary obesity surgery and indication for gastric bypass
- •age: 18 - 65 years
- •BMI > 40 kg/m² or BMI > 35 kg/m² with obesity related comorbidities
- •informed consent
排除标准
- •obesity surgery in the anamnesis
- •visceral surgery in the anamnesis (excluding appendectomy and cholecystectomy)
结局指标
主要结局
complications
时间窗: up to 2 years after surgery
complications classified next to Clavien-Dindo
次要结局
- quality of life questionnaire(up to 2 years after surgery)
- weight loss(up to 2 years after surgery)
- operation time(operation time during surgery in minutes)
- remission of type 2 diabetes mellitus(up to 2 years after surgery)
- gastro-esophageal reflux disease(up to 2 years after surgery)
- malnutrition 3(up to 2 years after surgery)
- malnutrition 4(up to 2 years after surgery)
- mortality(up to 2 years after surgery)
- remission of sleep apnea(up to 2 years after surgery)
- remission of hypercholesterinemia(up to 2 years after surgery)
- malnutrition 2(up to 2 years after surgery)
- remission of hypertonus(up to 2 years after surgery)
- malnutrition 1(up to 2 years after surgery)
- malnutrition 5(up to 2 years after surgery)
- revisional surgery(up to 2 years after surgery)
- remission of hypertrigliceridemia(up to 2 years after surgery)
- malnutrition 6(up to 2 years after surgery)
- malnutrition 8(up to 2 years after surgery)
- malnutrition 7(up to 2 years after surgery)
研究者
Sonja Chiappetta, MD
Principal investigator: Dr. Sonja Chiappetta
Sana Klinikum Offenbach