Registry of Outcomes From AntiReflux Surgery (ROARS)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,941
- 试验地点
- 34
- 主要终点
- Quality of Life reported by patient
研究概览
简要总结
Prospective registry comparing outcomes after laparoscopic treatment of gastroesophageal reflux disease and hiatal hernia.
详细描述
This is a prospective, multi center, observational database of patients that are having surgical laparoscopic antireflux procedure and/or hiatal hernia repair, including laparoscopic Nissen fundoplication and Magnetic Sphincter Augmentation with the LINX device. Patients meeting registry inclusion and exclusion will be followed for 5 years with standardized quality of life surveys and appropriate standard of care testing. Up to 40 sites will participate with total enrollment of 1000 patients.
The main objectives are to collect data from everyday clinical practices and track patients from preoperative assessments to 5 years post surgical intervention to evaluate symptoms, medication use and side effects.
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject must be at least 21years of age and at least the minimum Age of Majority according to applicable state law.
- •Subject is a suitable surgical candidate, i.e. is able to undergo appropriate anesthesia and endoscopic procedure or laparoscopic surgery.
- •Appropriate indications for and documentation of disease process requiring surgery. (Documented gastroesophageal reflux disease by accepted endoscopic or ambulatory reflux monitoring criteria, or have a hiatal hernia that meets accepted criteria for repair (e.g. large paraesophageal hernia with chest pain)).
- •Subject is willing and able to cooperate with follow-up examinations
- •Subject has been informed of the study procedures and treatment and has signed an informed consent for the study.
排除标准
- •Suspected or confirmed esophageal or gastric cancer.
- •Cannot understand trial requirements or is unable to comply with follow-up schedule
- •Pregnant or nursing, or plans to become pregnant during the course of the study
- •Medical illness (i.e. congestive heart failure) that may cause the subject to be non-compliant with or able to meet the protocol requirements or is associated with limited life expectancy (i.e. less than 3 years)
- •Diagnosed psychiatric disorder (e.g. bipolar, schizophrenia, etc.), subjects that exhibit depression that are on appropriate medication(s) are allowable.
研究组 & 干预措施
Laparoscopic Fundoplication Group
This group of patients are surgical candidates based on preoperative testing results for laparoscopic fundoplication antireflux procedure and possible hiatal hernia repair.
LINX Antireflux Device Group
This group of patients are surgical candidates based on preoperative testing results for the laparoscopic LINX antireflux device placement and possible hiatal hernia repair.
干预措施: LINX Antireflux (Device)
结局指标
主要结局
Quality of Life reported by patient
时间窗: 5 Years
Standard GERD Quality of Life Assessment
次要结局
未报告次要终点