Flap Valve-Preserving Vertical Sleeve Gastrectomy (INNOVATE-VSG): Clinical Trial Study Protocol

Area of Science:

• Bariatric Surgery
• Gastroenterology
• Surgical Innovation

Background:

• Conventional vertical sleeve gastrectomy (cVSG) is a common bariatric procedure with proven weight loss benefits.
• However, cVSG can lead to new or worsening gastroesophageal reflux disease (GERD) due to negative impacts on the gastroesophageal junction.
• Chronic GERD poses risks for Barrett's esophagus and esophageal cancer, necessitating procedural improvements.

Purpose of the Study:

• To evaluate if a modified flap valve-preserving sleeve gastrectomy (fvpVSG) can improve pre-existing GERD compared to cVSG.
• To assess the efficacy of surgical modifications designed to strengthen the antireflux barrier during sleeve gastrectomy.

Main Methods:

• A pilot randomized clinical trial involving 44 obese patients (BMI 35-50 kg/m²) with diagnosed GERD.
• Patients were randomly assigned to either cVSG or fvpVSG.
• Primary outcome: change in acid exposure time (AET) at 6-9 months post-surgery. Secondary outcomes included lower esophageal sphincter pressure, esophagogastric junction compliance, weight loss, and quality of life.

Main Results:

• This section is not available in the provided abstract.

Conclusions:

• Data from the INNOVATE-VSG trial will inform the design of a larger, multi-center randomized clinical trial.
• The study aims to confirm the benefits of preserving a functional gastroesophageal valve after sleeve gastrectomy.