The Impact of Gastric Bypass on Gastroesophageal Reflux Disease in Patients With Morbid Obesity: a Prospective Study Based on Montreal Consensus
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 53
- 试验地点
- 1
- 主要终点
- Number of Participants Presenting Reflux Symptoms
研究概览
简要总结
The hypothesis of this study was that gastric bypass (GBP) ameliorates gastroesophageal reflux disease (GERD) in morbidly obese patients.
详细描述
The investigators studied the impact of this surgical procedure on GERD in patients with morbid obesity.
Esophageal syndromes were evaluated according to the Montreal 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 was determined through 24h pH monitoring. Increased acid exposure was characterized when total esophageal pH < 4 for at least 4% of the total monitoring time.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Morbid obesity
- •Acceptance to undergo open gastric bypass
排除标准
- •Prior gastroesophageal surgery
- •Achalasia
结局指标
主要结局
Number of Participants Presenting Reflux Symptoms
时间窗: Before GBP, 6 months after GBP and 39 months after GBP
Prevalence of typical reflux syndrome according to the Montreal Consensus. This Consensus institutes that GERD can be outlined when troublesome symptoms and/or complications induced by reflux of the gastric content back to the esophagus are present. In order to assess such troublesome symptoms a validated questionnaire translated into Portuguese language was used.
Esophageal Acid Exposure at 24h pH Monitoring in Supine Position
时间窗: Before GBP, 6 months after GBP and 39 months after GBP
Esophageal acid exposure was measured through 24h pH monitoring. Esophageal pH was measured and recorded as the percent of time pH was below 4 while participant in supine position
Number of Participants With Esophageal Injury
时间窗: Before GBP, 6 months after GBP and 39 months after GBP
Syndromes with esophageal injury were represented exclusively by the presence of reflux esophagitis
Number of Participants With Gastroesophageal Reflux Disease (GERD)
时间窗: Before GBP, 6 months after GBP and 39 months after GBP
Prevalence of GERD in patients characterized according to troublesome symptomatic syndromes assessed through a validated questionnaire based on the Montreal Consensus.
Total Esophageal Acid Exposure at 24h pH Monitoring
时间窗: Before GBP, 6 months after GBP and 39 months after GBP
Esophageal acid exposure was measured through 24h pH monitoring. During the entire period, esophageal pH was measured and recorded as the percent of time pH was below 4.
Esophageal Acid Exposure at 24h pH Monitoring in Upright Position
时间窗: Before GBP, 6 months after GBP and 39 months after GBP
Esophageal acid exposure was measured through 24h pH monitoring. Esophageal pH was measured and recorded as the percent of time pH was below 4 while participant in upright position
Number of Participants With Increased Acid Exposure
时间窗: Before GBP, 6 months after GBP and 39 months after GBP
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.
次要结局
未报告次要终点
研究者
Carlos AS Madalosso
Director of Department of Metabolic and Bariatric Surgery
Clinica Gastrobese