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the Related Factors of Bariatric Surgery on Gastroesophageal Reflux Disease

2018年4月12日 更新者:Jingge Yang、First Affiliated Hospital of Jinan University

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

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

介入性

注册 (预期的)

180

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Guangdong
      • Guangzhou、Guangdong、中国、510630
        • The frist affiliated hospital of Jinan University

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 65年 (成人、年长者)

接受健康志愿者

是的

有资格学习的性别

全部

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

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

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:
  • laparoscopic Roux-en-Y gastric bypass
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.

  • Greatest possible score (worst symptoms) = 75
  • Lowest possible score (no symptoms) = 0 Heartburn Score: Calculated by summing the individual scores to questions 1-6 .
  • Worst heartburn symptoms = 30
  • No heartburn symptoms = 0
  • Scores of ≤ 12 with each individual question not exceeding 2 indicate heartburn elimination. 2 Regurgitation Score: Calculated by summing the individual scores to questions 10-15.
  • Worst regurgitation symptoms = 30
  • No regurgitation symptoms = 0
  • Scores of ≤ 12 with each individual question not exceeding 2 indicate regurgitation elimination.
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

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2018年1月20日

初级完成 (预期的)

2019年12月30日

研究完成 (预期的)

2020年12月30日

研究注册日期

首次提交

2018年3月15日

首先提交符合 QC 标准的

2018年4月12日

首次发布 (实际的)

2018年4月13日

研究记录更新

最后更新发布 (实际的)

2018年4月13日

上次提交的符合 QC 标准的更新

2018年4月12日

最后验证

2018年4月1日

更多信息

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