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NCT04763993Not yet recruiting

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

Reflux Disease After Gastric Bypass Versus Sleeve Gastrectomy in Morbid Obese Patients: an Italian Monocentric Randomized Clinical Study (ReBvSS)

Source: ClinicalTrials.gov · Last updated 16 Apr 2026

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Interventional
Enrollment
128 (estimated)
First submitted
10 Feb 2021
Start date
1 May 2026
Primary completion date
1 May 2028
Lead sponsor
Niguarda Hospital
Diseases
Obesity
NCT number
NCT04763993

What you commit to

  • Study type: Interventional
  • Planned participants: 128
  • From 1 May 2026 to the primary completion date, 1 May 2028
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Previous bariatric surgery or major general surgery;

Other illness

  • Medical or psychiatric conditions that compromises the patient's ability to give informed consent or comply with the study protocol;
  • Spastic motor disorders and esophageal hypomotility;

Age

  • Type 2 diabetes (T2D) for more than \> 5 years;

Other

  • Barrett's esophagus (BE);
  • Peptic strictures;
  • Absence of GERD (DMS\<14.72);
  • Severe GERD (DMS\>100);
  • Hiatal hernia \> 5 cm;
  • Necessity to explore stomach, the duodenum or the biliary tract;
  • Refuse of randomization;
  • Personal reasons.

Who the study is looking for

  • 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.

Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.