Physiopathologic Evaluation of Esophageal Function After Laparoscopic Sleeve Gastrectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- Change from baseline in DeMeester's score
研究概览
简要总结
Symptomatic Gastroesophageal Reflux (GER) is considered by many a contraindication to laparoscopic sleeve gastrectomy (LSG). However, of the few studies that have investigated the relationship between LSG and GER the majority reported only changes in symptoms and manometric data, while assessment of GER using 24-hour pH monitoring is lacking.
The aim of this study is to evaluate the effect of LSG on GER in morbidly obese patients.
详细描述
Consecutive morbidly obese patients selected for LSG are included in a prospective clinical study. Gastroesophageal function is evaluated using a clinical validated questionnaire, upper endoscopy, esophageal manometry and 24-h pH monitoring before and 24 months after LSG.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •history of obesity exceeding 5 years
- •documented previous weight loss attempts,
- •body mass index (BMI)) of 40-50 kg/m2
- •age of 18-60 years.
排除标准
- •contraindications to pneumoperitoneum
- •large esophageal hiatal hernia
- •pregnancy,
- •drug or alcohol abuse,
- •psychological disorders (e.g., bulimia, depression)
- •hormonal or genetic obesity-related disease,
- •previous gastric surgery
结局指标
主要结局
Change from baseline in DeMeester's score
时间窗: baseline, 24 months after LSG
Use of the composite score that evaluates GER at 24-h pH monitoring before and 24 months after LSG. It includes numbers of reflux episodes, upright time in reflux, recumbent time in reflux, total time in reflux, reflux episodes over 5 minutes, longest reflux episodes
次要结局
- Change from baseline in Gastroesophageal reflux disease Symptom Assessment Scale score(Baseline, 24 months after LSG)
- Change from baseline in lower esophageal sphincter pressure(baseline, 24 months after LSG)
- Change from baseline in amplitude of esophageal peristaltic waves(baseline, 24 months after LSG)
- Change from baseline in grade of esophagitis(baseline, 24 months after LSG)
研究者
Fabrizio Rebecchi
MD
University of Turin, Italy