NCT03692455

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

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

• Status: Enrolling By Invitation
• Phase: —
• Study type: Observational
• Enrollment: 75 (estimated)
• Sponsor: Clinica Gastrobese · Academic / Other
• Sex: All
• Age: 18 Years – 78 Years
• Healthy volunteers: Not accepted

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).

Detailed description

In order to determine the long term impact of Bariatric surgery on GERD, esophageal syndromes will be evaluated following the Lyon 2.0 Consensus, where troublesome symptoms were defined as score ≥ 2 on a validated questionnaire of symptoms for Portuguese language along with esophageal syndromes with injury assessed through upper endoscopy. Esophageal acid exposure will be determined through 24h pH monitoring. Increased acid exposure will be characterized when total esophageal pH \< 4 for at least 4% of its total monitoring time. The data will be collected 8 years after de surgical intervention.

Conditions

• Gastroesophageal Reflux Disease
• Morbid Obesity

Timeline

• Start date: 2025-09-17
• Primary completion: 2025-10-17
• Completion: 2025-11-08
• First posted: 2018-10-02
• Last updated: 2025-09-25

Locations

1 site across 1 country: Brazil