Reflux Disease After Gastric Bypass Versus Sleeve Gastrectomy in Morbid Obese Patients: an Italia… (NCT04763993) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Reflux Disease After Gastric Bypass Versus Sleeve Gastrectomy in Morbid Obese Patients: an Italian Study
128 participantsStarted 2026-05-01
Plain-language 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. 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.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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;
* 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.
Exclusion criteria
* 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);
* 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change of the pre-existing Gastro-Esophageal Reflux Disease (GERD) from baseline in patients underwent SG and RYGBP
Timeframe: Change from baseline DeMeester Score 24 months after surgery