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临床试验/NCT03497494
NCT03497494Unknown不适用

Analysis the Related Factors of Bariatric Surgery on Gastroesophageal Reflux Disease and Its Prevention and Treatment: a Prospective, Multicenter and Randomized Controlled Study

First Affiliated Hospital of Jinan University1 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2018年1月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
180
试验地点
1
主要终点
GERD-Health Related Quality of Life Questionnaire

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Triple (Participant, Care Provider, Investigator)

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

入选标准

  • 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.

排除标准

  • BMI<27.5

研究组 & 干预措施

Without hiatal suture

Active Comparator

the different distance of pylorus without hiatal suture

干预措施: 2 cm away from the pylorus edge (Procedure)

Without hiatal suture

Active Comparator

the different distance of pylorus without hiatal suture

干预措施: 4 cm away from the pylorus edge (Procedure)

Without hiatal suture

Active Comparator

the different distance of pylorus without hiatal suture

干预措施: 6 cm away from the pylorus edge (Procedure)

Without hiatal suture

Active Comparator

the different distance of pylorus without hiatal suture

干预措施: LRYGB (Procedure)

With hiatal suture

Active Comparator

the different distance of pylorus without hiatal suture

干预措施: 2 cm away from the pylorus edge (Procedure)

With hiatal suture

Active Comparator

the different distance of pylorus without hiatal suture

干预措施: 4 cm away from the pylorus edge (Procedure)

With hiatal suture

Active Comparator

the different distance of pylorus without hiatal suture

干预措施: 6 cm away from the pylorus edge (Procedure)

结局指标

主要结局

GERD-Health Related Quality of Life Questionnaire

时间窗: 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.

次要结局

  • Preoperative and postoperative abdominal circumference(1 year)
  • Preoperative and postoperative neck circumference(1 year)
  • Preoperative and postoperative bone mineral density(1 year)
  • preoperative and postoperative of abdominal ultrasound to examine the abdominal fat thickness(1 year)
  • Preoperative and postoperative BMI(1 year)
  • Preoperative and postoperative waist circumference(1 year)
  • Preoperative and postoperative chest circumference(1 year)
  • Preoperative and postoperative body fat measured(1 year)

研究者

发起方
First Affiliated Hospital of Jinan University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jingge Yang

Director of bariatric surgery

First Affiliated Hospital of Jinan University

研究点 (1)

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