This is a two-site randomized clinical trial aiming to test whether a modified investigational bariatric surgical procedure can improve gastroesophageal reflux disease (GERD) after sleeve gastrectomy.
Male and female subjects aged 18-65 years
Body mass index (BMI) 35-55 kg/m2
Must meet the BMI criteria before and after 6 months of nonsurgical weight management
Presence of GERD defined for this trial as acid exposure time (AET) of 4.9% or above as assessed with the Bravo pH test.
Hiatal hernia >2cm (defined as maximum axial height from end of the esophagus to diaphragm by any study including upper endoscopy esophagram and or at the time of surgery)
Evidence of clinically significant major esophageal motility disorder as determined by the site primary investigator
Severe gastroparesis
Previous bariatric or anti-reflux procedure
University of California, Irvine
Lead sponsor
University of California, San Diego
Collaborator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator