This is a prospective randomized clinical trial evaluating the impact of antrum andfundus calibration during laparoscopic vertical gastrectomy (VG) on postoperativegastroesophageal reflux disease (GERD), quality of life, and surgical costs. Eligibleparticipants are adults with morbid obesity (BMI ≥35 kg/m²) undergoing LSG. Patients arerandomized into four groups based on whether antral and/or fundal calibration isperformed. Primary outcomes include the incidence of de novo GERD at 12 months. Secondaryoutcomes include postoperative quality of life, vomiting , surgical complications, weightloss, and operative costs. The study aims to optimize the LSG technique by identifyinganatomical modifications that minimize GERD while improving clinical outcomes
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.
Device: Antrum calibration
For antral calibration, a 50 cc balloon catheter was used to guide the staple line.
Other Name: Antrum section
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).
Other Name: fundus section
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.
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
Regional University Hospital of Málaga
Málaga, Malaga, Spain
Dr. Francisco Javier Moreno Ruiz, MD Head of the Bariatric Surgery Unit, Study Director
Regional University Hospital of Málaga