Reflux Disease After Gastric Bypass Versus Sleeve Gastrectomy in Morbid Obese Patients: an Italian Study
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorNiguarda Hospital
About this trial
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.
Eligibility criteria
Qualifiers
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;
Disqualifiers
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;
Trial design
Treatments tested in this trial
- Roux-en-Y-Gastric bypass, Sleeve gastrectomy
- SG
Treatment groups
128 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov