Mini Gastric Bypass vs Roux enY Gastric Bypass (MGB vs RYGB)
研究概览
详细说明
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.
研究类型
阶段
- 不适用
联系人和位置
学习地点
-
-
South Yorkshire
-
Doncaster、South Yorkshire、英国、DN2 5LT
- Doncaster & Bassetlaw Teaching Hospitals NHS Foundation Trust
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- Not meeting the eligibility criteria
- Under 18s
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：MGB
Mini gastric bypass
|
Surgical method of gastric bypass
|
|
有源比较器：Roux enY gastric bypass
|
Surgical method of gastric bypass
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Excess weight loss
大体时间：2 years post surgery
|
Amount of weight lost
|
2 years post surgery
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Type 2 diabetes remission
大体时间：6 months, 2 years, 5 years and 10 years
|
Type 2 diabetes remission
|
6 months, 2 years, 5 years and 10 years
|
|
Morbidity
大体时间：6 months, 2 years, 5 years and 10 years
|
Morbidity
|
6 months, 2 years, 5 years and 10 years
|
|
Mortality
大体时间：6 months, 2 years, 5 years and 10 years
|
Mortality
|
6 months, 2 years, 5 years and 10 years
|
|
Operative time
大体时间：6 months, 2 years, 5 years and 10 years
|
Operative time
|
6 months, 2 years, 5 years and 10 years
|
|
Length of stay
大体时间：6 months, 2 years, 5 years and 10 years
|
Length of stay
|
6 months, 2 years, 5 years and 10 years
|
|
Readmission rate
大体时间：6 months, 2 years, 5 years and 10 years
|
Readmission rate
|
6 months, 2 years, 5 years and 10 years
|
|
Lipid profile
大体时间：6 months, 2 years, 5 years and 10 years
|
Lipid profile
|
6 months, 2 years, 5 years and 10 years
|
|
Malnutrition
大体时间：6 months, 2 years, 5 years and 10 years
|
Malnutrition
|
6 months, 2 years, 5 years and 10 years
|
|
Liver failure
大体时间：6 months, 2 years, 5 years and 10 years
|
Liver failure
|
6 months, 2 years, 5 years and 10 years
|
|
Gastro-oesophageal reflux
大体时间：6 months, 2 years, 5 years and 10 years
|
Gastro-oesophageal reflux
|
6 months, 2 years, 5 years and 10 years
|
|
Upper GI cancer
大体时间：6 months, 2 years, 5 years and 10 years
|
Upper GI cancer
|
6 months, 2 years, 5 years and 10 years
|
|
Diarrhoea
大体时间：6 months, 2 years, 5 years and 10 years
|
Diarrhoea
|
6 months, 2 years, 5 years and 10 years
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (预期的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- 0945 2018 NCTS
计划个人参与者数据 (IPD)
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IPD 计划说明
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