Gastroesophageal Reflux DiseaseReBvSSNCT04763993
Reflux Disease After Gastric Bypass Versus Sleeve Gastrectomy in Morbid Obese Patients: an Italian Study
A study testing Roux-en-Y-Gastric bypass, Sleeve gastrectomy and SG in people with Gastroesophageal Reflux Disease and Obesity, run by Niguarda Hospital.
Trial summary
The study aims to clarify if GERD, defined by results of 24 hours potential of hydrogen (pH) monitoring and abnormal DeMeester Score (DMS), in obese patients could worsen after Sleeve Gastrectomy (SG) more than after RYGBP. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Gastroesophageal Reflux Disease, Obesity
- What is being tested?
- Roux-en-Y-Gastric bypass, Sleeve gastrectomy and SG
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2026to 1 May 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Acceptance of randomization to surgery;
- Participant is willing and able to give informed consent for participation in the trial;
- Written informed consent;
- Compliance to follow-up;
- Male and female;
- ≥18 and ≤70 years old;
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- BMI ≥ 35 with obesity-related comorbidities;
- BMI ≥ 40 with or without obesity-related comorbidities;
- GERDQ score ≥ 3 points;
- Use of proton pump inhibitor;
- Mild and Moderate GERD (DMS ≥14.72 ≤100)
- Incompetence of the Esophagogastric junction
- Los Angeles grade A, B, C, D esophagitis.
Who cannot join
- Medical or psychiatric conditions that compromises the patient's ability to give informed consent or comply with the study protocol;
- Barrett's esophagus (BE);
- Spastic motor disorders and esophageal hypomotility;
- Peptic strictures;
- Absence of GERD (DMS<14.72);
- Severe GERD (DMS>100);
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- Hiatal hernia > 5 cm;
- Previous bariatric surgery or major general surgery;
- Type 2 diabetes (T2D) for more than > 5 years;
- Necessity to explore stomach, the duodenum or the biliary tract;
- Refuse of randomization;
- Personal reasons.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Reflux Disease After Gastric Bypass Versus Sleeve Gastrectomy in Morbid Obese Patients: an Italian Monocentric Randomized Clinical Study (ReBvSS)
The study aims to clarify if GERD, defined by results of 24 hours potential of hydrogen (pH) monitoring and abnormal DeMeester Score (DMS), in obese patients could worsen after Sleeve Gastrectomy (SG) more than after RYGBP. To demonstrate this hypothesis, the investigators will study the obese population suspected for GERD with 24 hours monitoring and High-Resolution Esophageal Manometry (HRM). DMS is calculated pre-operatively and, once GERD is confirmed, the patients are enrolled for randomization to SG or RYGBP. The suspicion of GERD is investigated with the GERDQ score and EGDS, that all obese patients have pre-operatory.
Read the detailed description
Obesity is an independent risk factor for GERD and its complications. Bariatric surgery is effective in treatment of obesity and at the same time in controlling GERD, but there is disparity in current literature if sleeve gastrectomy could worsen it, more than gastric bypass. Our study aims to investigate if there is a difference in postoperative GERD between these two surgical procedures in obese patients with pre-existing GERD, defined by results of 24 hours pH monitoring, expressed by an abnormal DeMeester Score (DMS). REBvSS is a monocentric randomized controlled trial (RCT). The investigators will study 128 obese patients, eligible for Bariatric Surgery (BMS), suspected for GERD, with 24-h pH monitoring and high-resolution manometry. DMS is calculated pre-operatively and, once GERD is confirmed, the patients are randomized to SG or RYGBP. The DMS is then calculated on 24 hours pH monitoring 24 months after the surgery and the degree of GERD is evaluated. The promoter centre is the Division of Minimally invasive Oncological General Surgery at Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda, Milan, Lombardy, that is an excellence centre for bariatric and metabolic surgery according to Società Italiana di Chirurgia dell'Obesità e delle malattie metaboliche (SICOB) accreditation policy, where the study will be carried out.
Medical history will be collected during the first outpatient examination and assessed as follows:
- Diagnosis of Obesity, based on value of BMI ≥ 35;
- Investigation of obesity-related diseases
- Clinical, nutritional and surgical history
- GERDQ score If the patient is eligible for BMS and there is the suspicion of GERD the preoperative evaluation will be carried out. It consists of a trial specific evaluation (EGDS, 24-h pH monitoring, HRM, DMS), that confirms the presence of GERD, and a standard evaluation (Ultrasonography of abdomen, ECG, Chest X-Ray, Blood exams, anesthaesiologic evaluation). When all the inclusion criteria are verified, the patient will be randomized to RYGBP or SG group and will undergo surgery. All patients will be randomized centrally using an online computer controlled permuted-block randomization module between SG and RYGBP in a 1:1 ratio.
The postoperative visits will be organised as follow:
- 90 days after surgery, to evaluate the presence or the absence of medical or surgical complications;
- 12 months and 24 months after surgery EGDS, 24 hours pH-monitoring and HRM will be performed to evaluate the degree of esophagitis and calculate the DMS; the quality of life and the symptoms will be assessed troughs BAROS and GERDQ score; also the trend of comorbidities will be examined.
Every patient will be analysed according to the allocated treatment. The investigators hope that our study will finally answer this issue, thanks to its randomized nature and the definition of GERD based on gold standard pH monitoring. These findings might influence decision-making in bariatric surgery and change or confirm the success of sleeve gastrectomy, also for what concerns the reflux disease.
- Conditions
- Gastroesophageal Reflux Disease, Obesity
- Being tested
- Roux-en-Y-Gastric bypass, Sleeve gastrectomy, SG
- Keywords
- Gastroesophageal Reflux Disease, Obesity, Sleeve gastrectomy, Gastric bypass, DeMeester score, pH-monitoring
- Medical subject headings
- Gastroesophageal Reflux, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Roux-en-Y-Gastric bypass, Sleeve gastrectomyProcedure or surgery
RYGBP consists in creating a small gastric pouch along the little curvature of the stomach, followed by the section of the small bowel. The restoration of the gastro-intestinal tract is achieved by performing a gastro-jejunal and a jejuno-jejunal anastomosis, giving this procedure the characteristic aspect of a Y. Also, for RYGBP the laparoscopic approach requires the placement of 5 trocars in the upper part of the abdomen.
SGProcedure or surgery
SG consists in removing the fundus and the body of the stomach, along the greater curvature. To perform it with a laparoscopic approach, we create the pneumoperitoneum with Veress needle and place 5 trocars in the upper part of the abdomen. The first step is the dissection of the greater curvature of the stomach, that starts at 6 centimetres from pylorus and it's conducted up to the angle of His, freeing the fundus and exposing the left pillar. A 38 Fr bougie is placed inside the stomach to calibrate its section. After it is carried out, the specimen is removed from the greater trocar site.
| Study group | Role | What they receive |
|---|---|---|
| RYGBP | Active comparator | RYGBP: Roun-en-Y Gastric Bypass Receives: Procedure: Roux-en-Y-Gastric bypass, Sleeve gastrectomy; Procedure: SG |
| SG | Experimental | SG: Sleeve Gastrectomy Receives: Procedure: Roux-en-Y-Gastric bypass, Sleeve gastrectomy; Procedure: SG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of the pre-existing Gastro-Esophageal Reflux Disease (GERD) from baseline in patients underwent SG and RYGBP
GERD will be evaluated performing 24-h pH monitoring before the surgery. The presence and the degree of GERD will be quantified calculating the DeMeester Score (DMS):
- DMS < 14.72 there is no evidence of GERD;
- DMS 14.72 - 50 mild GERD;
- DMS 50 - 100 moderate GERD;
- DMS > 100 severe GERD An upgrading in DMS class will determine a worsening in GERD
Measured: Change from baseline DeMeester Score 24 months after surgery
Secondary outcomes (6)
Postoperative Gastroesophageal Reflux Disease (GERD) from baseline
The degree of GERD will be quantified calculating the DeMeester Score (DMS):
- DMS < 14.72 there is no evidence of GERD;
- DMS 14.72 - 50 mild GERD;
- DMS 50 - 100 moderate GERD;
- DMS > 100 severe GERD An upgrading in DMS class will determine a worsening in GERD
Measured: Change from baseline DeMeester Score 12 months after surgery
Postoperative reflux symptoms
Expressed by Gastroesophageal Reflux Disease Questionnaire (GERDQ) Scoring How many times per week do each of the following symptoms occur per week Score 0: Occurs on 0 days Score 1: Occurs on 1 day Score 2: Occurs on 2-3 days Score 3: Occurs on 4-7 days Questions (Score 0-3 for each based on above) Burning feeling behind the Breastbone (Heartburn)? Stomach contents moving up to the throat or mouth (regurgitation)? Pain in the middle of the upper Stomach area? Nausea? Trouble getting a good night's sleep because of Heartburn or regurgitation? Need for over-the-counter medicine for Heartburn or regurgitation? Examples: Tums, Rolaids, Maalox, or other Antacids) In addition to the medicine your doctor prescribed Interpretation Total score of 0-2 points Likelihood of GERD: 0 percent Total score of 3-7 points Likelihood of GERD: 50 percent Total score of 8-10 points Likelihood of GERD: 79 percent Total score of 11-18 points Likelihood of GERD: 89 percent
Measured: Baseline and 12 and 24 months from the surgery
Quality of life Questionnaire
Expressed by Bariatric Analysis and Reporting Outcome System (BAROS) Score, calculated after 12 and 24 months from the surgery. The scoring key is assessed as follows: Failure ≤1 point; Fair > 1 to 3 points; Good > 3 to 5 points; Very Good > 5 to 7 points; Excellent > 7 to 9 points
Measured: month 12 and 24 after surgery
Trend of the obesity-related diseases (Arterial hypertension, Type 2 Diabetes, continuous positive airway pressure (CPAP) use
Anti-hypertensive drugs (AH) taken before surgery:stability=no change in AH,resolution= no AH,improvement=decrease in AH,worsening=increase in AH In no hypertension pts before surgery;new onset=introduction of AH Oral anti-glycemic (AG) medication taken before surgery:Stability=no change in number of oral AG.Resolution=defined as no oral AG,Improvement=decrease in number of oral AG,Worsening=increase in number of oral AG or switch to insulin-dependence In pts with insulin dependence before surgery:Stability=no change in number of insulin units,Resolution=no anti-diabetic therapy,Improvement=decrease in number of insulin units or oral AG,Worsening=increase in number of insulin units In pts not affected by type 2 diabetes before surgery:new onset=introduction of anti-diabetic therapy In pts using CPAP before surgery:Stability=continued use of CPAP,Resolution=discontinued use of CPAP In pts not affected by obstructive sleep apnea syndrome (OSAS) before surgery:new onset=use of CPAP
Measured: month 12 and 24 after surgery
Demographic
Demographic data
Measured: Enrollment
Medical/Surgical complications
The number of patients that experienced medical and/or surgical complications within 90 days from surgery, graded according to Clavien-Dindo classification (grade I, II, IIIa, IIIb, Iva, IVb, V)
Measured: day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2021
- Study start1 May 2026 (estimated)
- Primary completion1 May 2028 (estimated)
- Study completion1 May 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Niguarda Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04763993
- Sponsor's protocol ID
- ReBvSS
- Acronym
- ReBvSS
- Status last verified
- Apr 2026
- First submitted
- 10 Feb 2021
- Last updated
- 16 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reflux Disease After Gastric Bypass Versus Sleeve Gastrectomy in Morbid Obese Patients: an Italian Monocentric Randomized Clinical Study (ReBvSS)
- ClinicalTrials.gov ID
- NCT04763993
- Acronym / sponsor ID
- ReBvSS / ReBvSS
- Conditions
- Gastroesophageal Reflux Disease, Obesity
- Keywords
- Gastroesophageal Reflux Disease, Obesity, Sleeve gastrectomy, Gastric bypass, DeMeester score, pH-monitoring
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Niguarda HospitalUniversity, hospital or other
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 1 May 2028 (estimated)
- Study completion
- 1 May 2030 (estimated)
- First posted
- 21 Feb 2021 (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 study aims to clarify if GERD, defined by results of 24 hours potential of hydrogen (pH) monitoring and abnormal DeMeester Score (DMS), in obese patients could worsen after Sleeve Gastrectomy (SG) more than after RYGBP. To demonstrate this hypothesis, the investigators will study the obese population suspected for GERD with 24 hours monitoring and High-Resolution Esophageal Manometry (HRM). DMS is calculated pre-operatively and, once GERD is confirmed, the patients are enrolled for randomization to SG or RYGBP. The suspicion of GERD is investigated with the GERDQ score and EGDS, that all obese patients have pre-operatory.
Detailed description
Obesity is an independent risk factor for GERD and its complications. Bariatric surgery is effective in treatment of obesity and at the same time in controlling GERD, but there is disparity in current literature if sleeve gastrectomy could worsen it, more than gastric bypass. Our study aims to investigate if there is a difference in postoperative GERD between these two surgical procedures in obese patients with pre-existing GERD, defined by results of 24 hours pH monitoring, expressed by an abnormal DeMeester Score (DMS). REBvSS is a monocentric randomized controlled trial (RCT). The investigators will study 128 obese patients, eligible for Bariatric Surgery (BMS), suspected for GERD, with 24-h pH monitoring and high-resolution manometry. DMS is calculated pre-operatively and, once GERD is confirmed, the patients are randomized to SG or RYGBP. The DMS is then calculated on 24 hours pH monitoring 24 months after the surgery and the degree of GERD is evaluated. The promoter centre is the Division of Minimally invasive Oncological General Surgery at Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda, Milan, Lombardy, that is an excellence centre for bariatric and metabolic surgery according to Società Italiana di Chirurgia dell'Obesità e delle malattie metaboliche (SICOB) accreditation policy, where the study will be carried out.
Medical history will be collected during the first outpatient examination and assessed as follows:
- Diagnosis of Obesity, based on value of BMI ≥ 35;
- Investigation of obesity-related diseases
- Clinical, nutritional and surgical history
- GERDQ score If the patient is eligible for BMS and there is the suspicion of GERD the preoperative evaluation will be carried out. It consists of a trial specific evaluation (EGDS, 24-h pH monitoring, HRM, DMS), that confirms the presence of GERD, and a standard evaluation (Ultrasonography of abdomen, ECG, Chest X-Ray, Blood exams, anesthaesiologic evaluation). When all the inclusion criteria are verified, the patient will be randomized to RYGBP or SG group and will undergo surgery. All patients will be randomized centrally using an online computer controlled permuted-block randomization module between SG and RYGBP in a 1:1 ratio.
The postoperative visits will be organised as follow:
- 90 days after surgery, to evaluate the presence or the absence of medical or surgical complications;
- 12 months and 24 months after surgery EGDS, 24 hours pH-monitoring and HRM will be performed to evaluate the degree of esophagitis and calculate the DMS; the quality of life and the symptoms will be assessed troughs BAROS and GERDQ score; also the trend of comorbidities will be examined.
Every patient will be analysed according to the allocated treatment. The investigators hope that our study will finally answer this issue, thanks to its randomized nature and the definition of GERD based on gold standard pH monitoring. These findings might influence decision-making in bariatric surgery and change or confirm the success of sleeve gastrectomy, also for what concerns the reflux disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RYGBP | Active comparator | Procedure: Roux-en-Y-Gastric bypass, Sleeve gastrectomy, Procedure: SGRYGBP: Roun-en-Y Gastric Bypass |
| SG | Experimental | Procedure: Roux-en-Y-Gastric bypass, Sleeve gastrectomy, Procedure: SGSG: Sleeve Gastrectomy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Acceptance of randomization to surgery;
- Participant is willing and able to give informed consent for participation in the trial;
- Written informed consent;
- Compliance to follow-up;
- Male and female;
Key exclusion criteria (12 listed)
- Medical or psychiatric conditions that compromises the patient's ability to give informed consent or comply with the study protocol;
- Barrett's esophagus (BE);
- Spastic motor disorders and esophageal hypomotility;
- Peptic strictures;
- Absence of GERD (DMS<14.72);
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 |
|---|---|---|
| Roux-en-Y-Gastric bypass, Sleeve gastrectomyRYGBP consists in creating a small gastric pouch along the little curvature of the stomach, followed by the section of the small bowel. The restoration of the gastro-intestinal tract is achieved by performing a gastro-jejunal and a jejuno-jejunal anastomosis, giving this procedure the characteristic aspect of a Y. Also, for RYGBP the laparoscopic approach requires the placement of 5 trocars in the upper part of the abdomen. | Procedure or surgery | RYGBP, SG |
| SGSG consists in removing the fundus and the body of the stomach, along the greater curvature. To perform it with a laparoscopic approach, we create the pneumoperitoneum with Veress needle and place 5 trocars in the upper part of the abdomen. The first step is the dissection of the greater curvature of the stomach, that starts at 6 centimetres from pylorus and it's conducted up to the angle of His, freeing the fundus and exposing the left pillar. A 38 Fr bougie is placed inside the stomach to calibrate its section. After it is carried out, the specimen is removed from the greater trocar site. | Procedure or surgery | RYGBP, SG |
Primary outcome
Change of the pre-existing Gastro-Esophageal Reflux Disease (GERD) from baseline in patients underwent SG and RYGBP
Time frame: Change from baseline DeMeester Score 24 months after surgery
GERD will be evaluated performing 24-h pH monitoring before the surgery. The presence and the degree of GERD will be quantified calculating the DeMeester Score (DMS): * DMS < 14.72 there is no evidence of GERD; * DMS 14.72 - 50 mild GERD; * DMS 50 - 100 moderate GERD; * DMS > 100 severe GERD An upgrading in DMS class will determine a worsening in GERD
6 secondary outcomes
Postoperative Gastroesophageal Reflux Disease (GERD) from baseline
Time frame: Change from baseline DeMeester Score 12 months after surgery
Postoperative reflux symptoms
Time frame: Baseline and 12 and 24 months from the surgery
Quality of life Questionnaire
Time frame: month 12 and 24 after surgery
Trend of the obesity-related diseases (Arterial hypertension, Type 2 Diabetes, continuous positive airway pressure (CPAP) use
Time frame: month 12 and 24 after surgery
Demographic
Time frame: Enrollment
Medical/Surgical complications
Time frame: day 90
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 16 Apr 2026.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Roux-en-Y-Gastric bypass, Sleeve gastrectomy and SG in people with Gastroesophageal Reflux Disease and Obesity, run by Niguarda Hospital.
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 13 inclusion and 12 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: opening soon, as of the sponsor's last update on 16 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Gisella Barone, MD (+39 026444 ext. 7918, gisella.barone89@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of the pre-existing Gastro-Esophageal Reflux Disease (GERD) from baseline in patients underwent SG and RYGBP (time frame: Change from baseline DeMeester Score 24 months after surgery). 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 16 Apr 2026; AzTrials last refreshed its copy on 7 Nov 2026.