Gastroesophageal Reflux Disease, Morbid Obesity
Conditions
Keywords
GERD, Roux-en-Y Gastric Bypass, Vertical Sleeve Gastrectomy, Lion 2.0 Consensus
Brief 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.
Interventions
None listed
Sponsors
UNIVERSIDADE FEDERAL DO RIO GRANDE DO SUL (UFRGS)
Clinica Gastrobese
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 78 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in number of Participants With Esophageal Injury | 8 years after intervention | Syndromes with esophageal injury should be determined exclusively by the presence of reflux esophagitis |
| Change in Total Esophageal Acid Exposure at 24h pH Monitoring | 8 years after intervention | 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. |
| Change in number of Participants Presenting GERD symptoms | 8 years after intervention | 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. |
| Change in Esophageal Acid Exposure at 24h pH Monitoring in Supine Position | 8 years after intervention | 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 |
| Change in number of Participants With Increased Acid Exposure | 8 years after intervention | 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. |
| Change in Esophageal Acid Exposure at 24h pH Monitoring in Upright Position | 8 years after intervention | 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 |
Countries
Brazil
Outcome results
None listed