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

H

Hospital San Juan de Dios Tenerife

Status

Active, not recruiting

Conditions

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

Treatments

Procedure: Fudus calibration
Procedure: No fundus calibration
Procedure: No antrum calibration
Device: Antrum calibration

Study type

Interventional

Funder types

Other

Identifiers

NCT07070908
25-00101

Details and patient eligibility

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

Full 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.

Enrollment

120 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Screening

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

120 participants in 4 patient groups

No antrum or fundus calibration
Experimental group
Description:
No antrum or fundus calibration
Treatment:
Procedure: No antrum calibration
Procedure: No fundus calibration
Fundus calibration
Experimental group
Description:
Fundus calibration only
Treatment:
Procedure: No antrum calibration
Procedure: Fudus calibration
Antrum and fundus calibration
Experimental group
Description:
Antrum and fundus calibration
Treatment:
Device: Antrum calibration
Procedure: Fudus calibration
Antrum calibration
Experimental group
Description:
Antrum calibration only
Treatment:
Device: Antrum calibration
Procedure: No fundus calibration

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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