Mechanistic and Clinical Outcomes of a Surgical Innovation Aimed at Minimizing GERD Associated With VSG (INNOVATE-VSG)

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) 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