Obesity, MorbidNCT07768202
AJYR+GV vs RYGB for GERD
A study testing sleeve gastrectomy with Roux-en-Y antrojejunal anastomosis, AJYR+SG and Roux-en-Y gastric bypass, RYGB in people with Obesity, Morbid and Gastroesophageal Reflux (GERD), run by Victor Dib Institute at 1 site in Brazil.
Trial summary
This study focuses on gastroesophageal reflux disease (GERD), a condition in which stomach acid flows back into the esophagus (the tube that carries food from the mouth to the stomach), causing heartburn and other symptoms. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity, Morbid, Gastroesophageal Reflux (GERD)
- What is being tested?
- sleeve gastrectomy with Roux-en-Y antrojejunal anastomosis, AJYR+SG and Roux-en-Y gastric bypass, RYGB
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- 28 Nov 2024to Jan 2030
- 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
- Candidates for AJYR+SG or RYGB, aged >18 and <65 years
- BMI ≥35 and ≤45 kg/m²
- Presence of gastroesophageal reflux symptoms
- Agreement to randomization between the AJYR+SG and RYGB techniques
- Signed informed consent form (ICF)
Who cannot join
- Severe esophageal motor disorders
- Crohn's disease
- Advanced-stage cancer or ongoing cancer treatment
- Failure to undergo the study examinations during follow-up, or withdrawal of informed consent at any time during follow-up (patients will be excluded, and their data analyzed up to the moment of dropout)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sleeve Gastrectomy With Roux-en-Y Antrum-jejunal Anastomosis Versus Roux-en-Y Gastric Bypass for Gastroesophageal Reflux Disease: A Randomized Surgical Trial
This study focuses on gastroesophageal reflux disease (GERD), a condition in which stomach acid flows back into the esophagus (the tube that carries food from the mouth to the stomach), causing heartburn and other symptoms. GERD is common among people with obesity.The standard surgical treatment for these patients is Roux-en-Y gastric bypass, a surgery that makes the stomach smaller and reroutes part of the digestive tract. This procedure promotes weight loss and usually improves reflux. However, recent studies show that up to 20% of patients continue to have, or develop, reflux after this surgery. Untreated reflux can seriously impair quality of life and may lead to complications such as esophageal ulcers and esophageal cancer. In addition, the bypass leaves parts of the digestive tract that cannot be examined with routine endoscopy, which may make it harder to detect cancers in those areas in the future.This study will compare the standard gastric bypass with a newer procedure that combines sleeve gastrectomy (removal of most of the stomach, leaving a narrow tube) with a Roux-en-Y antrum-jejunal anastomosis (a connection between the lower part of the stomach and the small intestine). This new technique may control reflux as effectively as the bypass while keeping the whole digestive tract accessible to endoscopic examination.Adults with obesity and GERD who are candidates for bariatric surgery may participate. Participants will be randomly assigned (by chance, like a coin flip) to receive one of the two procedures. The main goals of the study are to evaluate whether the new technique treats or controls reflux as well as, or better than, the standard bypass; to compare weight loss between the two procedures; to compare changes in metabolism (how the body processes sugar and fats); to check whether the duodenum (the first part of the small intestine) can be easily examined by endoscopy after the new procedure; and to understand how food moves through the digestive tract after the new procedure.
Read the detailed description
Bariatric surgery is the treatment of choice for clinically severe obesity. Among the surgical options, Roux-en-Y gastric bypass (RYGB) remains one of the most frequently indicated techniques. Despite the advantages of this operation - namely, its control of gastroesophageal reflux (GER), its satisfactory and durable weight loss, and its favorable metabolic effects - one must consider the creation of excluded gastrointestinal segments that it promotes, rendering them inaccessible to peroral endoscopy, particularly the excluded stomach, the duodenum, the biliary tract, and the pancreatic ducts. These drawbacks may contraindicate RYGB in certain specific situations. Maintaining the beneficial effects of RYGB while avoiding digestive exclusions and preserving peroral endoscopic access to the biliopancreatic ducts would add advantages to this surgical model.With regard to sleeve gastrectomy (SG), its refluxogenic potential is widely demonstrated. However, a series of protective mechanisms against gastroesophageal reflux may be provided by adding a wide Roux-en-Y antrojejunostomy (AJYR) to the gastric tube of the SG. Thus, the present project aims to evaluate the effects of AJYR added to SG on GER and to compare them with the antireflux effects produced by RYGB, through a prospective, double-blind, randomized study that will follow patients with continuous assessments for gastroesophageal reflux disease (GERD). The technique under study would avoid digestive exclusions and maintain peroral access to the biliary tract and pancreatic ducts.Roux-en-Y gastric bypass (RYGB), although a well-established bariatric surgical technique that yields the best results in the treatment of gastroesophageal reflux (GER) in patients with obesity, leads to gastroduodenojejunal and biliopancreatic exclusion, rendering these segments endoscopically inaccessible on routine peroral endoscopy. These limitations can be highly relevant in certain groups of patients, which could contraindicate the use of this technique on various occasions. Accordingly, and with the purpose of overcoming these limitations of RYGB, we seek to evaluate a technical modification of sleeve gastrectomy (SG) that could reproduce the beneficial effects of RYGB in controlling GER, yet without promoting digestive exclusions or preventing peroral endoscopic access to the biliary tract and pancreatic ducts. These results are intended to be achieved by adding a wide Roux-en-Y antrojejunostomy (AJYR) to the anterior antral wall of the gastric tube of the SG. Possible mechanisms of action that would justify AJYR combined with SG in controlling gastroesophageal reflux disease (GERD) would be: (1) caudal traction of the gastric tube by the antrojejunal anastomosis, helping to fix it below the diaphragm and keep it straightened; (2) a long, narrow gastric tube decompressed by a wide AJYR, decreasing intragastric pressure, facilitating distal food flow, and reducing proximal reflux of acidic content through the cardia; and (3) improved gastric emptying through the wide AJYR, leading to reduced gastric stasis. Thus, confirmation of the hypotheses that the adoption of AJYR combined with SG reduces the occurrence of GERD more effectively than RYGB, and that it directs the main food flow to the jejunal limb, may represent an important surgical alternative for resolving some of the obstacles related to the use of RYGB, improving the benefits of this technique.
- Conditions
- Obesity, Morbid, Gastroesophageal Reflux (GERD)
- Being tested
- sleeve gastrectomy with Roux-en-Y antrojejunal anastomosis, AJYR+SG, Roux-en-Y gastric bypass, RYGB
- Keywords
- Bariatric Surgery, Gastroesophageal Reflux Disease, Gastroenteroanastomosis, Roux-en-Y Gastric Bypass, Sleeve Gastrectomy, Roux-en-Y Antrojejunostomy, Morbid Obesity
- Medical subject headings
- Obesity, Morbid, Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sleeve gastrectomy with Roux-en-Y antrojejunal anastomosis, AJYR+SGProcedure or surgery
Sleeve gastrectomy with Roux-en-Y antrojejunal anastomosis (AJYR+SG). The greater curvature of the stomach is released from 1 cm proximal to the pylorus to the angle of His, sealing the vessels of the right and left gastroepiploic arcades and the short gastric vessels. A sleeve gastrectomy is performed with an ascending, proximal gastric partition calibrated by a 32-Fr Fouchet bougie positioned along the lesser curvature, resulting in a gastric tube of approximately 150 mL. A Roux-en-Y reconstruction is then created: the jejunum is transected 150 cm distal to the ligament of Treitz with a 45-mm white cartridge, and an 80-cm Roux (alimentary) limb is constructed, preserving at least 3 meters of common intestinal channel. The distal jejunal limb is brought to the gastric antrum in an antecolic fashion. An antrojejunal anastomosis is created between the anterior antral wall of the gastric tube and the antimesenteric border of the jejunal limb, using a continuous, single full-thickness lay
Roux-en-Y gastric bypass, RYGBProcedure or surgery
The angle of His is dissected, and the lesser curvature of the stomach is dissected close to the gastric wall, 5 cm distal to the cardia, entering the lesser sac. A horizontal gastric stapling is performed at this level with a 45-mm blue cartridge. A 32-Fr Fouchet bougie is introduced orally and advanced to the level of the horizontal gastric partition. Two sequential vertical staple firings are then performed with two 45-mm blue cartridges, immediately adjacent to the bougie, completing the gastric partition at the angle of His, 1 cm lateral to the cardia, creating a small gastric pouch. The jejunum is transected 150 cm distal to the ligament of Treitz with a 45-mm white cartridge, preserving at least 3 meters of common intestinal channel. The distal jejunal segment (Roux alimentary limb) is brought to the small gastric pouch in an antecolic, antegastric fashion. A hand-sewn end-to-side gastrojejunal anastomosis is created with a 3-cm diameter, in a single extramucosal layer, with 3-0
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | sleeve gastrectomy with Roux-en-Y antrojejunal anastomosis, AJYR+SG Receives: Procedure: sleeve gastrectomy with Roux-en-Y antrojejunal anastomosis, AJYR+SG |
| Group B | Active comparator | Roux-en-Y gastric bypass, RYGB Receives: Procedure: Roux-en-Y gastric bypass, RYGB |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure: Resolution or improvement of gastroesophageal reflux disease (GERD)
Presence of postoperative GERD (yes/no), assessed by objective measures - reduction or absence of esophagitis detected by upper endoscopy, and reduction or absence of esophageal acid exposure detected by pH monitoring - and by the subjective measure of improvement or absence of patient-reported GERD symptoms assessed during clinic visits and by the QS-DRGE questionnaire.
Measured: Before surgery and at 6, 12, 24, and 60 months postoperatively
Secondary outcomes (5)
Change in body weight
Change in body weight after AJYR+SG in the postoperative period, compared with RYGB.
Measured: At 6, 12, 24, and 60 months postoperatively
Change in HbA1c
Change in glycated hemoglobin (HbA1c), expressed as a percentage (%), measured by laboratory blood analysis, after AJYR+SG in the postoperative period, compared with RYGB.
Measured: At 6, 12, 24, and 60 months postoperatively
Change in fasting plasma glucose
Change in fasting plasma glucose, expressed in mg/dL, measured by laboratory blood analysis, after AJYR+SG in the postoperative period, compared with RYGB.
Measured: At 6, 12, 24, and 60 months postoperatively
Change in blood pressure
Change in systolic and diastolic blood pressure, expressed in mmHg, measured by standardized office blood pressure measurement, after AJYR+SG in the postoperative period, compared with RYGB.
Measured: At 6, 12, 24, and 60 months postoperatively
Change in lipid profile
Change in total cholesterol, LDL cholesterol, HDL cholesterol, and triglycerides, expressed in mg/dL, measured by laboratory blood analysis, after AJYR+SG in the postoperative period, compared with RYGB.
Measured: At 6, 12, 24, and 60 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2026
- Study start28 Nov 2024
- Primary completionAug 2026 (estimated)
- Study completionJan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity, MorbidStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a prospective, double-blind, randomized clinical trial with parallel groups, conducted at Instituto Victor Dib and Hospital Beneficente Portuguesa. A total of 60 patients with clinically severe obesity (BMI 35-45 kg/m²) and symptoms of gastroesophageal reflux, aged between 18 and 65 years, will be randomly allocated in a 1:1 ratio to one of two surgical groups: Group A (sleeve gastrectomy with Roux-en-Y antrojejunal anastomosis, AJYR+SG) or Group B (Roux-en-Y gastric bypass, RYGB). Randomization is performed by drawing lots immediately after induction of anesthesia, following pre-allocation of patients into two strata matched by BMI (35-40 kg/m² and \>40 kg/m²). Patients will be followed with assessments for gastroesophageal reflux disease before surgery and at 6, 12, 24, and 60 months postoperatively. The primary outcome is the presence of postoperative GERD (dichotomous, yes/no), also analyzed in subcategories (resolved, improved, worsened, de novo). Secondary outcomes include
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Victor Dib Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Victor Ramos Mussa Dib, Victor Dib Institute
- Investigators
- Victor RM Dib, PhD, Principal investigator, Victor Dib Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07768202
- Sponsor's protocol ID
- AJYR+GVxRYGB/GERD
- Status last verified
- Aug 2026
- First submitted
- 6 Aug 2026
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleeve Gastrectomy With Roux-en-Y Antrum-jejunal Anastomosis Versus Roux-en-Y Gastric Bypass for Gastroesophageal Reflux Disease: A Randomized Surgical Trial
- ClinicalTrials.gov ID
- NCT07768202
- Acronym / sponsor ID
- AJYR+GVxRYGB/GERD
- Conditions
- Obesity, Morbid, Gastroesophageal Reflux (GERD)
- Keywords
- Bariatric Surgery, Gastroesophageal Reflux Disease, Gastroenteroanastomosis, Roux-en-Y Gastric Bypass, Sleeve Gastrectomy, Roux-en-Y Antrojejunostomy, Morbid Obesity
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Victor Dib InstituteUniversity, hospital or other
- Study start
- 28 Nov 2024 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Jan 2030 (estimated)
- First posted
- 17 Aug 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.
This study focuses on gastroesophageal reflux disease (GERD), a condition in which stomach acid flows back into the esophagus (the tube that carries food from the mouth to the stomach), causing heartburn and other symptoms. GERD is common among people with obesity.The standard surgical treatment for these patients is Roux-en-Y gastric bypass, a surgery that makes the stomach smaller and reroutes part of the digestive tract. This procedure promotes weight loss and usually improves reflux. However, recent studies show that up to 20% of patients continue to have, or develop, reflux after this surgery. Untreated reflux can seriously impair quality of life and may lead to complications such as esophageal ulcers and esophageal cancer. In addition, the bypass leaves parts of the digestive tract that cannot be examined with routine endoscopy, which may make it harder to detect cancers in those areas in the future.This study will compare the standard gastric bypass with a newer procedure that combines sleeve gastrectomy (removal of most of the stomach, leaving a narrow tube) with a Roux-en-Y antrum-jejunal anastomosis (a connection between the lower part of the stomach and the small intestine). This new technique may control reflux as effectively as the bypass while keeping the whole digestive tract accessible to endoscopic examination.Adults with obesity and GERD who are candidates for bariatric surgery may participate. Participants will be randomly assigned (by chance, like a coin flip) to receive one of the two procedures. The main goals of the study are to evaluate whether the new technique treats or controls reflux as well as, or better than, the standard bypass; to compare weight loss between the two procedures; to compare changes in metabolism (how the body processes sugar and fats); to check whether the duodenum (the first part of the small intestine) can be easily examined by endoscopy after the new procedure; and to understand how food moves through the digestive tract after the new procedure.
Detailed description
Bariatric surgery is the treatment of choice for clinically severe obesity. Among the surgical options, Roux-en-Y gastric bypass (RYGB) remains one of the most frequently indicated techniques. Despite the advantages of this operation - namely, its control of gastroesophageal reflux (GER), its satisfactory and durable weight loss, and its favorable metabolic effects - one must consider the creation of excluded gastrointestinal segments that it promotes, rendering them inaccessible to peroral endoscopy, particularly the excluded stomach, the duodenum, the biliary tract, and the pancreatic ducts. These drawbacks may contraindicate RYGB in certain specific situations. Maintaining the beneficial effects of RYGB while avoiding digestive exclusions and preserving peroral endoscopic access to the biliopancreatic ducts would add advantages to this surgical model.With regard to sleeve gastrectomy (SG), its refluxogenic potential is widely demonstrated. However, a series of protective mechanisms against gastroesophageal reflux may be provided by adding a wide Roux-en-Y antrojejunostomy (AJYR) to the gastric tube of the SG. Thus, the present project aims to evaluate the effects of AJYR added to SG on GER and to compare them with the antireflux effects produced by RYGB, through a prospective, double-blind, randomized study that will follow patients with continuous assessments for gastroesophageal reflux disease (GERD). The technique under study would avoid digestive exclusions and maintain peroral access to the biliary tract and pancreatic ducts.Roux-en-Y gastric bypass (RYGB), although a well-established bariatric surgical technique that yields the best results in the treatment of gastroesophageal reflux (GER) in patients with obesity, leads to gastroduodenojejunal and biliopancreatic exclusion, rendering these segments endoscopically inaccessible on routine peroral endoscopy. These limitations can be highly relevant in certain groups of patients, which could contraindicate the use of this technique on various occasions. Accordingly, and with the purpose of overcoming these limitations of RYGB, we seek to evaluate a technical modification of sleeve gastrectomy (SG) that could reproduce the beneficial effects of RYGB in controlling GER, yet without promoting digestive exclusions or preventing peroral endoscopic access to the biliary tract and pancreatic ducts. These results are intended to be achieved by adding a wide Roux-en-Y antrojejunostomy (AJYR) to the anterior antral wall of the gastric tube of the SG. Possible mechanisms of action that would justify AJYR combined with SG in controlling gastroesophageal reflux disease (GERD) would be: (1) caudal traction of the gastric tube by the antrojejunal anastomosis, helping to fix it below the diaphragm and keep it straightened; (2) a long, narrow gastric tube decompressed by a wide AJYR, decreasing intragastric pressure, facilitating distal food flow, and reducing proximal reflux of acidic content through the cardia; and (3) improved gastric emptying through the wide AJYR, leading to reduced gastric stasis. Thus, confirmation of the hypotheses that the adoption of AJYR combined with SG reduces the occurrence of GERD more effectively than RYGB, and that it directs the main food flow to the jejunal limb, may represent an important surgical alternative for resolving some of the obstacles related to the use of RYGB, improving the benefits of this technique.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a prospective, double-blind, randomized clinical trial with parallel groups, conducted at Instituto Victor Dib and Hospital Beneficente Portuguesa. A total of 60 patients with clinically severe obesity (BMI 35-45 kg/m²) and symptoms of gastroesophageal reflux, aged between 18 and 65 years, will be randomly allocated in a 1:1 ratio to one of two surgical groups: Group A (sleeve gastrectomy with Roux-en-Y antrojejunal anastomosis, AJYR+SG) or Group B (Roux-en-Y gastric bypass, RYGB). Randomization is performed by drawing lots immediately after induction of anesthesia, following pre-allocation of patients into two strata matched by BMI (35-40 kg/m² and >40 kg/m²). Patients will be followed with assessments for gastroesophageal reflux disease before surgery and at 6, 12, 24, and 60 months postoperatively. The primary outcome is the presence of postoperative GERD (dichotomous, yes/no), also analyzed in subcategories (resolved, improved, worsened, de novo). Secondary outcomes include
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Procedure: sleeve gastrectomy with Roux-en-Y antrojejunal anastomosis, AJYR+SGsleeve gastrectomy with Roux-en-Y antrojejunal anastomosis, AJYR+SG |
| Group B | Active comparator | Procedure: Roux-en-Y gastric bypass, RYGBRoux-en-Y gastric bypass, RYGB |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Candidates for AJYR+SG or RYGB, aged >18 and <65 years
- BMI ≥35 and ≤45 kg/m²
- Presence of gastroesophageal reflux symptoms
- Agreement to randomization between the AJYR+SG and RYGB techniques
- Signed informed consent form (ICF)
Key exclusion criteria (4 listed)
- Severe esophageal motor disorders
- Crohn's disease
- Advanced-stage cancer or ongoing cancer treatment
- Failure to undergo the study examinations during follow-up, or withdrawal of informed consent at any time during follow-up (patients will be excluded, and their data analyzed up to the moment of dropout)
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 |
|---|---|---|
| sleeve gastrectomy with Roux-en-Y antrojejunal anastomosis, AJYR+SGSleeve gastrectomy with Roux-en-Y antrojejunal anastomosis (AJYR+SG). The greater curvature of the stomach is released from 1 cm proximal to the pylorus to the angle of His, sealing the vessels of the right and left gastroepiploic arcades and the short gastric vessels. A sleeve gastrectomy is performed with an ascending, proximal gastric partition calibrated by a 32-Fr Fouchet bougie positioned along the lesser curvature, resulting in a gastric tube of approximately 150 mL. A Roux-en-Y reconstruction is then created: the jejunum is transected 150 cm distal to the ligament of Treitz with a 45-mm white cartridge, and an 80-cm Roux (alimentary) limb is constructed, preserving at least 3 meters of common intestinal channel. The distal jejunal limb is brought to the gastric antrum in an antecolic fashion. An antrojejunal anastomosis is created between the anterior antral wall of the gastric tube and the antimesenteric border of the jejunal limb, using a continuous, single full-thickness lay | Procedure or surgery | Group A |
| Roux-en-Y gastric bypass, RYGBThe angle of His is dissected, and the lesser curvature of the stomach is dissected close to the gastric wall, 5 cm distal to the cardia, entering the lesser sac. A horizontal gastric stapling is performed at this level with a 45-mm blue cartridge. A 32-Fr Fouchet bougie is introduced orally and advanced to the level of the horizontal gastric partition. Two sequential vertical staple firings are then performed with two 45-mm blue cartridges, immediately adjacent to the bougie, completing the gastric partition at the angle of His, 1 cm lateral to the cardia, creating a small gastric pouch. The jejunum is transected 150 cm distal to the ligament of Treitz with a 45-mm white cartridge, preserving at least 3 meters of common intestinal channel. The distal jejunal segment (Roux alimentary limb) is brought to the small gastric pouch in an antecolic, antegastric fashion. A hand-sewn end-to-side gastrojejunal anastomosis is created with a 3-cm diameter, in a single extramucosal layer, with 3-0 | Procedure or surgery | Group B |
Primary outcome
Measure: Resolution or improvement of gastroesophageal reflux disease (GERD)
Time frame: Before surgery and at 6, 12, 24, and 60 months postoperatively
Presence of postoperative GERD (yes/no), assessed by objective measures - reduction or absence of esophagitis detected by upper endoscopy, and reduction or absence of esophageal acid exposure detected by pH monitoring - and by the subjective measure of improvement or absence of patient-reported GERD symptoms assessed during clinic visits and by the QS-DRGE questionnaire.
5 secondary outcomes
Change in body weight
Time frame: At 6, 12, 24, and 60 months postoperatively
Change in HbA1c
Time frame: At 6, 12, 24, and 60 months postoperatively
Change in fasting plasma glucose
Time frame: At 6, 12, 24, and 60 months postoperatively
Change in blood pressure
Time frame: At 6, 12, 24, and 60 months postoperatively
Change in lipid profile
Time frame: At 6, 12, 24, and 60 months postoperatively
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 Aug 2026.
- Individual participant dataSharing planned: No
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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.
Victor RM Dib, PhD principal investigator
Victor Dib Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sleeve gastrectomy with Roux-en-Y antrojejunal anastomosis, AJYR+SG and Roux-en-Y gastric bypass, RYGB in people with Obesity, Morbid and Gastroesophageal Reflux (GERD), run by Victor Dib Institute 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 5 inclusion and 4 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 Aug 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. 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?
Measure: Resolution or improvement of gastroesophageal reflux disease (GERD) (time frame: Before surgery and at 6, 12, 24, and 60 months postoperatively). 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 Aug 2026.