Gastroesophageal Reflux DiseaseNCT03692455
Effect of Laparoscopic Sleeve Gastrectomy Versus Roux-en-Y Gastric Bypass on Gastroesophageal Reflux Disease: An 8-Year Prospective Cohort Study
An observational study of Gastroesophageal Reflux Disease and Morbid Obesity, run by Clinica Gastrobese at 1 site in Brazil.
Trial summary
This study represents a long-term observational follow-up of patients who had previously undergone bariatric surgery (laparoscopic sleeve gastrectomy or Roux-en-Y gastric bypass) in the context of an earlier interventional trial (NCT03692455). No new interventions are assigned in the follow-up phase. Read more about this study
- Who is it for?
- Ages 18 to 78 years
- Conditions the study is for
- Gastroesophageal Reflux Disease, Morbid Obesity
- How many people
- 75 participants
- Where
- 1 siteBrazil
- Study dates
- 17 Sep 2025to 8 Nov 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 18 to 78 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study represents a long-term observational follow-up of 75 patients who had previously undergone bariatric surgery (laparoscopic sleeve gastrectomy or Roux-en-Y gastric bypass) in the context of an earlier interventional trial (NCT03692455). No new interventions are assigned in the follow-up phase. Participants are evaluated clinically and functionally at predefined intervals using standardized multimodal assessments (symptom questionnaires, endoscopy, manometry, radiology, and pH monitoring).
Who may be able to join
- Patients enrolled in a previous prospective dual-cohort extension with 75 patients of the original Trial.
- Original Inclusion Criteria: Inclusion criteria were age 18-70 years and body mass index (BMI) ≥40 kg/m², or ≥35 kg/m² with obesity-related comorbidities. A total of 75 patients completed the original trial.
- Exclusion Criteria: Been previously submitted to any gastroesophageal surgical procedure. Presence of chronical diseases that affects esophageal motility. Do not tolerate any of the required exams
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effect of Laparoscopic Sleeve Gastrectomy Versus Roux-en-Y Gastric Bypass on Gastroesophageal Reflux Disease: An 8-Year Prospective Cohort Study.
This study represents a long-term observational follow-up of patients who had previously undergone bariatric surgery (laparoscopic sleeve gastrectomy or Roux-en-Y gastric bypass) in the context of an earlier interventional trial (NCT03692455). No new interventions are assigned in the follow-up phase. Participants are evaluated clinically and functionally at predefined intervals using standardized multimodal assessments (symptom questionnaires, endoscopy, manometry, radiology, and pH monitoring).
Read the detailed description
In order to determine the long term impact of Bariatric surgery on GERD, esophageal syndromes will be evaluated following the Lyon 2.0 Consensus, where troublesome symptoms were defined as score ≥ 2 on a validated questionnaire of symptoms for Portuguese language along with esophageal syndromes with injury assessed through upper endoscopy.
Esophageal acid exposure will be determined through 24h pH monitoring. Increased acid exposure will be characterized when total esophageal pH < 4 for at least 4% of its total monitoring time. The data will be collected 8 years after de surgical intervention.
- Conditions
- Gastroesophageal Reflux Disease, Morbid Obesity
- Keywords
- GERD, Roux-en-Y Gastric Bypass, Vertical Sleeve Gastrectomy, Lion 2.0 Consensus
- Medical subject headings
- Gastroesophageal Reflux, Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| LRSYGP Group | Patients will undergo Clinical evaluation and Exams, 8 years after Laparoscopic Roux-Y Gastric Bypass. | |
| LSG group | Patients will undergo Clinical evaluation and Exams 8 years after Laparoscopic Sleeve Gastrectomy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in number of Participants With Gastroesophageal Reflux Disease (GERD)
Prevalence of GERD in patients will be characterized according to Lyon 2.0 consensus
Measured: 8 years after intervention
Secondary outcomes (6)
Change in number of Participants Presenting GERD symptoms
Prevalence of typical reflux syndrome will be evaluated. In order to assess such troublesome symptoms a validated questionnaire translated into Portuguese language will be used.
Measured: 8 years after intervention
Change in number of Participants With Esophageal Injury
Syndromes with esophageal injury should be determined exclusively by the presence of reflux esophagitis
Measured: 8 years after intervention
Change in Total Esophageal Acid Exposure at 24h pH Monitoring
Esophageal acid exposure will be measured through 24h pH monitoring. During such period, esophageal pH will be measured and recorded as the percent of time pH stays below 4.
Measured: 8 years after intervention
Change in Esophageal Acid Exposure at 24h pH Monitoring in Upright Position
Esophageal acid exposure will be measured through 24h pH monitoring. Esophageal pH will be measured and recorded as the percent of time pH stays below 4 while participant in upright position
Measured: 8 years after intervention
Change in Esophageal Acid Exposure at 24h pH Monitoring in Supine Position
Esophageal acid exposure will be measured through 24h pH monitoring. Esophageal pH will be measured and recorded as the percent of time pH stays below 4 while participant in supine position
Measured: 8 years after intervention
Change in number of Participants With Increased Acid Exposure
Increased Acid Exposure occurs when esophageal pH is <4 for a period longer than 4% of the total test time on a 24h pH monitoring.
Measured: 8 years after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2018
- Study start17 Sep 2025
- Primary completion17 Oct 2025 (estimated)
- Study completion8 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastroesophageal Reflux DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Prospective
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clinica Gastrobese
- Sponsor type
- University, hospital or other
- Collaborators
- Federal University of Rio Grande do Sul
- Responsible party
- Principal investigator, Carlos AS Madalosso, Clinica Gastrobese
- Investigators
- Richard R Gursky, PhD, Study chair, Federal University of Rio Grande do Sul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03692455
- Sponsor's protocol ID
- PP3 Folow-up
- Status last verified
- Sep 2025
- First submitted
- 21 Dec 2015
- Last updated
- 25 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The data will be made publicly available in accordance with the requirements of the journal in which the study will be submitted
Publications
Navarini D, Madalosso CAS, Fornari F, Tognon AP, Ghiasson C, Scortegagna GT, Gurski RR. Gastroesophageal Reflux Disease After Sleeve Gastrectomy versus Roux-en-Y Gastric Bypass: An 8-Year Prospective Cohort Study. World J Surg. 2026 Jun;50(6):1460-1467. doi: 10.1002/wjs.70367. Epub 2026 Apr 12.
PubMed 41968616
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Laparoscopic Sleeve Gastrectomy Versus Roux-en-Y Gastric Bypass on Gastroesophageal Reflux Disease: An 8-Year Prospective Cohort Study.
- ClinicalTrials.gov ID
- NCT03692455
- Acronym / sponsor ID
- PP3 Folow-up
- Conditions
- Gastroesophageal Reflux Disease, Morbid Obesity
- Keywords
- GERD, Roux-en-Y Gastric Bypass, Vertical Sleeve Gastrectomy, Lion 2.0 Consensus
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Clinica GastrobeseUniversity, hospital or other
- Collaborators
- Federal University of Rio Grande do Sul
- Study start
- 17 Sep 2025 (actual)
- Primary completion
- 17 Oct 2025 (estimated)
- Study completion
- 8 Nov 2025 (estimated)
- First posted
- 2 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study represents a long-term observational follow-up of patients who had previously undergone bariatric surgery (laparoscopic sleeve gastrectomy or Roux-en-Y gastric bypass) in the context of an earlier interventional trial (NCT03692455). No new interventions are assigned in the follow-up phase. Participants are evaluated clinically and functionally at predefined intervals using standardized multimodal assessments (symptom questionnaires, endoscopy, manometry, radiology, and pH monitoring).
Detailed description
In order to determine the long term impact of Bariatric surgery on GERD, esophageal syndromes will be evaluated following the Lyon 2.0 Consensus, where troublesome symptoms were defined as score ≥ 2 on a validated questionnaire of symptoms for Portuguese language along with esophageal syndromes with injury assessed through upper endoscopy.
Esophageal acid exposure will be determined through 24h pH monitoring. Increased acid exposure will be characterized when total esophageal pH < 4 for at least 4% of its total monitoring time. The data will be collected 8 years after de surgical intervention.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LRSYGP Group | – | –Patients will undergo Clinical evaluation and Exams, 8 years after Laparoscopic Roux-Y Gastric Bypass. |
| LSG group | – | –Patients will undergo Clinical evaluation and Exams 8 years after Laparoscopic Sleeve Gastrectomy. |
Who may qualify
- Ages
- 18 to 78 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study represents a long-term observational follow-up of 75 patients who had previously undergone bariatric surgery (laparoscopic sleeve gastrectomy or Roux-en-Y gastric bypass) in the context of an earlier interventional trial (NCT03692455). No new interventions are assigned in the follow-up phase. Participants are evaluated clinically and functionally at predefined intervals using standardized multimodal assessments (symptom questionnaires, endoscopy, manometry, radiology, and pH monitoring).
Key inclusion criteria (3 listed)
- Patients enrolled in a previous prospective dual-cohort extension with 75 patients of the original Trial.
- Original Inclusion Criteria: Inclusion criteria were age 18-70 years and body mass index (BMI) ≥40 kg/m², or ≥35 kg/m² with obesity-related comorbidities. A total of 75 patients completed the original trial.
- Exclusion Criteria: Been previously submitted to any gastroesophageal surgical procedure. Presence of chronical diseases that affects esophageal motility. Do not tolerate any of the required exams
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in number of Participants With Gastroesophageal Reflux Disease (GERD)
Time frame: 8 years after intervention
Prevalence of GERD in patients will be characterized according to Lyon 2.0 consensus
6 secondary outcomes
Change in number of Participants Presenting GERD symptoms
Time frame: 8 years after intervention
Change in number of Participants With Esophageal Injury
Time frame: 8 years after intervention
Change in Total Esophageal Acid Exposure at 24h pH Monitoring
Time frame: 8 years after intervention
Change in Esophageal Acid Exposure at 24h pH Monitoring in Upright Position
Time frame: 8 years after intervention
Change in Esophageal Acid Exposure at 24h pH Monitoring in Supine Position
Time frame: 8 years after intervention
Change in number of Participants With Increased Acid Exposure
Time frame: 8 years after intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2025.
- Derived from this study: PubMed 41968616Navarini D, Madalosso CAS, Fornari F, Tognon AP, Ghiasson C, Scortegagna GT, Gurski RR. Gastroesophageal Reflux Disease After Sleeve Gastrectomy versus Roux-en-Y Gastric Bypass: An 8-Year Prospective Cohort Study. World J Surg. 2026 Jun;50(6):1460-1467. doi: 10.1002/wjs.70367. Epub 2026 Apr 12.
- Individual participant dataSharing planned: Undecided. The data will be made publicly available in accordance with the requirements of the journal in which the study will be submitted
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Richard R Gursky, PhD study chair
Federal University of Rio Grande do Sul
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastroesophageal Reflux Disease and Morbid Obesity, run by Clinica Gastrobese at 1 site in Brazil.
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 3 inclusion and 0 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: enrolling by invitation, as of the sponsor's last update on 25 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 Brazil. 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?
Change in number of Participants With Gastroesophageal Reflux Disease (GERD) (time frame: 8 years after intervention). 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 NCT03692455, which also lists 1 linked publication.
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 25 Sep 2025.