NCT06783751

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 44 (estimated)
• Sponsor: University of California, Irvine · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed 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

Conditions

• Obesity
• Bariatric Surgery
• Sleeve Gastrectomy
• Gastroesophageal Reflux Disease

Interventions

Type	Name	Description
PROCEDURE	Modified Vertical Sleeve Gastrectomy (mVSG)	The modified procedure preserves the gastric sling fibers and re-establishes the gastroesophageal flap valve (GEFV).
PROCEDURE	Conventional Vertical Sleeve Gastrectomy (cVSG)	Vertical Sleeve Gastrectomy as standard procedure

Timeline

• Start date: 2025-03-21
• Primary completion: 2027-04-30
• Completion: 2027-07-31
• First posted: 2025-01-20
• Last updated: 2026-04-13

Locations

2 sites across 1 country: United States