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Active, Not Recruiting

NCT Number: NCT07070908

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

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Obese Patients (BMI ≥ 30 kg/m²) Body Weight Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Gastroesophageal Reflux Gastrointestinal Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obese Patients Obese Patients With Bariatric Surgery Obese With Comorbidities Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Regional University Hospital of Málaga

Málaga, Malaga, 29010, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Antrum calibration

Device

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

Other names: Antrum section

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).

Other names: fundus section

No antrum calibration

Procedure

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

No fundus calibration

Procedure

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

Primary outcomes

  1. Incidence of de novo Gastroesophageal Reflux Disease (GERD)

    Time frame: 12 months postoperatively

    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

Secondary outcomes

  1. Incidence of Postoperative Vomiting

    Time frame: 12 months postoperatively

    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.

  2. Incidence of Postoperative Regurgitation

    Time frame: 12 months postoperatively

    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.

  3. Food intake volume per meal

    Time frame: 12 months postoperatively

    Food intake volume will be assessed during follow-up visits at 2 weeks, 3 months, 6 months, and 12 months.

  4. Percentage of excess weight loss (%EWL)

    Time frame: 12 months postoperatively

    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

  5. Change in Hypertension Status from Baseline to 12 Months Post-Surgery

    Time frame: Baseline and within 12 months after surgery

    Hypertension improvement or resolution will be determined by comparing preoperative and postoperative clinical records, and antihypertensive medication usage.

  6. Postoperative BMI

    Time frame: Within 12 months after surgery

    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)

  7. Weight loss

    Time frame: Within 12 months after surgery

    Weight loss will be calculated at each postoperative follow-up visit (2 weeks, 3 months, 6 months, and 12 months)

  8. Postoperative Morbidity

    Time frame: Up to 30 days after surgery

    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.

  9. Number of stapler cartridges used

    Time frame: During the surgical procedure

    The total number of stapler cartridges used during vertical gastrectomy will be recorded for each patient.

  10. Intraoperative complications

    Time frame: During the surgical procedure

    All adverse events occurring during surgery will be recorded, including bleeding, injury to adjacent organs, anesthetic incidents, or other unforeseen technical difficulties

  11. Change in Type 2 Diabetes Mellitus Status from Baseline to 12 Months Post-Surgery

    Time frame: Baseline and within 12 months after surgery

    Improvement or resolution of Type 2 Diabetes Mellitus will be assessed through levels, HbA1c, and antidiabetic medication requirements

  12. Change in Hypercholesterolemia Status from Baseline to 12 Months Post-Surgery

    Time frame: Baseline and within 12 months after surgery

    Evaluated through serum cholesterol levels and lipid-lowering medication usage before and after surgery.

  13. Change in Obstructive Sleep Apnea Syndrome (OSAS) Status from Baseline to 12 Months Post-Surgery

    Time frame: Baseline and within 12 months after surgery

    Improvement or resolution based on patient-reported symptoms, CPAP usage, and clinical evaluation

  14. Change in Hypertriglyceridemia Status from Baseline to 12 Months Post-Surgery

    Time frame: Baseline and within 12 months after surgery

    Improvement or resolution of hypertriglyceridemia will be assessed by comparing preoperative and postoperative triglyceride levels and the need for lipid-lowering therapy

  15. Change in Postoperative Satiety Over Time

    Time frame: 2 weeks, 3 months, 6 months, and 12 months postoperatively

    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.

  16. Tolerance to Oral Liquid Intake After Surgery

    Time frame: 2 weeks, 3 months, 6 months, and 12 months postoperatively

    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.

  17. Tolerance to Oral Solid Intake After Surgery

    Time frame: 2 weeks, 3 months, 6 months, and 12 months postoperatively

    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.

  18. Tolerance to Oral Meat Intake After Surgery

    Time frame: 2 weeks, 3 months, 6 months, and 12 months postoperatively

    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

Sponsors and collaborators

Lead sponsor

Hospital San Juan de Dios Tenerife

Other

Collaborators

  • Hospital Regional de Malaga

Registry information

Official study title

Modifications to Gastric Tube Construction in Vertical Gastrectomy: Implications for Gastroesophageal Reflux Disease and Patient Quality of Life

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
Jul 17, 2025
Registry last updated
Jul 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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