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

NCT06835933 | Active Not Recruiting

• 1 other identifier: SG-GERD
• Study Type: observational
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

  before laparoscopic sleeve gastrectomy and at 1, 3, 6, 9, 12 months after surgery

Secondary Outcomes (2)

• Hiatal hernia repair with laparoscopic sleeve gastrectomy (performed or not)

  during laparoscopic sleeve gastrectomy

• 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)

Study Arms (2)

Preoperative symptom presence group

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

Preoperative symptom absence group

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

Interventions

Laparoscopic sleeve gastrectomy PROCEDURE

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.

Preoperative symptom absence group; Preoperative symptom presence group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who underwent laparoscopic sleeve gastrectomy

You may qualify if:

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

You may not qualify if:

• \) patients with missing or incomplete postoperative GERD questionnaires

Sponsors & Collaborators

• Korea University Anam Hospital: lead

Study Sites (1)

Korea University Anam Hospital

Seoul, 02841, South Korea

Location

Related Publications (5)

• Balla A, Leone G, Ribichini E, Sacchi MC, Genco A, Pronio A, Paganini AM, Badiali D. Gastroesophageal Reflux Disease - Health-Related Quality of Life Questionnaire: prospective development and validation in Italian. Eur J Gastroenterol Hepatol. 2021 Mar 1;33(3):339-345. doi: 10.1097/MEG.0000000000001914.

  PMID: 32925505 BACKGROUND

• Velanovich V, Vallance SR, Gusz JR, Tapia FV, Harkabus MA. Quality of life scale for gastroesophageal reflux disease. J Am Coll Surg. 1996 Sep;183(3):217-24.

  PMID: 8784314 BACKGROUND

• Eisenberg D, Shikora SA, Aarts E, Aminian A, Angrisani L, Cohen RV, de Luca M, Faria SL, Goodpaster KPS, Haddad A, Himpens JM, Kow L, Kurian M, Loi K, Mahawar K, Nimeri A, O'Kane M, Papasavas PK, Ponce J, Pratt JSA, Rogers AM, Steele KE, Suter M, Kothari SN. 2022 American Society of Metabolic and Bariatric Surgery (ASMBS) and International Federation for the Surgery of Obesity and Metabolic Disorders (IFSO) Indications for Metabolic and Bariatric Surgery. Obes Surg. 2023 Jan;33(1):3-14. doi: 10.1007/s11695-022-06332-1.

  PMID: 36336720 BACKGROUND

• Kim MS, Lee I, Natarajan P, Do R, Kwon Y, Shin JI, Solmi M, Kim JY, Won HH, Park S. Integration of observational and causal evidence for the association between adiposity and 17 gastrointestinal outcomes: An umbrella review and meta-analysis. Obes Rev. 2024 Dec;25(12):e13823. doi: 10.1111/obr.13823. Epub 2024 Sep 4.

  PMID: 39233338 BACKGROUND

• Silveira FC, Poa-Li C, Pergamo M, Gujral A, Kolli S, Fielding GA, Ren-Fielding CJ, Schwack BF. The Effect of Laparoscopic Sleeve Gastrectomy on Gastroesophageal Reflux Disease. Obes Surg. 2021 Mar;31(3):1139-1146. doi: 10.1007/s11695-020-05111-0. Epub 2020 Nov 26.

  PMID: 33244654 BACKGROUND

MeSH Terms

Conditions

Obesity; Gastroesophageal Reflux; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 13, 2025
• First Posted: February 19, 2025
• Study Start: April 1, 2020
• Primary Completion: March 31, 2024
• Study Completion: August 31, 2025
• Last Updated: September 5, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)