Clinical trial
Effect of Laparoscopic Sleeve Gastrectomy Versus Roux-en-Y Gastric Bypass on Gastroesophageal Reflux Disease: An 8-Year Prospective Cohort Study
Invitation only · Not applicable · 1 countries · Registry ID NCT03692455
Invitation onlyNot applicableObservational
What this study is about
This study represents a long-term observational follow-up of patients who had previously undergone bariatric surgery (laparoscopic sleeve gastrectomy or Roux-en-Y gastric bypass) in the context of an earlier interventional trial (NCT03692455). No new interventions are assigned in the follow-up phase. Participants are evaluated clinically and functionally at predefined intervals using standardized multimodal assessments (symptom questionnaires, endoscopy, manometry, radiology, and pH monitoring).
A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.
Basic eligibility
Age18 Years to 78 Years
SexAll
Healthy volunteersNot accepted
ConditionGastroesophageal Reflux Disease, Morbid Obesity
Full registry criteria
Inclusion Criteria: Patients enrolled in a previous prospective dual-cohort extension with 75 patients of the original Trial. Original Inclusion Criteria: Inclusion criteria were age 18-70 years and body mass index (BMI) ≥40 kg/m², or ≥35 kg/m² with obesity-related comorbidities. A total of 75 patients completed the original trial. Exclusion Criteria: Been previously submitted to any gastroesophageal surgical procedure. Presence of chronical diseases that affects esophageal motility. Do not tolerate any of the required exams
Treatments and study arms
The registry does not list a named intervention.
Primary outcomes
Change in number of Participants With Gastroesophageal Reflux Disease (GERD)8 years after intervention
Prevalence of GERD in patients will be characterized according to Lyon 2.0 consensus
Study locations
1 locations were listed when this page was built. The first 40 are shown.
Gastrobese Clinic🇧🇷 Passo Fundo, Rio Grande do Sul, Brazil