Effect of Laparoscopic Sleeve Gastrectomy Versus Roux-en-Y Gastric Bypass on Gastroesophageal Reflux Disease: An 8-Year Prospective Cohort Study.
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Change in number of Participants With Gastroesophageal Reflux Disease (GERD)
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 78 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Been previously submitted to any gastroesophageal surgical procedure. Presence of chronical diseases that affects esophageal motility. Do not tolerate any of the required exams
结局指标
主要结局
Change in number of Participants With Gastroesophageal Reflux Disease (GERD)
时间窗: 8 years after intervention
Prevalence of GERD in patients will be characterized according to Lyon 2.0 consensus
次要结局
- Change in number of Participants Presenting GERD symptoms(8 years after intervention)
- Change in number of Participants With Esophageal Injury(8 years after intervention)
- Change in Esophageal Acid Exposure at 24h pH Monitoring in Upright Position(8 years after intervention)
- Change in Total Esophageal Acid Exposure at 24h pH Monitoring(8 years after intervention)
- Change in Esophageal Acid Exposure at 24h pH Monitoring in Supine Position(8 years after intervention)
- Change in number of Participants With Increased Acid Exposure(8 years after intervention)
研究者
Carlos AS Madalosso
Clinical Director
Clinica Gastrobese