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.
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) High resolution esophageal manometry (HREM) to determine the lower esophageal sphincter (LES) and intragastric pressure; b) The endoluminal functional lumen imaging probe (EndoFLIP) testing to examine changes in compliance of the LES; c) Measure the length of the gastroesophageal flap valve (GEFV) on the retroflex view during endoscopic exam. The investigators hypothesize that, at Month 6-9, compared to cVSG: * H2a. mVSG will be associated with higher LES pressure and lower intragastric pressure * H2b. mVSG will be associated with lower LES compliance * H2c. GEFV will be present after mVSG (vs absence after cVSG) Aim 3: Examine the impact of GERD on quality of life (QoL) with two validated rating scales - Gastroesophageal reflux disease-health related quality of life (GERD-HRQL) and Short Form-36 (SF-36). The investigators hypothesize that, at 12 months, compared to cVSG: • H3. mVSG will lead to superior QoL
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
44
The modified procedure preserves the gastric sling fibers and re-establishes the gastroesophageal flap valve (GEFV).
Vertical Sleeve Gastrectomy as standard procedure
University of California, Irvine
Orange, California, United States
RECRUITINGUniversity of California, San Diego
San Diego, California, United States
RECRUITING% Acid Exposure Time (%AET)
Change in %AET in percentage points at Month 6-9 relative to pre-surgery %AET assessed with the Bravo pH test
Time frame: Pre-surgery, Month 6-9 post surgery
LES pressure
Change in LES pressure in millimeters of mercury (mmHg) assessed with High Resolution Esophageal Manometry (HREM)
Time frame: Pre-surgery, Month 6-9 post surgery
Intragastric pressure
Change in intragastric pressure in millimeters of mercury (mmHg) assessed with HREM
Time frame: Pre-surgery, Month 6-9 post surgery
LES compliance
Change in LES compliance in ratio of mm3/mmHg assessed with EndoFLIP
Time frame: Pre-surgery, Month 6-9 post surgery
GEFV length
Change in GEFV length in millimeters (mm) assessed with endoscopic exam
Time frame: Pre-surgery, Month 6-9 post surgery
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