Gastroesophageal RefluxNCT03497494
the Related Factors of Bariatric Surgery on Gastroesophageal Reflux Disease
A study testing 2 cm away from the pylorus edge, 4 cm away from the pylorus edge and 6 cm away from the pylorus edge in people with Gastroesophageal Reflux and Bariatric Surgery, run by First Affiliated Hospital of Jinan University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastroesophageal Reflux, Bariatric Surgery
- What is being tested?
- 2 cm away from the pylorus edge, 4 cm away from the pylorus edge and 6 cm away from the pylorus edge
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteChina
- Study dates
- 20 Jan 2018to 30 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- BMI<27.5
Trial locations and contacts
1 site in 1 country.
China1 site
The frist affiliated hospital of Jinan University
Guangzhou, Guangdong, 510630
About this study
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
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.
Read the 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.
- Conditions
- Gastroesophageal Reflux, Bariatric Surgery
- Being tested
- 2 cm away from the pylorus edge, 4 cm away from the pylorus edge, 6 cm away from the pylorus edge, LRYGB
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2 cm away from the pylorus edgeProcedure or surgery
2 cm away from the pylorus edge
4 cm away from the pylorus edgeProcedure or surgery
4 cm away from the pylorus edge
6 cm away from the pylorus edgeProcedure or surgery
6 cm away from the pylorus edge
LRYGBProcedure or surgery
Also called laparoscopic Roux-en-Y gastric bypass
laparoscopic Roux-en-Y gastric bypass
| Study group | Role | What they receive |
|---|---|---|
| Without hiatal suture | Active comparator | the different distance of pylorus without hiatal suture Receives: Procedure: 2 cm away from the pylorus edge; Procedure: 4 cm away from the pylorus edge; Procedure: 6 cm away from the pylorus edge; Procedure: LRYGB |
| With hiatal suture | Active comparator | the different distance of pylorus without hiatal suture Receives: Procedure: 2 cm away from the pylorus edge; Procedure: 4 cm away from the pylorus edge; Procedure: 6 cm away from the pylorus edge |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary outcomes (8)
preoperative and postoperative of abdominal ultrasound to examine the abdominal fat thickness
abdominal fat thickness in centimeter
Measured: 1 year
Preoperative and postoperative BMI
The patient's weight and height will be combined to report BMI in kg/m^2
Measured: 1 year
Preoperative and postoperative waist circumference
waist circumference in centimeter
Measured: 1 year
Preoperative and postoperative abdominal circumference
abdominal circumference in centimeter
Measured: 1 year
Preoperative and postoperative chest circumference
chest circumference in centimeter
Measured: 1 year
Preoperative and postoperative neck circumference
neck circumference in centimeter
Measured: 1 year
Preoperative and postoperative bone mineral density
bone mineral density in percentage
Measured: 1 year
Preoperative and postoperative body fat measured
body fat measured in percentage
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2018
- Study start20 Jan 2018
- Primary completion30 Dec 2019 (estimated)
- Study completion30 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastroesophageal RefluxStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Jinan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jingge Yang, First Affiliated Hospital of Jinan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03497494
- Sponsor's protocol ID
- FirstJinanU20180120
- Status last verified
- Apr 2018
- First submitted
- 15 Mar 2018
- Last updated
- 13 Apr 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03497494
- Acronym / sponsor ID
- FirstJinanU20180120
- Conditions
- Gastroesophageal Reflux, Bariatric Surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Jinan UniversityUniversity, hospital or other
- Study start
- 20 Jan 2018 (actual)
- Primary completion
- 30 Dec 2019 (estimated)
- Study completion
- 30 Dec 2020 (estimated)
- First posted
- 13 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- 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;
| Arm | Type | Receives |
|---|---|---|
| Without hiatal suture | Active comparator | Procedure: 2 cm away from the pylorus edge, Procedure: 4 cm away from the pylorus edge, Procedure: 6 cm away from the pylorus edge, Procedure: LRYGBthe different distance of pylorus without hiatal suture |
| With hiatal suture | Active comparator | Procedure: 2 cm away from the pylorus edge, Procedure: 4 cm away from the pylorus edge, Procedure: 6 cm away from the pylorus edgethe different distance of pylorus without hiatal suture |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- BMI<27.5
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 2 cm away from the pylorus edge2 cm away from the pylorus edge | Procedure or surgery | With hiatal suture, Without hiatal suture |
| 4 cm away from the pylorus edge4 cm away from the pylorus edge | Procedure or surgery | With hiatal suture, Without hiatal suture |
| 6 cm away from the pylorus edge6 cm away from the pylorus edge | Procedure or surgery | With hiatal suture, Without hiatal suture |
| LRYGBAlso: laparoscopic Roux-en-Y gastric bypasslaparoscopic Roux-en-Y gastric bypass | Procedure or surgery | Without hiatal suture |
Primary outcome
GERD-Health Related Quality of Life Questionnaire
Time frame: 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.
8 secondary outcomes
preoperative and postoperative of abdominal ultrasound to examine the abdominal fat thickness
Time frame: 1 year
Preoperative and postoperative BMI
Time frame: 1 year
Preoperative and postoperative waist circumference
Time frame: 1 year
Preoperative and postoperative abdominal circumference
Time frame: 1 year
Preoperative and postoperative chest circumference
Time frame: 1 year
Preoperative and postoperative neck circumference
Time frame: 1 year
Preoperative and postoperative bone mineral density
Time frame: 1 year
Preoperative and postoperative body fat measured
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 2 cm away from the pylorus edge, 4 cm away from the pylorus edge and 6 cm away from the pylorus edge in people with Gastroesophageal Reflux and Bariatric Surgery, run by First Affiliated Hospital of Jinan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
GERD-Health Related Quality of Life Questionnaire (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2018.