Long Term Effects of Laparoscopic Roux-en-Y Gastric Bypass on Gastro-esophageal Reflux: Clinical Impact of Weakly Acidic Reflux
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 86
- 主要终点
- Number of weakly acidic reflux
研究概览
简要总结
Laparoscopic Roux-en-Y Gastric Bypass (LRYGB) is considered the weight loss procedure of choice for patients suffering of gastro-esophageal reflux (GER). However, long term instrumental evaluations of GER after LRYGB are not available.
The aim of this study is to evaluate the long-term effects of laparoscopic Roux-en-Y Gastric Bypass (LRYGB) on gastro-esophageal function.
详细描述
Consecutive morbidly obese patients selected for LRYGB were included in a prospective study. The investigators performed clinical evaluation with GERD-HRQoL and GIS questionnaire, upper endoscopy, esophageal manometry and 24h-impedance pH monitoring (24h-MII-pH) preoperatively and at 12 and 60 months after surgery. Patients were divided into 2 groups according to the presence of GER at preoperative 24h-MII-pH.
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
Number of weakly acidic reflux
时间窗: preoperatively, 12 and 60 months after LRYGB
number of weakly acidic reflux at 24 hour pH impedance monitoring
次要结局
- Lower esophageal sphincter pressure(preoperatively, 12 and 60 months after LRYGB)
- GERD-HRQoL clinical score(preoperatively, 12 and 60 months after LRYGB)
- Amplitude of esophageal peristaltic waves(preoperatively, 12 and 60 months after LRYGB)
- Grade of esophagitis(preoperatively, 12 and 60 months after LRYGB)
- Number of acidic reflux(preoperatively, 12 and 60 months after LRYGB)
研究者
Fabrizio Rebecchi
MD
University of Turin, Italy