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
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SCREENING
Masking
SINGLE
Enrollment
120
For antral calibration, a 50 cc balloon catheter was used to guide the staple line.
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).
In patients without antrum calibration, gastric transection was performed 5 cm from the pylorus.
Fundus transection was performed adjacent to the "fat pad" in no calibrated cases.
Regional University Hospital of Málaga
Málaga, Malaga, Spain
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
Time frame: 12 months postoperatively
Incidence of Postoperative Vomiting
Postoperative vomiting will be assessed during follow-up visits at 2 weeks, 3 months, 6 months, and 12 months. Patients will self-report the presence, frequency, and severity of vomiting episodes related to food intake.
Time frame: 12 months postoperatively
Incidence of Postoperative Regurgitation
Postoperative regurgitation will be assessed during follow-up visits at 2 weeks, 3 months, 6 months, and 12 months. Patients will self-report the presence, frequency, and severity of regurgitation related to food intake. In addition, regurgitation will be evaluated using the specific item in the GERD-Health-Related Quality of Life (GERD-HRQL) questionnaire.
Time frame: 12 months postoperatively
Food intake volume per meal
Food intake volume will be assessed during follow-up visits at 2 weeks, 3 months, 6 months, and 12 months.
Time frame: 12 months postoperatively
Percentage of excess weight loss (%EWL)
The percentage of excess weight loss (%EWL) will be calculated at 12 months postoperatively. %EWL is defined as: Ideal weight will be based on a BMI of 25 kg/m². This measure evaluates the effectiveness of the procedure in achieving weight reduction
Time frame: 12 months postoperatively
Change in Hypertension Status from Baseline to 12 Months Post-Surgery
Hypertension improvement or resolution will be determined by comparing preoperative and postoperative clinical records, and antihypertensive medication usage.
Time frame: Baseline and within 12 months after surgery
Postoperative BMI
The Body Mass Index (BMI) will be calculated at each postoperative follow-up visit (2 weeks, 3 months, 6 months, and 12 months) to assess the evolution of weight loss. BMI is calculated as weight in kilograms divided by the square of height in meters (kg/m²)
Time frame: Within 12 months after surgery
Weight loss
Weight loss will be calculated at each postoperative follow-up visit (2 weeks, 3 months, 6 months, and 12 months)
Time frame: Within 12 months after surgery
Postoperative Morbidity
Postoperative complications will be assessed and classified according to the Clavien-Dindo classification system. All adverse events occurring within 30 days of surgery will be recorded and categorized by severity.
Time frame: Up to 30 days after surgery
Number of stapler cartridges used
The total number of stapler cartridges used during vertical gastrectomy will be recorded for each patient.
Time frame: During the surgical procedure
Intraoperative complications
All adverse events occurring during surgery will be recorded, including bleeding, injury to adjacent organs, anesthetic incidents, or other unforeseen technical difficulties
Time frame: During the surgical procedure
Change in Type 2 Diabetes Mellitus Status from Baseline to 12 Months Post-Surgery
Improvement or resolution of Type 2 Diabetes Mellitus will be assessed through levels, HbA1c, and antidiabetic medication requirements
Time frame: Baseline and within 12 months after surgery
Change in Hypercholesterolemia Status from Baseline to 12 Months Post-Surgery
Evaluated through serum cholesterol levels and lipid-lowering medication usage before and after surgery.
Time frame: Baseline and within 12 months after surgery
Change in Obstructive Sleep Apnea Syndrome (OSAS) Status from Baseline to 12 Months Post-Surgery
Improvement or resolution based on patient-reported symptoms, CPAP usage, and clinical evaluation
Time frame: Baseline and within 12 months after surgery
Change in Hypertriglyceridemia Status from Baseline to 12 Months Post-Surgery
Improvement or resolution of hypertriglyceridemia will be assessed by comparing preoperative and postoperative triglyceride levels and the need for lipid-lowering therapy
Time frame: Baseline and within 12 months after surgery
Change in Postoperative Satiety Over Time
Satiety will be assessed through patient self-reported feedback during postoperative visits at 2 weeks, 3 months, 6 months, and 12 months. The evaluation includes perceived fullness after meals and the volume of food tolerated per intake.
Time frame: 2 weeks, 3 months, 6 months, and 12 months postoperatively
Tolerance to Oral Liquid Intake After Surgery
Tolerance to oral liquid intake will be assessed at 2 weeks, 3 months, 6 months, and 12 months after surgery. This variable evaluates the patient's ability to ingest and retain clear liquids without nausea, vomiting, or discomfort. Data will be collected through clinical interviews, patient-reported outcomes, and medical records during scheduled follow-up visits.
Time frame: 2 weeks, 3 months, 6 months, and 12 months postoperatively
Tolerance to Oral Solid Intake After Surgery
Assessment of the patient's ability to tolerate solid food intake following vertical gastrectomy. Tolerance will be evaluated based on patient self-reported ability to consume solid foods without discomfort, vomiting, or regurgitation.
Time frame: 2 weeks, 3 months, 6 months, and 12 months postoperatively
Tolerance to Oral Meat Intake After Surgery
Patient-reported ability to consume and tolerate meat (solid protein) without nausea, vomiting, regurgitation, or abdominal discomfort. Data will be collected via clinical interviews at each postoperative visit
Time frame: 2 weeks, 3 months, 6 months, and 12 months postoperatively
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.