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| Name | Class |
|---|---|
| Hospital Regional de Malaga | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No antrum or fundus calibration | Experimental | No antrum or fundus calibration |
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| Fundus calibration | Experimental | Fundus calibration only |
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| Antrum and fundus calibration | Experimental | Antrum and fundus calibration |
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| Antrum calibration | Experimental | Antrum calibration only |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Antrum calibration | Device | For antral calibration, a 50 cc balloon catheter was used to guide the staple line. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 months postoperatively |
| Incidence of Postoperative Regurgitation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dr. Francisco Javier Moreno Ruiz, MD Head of the Bariatric Surgery Unit | Regional University Hospital of Málaga | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Regional University Hospital of Málaga | Málaga | Malaga | 29010 | Spain |
The data presented in this study are available on request from the corresponding author, in accordance with the informed consent provided by study participants and subject to patient confidentiality and data protection policies
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| 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). |
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| No antrum calibration | Procedure | In patients without antrum calibration, gastric transection was performed 5 cm from the pylorus. |
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| No fundus calibration | Procedure | Fundus transection was performed adjacent to the "fat pad" in no calibrated cases. |
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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. |
| 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. | 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 | 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. | 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) | 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) | 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. | 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. | 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 | 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 | 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. | 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 | 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 | 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. | 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. | 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. | 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 | 2 weeks, 3 months, 6 months, and 12 months postoperatively |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D005764 | Gastroesophageal Reflux |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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