Comparison of Treatment Effectiveness and Evaluation of Cost Between Surgical and Non-surgical Treatment for Gastroesophageal Reflux Disease (GERD)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Symptom Control Rate of Surgical and Non-surgical Treatment for Gastroesophageal Reflux Disease (GERD)
研究概览
简要总结
This study was designed to evaluate the effectiveness of laparoscopic antireflux surgery for treatment of gastroesophageal reflux disease (GERD) comparing with that of non-surgical treatment.
详细描述
To treat GERD, the most patients with GERD are managed with acid suppressive medication first, and followed by antireflux surgery when the medical therapy is not effective or when the patient prefer surgery to quit the medicine.
This study has a single cohort in which the patient has the past history of GERD and medical treatment with proton pump inhibitors, and has scheduled to have laparoscopic antireflux surgery for treatment of GERD.
Treatment outcome of surgery will be evaluated comparing with the outcome of medical treatment before registration.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Objectively diagnosed GERD
- •Past history of medical treatment with PPI more than 8 weeks at any time before antireflux surgery
- •Patients scheduled to undergo antireflux surgery to treat GERD
排除标准
- •Other pathologic condition in upper gastrointestinal tract which needs surgical treatment
- •No (or less than 8 weeks) past history of acid suppressive medical therapy with PPI
- •Patients who underwent endoscopic antireflux procedure
结局指标
主要结局
Symptom Control Rate of Surgical and Non-surgical Treatment for Gastroesophageal Reflux Disease (GERD)
时间窗: Change from baseline GERD symptom at 3 months after antireflux surgery
GERD symptom control rate of surgical and non-surgical treatment for GERD based on the GERD symptom questionaire
次要结局
- Complication rate and adverse symptom rate related with antireflux surgery(Change from baseline GERD symptom at 3 months after antireflux surgery)
- Medical Cost of Surgical and Non-surgical Treatment for Gastroesophageal Reflux Disease (GERD)(Change from baseline medical cost (non-surgical) at 3 months after antireflux surgery)
研究者
Sungsoo Park
Professor
Korea University Anam Hospital