Observational Registry of Transoral Incisionless Fundoplication (Creation of a New Gastroesophageal Valve) in Patients With Gastroesophageal Reflux Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Medical use and dosage
研究概览
简要总结
This observational registry aims to: 1) record the TIF interventions in patients with esophageal or extra-esophageal symptoms; 2) to monitor the therapy response through the clinical experience in terms of effect on the use and dosage of proton pump inhibitors (PPIs) and on the GERD-Health Related Quality of Life (HRQL) and Reflux Symptom Index (RSI) questionnaires scores; 3) to characterize the treated patients population and the predictive factors of TIF success, identifying the subpopulation who may effectively benefit from TIF.
详细描述
After being evaluated according to the clinical indication for the treatment of symptomatic gastro-esophageal reflux disease (GERD with esophageal or extraesophageal symptoms) by transoral incisionless fundoplication (TIF) and, thus, being treated by TIF using the EsophyX device, all patients giving specific informed consent will enter a 3-year enrollment registry with a 5-year follow-up for each patient through post-TIF routine practice visits and examinations.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Medical use and dosage
时间窗: Yearly, up to 5 years from the date of the intervention
Need to use proton pump inhibitors (PPI), and at what dosage, to control the gastro-esophageal reflux symptoms after intervention
次要结局
- Health Related Quality of Life questionnaire score(Yearly, up to 5 years from the date of the intervention)
- Reflux Symptom Index questionnaire score(Yearly, up to 5 years from the date of the intervention)
- Esophagitis(6 months and 12 months after the date of the intervention)
- Hill's grade of the gastro-esophageal flap valve(6 months and 12 months after the date of the intervention)
- High-resolution esophageal manometry findings(12 months after the date of the intervention)
- 24-hour esophageal pH-metry findings(12 months and 24 months after the date of the intervention)
- Jobe's length of the gastro-esophageal valve(6 months and 12 months after the date of the intervention)
- Barrett's esophagus(6 months and 12 months after the date of the intervention)
- 24-hour esophageal impedancemetry findings(12 months and 24 months after the date of the intervention)
研究者
Pier Alberto Testoni
Head of Gastroenterology and Digestive Endoscopy
IRCCS San Raffaele