Long Term Outcomes of Bariatric Patients Treated With Surgery or Endoscopy (NCT03705416) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Long Term Outcomes of Bariatric Patients Treated With Surgery or Endoscopy
United States250 participantsStarted 2019-03-30
Plain-language summary
GERD is common in the obese population. Bariatric procedures are the mainstay of therapy for these patients. Bariatric procedures can be surgical (Roux-en-Y gastric bypass and Vertical sleeve gastrectomy) or endoscopic (endoscopic sleeve gastroplasty). The rate of GERD after either treatment is unknown as is the rate of silent reflux. The study primary objective is to assess the incidence rate of GERD in bariatric patients that undergo either therapy.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* BMI ≥ 30 Kg/m2
* Patients scheduled to undergo a bariatric weight loss procedure (endoscopic or surgical)
* Patients older than 18 years and younger than 75 years of age at time of consent
* Patients able to provide written informed consent on the Institutional review board (IRB) approved informed consent form
* Patients willing and able to comply with study requirements for follow-up
Exclusion Criteria:
* Any patient with BMI \< 30 Kg/m2
* Patients treated with intragastric balloons.
* Pre-existing esophageal stenosis/stricture preventing advancement of an endoscope during screening/baseline Esophagogastroduodenoscopy (EGD)
* Esophageal, gastric or duodenal malignancy
* Severe medical comorbidities precluding endoscopy, or limiting life expectancy to less than 2 years in the judgment of the endoscopist
* Uncontrolled coagulopathy or inability to be off anticoagulation or anti-platelet medication (ASA, Plavix) for 1 week prior to and 2 weeks after each endoscopy
* Active fungal esophagitis
* Known portal hypertension, visible esophageal or gastric varices, or history of esophageal varices
* General poor health, multiple co-morbidities placing the patient at risk, or otherwise unsuitable for trial participation
* Pregnant or planning to become pregnant during period of study participation
* Patient refuses or is unable to provide written informed consent
* Prior bariatric treatment procedure
* Prior surgical or endoscopic anti-reflux procedure
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percentage of participants with GERD based on symptoms, and abnormal acid exposure time and/or reflux esophagitis