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

NCT ID: NCT06835933

Last Updated: 2025-09-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

64 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-04-01

Study Completion Date

2025-08-31

Brief Summary

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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

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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.

Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

Laparoscopic sleeve gastrectomy

Intervention Type 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

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.

Laparoscopic sleeve gastrectomy

Intervention Type 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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Korea University Anam Hospital

OTHER

Sponsor Role lead

Responsible Party

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Sungsoo Park

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Korea University Anam Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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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.

Reference Type BACKGROUND
PMID: 32925505 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8784314 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 36336720 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 39233338 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33244654 (View on PubMed)

Other Identifiers

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SG-GERD

Identifier Type: -

Identifier Source: org_study_id

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