Creating a Laparoscopic Banded Sleeve Gastrectomy
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 211
- 试验地点
- 6
- 主要终点
- Percentage Total Body Weight loss (%TBWL)
研究概览
简要总结
A Sleeve Gastrectomy (SG) is on the long term not always successful in every patient because weight regain can occur. An intervention to prevent weight regain in the future is to place a silicone band (non-adjustable) around the sleeve (Banded-Sleeve Gastrectomy: BSG) which increases weight loss and decreases weight regain on the longer term. The question is whether primary application of a banded sleeve gives a greater weight loss and / or prevent weight regain in the future versus a standard sleeve gastrectomy.
详细描述
A Sleeve Gastrectomy (SG) is on the long term not always successful in every patient because weight regain can occur. An intervention to prevent weight regain in the future is to place a silicone band (non-adjustable) around the sleeve (Banded-Sleeve Gastrectomy: BSG) which increases weight loss and decreases weight regain on the longer term. The question is whether primary application of a banded sleeve gives a greater weight loss and / or prevent weight regain in the future versus a standard sleeve gastrectomy.
Study is a prospective, randomized, multi centre trial.
Study population: patients who qualify for a SG are eligible to participate. The primary SG patients may participate if there is a BMI of 35 kg / m2 with a morbidly obesity-related comorbidity or a BMI of 40kg / m2 or higher.
Intervention: The standard SG is compared with a banded-SG (BSG)
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
- •Alle patients who are eligible for a primary SG
排除标准
- •Bariatric surgery in medical history
- •BMI > 60kg/m2 or a planned two-stage procedure.
- •Patients with a language barrier which may affect the compliance with medical advice
- •Patients with a disease not related to morbid obesity, such as Cushing or drug related.
- •Chronic bowel disease for example Crohn's disease or colitis Colitis.
- •Renal impairment (MDRD <30) or hepatic dysfunction (liver function twice the normal values)
- •Pregnancy during follow-up
- •Patients with treatment-resistant reflux symptoms. Defined as reflux persistent symptoms despite the use of a minimum dose of proton-pump inhibitors
结局指标
主要结局
Percentage Total Body Weight loss (%TBWL)
时间窗: 3 years
((preoperative weight - current weight) / (preoperative weight)) x 100%. Weight loss measured in kilograms
次要结局
- Reduction of comorbidities(3 years)
- Gastroesophageal reflux disease(3 years)
- Percentage Excess Weight Loss (%EWL)(3 years)
- Quality of life due to questionnaire(3 years)