Mechanistic and Clinical Outcomes of a Surgical Innovation Aimed at Minimizing GERD Associated With Vertical Sleeve Gastrectomy (INNOVATE-VSG)
University of California, Irvine
Summary
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.
Description
The study will examine whether a modified vertical sleeve gastrectomy (mVSG) will improve GERD and quality of life. Aim 1 (Primary): to determine whether mVSG, in comparison to conventional vertical sleeve gastrectomy (cVSG), will be associated with lower acid exposure time (AET, measured by the Bravo pH test) at 6-9 months. The investigators hypothesize that, at Month 6-9, compared to cVSG: • H1. mVSG will be associated with lower AET Aim 2 (Secondary): To elucidate the mechanistic basis for Aim 1, the investigators will perform following tests, before and at 6-9 months post-surgery: a) Hi…
Eligibility
- Age range
- 18–65 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Male and female subjects aged 18-65 years 2. Body mass index (BMI) 35-55 kg/m2 3. Must meet the BMI criteria before and after 6 months of nonsurgical weight management 4. Presence of GERD defined for this trial as acid exposure time (AET) of 4.9% or above as assessed with the Bravo pH test. 5. Have health insurance which pays for the costs of bariatric surgery and standard medical care before and after surgery 6. Women of childbearing potential must be using appropriate contraception to avoid pregnancy throughout the study, and must have a negative pregnancy test at stu…
Interventions
- ProcedureModified Vertical Sleeve Gastrectomy (mVSG)
The modified procedure preserves the gastric sling fibers and re-establishes the gastroesophageal flap valve (GEFV).
- ProcedureConventional Vertical Sleeve Gastrectomy (cVSG)
Vertical Sleeve Gastrectomy as standard procedure
Locations (2)
- University of California, IrvineOrange, California
- University of California, San DiegoSan Diego, California