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

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Study 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

Eligibility

Primary outcome measure(s)

• Incidence of de novo Gastroesophageal Reflux Disease (GERD) — 12 months postoperatively
  De novo GERD will be diagnosed if any of the following criteria are met: Presence of esophagitis according to the Los Angeles classification DeMeester index \> 14.72 Acid exposure time \> 4% on 24-hour pH-metry GERD-HRQL questionnaire score ≥ 12

Trial sites (1)

More Hospital San Juan de Dios Tenerife trials in Spain

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