An observational study in Obesity and Obesity-related Medical Conditions, Laparoscopic Sleeve Gastrectomy and Gastro-oesophageal Reflux, sponsored by Korea University Anam Hospital. Active, not recruiting at 1 site in South Korea. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2025-09-05.
Sponsored by Korea University Anam Hospital · Observational
This study aims to investigate the patterns of reflux symptoms after laparoscopic sleeve gastrectomy based on the presence or absence of preoperative gastroesophageal reflux symptoms.
Obesity is a well-known risk factor for gastroesophageal reflux disease (GERD), and laparoscopic sleeve gastrectomy (LSG) is the most commonly performed bariatric/metabolic surgery. However, patients often experience reflux symptoms after LSG, and those with severe reflux symptoms or severe erosive esophagitis have been excluded from candidates for LSG. This study aims to analyze the patterns of postoperative reflux symptoms based on the presence of preoperative reflux symptoms.
Prospectively established databases of patients assessed for reflux symptoms at a single institution will be retrospectively reviewed. A total of 64 patients who underwent LSG between April 2020 and March 2023 will be included in this study. The modified GERD-HRQL (GERD- health-related quality of life) questionnaire was used to evaluate gastroesophageal reflux symptoms before LSG and at 1, 3, 6, 9, and 12 months after surgery. Reflux symptoms will be categorized into heartburn and regurgitation, and the patterns of heartburn and regurgitation scores included in the modified GERD-HRQL questionnaire will be analyzed. The patients will be classified based on the presence or absence of preoperative reflux symptoms, and the patterns of symptom scores within each group will be analyzed. We will also measure the correlation between whether hiatal hernia repair was performed with laparoscopic sleeve gastrectomy and adiposity-related parameters, including preoperative and postoperative body mass index (BMI), preoperative and postoperative waist circumference (WC), the percentage of total weight loss (%TWL), and the percentage of WC reduction, and changes in postoperative symptom scores.
6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.
This study's enrollment of 64 is below the median of 135 across 1,283 observational studies indexed under Obesity.
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Patients who underwent laparoscopic sleeve gastrectomy
Exclusion Criteria:
1) patients with missing or incomplete postoperative GERD questionnaires
Patients whose preoperative symptom score from the modified GERD-HRQL questionnaire is not zero. For analyses of each symptom (heartburn and regurgitation), patients will be grouped based on the presence of the respective symptom: the heartburn symptom presence group for heartburn analysis and the regurgitation symptom presence group for regurgitation analysis.
Procedure: Laparoscopic sleeve gastrectomy
Patients whose preoperative symptom score is zero, as assessed by the modified GERD-HRQL questionnaire. For each symptom analysis (heartburn and regurgitation), patients will be grouped based on the presence of the respective symptom: the heartburn symptom absence group for heartburn analysis and the regurgitation symptom absence group for regurgitation analysis.
Procedure: Laparoscopic sleeve gastrectomy
Laparoscopic sleeve gastrectomy (LSG) is most commonly performed bariatric/metabolic surgery. LSG is performed in patients with obesity and/or obesity-related comorbidities. During LSG, the stomach was resected from 5 cm proximal to the pylorus to the angle of His, guided by a 36-French bougie. In patients with hiatal hernia, concomitant HHR was also performed with LSG using non-absorbable sutures. Routine oral potassium-competitive acid blocker (PCAB) was prescribed for 3 months after surgery and the discontinuation of PCAB was determined based on GERD symptoms at the 3-month visit.
Symptom scores from the modified GERD-HRQL
The modified GERD-HRQL consists of 15 questions with a 6-point Likert scale ranging from 0 to 5. Among these, six questions are related to heartburn, while another six focus on regurgitation. Symptom scores including heartburn and regurgitation scores were defined as the sum of the six questions related to each symptom.
Time frame: before laparoscopic sleeve gastrectomy and at 1, 3, 6, 9, 12 months after surgery
Hiatal hernia repair with laparoscopic sleeve gastrectomy (performed or not)
In patients with hiatal hernia, hiatal hernia repair was performed with laparoscopic sleeve gastrectomy. A subgroup analysis will be conducted based on the presence or absence of a hiatal hernia. We will also analyze the correlation between whether hiatal hernia repair was performed with laparoscopic sleeve gastrectomy and the changes in postoperative symptom scores. \* The changes in postoperative symptom scores = postoperative symptom scores - preoperative symptom scores
Time frame: during laparoscopic sleeve gastrectomy
Adiposity-related parameters
We will analyze the correlation between adiposity-related parameters, including preoperative and postoperative body mass index (BMI), preoperative and postoperative waist circumference (WC), the percentage of total weight loss (%TWL), and the percentage of WC reduction, and the changes in postoperative symptom scores. \* The changes in postoperative symptom scores = postoperative symptom scores - preoperative symptom scores; BMI = body weight (kg) / height (m)\^2; * TWL = (preoperative body weight - postoperative body weight)/preoperative body weight x 100 (%); WC reduction = (preoperative WC - postoperative WC)/preoperative WC x 100 (%); \*\* WC was measured at the level of the umbilicus.
Time frame: before laparoscopic sleeve gastrectomy and at 1, 3, 6, 9, 12 months after surgery (WC: before laparoscopic sleeve gastrectomy and at 3, 6, 9, 12 months after surgery)
Plan to share: No — According to private information law, the IPD generated and/or analyzed for this study will not be shared.
This study is active, not recruiting, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
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Korea University Anam Hospital