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the Related Factors of Bariatric Surgery on Gastroesophageal Reflux Disease

Primary Purpose

Gastroesophageal Reflux, Bariatric Surgery

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
2 cm away from the pylorus edge
4 cm away from the pylorus edge
6 cm away from the pylorus edge
LRYGB
Sponsored by
First Affiliated Hospital of Jinan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Gastroesophageal Reflux

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • The frist affiliated hospital of Jinan University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Without hiatal suture

With hiatal suture

Arm Description

the different distance of pylorus without hiatal suture

the different distance of pylorus without hiatal suture

Outcomes

Primary Outcome Measures

GERD-Health Related Quality of Life Questionnaire
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.

Secondary Outcome Measures

preoperative and postoperative of abdominal ultrasound to examine the abdominal fat thickness
abdominal fat thickness in centimeter
Preoperative and postoperative BMI
The patient's weight and height will be combined to report BMI in kg/m^2
Preoperative and postoperative waist circumference
waist circumference in centimeter
Preoperative and postoperative abdominal circumference
abdominal circumference in centimeter
Preoperative and postoperative chest circumference
chest circumference in centimeter
Preoperative and postoperative neck circumference
neck circumference in centimeter
Preoperative and postoperative bone mineral density
bone mineral density in percentage
Preoperative and postoperative body fat measured
body fat measured in percentage

Full Information

First Posted
March 15, 2018
Last Updated
April 12, 2018
Sponsor
First Affiliated Hospital of Jinan University
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1. Study Identification

Unique Protocol Identification Number
NCT03497494
Brief Title
the Related Factors of Bariatric Surgery on Gastroesophageal Reflux Disease
Official Title
Analysis the Related Factors of Bariatric Surgery on Gastroesophageal Reflux Disease and Its Prevention and Treatment: a Prospective, Multicenter and Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Unknown status
Study Start Date
January 20, 2018 (Actual)
Primary Completion Date
December 30, 2019 (Anticipated)
Study Completion Date
December 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
First Affiliated Hospital of Jinan University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroesophageal Reflux, Bariatric Surgery

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
All patients enrolled in this study underwent laparoscopic sleeve gastrectomy. According to the starting point of resection to pylorus distance and whether to the strengthen suture of esophageal hole, the cases were randomly divided into 6 groups: G1: 2 cm away from the pylorus edge, without hiatal suture; G2: 4 cm away from the pylorus edge, without hiatal suture; G3: 6 cm away from the pylorus edge, without hiatal suture; G4: 2 cm away from the pylorus edge, with hiatal suture G5: 4 cm away from the pylorus edge, with hiatal suture; G6: 6 cm away from the pylorus edge, with hiatal suture;
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Without hiatal suture
Arm Type
Active Comparator
Arm Description
the different distance of pylorus without hiatal suture
Arm Title
With hiatal suture
Arm Type
Active Comparator
Arm Description
the different distance of pylorus without hiatal suture
Intervention Type
Procedure
Intervention Name(s)
2 cm away from the pylorus edge
Intervention Description
2 cm away from the pylorus edge
Intervention Type
Procedure
Intervention Name(s)
4 cm away from the pylorus edge
Intervention Description
4 cm away from the pylorus edge
Intervention Type
Procedure
Intervention Name(s)
6 cm away from the pylorus edge
Intervention Description
6 cm away from the pylorus edge
Intervention Type
Procedure
Intervention Name(s)
LRYGB
Other Intervention Name(s)
laparoscopic Roux-en-Y gastric bypass
Intervention Description
laparoscopic Roux-en-Y gastric bypass
Primary Outcome Measure Information:
Title
GERD-Health Related Quality of Life Questionnaire
Description
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.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
preoperative and postoperative of abdominal ultrasound to examine the abdominal fat thickness
Description
abdominal fat thickness in centimeter
Time Frame
1 year
Title
Preoperative and postoperative BMI
Description
The patient's weight and height will be combined to report BMI in kg/m^2
Time Frame
1 year
Title
Preoperative and postoperative waist circumference
Description
waist circumference in centimeter
Time Frame
1 year
Title
Preoperative and postoperative abdominal circumference
Description
abdominal circumference in centimeter
Time Frame
1 year
Title
Preoperative and postoperative chest circumference
Description
chest circumference in centimeter
Time Frame
1 year
Title
Preoperative and postoperative neck circumference
Description
neck circumference in centimeter
Time Frame
1 year
Title
Preoperative and postoperative bone mineral density
Description
bone mineral density in percentage
Time Frame
1 year
Title
Preoperative and postoperative body fat measured
Description
body fat measured in percentage
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
The frist affiliated hospital of Jinan University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510630
Country
China

12. IPD Sharing Statement

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the Related Factors of Bariatric Surgery on Gastroesophageal Reflux Disease

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