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).
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.
Study Type
OBSERVATIONAL
Enrollment
75
Gastrobese Clinic
Passo Fundo, Rio Grande do Sul, Brazil
Change in number of Participants With Gastroesophageal Reflux Disease (GERD)
Prevalence of GERD in patients will be characterized according to Lyon 2.0 consensus
Time frame: 8 years after intervention
Change in number of Participants Presenting GERD symptoms
Prevalence of typical reflux syndrome will be evaluated. In order to assess such troublesome symptoms a validated questionnaire translated into Portuguese language will be used.
Time frame: 8 years after intervention
Change in number of Participants With Esophageal Injury
Syndromes with esophageal injury should be determined exclusively by the presence of reflux esophagitis
Time frame: 8 years after intervention
Change in Total Esophageal Acid Exposure at 24h pH Monitoring
Esophageal acid exposure will be measured through 24h pH monitoring. During such period, esophageal pH will be measured and recorded as the percent of time pH stays below 4.
Time frame: 8 years after intervention
Change in Esophageal Acid Exposure at 24h pH Monitoring in Upright Position
Esophageal acid exposure will be measured through 24h pH monitoring. Esophageal pH will be measured and recorded as the percent of time pH stays below 4 while participant in upright position
Time frame: 8 years after intervention
Change in Esophageal Acid Exposure at 24h pH Monitoring in Supine Position
Esophageal acid exposure will be measured through 24h pH monitoring. Esophageal pH will be measured and recorded as the percent of time pH stays below 4 while participant in supine position
Time frame: 8 years after intervention
Change in number of Participants With Increased Acid Exposure
Increased Acid Exposure occurs when esophageal pH is \<4 for a period longer than 4% of the total test time on a 24h pH monitoring.
Time frame: 8 years after intervention
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.