Postoperative Gastroesophageal Reflux Symptoms After Laparoscopic Sleeve Gastrectomy Based on the Presence of Preoperative Symptoms

Active, not recruiting

• Conditions: Obesity and Obesity-related Medical Conditions; Laparoscopic Sleeve Gastrectomy; Gastro-oesophageal Reflux

• Registration Number: NCT06835933
• Lead Sponsor: Korea University Anam Hospital

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2020-04-01
• Primary Completion: 2024-03-31
• Status Verified: 2025-02
• Study First Submitted: 2025-02-13
• Study First Submitted QC: 2025-02-14
• Last Update Submitted: 2025-02-14
• Study First Posted: 2025-02-19
• Last Update Posted: 2025-02-19
• Study Completion: 2025-08-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

1. patients with age greater than 19 years
2. patients who underwent laparoscopic sleeve gastrectomy from March 2019 to March 2023
3. patients with postoperative follow-up longer than one month after LSG
4. patients who answered preoperative and postoperative GERD questionnaire (Korean translated version of modified GERD-HRQL)

Exclusion Criteria

1. patients with missing or incomplete postoperative GERD questionnaires

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Symptom scores from the modified GERD-HRQL	before laparoscopic sleeve gastrectomy and at 1, 3, 6, 9, 12 months after surgery	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.

Secondary Outcome Measures

Name	Time	Method
Hiatal hernia repair with laparoscopic sleeve gastrectomy (performed or not)	during laparoscopic sleeve gastrectomy	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
Adiposity-related parameters	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)	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.

Trial Locations

Locations (1)

Korea University Anam Hospital; 🇰🇷 Seoul, Korea, Republic of