Clinical Trial

Reflux Disease After Gastric Bypass Versus Sleeve Gastrectomy in Morbid Obese Patients: an Italian Study

Study acronym: ReBvSS
Not Yet Recruiting
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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.
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2021-02-19; most recent amendment 2026-04-13.
Trial Details
NCT Number NCT04763993
Lead Sponsor Niguarda Hospital
Conditions Gastroesophageal Reflux Disease, Obesity
Enrollment 128 participants
Start Date 2026-05-01
Primary Completion 2028-05-01 (estimated)
Study Completion 2030-05-01 (estimated)
Updated on ClinicalTrials.gov 2026-04-16