Randomized Study to Compare Pneumatic Dilatation With Surgical Myotomy for Treatment of Achalasia - Long Term Follow up
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 56
- 试验地点
- 2
- 主要终点
- Treatment failures
研究概览
简要总结
Patients with newly diagnosed achalasia have been submitted to either treatment with pneumatic dilatation or surgical myotomy. Minimal follow up five years.
详细描述
Patients with newly diagnosed achalasia have been submitted to either treatment with pneumatic dilatation or surgical myotomy. Minimal follow up five years.
During follow up patients have been interviewed with regular intervals, by use validated questionnaires. The level of symptom control has been assessed as well as the scoring cumulative incidence of treatment failures.
Health Related Quality of Life (HRQL) has been regularly checked.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Newly diagnosed achalasia
- •Age 18-80 years
- •Informed consent
排除标准
- •Previous treatment for achalasia.
- •Stage IV achalasia.
- •Unwillingness to participate.
结局指标
主要结局
Treatment failures
时间窗: At least five years after intervention
Treatment failure is defined as a Composite variabel containing a number of different Clinically relevant outcomes.
次要结局
- Dysphagia scoring(At least five years after intervention)
- Health Related Quality of Life(At least five years after intervention.)
- Direct medical costs.(At least five years after intervention.)
研究者
Lars Lundell
Professor
Karolinska University Hospital