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Obesity and Obesity-related Medical ConditionsNCT06835933

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

An observational study of Obesity and Obesity-related Medical Conditions and Laparoscopic Sleeve Gastrectomy, run by Korea University Anam Hospital at 1 site in South Korea.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 years and older
What is being tested?
Laparoscopic sleeve gastrectomy
How many people
64 participants
Where
1 siteSouth Korea
Study dates
1 Apr 2020to 31 Aug 2025
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients who underwent laparoscopic sleeve gastrectomy

Who may be able to join

  • 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)

Who cannot join

  • 1) patients with missing or incomplete postoperative GERD questionnaires

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Korea University Anam Hospital

    Seoul, 02841

Other trials in South Korea

About this study

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

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.

Read the 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.

Being tested
Laparoscopic sleeve gastrectomy
Keywords
obesity, diabetes mellitus, sleeve gastrectomy, gastro-esophageal reflux
Medical subject headings
Obesity, Gastroesophageal Reflux, Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Laparoscopic sleeve gastrectomyProcedure or surgery

    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.

Study groups in NCT06835933
Study groupRoleWhat they receive
Preoperative symptom presence groupPatients 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.
Receives: Procedure: Laparoscopic sleeve gastrectomy
Preoperative symptom absence groupPatients 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.
Receives: Procedure: Laparoscopic sleeve gastrectomy

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (2)

  1. 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

    Measured: during laparoscopic sleeve gastrectomy

  2. 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.

    Measured: 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)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Feb 2025
  2. Study start1 Apr 2020
  3. Primary completion31 Mar 2024
  4. Study completion31 Aug 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
64 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06835933
Sponsor's protocol ID
SG-GERD
Status last verified
Feb 2025
First submitted
13 Feb 2025
Last updated
5 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: According to private information law, the IPD generated and/or analyzed for this study will not be shared.

Publications

  • 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.

    PubMed 32925505

  • 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.

    PubMed 8784314

  • 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.

    PubMed 36336720

  • 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.

    PubMed 39233338

  • 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.

    PubMed 33244654

Questions about this trial

What is this clinical trial studying?

An observational study of Obesity and Obesity-related Medical Conditions and Laparoscopic Sleeve Gastrectomy, run by Korea University Anam Hospital at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 5 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Symptom scores from the modified GERD-HRQL (time frame: before laparoscopic sleeve gastrectomy and at 1, 3, 6, 9, 12 months after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06835933, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2025.

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