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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06835933
Enrollment
64
Registered
2025-02-19
Start date
2020-04-01
Completion date
2025-08-31
Last updated
2025-09-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastro-oesophageal Reflux, Laparoscopic Sleeve Gastrectomy, Obesity and Obesity-related Medical Conditions

Keywords

obesity, diabetes mellitus, sleeve gastrectomy, gastro-esophageal reflux

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.

Interventions

PROCEDURELaparoscopic 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.

Sponsors

Korea University Anam Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Symptom scores from the modified GERD-HRQLbefore laparoscopic sleeve gastrectomy and at 1, 3, 6, 9, 12 months after surgeryThe 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

MeasureTime frameDescription
Hiatal hernia repair with laparoscopic sleeve gastrectomy (performed or not)during laparoscopic sleeve gastrectomyIn 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 parametersbefore 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.

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026