Gastroesophageal Reflux DiseaseNCT00951093
Gastroesophageal Reflux Disease (GERD) Before and After Gastric Bypass
An observational study of Gastroesophageal Reflux Disease and Morbid Obesity, run by Clinica Gastrobese at 1 site in Brazil.
Trial summary
The hypothesis of this study was that gastric bypass (GBP) ameliorates gastroesophageal reflux disease (GERD) in morbidly obese patients. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Gastroesophageal Reflux Disease, Morbid Obesity
- What is being tested?
- Gastric bypass
- Type of treatment
- Surgery or procedure
- How many people
- 53 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2007to Dec 2012
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Primary care clinic patients
Who may be able to join
- Morbid obesity
- Acceptance to undergo open gastric bypass
Who cannot join
- Prior gastroesophageal surgery
- Achalasia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of Gastric Bypass on Gastroesophageal Reflux Disease in Patients With Morbid Obesity: a Prospective Study Based on Montreal Consensus
The hypothesis of this study was that gastric bypass (GBP) ameliorates gastroesophageal reflux disease (GERD) in morbidly obese patients.
Read the detailed description
The investigators studied the impact of this surgical procedure on GERD in patients with morbid obesity.
Esophageal syndromes were evaluated according to the Montreal 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 was determined through 24h pH monitoring. Increased acid exposure was characterized when total esophageal pH < 4 for at least 4% of the total monitoring time.
- Conditions
- Gastroesophageal Reflux Disease, Morbid Obesity
- Being tested
- Gastric bypass
- Keywords
- GERD, Gastric bypass
- 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.
Gastric bypassProcedure or surgery
Open Silastic® ring Roux-en Y gastric bypass was performed through an upper midline incision. A gastric pouch was created by dividing the stomach with a 10-cm stapler from the lesser curvature (7 cm vertically from the cardia) to 1 cm to the left of the Hiss angle. The estimated volume of the gastric pouch was 20 to 30 ml that was banded with a 6.5 cm long Silastic® ring. A gastrojejunal anastomosis was performed with two-layers hand sewn absorbable suture over a 1.2 cm bougie distal to the ring, keeping an alimentary limb with 100 cm in length, and a biliopancreatic limb ranging 60 and 80 cm.
| Study group | Role | What they receive |
|---|---|---|
| Patients assessed for GERD | Patients who had an open gastric bypass were assessed for GERD before and after surgery following the Montreal Consensus through a validated questionnaire in Portuguese language Receives: Procedure: Gastric bypass |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Presenting Reflux Symptoms
Prevalence of typical reflux syndrome according to the Montreal Consensus. This Consensus institutes that GERD can be outlined when troublesome symptoms and/or complications induced by reflux of the gastric content back to the esophagus are present.
In order to assess such troublesome symptoms a validated questionnaire translated into Portuguese language was used.
Measured: Before GBP, 6 months after GBP and 39 months after GBP
Number of Participants With Esophageal Injury
Syndromes with esophageal injury were represented exclusively by the presence of reflux esophagitis
Measured: Before GBP, 6 months after GBP and 39 months after GBP
Number of Participants With Gastroesophageal Reflux Disease (GERD)
Prevalence of GERD in patients characterized according to troublesome symptomatic syndromes assessed through a validated questionnaire based on the Montreal Consensus.
Measured: Before GBP, 6 months after GBP and 39 months after GBP
Total Esophageal Acid Exposure at 24h pH Monitoring
Esophageal acid exposure was measured through 24h pH monitoring. During the entire period, esophageal pH was measured and recorded as the percent of time pH was below 4.
Measured: Before GBP, 6 months after GBP and 39 months after GBP
Esophageal Acid Exposure at 24h pH Monitoring in Upright Position
Esophageal acid exposure was measured through 24h pH monitoring. Esophageal pH was measured and recorded as the percent of time pH was below 4 while participant in upright position
Measured: Before GBP, 6 months after GBP and 39 months after GBP
Esophageal Acid Exposure at 24h pH Monitoring in Supine Position
Esophageal acid exposure was measured through 24h pH monitoring. Esophageal pH was measured and recorded as the percent of time pH was below 4 while participant in supine position
Measured: Before GBP, 6 months after GBP and 39 months after GBP
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: Before GBP, 6 months after GBP and 39 months after GBP
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2009 (estimated)
- Study startMar 2007
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinica Gastrobese
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carlos AS Madalosso, Clinica Gastrobese
- Investigators
- Carlos AS Madalosso, PhD, Principal investigator, Clinica Gastrobese
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00951093
- Sponsor's protocol ID
- GASTROBESE-004
- Status last verified
- Mar 2025
- First submitted
- 2 Aug 2009
- Last updated
- 1 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Madalosso CA, Gurski RR, Callegari-Jacques SM, Navarini D, Thiesen V, Fornari F. The impact of gastric bypass on gastroesophageal reflux disease in patients with morbid obesity: a prospective study based on the Montreal Consensus. Ann Surg. 2010 Feb;251(2):244-8. doi: 10.1097/SLA.0b013e3181bdff20.
PubMed 20010088
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Gastric Bypass on Gastroesophageal Reflux Disease in Patients With Morbid Obesity: a Prospective Study Based on Montreal Consensus
- ClinicalTrials.gov ID
- NCT00951093
- Acronym / sponsor ID
- GASTROBESE-004
- Conditions
- Gastroesophageal Reflux Disease, Morbid Obesity
- Keywords
- GERD, Gastric bypass
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Clinica GastrobeseUniversity, hospital or other
- Study start
- Mar 2007
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 4 Aug 2009 (estimated)
- Results
- Posted 4 Apr 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The hypothesis of this study was that gastric bypass (GBP) ameliorates gastroesophageal reflux disease (GERD) in morbidly obese patients.
Detailed description
The investigators studied the impact of this surgical procedure on GERD in patients with morbid obesity.
Esophageal syndromes were evaluated according to the Montreal 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 was determined through 24h pH monitoring. Increased acid exposure was characterized when total esophageal pH < 4 for at least 4% of the total monitoring time.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients assessed for GERD | – | Procedure: Gastric bypassPatients who had an open gastric bypass were assessed for GERD before and after surgery following the Montreal Consensus through a validated questionnaire in Portuguese language |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Primary care clinic patients
Key inclusion criteria (2 listed)
- Morbid obesity
- Acceptance to undergo open gastric bypass
Key exclusion criteria (2 listed)
- Prior gastroesophageal surgery
- Achalasia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gastric bypassOpen Silastic® ring Roux-en Y gastric bypass was performed through an upper midline incision. A gastric pouch was created by dividing the stomach with a 10-cm stapler from the lesser curvature (7 cm vertically from the cardia) to 1 cm to the left of the Hiss angle. The estimated volume of the gastric pouch was 20 to 30 ml that was banded with a 6.5 cm long Silastic® ring. A gastrojejunal anastomosis was performed with two-layers hand sewn absorbable suture over a 1.2 cm bougie distal to the ring, keeping an alimentary limb with 100 cm in length, and a biliopancreatic limb ranging 60 and 80 cm. | Procedure or surgery | Patients assessed for GERD |
Primary outcome
Number of Participants Presenting Reflux Symptoms
Time frame: Before GBP, 6 months after GBP and 39 months after GBP
Prevalence of typical reflux syndrome according to the Montreal Consensus. This Consensus institutes that GERD can be outlined when troublesome symptoms and/or complications induced by reflux of the gastric content back to the esophagus are present. In order to assess such troublesome symptoms a validated questionnaire translated into Portuguese language was used.
Number of Participants With Esophageal Injury
Time frame: Before GBP, 6 months after GBP and 39 months after GBP
Syndromes with esophageal injury were represented exclusively by the presence of reflux esophagitis
Number of Participants With Gastroesophageal Reflux Disease (GERD)
Time frame: Before GBP, 6 months after GBP and 39 months after GBP
Prevalence of GERD in patients characterized according to troublesome symptomatic syndromes assessed through a validated questionnaire based on the Montreal Consensus.
Total Esophageal Acid Exposure at 24h pH Monitoring
Time frame: Before GBP, 6 months after GBP and 39 months after GBP
Esophageal acid exposure was measured through 24h pH monitoring. During the entire period, esophageal pH was measured and recorded as the percent of time pH was below 4.
Esophageal Acid Exposure at 24h pH Monitoring in Upright Position
Time frame: Before GBP, 6 months after GBP and 39 months after GBP
Esophageal acid exposure was measured through 24h pH monitoring. Esophageal pH was measured and recorded as the percent of time pH was below 4 while participant in upright position
Esophageal Acid Exposure at 24h pH Monitoring in Supine Position
Time frame: Before GBP, 6 months after GBP and 39 months after GBP
Esophageal acid exposure was measured through 24h pH monitoring. Esophageal pH was measured and recorded as the percent of time pH was below 4 while participant in supine position
Number of Participants With Increased Acid Exposure
Time frame: Before GBP, 6 months after GBP and 39 months after GBP
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 20010088Madalosso CA, Gurski RR, Callegari-Jacques SM, Navarini D, Thiesen V, Fornari F. The impact of gastric bypass on gastroesophageal reflux disease in patients with morbid obesity: a prospective study based on the Montreal Consensus. Ann Surg. 2010 Feb;251(2):244-8. doi: 10.1097/SLA.0b013e3181bdff20.
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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. This study is not recruiting at the moment.
Carlos AS Madalosso, PhD principal investigator
Clinica Gastrobese
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 2 inclusion and 2 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: finished, as of the sponsor's last update on 1 Apr 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?
Yes. Results are posted in the registry (first posted 4 Apr 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants Presenting Reflux Symptoms (time frame: Before GBP, 6 months after GBP and 39 months after GBP). The study lists 7 primary outcomes in all. 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 NCT00951093, 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 1 Apr 2025.