NCT01624506已完成不适用
Observational Study of Anti-Reflux Surgery: Clinical Experience With the LINX Reflux Management System and Fundoplication
Torax Medical Incorporated21 个研究点 分布在 4 个国家目标入组 760 人开始时间: 2010年1月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 760
- 试验地点
- 21
- 主要终点
- Gastroesophageal Reflux Disease Health Related Quality of Life Outcome (GERD-HRQL)
研究概览
简要总结
The Anti-Reflux Surgical Study has been established to:
- Collect data about anti-reflux surgical treatment options (magnetic sphincter augmentation and Fundoplication) in everyday clinical practice
- Track the clinical course of patients from pre-operative assessment to three years post-surgery
详细描述
This study will track and monitor patients treated with either the magnetic sphincter augmentation or Fundoplication, making it the first Registry to collect data on both anti-reflux surgical options in the setting of everyday clinical experience.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
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
- •Individuals treated with LINX Reflux Management System or Fundoplication
- •Individuals who have provided appropriate authorization per institutional policy and procedure to have clinical and health information collected for the Anti-Reflux Surgical Registry.
- •Individuals willing to complete questionnaires and comply with the three years of follow-up.
排除标准
- •Known circumstances that would make it unlikely for an individual to complete the three year follow-up (e.g. life expectancy <3 years)
结局指标
主要结局
Gastroesophageal Reflux Disease Health Related Quality of Life Outcome (GERD-HRQL)
时间窗: 3 years post-surgery
Gastroesophageal Reflux Disease Health Related Quality of Life Outcomes (GERD-HRQL) Total scores range from 0-50 (min/max) 10 questions total, each rating 0-5 (min/max) Lower is better; higher is worse
次要结局
未报告次要终点
研究者
研究点 (21)
Loading locations...
相似试验
Unknown
不适用
ARMA for Postoperative GERD After Sleeve GastrectomyGastroesophageal RefluxNCT05259579Chinese University of Hong Kong15
Enrolling By Invitation
不适用
The Nordic Rectal Prolapse StudyRectal ProlapseSurgeryRecurrenceQuality of LifeNCT05569980Aarhus University Hospital430
已完成
不适用
A Prospective, Multicenter Observational Study on MAST™ (Minimal Access Spinal Technologies) Fusion Procedures for the Treatment of the Degenerative Lumbar SpineDegenerative Lumbar Spine Causing Back and/or Leg PainLumbar Spine DegenerationNCT01143324Medtronic Spinal and Biologics255
尚未招募
不适用
Anti-reflux Mucosal Ablation Therapy Randomized Sham Control Trial for Gastroesophageal Reflux DiseaseGastroesophageal Reflux DiseaseNCT06106100Far Eastern Memorial Hospital68
Unknown
不适用
Comparison of Treatment Outcome and Cost-effectiveness for GERDGastroesophageal RefluxNCT03661151Sungsoo Park100