The Banded Mini Gastric Bypass Trial: A Prospective Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 210
- 试验地点
- 1
- 主要终点
- Total Body Weight Change 5 years after surgery
研究概览
简要总结
Rationale: Investigate if there is a significant weight reduction expressed in total body weight loss percentage (%TBWL) in patients 5 years after surgery, whom underwent a mini gastric bypass (MGB-OAGB) with addition of the implantation of a MiniMizer Ring.
Study design: A prospective non blinded single centre randomized controlled trial.
Sudy population: The study population will exist of patients eligible for MGB-OAGB surgery. Patients are invited to participate if Body Mass Index (BMI) ≥ 35kg/m2 with a comorbidity related to morbid obesity, or a BMI exceeding 40kg/m2.
Intervention: Insertion of the MiniMizer Ring around the gastric pouch in addition to the 'standard' MGB-OAGB.
Main study parameters/endpoints:
Primary Objective:
- %TBWL 5 years after surgery.
Secondary Objectives: 2. Percentage Excess Weight Loss (%EWL) 5 years after surgery. 3. Decrease or reduction of comorbidities (diabetes mellitus, hypertension, hyperlipidemia, sleep apnoea, and joint complaints). 4. Improvement of quality of life: SF-36 and OBESI-Q questionnaires. 5. Incidence and severity of dumping syndrome. 6. Incidence and severity of reflux symptoms: GERD-HRQoL questionnaire. 7. Incidence and complications due to silicone band.
Measurement of objectives are before surgery and six times after surgery combined with the standard postoperative care for patients who undergo bariatric surgery:
Expected advantages of bOLGB versus OLGB:
- Increase of weight reduction, and due to that decrease of comorbidities and/or mortality related to overweight.
- Long term decrease of weight regain.
- Decrease of incidence of dumping.
Possible disadvantages of bOLGB versus OLGB:
- Band-related complications such as erosion, infection, stenosis, or pouch dilatation.
- Functional gastro-intestinal complains such as dysphagia and reflux.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients meet IFSO criteria for Bariatric Surgery
- •Age 18 and above
排除标准
- •Previous Bariatric surgery
- •Inability to read and understand written information
- •Any genetic condition that can hamper the acceptance of medical advice
- •chronic bowel disease
- •Severe kidney of liver disease
- •Pregnancy at the start or during the research period
- •Patients with pre-existing therapy refractory GERD
- •Patients with an allergy to silicone
结局指标
主要结局
Total Body Weight Change 5 years after surgery
时间窗: 5 Years
Percentage total body weight change 5 years after the procedure
次要结局
- Outcome measurement of SF-36 questionnaire(5 years)
- Change in Percentage Excess Weight (%EWL) 5 years after surgery(5 years)
- Change in (existing) co-morbidities 5 years after surgery(5 years)
- Outcome measurement of OBESI-Q questionnaire(5 years)
- Complications(5 years)
- Dumping Syndrome(5 years)
研究者
Marc van Det
principal investigator
Ziekenhuisgroep Twente