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 range18 Years – 70 Years
SexALL
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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.
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