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

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

Conditions

• Obese Patients (BMI ≥ 30 kg/m²)
• Obese Patients
• Obese Patients With Bariatric Surgery
• Obese With Comorbidities

Interventions

DEVICE

Antrum calibration

For antral calibration, a 50 cc balloon catheter was used to guide the staple line.

PROCEDURE

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).

PROCEDURE

No antrum calibration

In patients without antrum calibration, gastric transection was performed 5 cm from the pylorus.

PROCEDURE

No fundus calibration

Fundus transection was performed adjacent to the "fat pad" in no calibrated cases.

Sponsors & Collaborators

• Hospital Regional de Malaga

  collaborator OTHER

• Hospital San Juan de Dios Tenerife

  lead OTHER

Principal Investigators

• Dr. Francisco Javier Moreno Ruiz, MD Head of the Bariatric Surgery Unit · Regional University Hospital of Málaga

Study Design

Allocation

RANDOMIZED

Purpose

SCREENING

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-04-06

Primary Completion

2025-12-31

Completion

2025-12-31

FDA Device

Yes

Countries

• Spain

Study Locations