Modifications to Gastric Sleeve: Implications for GRED and Quality of Life

This is a prospective randomized clinical trial evaluating the impact of antrum and fundus calibration during laparoscopic vertical gastrectomy (VG) on postoperative gastroesophageal reflux disease (GERD), quality of life, and surgical costs. Eligible participants are adults with morbid obesity (BMI ≥35 kg/m²) undergoing LSG. Patients are randomized into four groups based on whether antral and/or fundal calibration is performed. Primary outcomes include the incidence of de novo GERD at 12 months. Secondary outcomes include postoperative quality of life, vomiting , surgical complications, weight loss, and operative costs. The study aims to optimize the LSG technique by identifying anatomical modifications that minimize GERD while improving clinical outcomes

NCT Number	NCT07070908
Lead Sponsor	Hospital San Juan de Dios Tenerife Collaborators: Hospital Regional de Malaga
Conditions	Obese Patients (BMI ≥ 30 kg/m²), Obese Patients, Obese Patients With Bariatric Surgery, Obese With Comorbidities
Enrollment	120 participants
Start Date	2020-04-06
Primary Completion	2025-12-31 (estimated)
Study Completion	2025-12-31 (estimated)
Updated on ClinicalTrials.gov	2025-07-17