The Use of EndoFlip as a Clinical Tool for the Prediction of Postoperative GERD After Sleeve Gastrectomy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 主要终点
- New-onset of gastroesophageal reflux disease
研究概览
简要总结
This study aims to determine if preoperative EndoFlip measurement can effectively predict postoperative GERD-related quality of life and lower esophageal acid exposure.
详细描述
Enrolled patients will be subjected to a pre-operative gastroscopy, 48-Hour Bravo pH study and EndoFlip. In addition, each patient will complete a GERD-related quality of life questionnaire (GERD-HRQL scale). One year after surgery, patients will undergo a follow up a gastroscopy, pH study, EndoFlip and the same quality of life questionnaire to predict the incidence of postoperative GERD and determine the effect of sleeve gastrectomy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 65 years old
排除标准
- •Hiatal hernia > 2 cm at preoperative gastroscopy
- •Erosive esophagitis at preoperative gastroscopy
- •Barrett's metaplasia/dysplasia at preoperative gastroscopy
- •Revision surgery before the end of the study
- •Pregnancy during the study period
- •Actively bleeding esophageal varices
结局指标
主要结局
New-onset of gastroesophageal reflux disease
时间窗: 12 months postoperatively
total time of esophageal acid exposure (minutes)
次要结局
未报告次要终点
研究者
Laurent Biertho
Clinical Professor
Laval University