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Modifications to Gastric Sleeve: Implications for GRED and Quality of Life
Sponsor: Hospital San Juan de Dios Tenerife
Summary
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
Official title: Modifications to Gastric Tube Construction in Vertical Gastrectomy: Implications for Gastroesophageal Reflux Disease and Patient Quality of Life
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
120
Start Date
2020-04-06
Completion Date
2025-12-31
Last Updated
2025-07-17
Healthy Volunteers
No
Conditions
Interventions
Antrum calibration
For antral calibration, a 50 cc balloon catheter was used to guide the staple line.
Fudus calibration
Fundus transection was performed 1 cm from the "fat pad" in calibrated cases (an anatomically constant area near the short gastric vessels that contains minimal fat and facilitates dissection toward the diaphragmatic crus).
No antrum calibration
In patients without antrum calibration, gastric transection was performed 5 cm from the pylorus.
No fundus calibration
Fundus transection was performed adjacent to the "fat pad" in no calibrated cases.
Locations (1)
Regional University Hospital of Málaga
Málaga, Malaga, Spain