Status:
UNKNOWN
Reflux Disease After Gastric Bypass Versus Sleeve Gastrectomy in Morbid Obese Patients: an Italian Study
Lead Sponsor:
Niguarda Hospital
Conditions:
Gastroesophageal Reflux Disease
Obesity
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief 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)...
Detailed Description
Obesity is an independent risk factor for GERD and its complications. Bariatric surgery is effective in treatment of obesity and at the same time in controlling GERD, but there is disparity in current...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
May 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2025
Estimated Enrollment :
128 Patients enrolled
Trial Details
Trial ID
NCT04763993
Start Date
May 1 2024
End Date
May 1 2025
Last Update
March 22 2023
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