Clinical trial

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

Active, not recruiting · Not applicable · 1 countries · Registry ID NCT07070908

Active, not recruitingNot applicableInterventional

What this study is about

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

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 65 Years

SexAll

Healthy volunteersNot accepted

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

Full registry criteria

Inclusion Criteria: * Patients with morbid obesity on the waiting list for bariatric surgery. * Both male and female participants. * Age between 18 and 65 years. * BMI \> 35 kg/m². * Availability to attend scheduled follow-up visits. * Indication for sleeve gastrectomy as the first bariatric procedure. Exclusion Criteria: * Obesity of endocrine origin. * Preoperative GERD (diagnosed by pH-metry or upper endoscopy following a positive GERD-HRQL test). * Active gastrointestinal disease (such as esophagitis, peptic ulcer, cancer, or esophageal motility disorder), diagnosed by endoscopy or manometry. * History of previous gastric surgery. * Patients not meeting the inclusion criteria

Treatments and study arms

Antrum calibration

Device

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

Fudus calibration

Procedure

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

Procedure

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

No fundus calibration

Procedure

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

Primary outcomes

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

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Regional University Hospital of Málaga🇪🇸 Málaga, Malaga, Spain

Open map