ObesityNCT07537244
Impact of GEA Simultaneous to VSG on Post-operative GERD
A study testing gastroenteroanastomosis simultaneous to vertical sleeve gastrectomy and vertical sleeve gastrectomy in people with Obesity and Reflux, Gastroesophageal, run by Clinica Gastrobese at 1 site in Brazil.
Trial summary
The goal of this clinical trial is to evaluate the effect of GEA on GERD in patients undergoing VSG. The main question it aims to answer is: Does adoption of GEA to VSG reduce the occurrence of GERD? Participants will complete a symptom questionnaire during follow-up visits. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity, Reflux, Gastroesophageal
- What is being tested?
- gastroenteroanastomosis simultaneous to vertical sleeve gastrectomy and vertical sleeve gastrectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- 18 Feb 2023to Apr 2028
- Phase
- Interventional
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All VSG candidate patients aged >18 and <65 years and BMI≥ 35 and BMI≤50 who agree to participate in the study
Who cannot join
- Presence of reflux esophagitis according to the Lyon Consensus
- Previous gastric surgery
- Esophagus' motor diseases
- Development of chronic diseases associated with the use of medications such as chemotherapy, anti-rheumatics, etc.
- Patients who fail to undergo the study exams during follow-up or who withdraw the informed consent form (TCLE) at any time during the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Gastroenteroanastomosis Simultaneous to Vertical Gastrectomy on Post-operative Gastroesophageal Reflux
The goal of this clinical trial is to evaluate the effect of GEA on GERD in patients undergoing VSG. The main question it aims to answer is:
- Does adoption of GEA to VSG reduce the occurrence of GERD? Participants will complete a symptom questionnaire during follow-up visits. All exams are already part of the surgical or GERD follow-up routine.
Researchers will compare with GEA (Group A) and Without GEA (Group B) to see if adopting GEA during VSG reduces the occurrence of GERD.
Read the detailed description
All patients aged between 18 and 65 years old who are candidates for bariatric surgery, who opt for VSG, will be consecutively invited to participate in the open study. Initially, patients will be allocated into two groups, matched by BMI and age. Regarding age, they will be separated into two categories: between 18 and 40 years old, ≥40 years old. Regarding BMI, they will be divided into two groups: BMI<40 and BMI≥40. After being allocated according to weight criteria, the randomization for the GEA will proceed through a draw during the surgical procedure, after making the gastric tube. So, we will have two groups: With GEA (Group A); and Without GEA (Group B), both with 30 patients each, totaling 60 research participants. All patients will be evaluated for GERD before, 12, 24 and 60 months after surgery, and will have permanent access to the team regarding the details of their operations that may be necessary.
- Conditions
- Obesity, Reflux, Gastroesophageal
- Being tested
- gastroenteroanastomosis simultaneous to vertical sleeve gastrectomy, vertical sleeve gastrectomy
- Keywords
- Gastroesophageal reflux disease, vertical sleeve gastrectomy, gastroenteroanastomosis
- Medical subject headings
- Obesity, Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gastroenteroanastomosis simultaneous to vertical sleeve gastrectomyProcedure or surgery
Also called GEA, VSG
GEA will be held after completion of GV. The small intestine is then measured every 5 cm, measured with the aid of markings on the laparoscopic clamps, and at 280 cm the manual laterolateral gastroileal anastomosis is performed between 4 and 5 cm in an isoperistaltic direction and 3 cm proximally to the pylorus. Then, 40 cm distally to the gastroileoanastomosis, the Roux-en-Y is constructed with a 2-cm diameter lateral-to-side manual anastomosis followed by the transection of the ileal limb segment interposed with the anastomoses.
vertical sleeve gastrectomyProcedure or surgery
Also called VSG
VSG will be performed as primary surgery. The greater curvature is released up to the angle of His in order to perform an ascending stapling from 5 cm proximal to the pylorus to 1 cm from the angle of His and guided by a 32 French Fouchet probe. Stapling starts 5 cm from the pylorus and extends to 1 cm from the angle of His. The result is a tube of approximately 150 ml as adapted in consensus.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | adoption of GEA to VSG Receives: Procedure: gastroenteroanastomosis simultaneous to vertical sleeve gastrectomy; Procedure: vertical sleeve gastrectomy |
| Group B | Sham comparator | Without GEA to VSG Receives: Procedure: vertical sleeve gastrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
GERD in endoscopy
decrease or absence of esophagitis, detected by endoscopy (Los Angeles classification), and esophageal acid exposure, detected by pH monitoring, in the group with GEA
Measured: until 60 months
GERD symptoms
improvement or absence of GERD symptoms reported by the patient in consultation and QS-GERD. The QS-GERD (Gastroesophageal Reflux Disease Symptom Questionnaire) is a self-administered tool designed to diagnose and quantify the intensity of GERD symptoms. It consists of approximately 11 questions (including self-perceived health), assessing typical and atypical symptoms, with scores ranging from 0 to 50 or 55, indicating the severity of reflux.
Measured: until 60 months
Secondary outcomes (1)
weight loss
Better weight loss with the combination of techniques during the postoperative period, measured through body mass index (BMI), bioelectrical impedance analysis (fat mass/lean mass), body weight, and percent excess BMI loss (% excess BMI loss).
Measured: until 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2026
- Study start18 Feb 2023
- Primary completion4 Mar 2024
- Study completionApr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clinica Gastrobese
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carlos AS Madalosso, Clinica Gastrobese
- Investigators
- Carlos Madalosso, PhD, Principal investigator, Clinica Gastrobese
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07537244
- Sponsor's protocol ID
- GEA+VSG on GERD
- Status last verified
- Apr 2026
- First submitted
- 31 Mar 2023
- Last updated
- 17 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Gastroenteroanastomosis Simultaneous to Vertical Gastrectomy on Post-operative Gastroesophageal Reflux
- ClinicalTrials.gov ID
- NCT07537244
- Acronym / sponsor ID
- GEA+VSG on GERD
- Conditions
- Obesity, Reflux, Gastroesophageal
- Keywords
- Gastroesophageal reflux disease, vertical sleeve gastrectomy, gastroenteroanastomosis
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Clinica GastrobeseUniversity, hospital or other
- Study start
- 18 Feb 2023 (actual)
- Primary completion
- 4 Mar 2024 (actual)
- Study completion
- Apr 2028 (estimated)
- First posted
- 17 Apr 2026 (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.
The goal of this clinical trial is to evaluate the effect of GEA on GERD in patients undergoing VSG. The main question it aims to answer is:
- Does adoption of GEA to VSG reduce the occurrence of GERD? Participants will complete a symptom questionnaire during follow-up visits. All exams are already part of the surgical or GERD follow-up routine.
Researchers will compare with GEA (Group A) and Without GEA (Group B) to see if adopting GEA during VSG reduces the occurrence of GERD.
Detailed description
All patients aged between 18 and 65 years old who are candidates for bariatric surgery, who opt for VSG, will be consecutively invited to participate in the open study. Initially, patients will be allocated into two groups, matched by BMI and age. Regarding age, they will be separated into two categories: between 18 and 40 years old, ≥40 years old. Regarding BMI, they will be divided into two groups: BMI<40 and BMI≥40. After being allocated according to weight criteria, the randomization for the GEA will proceed through a draw during the surgical procedure, after making the gastric tube. So, we will have two groups: With GEA (Group A); and Without GEA (Group B), both with 30 patients each, totaling 60 research participants. All patients will be evaluated for GERD before, 12, 24 and 60 months after surgery, and will have permanent access to the team regarding the details of their operations that may be necessary.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Procedure: gastroenteroanastomosis simultaneous to vertical sleeve gastrectomy, Procedure: vertical sleeve gastrectomyadoption of GEA to VSG |
| Group B | Sham comparator | Procedure: vertical sleeve gastrectomyWithout GEA to VSG |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All VSG candidate patients aged >18 and <65 years and BMI≥ 35 and BMI≤50 who agree to participate in the study
Key exclusion criteria (5 listed)
- Presence of reflux esophagitis according to the Lyon Consensus
- Previous gastric surgery
- Esophagus' motor diseases
- Development of chronic diseases associated with the use of medications such as chemotherapy, anti-rheumatics, etc.
- Patients who fail to undergo the study exams during follow-up or who withdraw the informed consent form (TCLE) at any time during the study
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 |
|---|---|---|
| gastroenteroanastomosis simultaneous to vertical sleeve gastrectomyAlso: GEA, VSGGEA will be held after completion of GV. The small intestine is then measured every 5 cm, measured with the aid of markings on the laparoscopic clamps, and at 280 cm the manual laterolateral gastroileal anastomosis is performed between 4 and 5 cm in an isoperistaltic direction and 3 cm proximally to the pylorus. Then, 40 cm distally to the gastroileoanastomosis, the Roux-en-Y is constructed with a 2-cm diameter lateral-to-side manual anastomosis followed by the transection of the ileal limb segment interposed with the anastomoses. | Procedure or surgery | Group A |
| vertical sleeve gastrectomyAlso: VSGVSG will be performed as primary surgery. The greater curvature is released up to the angle of His in order to perform an ascending stapling from 5 cm proximal to the pylorus to 1 cm from the angle of His and guided by a 32 French Fouchet probe. Stapling starts 5 cm from the pylorus and extends to 1 cm from the angle of His. The result is a tube of approximately 150 ml as adapted in consensus. | Procedure or surgery | Group A, Group B |
Primary outcome
GERD in endoscopy
Time frame: until 60 months
decrease or absence of esophagitis, detected by endoscopy (Los Angeles classification), and esophageal acid exposure, detected by pH monitoring, in the group with GEA
GERD symptoms
Time frame: until 60 months
improvement or absence of GERD symptoms reported by the patient in consultation and QS-GERD. The QS-GERD (Gastroesophageal Reflux Disease Symptom Questionnaire) is a self-administered tool designed to diagnose and quantify the intensity of GERD symptoms. It consists of approximately 11 questions (including self-perceived health), assessing typical and atypical symptoms, with scores ranging from 0 to 50 or 55, indicating the severity of reflux.
1 secondary outcome
weight loss
Time frame: until 60 months
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 17 Apr 2026.
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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 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?
A study testing gastroenteroanastomosis simultaneous to vertical sleeve gastrectomy and vertical sleeve gastrectomy in people with Obesity and Reflux, Gastroesophageal, 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 1 inclusion and 5 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 17 Apr 2026. 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. Some participants in this study may receive a placebo. 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?
GERD in endoscopy (time frame: until 60 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Apr 2026.