Mini Gastric Bypass vs Roux enY Gastric Bypass
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- Excess weight loss
研究概览
简要总结
The primary aim of this research project is to assess the safety and efficacy of the MGB operation in the UK
详细描述
The main aim of this project is to develop an ideal bariatric/metabolic surgery operation.
The ideal features are highly safe operation, revisable, reversible, extremely effective, short operative time, short hospital stay, cost-effective, no long-term complications and acceptable to the patients.
Mini Gastric Bypass/One Anastomosis Gastric Bypass MGB/OAGB is relatively a new bariatric /metabolic surgery operation that is increasing in popularity and currently more than 60,000 operations are performed worldwide. Only 125 MGB operations are published from UK.
No previous RCT to date in the UK to test the new operation although RCT was done in Taiwan 2005 and showed that MGB is not inferior to the Roux EnY Gastric Bypass RYGB. This research project is assessing the outcomes of this operation and opening the doors to understand its effects and how it works compared to the standard RYGB. The possible development in the project is to study the hormonal changes after the MGB.
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)
盲法说明
Participant will not know the arm prior to surgery, but will be made aware of it afterward
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •They have a BMI of 40 kg/m2 or more, or between 35 kg/m2 and 40 kg/m2 and other significant disease (for example, type 2 diabetes or high blood pressure) that could be improved if they lost weight.
- •All appropriate non-surgical measures have been tried but the person has not achieved or maintained adequate, clinically beneficial weight loss.
- •The person has been receiving or will receive intensive management in a tier 3 service.
- •The person is generally fit for anaesthesia and surgery.
- •The person commits to the need for long-term follow-up
排除标准
- •Not meeting the eligibility criteria
- •Under 18s
研究组 & 干预措施
MGB
Mini gastric bypass
干预措施: Gastric bypass (Procedure)
Roux enY gastric bypass
Roux enY gastric bypass
干预措施: Gastric bypass (Procedure)
结局指标
主要结局
Excess weight loss
时间窗: 2 years post surgery
Amount of weight lost
次要结局
- Mortality(6 months, 2 years, 5 years and 10 years)
- Liver failure(6 months, 2 years, 5 years and 10 years)
- Operative time(6 months, 2 years, 5 years and 10 years)
- Readmission rate(6 months, 2 years, 5 years and 10 years)
- Gastro-oesophageal reflux(6 months, 2 years, 5 years and 10 years)
- Upper GI cancer(6 months, 2 years, 5 years and 10 years)
- Diarrhoea(6 months, 2 years, 5 years and 10 years)
- Length of stay(6 months, 2 years, 5 years and 10 years)
- Lipid profile(6 months, 2 years, 5 years and 10 years)
- Malnutrition(6 months, 2 years, 5 years and 10 years)
- Type 2 diabetes remission(6 months, 2 years, 5 years and 10 years)
- Morbidity(6 months, 2 years, 5 years and 10 years)