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

NCT07070908 | Active Not Recruiting FDA Device

• 1 other identifier: 25-00101
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Obesity; Vertical gastrectomy; Gastroesophageal reflux disease; Quality of life

Outcome Measures

Primary Outcomes (1)

• Incidence of de novo Gastroesophageal Reflux Disease (GERD)

  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

  12 months postoperatively

Secondary Outcomes (18)

• Incidence of Postoperative Vomiting

  12 months postoperatively

• Incidence of Postoperative Regurgitation

  12 months postoperatively

• Food intake volume per meal

  12 months postoperatively

• Percentage of excess weight loss (%EWL)

  12 months postoperatively

• Change in Hypertension Status from Baseline to 12 Months Post-Surgery

  Baseline and within 12 months after surgery

Study Arms (4)

No antrum or fundus calibration

EXPERIMENTAL

No antrum or fundus calibration

Procedure: No antrum calibration; Procedure: No fundus calibration

Fundus calibration

EXPERIMENTAL

Fundus calibration only

Procedure: Fudus calibration; Procedure: No antrum calibration

Antrum and fundus calibration

EXPERIMENTAL

Antrum and fundus calibration

Device: Antrum calibration; Procedure: Fudus calibration

Antrum calibration

EXPERIMENTAL

Antrum calibration only

Device: Antrum calibration; Procedure: No fundus calibration

Interventions

Antrum calibration DEVICE

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

Also known as: Antrum section

Antrum and fundus calibration; Antrum calibration

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).

Also known as: fundus section

Antrum and fundus calibration; Fundus calibration

No antrum calibration PROCEDURE

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

Fundus calibration; No antrum or fundus calibration

No fundus calibration PROCEDURE

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

Antrum calibration; No antrum or fundus calibration

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital San Juan de Dios Tenerife: lead
• Hospital Regional de Malaga: collaborator

Study Sites (1)

Regional University Hospital of Málaga

Málaga, Malaga, 29010, Spain

Location

MeSH Terms

Conditions

Obesity; Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Dr. Francisco Javier Moreno Ruiz, MD Head of the Bariatric Surgery Unit

  Regional University Hospital of Málaga

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 27, 2025
• First Posted: July 17, 2025
• Study Start: April 6, 2020
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: July 17, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)