By InvitationNot Applicable

Effect of Laparoscopic Sleeve Gastrectomy Versus Roux-en-Y Gastric Bypass on Gastroesophageal Reflux Disease: An 8-Year Prospective Cohort Study

Brazil75 participantsStarted 2025-09-17

Plain-language summary

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).

Who can participate

Age range18 Years – 78 Years

SexALL

See this in plain English?

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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

What they're measuring

Change in number of Participants With Gastroesophageal Reflux Disease (GERD)

Timeframe: 8 years after intervention

Trial details

NCT IDNCT03692455

SponsorClinica Gastrobese

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-10-17

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