Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Federal University of Rio Grande do Sul | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LRSYGP Group | Patients will undergo Clinical evaluation and Exams, 8 years after Laparoscopic Roux-Y Gastric Bypass. | ||
| LSG group | Patients will undergo Clinical evaluation and Exams 8 years after Laparoscopic Sleeve Gastrectomy. |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Change in number of Participants With Gastroesophageal Reflux Disease (GERD) | Prevalence of GERD in patients will be characterized according to Lyon 2.0 consensus | 8 years after intervention |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 8 years after intervention |
| Change in number of Participants With Esophageal Injury |
Not provided
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
Not provided
Not provided
This study represents a long-term observational follow-up of 75 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).
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Richard R Gursky, PhD | Federal University of Rio Grande do Sul | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gastrobese Clinic | Passo Fundo | Rio Grande do Sul | 99010-112 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41968616 | Derived | Navarini D, Madalosso CAS, Fornari F, Tognon AP, Ghiasson C, Scortegagna GT, Gurski RR. Gastroesophageal Reflux Disease After Sleeve Gastrectomy versus Roux-en-Y Gastric Bypass: An 8-Year Prospective Cohort Study. World J Surg. 2026 Jun;50(6):1460-1467. doi: 10.1002/wjs.70367. Epub 2026 Apr 12. |
Not provided
Not provided
The data will be made publicly available in accordance with the requirements of the journal in which the study will be submitted
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Syndromes with esophageal injury should be determined exclusively by the presence of reflux esophagitis |
| 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. | 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 | 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 | 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. | 8 years after intervention |
| ID | Term |
|---|---|
| D005764 | Gastroesophageal Reflux |
| D009767 | Obesity, Morbid |
| ID | Term |
|---|---|
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided