NCT07070908

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

Modifications to Gastric Tube Construction in Vertical Gastrectomy: Implications for Gastroesophageal Reflux Disease and Patient Quality of Life

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Hospital San Juan de Dios Tenerife · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Detailed description

This is a prospective, randomized clinical trial conducted at the Regional University Hospital of Málaga. The objective is to evaluate the effect of antrum and fundus calibration during vertical gastrectomy (VG) on the incidence of gastroesophageal reflux disease (GERD), quality of life, weight loss, and surgical costs. Eligibility Criteria: Inclusion criteria include adults with an indication for VG, a body mass index (BMI) ≥ 35 kg/m², and provision of written informed consent. Exclusion criteria include endocrine-related obesity, active gastrointestinal disease (such as GERD, esophagitis, peptic ulcer, or motility disorders), or a history of gastric surgery. Randomization and Study Arms: Patients are randomized to one of four groups: Group A: No antrum or fundus calibration Group B: Fundus calibration only Group C: Antrum and fundus calibration Group D: Antrum calibration only Surgical Protocol: All patients receive a 36 Fr bougie to shape the gastric tube. In cases with antrum calibration, a 50 cc balloon catheter (MidSleeve®) guides the staple line. For fundus calibration, transection is performed 1 cm from the anatomical fat pad. Stapler height is adjusted according to tissue thickness, and the staple line is reinforced. GERD Assessment: De novo GERD is defined by endoscopic findings (esophagitis), pathological pH monitoring (DeMeester index \> 14.72 or acid exposure \> 4%), or clinically significant reflux symptoms with a GERD-HRQL score ≥ 12. Preoperative GERD is ruled out by endoscopy and questionnaire, followed by pH monitoring if symptoms are present. Follow-Up and Monitoring: Patients are followed at 2 weeks, 3, 6, and 12 months. In those reporting symptoms postoperatively, endoscopy and pHmetry are repeated. Variables Collected: Data include age, sex, BMI, comorbidities, operative details (e.g., number of stapler cartridges), complications (Clavien-Dindo classification), weight loss (%EWL), quality of life metrics (vomiting, regurgitation, satiety, food tolerance), and presence of GERD. Statistical Analysis: Comparisons are made across the four study groups, as well as pooled analyses for fundus calibration (yes vs. no) and antrum calibration (yes vs. no). Quantitative data are analyzed using Student's t-test or Mann-Whitney U test, and categorical variables by chi-square or Kruskal-Wallis test as appropriate. Spearman's correlation is used for association between variables. A p-value \< 0.05 is considered statistically significant.

Conditions

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-04-06
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2025-07-17
• Last updated: 2025-07-17

Locations

1 site across 1 country: Spain

Regulatory

• FDA-regulated device study