the Related Factors of Bariatric Surgery on Gastroesophageal Reflux Disease
Analysis the Related Factors of Bariatric Surgery on Gastroesophageal Reflux Disease and Its Prevention and Treatment: a Prospective, Multicenter and Randomized Controlled Study
Obesity and related metabolic diseases have become a chronic disease that is a threat to human health. Bariatric surgery can effectively and long-term reduce excess body weight and relieve related metabolic diseases, including type 2 diabetes. Laparoscopic gastric bypass surgery and laparoscopic sleeve gastrectomy are commonly used in bariatric surgery. Laparoscopic sleeve gastrectomy due to simple operation, good weight loss, and metabolic disease control effect, which is more widely used. However, there are several studies that show an increased chance of gastroesophageal reflux disease after laparoscopic sleeve gastrectomy. Long-term gastroesophageal reflux may lead to Barrett's esophagus or esophageal cancer. Nowadays, the cause of gastroesophageal reflux disease after sleeve gastrectomy is not clear and precautionary measures are not precise.
In this study, prospective randomized controlled trials were conducted to explore the possible causes of gastroesophageal reflux after sleeve gastrectomy and to explore ways to prevent gastroesophageal reflux disease after sleeve gastrectomy.
研究概览
地位
详细说明
With the social development and changes in the lifestyle, the incidence of obesity and type 2diabetes is rapidly increasing. In 2010, the global incidence of type 2 diabetes was 8.3% in adults, 11.6% in China and 50.1% in China. In overweight and obese people, the prevalence of type 2 diabetes also increased significantly, and the prevalence of type 2diabetes in those people with BMI> 30 reached 18.5-23%. Diabetes-induced cardiovascular and cerebrovascular diseases, renal insufficiency and other complications, seriously affecting the quality of life of the patients, endangering the safety of life, the treatment of type 2 diabetes and related complications to public health expenditure has brought tremendous pressure.
Traditional medical methods are difficult to achieve long-term and effective control of type 2 diabetes. Surgery has been shown to achieve 75-95% long-term relief of obesity in patients. Roux-en-Y gastric bypass (Roux-en-Y gastric bypass, RYGB) and laparoscopic sleeve gastrectomy are most commonly used. Among them, laparoscopic sleeve gastrectomy is relatively simple, low incidence of complications, lower operating costs, and gradually become the most important surgical methods of weight loss and metabolic disease surgery. Numerous clinical studies are shown that sleeve gastrectomy in patients with type 2 diabetes has the same therapeutic effect as gastric bypass with a complete remission rate of 70-90% for T2DM.
For the choice of surgical approach, numerous studies have shown that BMI ≧ 45, the general choice of gastric bypass surgery, BMI <45, participants can choose sleeve gastrectomy. The remission rate for T2DM, sleeve gastrectomy has a good result for young patients with shorter duration. In China, the BMI less than 45 is majorities.
According to the previous survey in 2012, the newly diagnosed diabetes patients in China constituted more than half of all diabetic patients. Since laparoscopic sleeve gastrectomy is relatively simple, so sleeve gastrectomy is easier to popularize in China and has wide application prospect.
As an invasive treatment, laparoscopic sleeve gastrectomy also presents opportunities of surgery-related complications, including gastric leak (0.5-1%), stenosis (0.1-0.5%), bleeding (about 0.5%), and gastroesophageal reflux disease (GERD). Gastroesophageal reflux disease is a most common upper gastrointestinal disease, numerous clinical studies shown that the incidence of GERD in western populations are 10-20%, while obese people are around 37-72%, if abdominal fat accumulation more obvious, the incidence of GERD will become higher. In China, there is still no relevant data. Gastric bypass surgery has a clear effect on the treatment of GERD, and the relationship between sleeve gastrectomy and GERD is still controversial. Some studies have shown that sleeve gastrectomy did not increase the incidence of postoperative GERD, while another study showed that the incidence of GERD after sleeve gastrectomy increased significantly. In addition, no studies have revealed the reasons for the occurrence of GERD after sleeve gastrectomy and no study showed how to prevent the occurrence of GERD after sleeve gastrectomy.
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
学习地点
-
-
Guangdong
-
Guangzhou、Guangdong、中国、510630
- The frist affiliated hospital of Jinan University
-
-
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:
- For the choice of surgical approach, numerous studies have shown that BMI ≧ 45, the general choice of gastric bypass surgery, BMI <45, you can choose sleeve gastrectomy. The remission rate for T2DM, sleeve gastrectomy has a good result for young patients with shorter duration. In our country, the BMI less than 45 is majorities.
Exclusion Criteria:
- BMI<27.5
学习计划
研究是如何设计的?
设计细节
- 主要用途:预防
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:三倍
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器:Without hiatal suture
the different distance of pylorus without hiatal suture
|
2 cm away from the pylorus edge
4 cm away from the pylorus edge
6 cm away from the pylorus edge
laparoscopic Roux-en-Y gastric bypass
其他名称:
|
|
有源比较器:With hiatal suture
the different distance of pylorus without hiatal suture
|
2 cm away from the pylorus edge
4 cm away from the pylorus edge
6 cm away from the pylorus edge
|
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 |
|---|---|---|
|
GERD-Health Related Quality of Life Questionnaire
大体时间:1 year
|
Total Score: Calculated by summing the individual scores to questions 1-15.
|
1 year
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
preoperative and postoperative of abdominal ultrasound to examine the abdominal fat thickness
大体时间:1 year
|
abdominal fat thickness in centimeter
|
1 year
|
|
Preoperative and postoperative BMI
大体时间:1 year
|
The patient's weight and height will be combined to report BMI in kg/m^2
|
1 year
|
|
Preoperative and postoperative waist circumference
大体时间:1 year
|
waist circumference in centimeter
|
1 year
|
|
Preoperative and postoperative abdominal circumference
大体时间:1 year
|
abdominal circumference in centimeter
|
1 year
|
|
Preoperative and postoperative chest circumference
大体时间:1 year
|
chest circumference in centimeter
|
1 year
|
|
Preoperative and postoperative neck circumference
大体时间:1 year
|
neck circumference in centimeter
|
1 year
|
|
Preoperative and postoperative bone mineral density
大体时间:1 year
|
bone mineral density in percentage
|
1 year
|
|
Preoperative and postoperative body fat measured
大体时间:1 year
|
body fat measured in percentage
|
1 year
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (预期的)
研究完成 (预期的)
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
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.