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This study is for men and women over 18 years of age who will undergo a clinically indicated bariatric procedure (endoscopic sleeve gastroplasty or surgical vertical sleeve gastrectomy or Roux-en-Y-gastric bypass). The purpose of this registry study is to study how common gastroesophageal reflux disease (GERD) is in obese patients before and after treatment for obesity (surgical or endoscopic).
The natural history of GERD symptoms in this population after undergoing a bariatric intervention is scarce or conflicting. Silent or asymptomatic GERD is not routinely diagnosed without formal testing. Routine evaluation for GERD prior to planned treatment is important since it could potentially change the treatment plan prevent unnecessary additional surgeries or procedures to address GERD that could be made worse by surgery.
The study doctor is planning to perform a bariatric treatment procedure as part of standard clinical care. The individual’s pre-procedure testing, procedure and any follow-up will not be affected by participating in this study and will be performed according to local standard-of-care. These may include an upper endoscopy, pH testing to assess the acid levels and GERD symptoms, x-rays, CT scan, or motility studies, depending upon the participant’s symptoms.
If an individual agrees to be in this study, we will ask the following things for research purposes:
The following data will be collected: presence of esophagitis, Barrett’s esophagus, measurement of hiatal hernia, use of medication to reduce acid in the stomach (PPI), and pathology data of biopsies taken on endoscopy.
In addition, we will contact the participant by phone or secure online research survey, or during post treatment clinic visits at 6, 12, 24, 36, 48 and 60 months after the bariatric intervention for follow up. If at any time the participant feels uncomfortable, they may refuse to answer questions.
Compensation for completing the study questionnaires will be provided.
Participation in this study will last up to 5 years.
Detailed eligibility reviewed when individual’s contact the study team.