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

NCT ID: NCT07070908

Last Updated: 2025-07-17

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-04-06
• Study Completion Date: 2025-12-31

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

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: SINGLE

Study Groups

No antrum or fundus calibration

No antrum or fundus calibration

Group Type: EXPERIMENTAL

No antrum calibration

Intervention Type: PROCEDURE

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

No fundus calibration

Intervention Type: PROCEDURE

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

Fundus calibration

Fundus calibration only

Group Type: EXPERIMENTAL

Fudus calibration

Intervention Type: 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

Intervention Type: PROCEDURE

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

Antrum and fundus calibration

Antrum and fundus calibration

Group Type: EXPERIMENTAL

Antrum calibration

Intervention Type: DEVICE

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

Fudus calibration

Intervention Type: 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).

Antrum calibration

Antrum calibration only

Group Type: EXPERIMENTAL

Antrum calibration

Intervention Type: DEVICE

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

No fundus calibration

Intervention Type: PROCEDURE

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

Interventions

Antrum calibration

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

Intervention Type: DEVICE

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).

Intervention Type: PROCEDURE

No antrum calibration

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

Intervention Type: PROCEDURE

No fundus calibration

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

Intervention Type: PROCEDURE

Other Intervention Names

Antrum section; fundus section

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Regional de Malaga

OTHER

Sponsor Role: collaborator

Hospital San Juan de Dios Tenerife

OTHER

Sponsor Role: lead

Responsible Party

Julen Ramon Rodríguez

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

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

Role: STUDY_DIRECTOR

Regional University Hospital of Málaga

Locations

Regional University Hospital of Málaga

Málaga, Malaga, Spain

Countries

Spain

Other Identifiers

25-00101

Identifier Type: -

Identifier Source: org_study_id