Prediction of Post-laparoscopic Sleeve Gastrectomy Gastroesophageal Reflux Disease With an Endolumenal Functional Lumen Imaging Probe (EndoFLIP)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Worsening or new-onset gastroesophageal reflux disease
研究概览
简要总结
Researchers are trying to identify predictors for gastroesophageal reflux disease after sleeve gastrectomy.
详细描述
Subjects will undergo an upper endoscopy with EndoFLIP before sleeve gastrectomy to measure parameters from endoscopy and EndoFLIP device to develop a prediction model for post-operative gastroesophageal reflux disease. Subjects will undergo a repeat upper endoscopy with EndoFLIP at 6 months if an upper endoscopy is clinically indicated after surgery and complete questionnaires during follow-ups up to 5 years.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients > 18 years
- •BMI 30 or greater kg/m2
- •Participants can give a consent to the procedure
- •Participants have no contraindications to LSG (gastric ulceration)
排除标准
- •Participants who have LA grade C or D esophagitis, Barrett mucosa or peptic stricture.
- •Patients who have evidence of a major motility abnormality defined by the Chicago classification version 3.0 (achalasia, absent contractility, esophagogastric junction outflow obstruction, distal esophageal spasm, or hypertensive peristalsis)
- •Patients with hiatal hernia > 3 cm
- •Patients with previous esophageal or stomach surgery
研究组 & 干预措施
Intervention arm
Undergo an upper endoscopy with EndoFLIP at baseline before sleeve gastrectomy
干预措施: EndoFLIP measurement (Device)
结局指标
主要结局
Worsening or new-onset gastroesophageal reflux disease
时间窗: Baseline, 6 months, and 5 years
Determined by the change in the GERD-Health Related Quality of Life questionnaire score with questions individually scored on a scale of 0-5, combined to determine a total score range of 0-75 where a higher score indicates worse quality of life and increased score would indicate new or worsening GERD.
次要结局
未报告次要终点