Digestive System Nutritional, Metabolic, Endocrine Surgery
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Adults 18–60 years old BMI =35 kg/m² with comorbidities or BMI =40 kg/m² Primary laparoscopic sleeve gastrectomy candidates No or well-controlled prior reflux symptoms Able to consent and comply with follow-up
Exclusion criteria
Exclusion criteria: Previous bariatric or upper GI surgery Known hiatal hernia requiring repair (except cruroplasty) Severe esophagitis, Barrett's esophagus, or esophageal motility disorder Contraindication to anesthesia or endoscopy Pregnancy or planned pregnancy during study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of objectively confirmed gastroesophageal reflux at 12 months postoperatively (abnormal DeMeester score >14.7 on 24-hour pH monitoring); development or worsening of esophagitis by endoscopy | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in symptom severity measured by validated standardized scores (GERD-Health Related Quality of Life [GERD-HRQL] questionnaire and Reflux Disease Questionnaire [RDQ]) at multiple follow-up intervals after surgery. | — |
Countries
Egypt
Contacts
Assiut University