Prospective Evaluation of the Safety and Efficacy of Transoral Incisionless Fundoplication 2.0 in the Management of Reflux: a European Registry
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 500
- 试验地点
- 7
- 主要终点
- Gastroesophageal reflux disease health-related quality of life questionnaire (GERD-HRQL)
研究概览
简要总结
This is a European, multi-centre, prospective registry that aims to determine the safety and efficacy of transoral incisionless fundoplication, with or without concomitant hiatal hernia repair, for the treatment of patients with gastro-oesophageal reflux disease (GORD).
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Any adult patient (≥18 years old) undergoing TIF2.0 or cTIF, at a participating centre, who can understand and sign the informed consent form, and is conducted in line with local institutional review board approval and recommendations.
排除标准
- •There are no specific exclusion criteria.
研究组 & 干预措施
Patients with gastro-oesophageal reflux disease or laryngo-pharyngeal reflux
干预措施: Transoral incisionless fundoplication with or without concomitant hiatal hernia repair with the EsophyX device (Device)
结局指标
主要结局
Gastroesophageal reflux disease health-related quality of life questionnaire (GERD-HRQL)
时间窗: 6-months, 1-year, 2-year, 3-years, 5-, years
Change in reflux-specific quality of life questionnaires (The GERD-HRQL used in the study is composed of 16 questions related to symptoms of heartburn, regurgitation, swallowing and overall satisfaction. Each question provides a scaled score between 0-5 (0=no symptoms, 5= Symptoms incapacitating to do daily activities) with a total score of 75.)
Reflux symptom index (RSI)
时间窗: 6-months, 1-year, 2-years, 3-years, 5-years
Change in reflux-specific quality of life questionnaire (The RSI used in the study is composed of 9 questions related to atypical symptoms of reflux or 'LPR'. Each question provides a scaled score between 0-5 (0=no problems, 5=severe problems) with a total score of 45.)
Proton pump inhibitor and/or histamine-2 receptor antagonist use
时间窗: 6-months, 1-year, 2-years, 3-years, 5-years
Change in acid suppression use
次要结局
- Physiological reflux testing(up to 5-years)
- Procedural outcomes (technical success)(30-days)
- Procedural outcomes (duration)(30-days)
- Procedural outcomes (length of hospital stay(30-days)
- Adverse events(up to 30-days)
- Adverse events of special interest(Up to 5-years)
- Need for revisional procedure(Up to 5-years)