Development of Endoscopic Treatment for Achalasia, POEM (Per Oral Esophageal Myotomy): A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 55
- 试验地点
- 4
- 主要终点
- The proportion of patients who develop gastroesophageal reflux disease (GERD)
研究概览
简要总结
Per Oral Endoscopic Myotomy (POEM); comparison of two surgical techniques division all the esophageal muscle layers versus division the inner circular muscle layer of the esophagus only.
详细描述
Prior to surgery, all patients undergo upper endoscopy , x-ray "time barium" manometry, 24 hours pH registration. Moreover Quality of Life instrument (RAND-36), GSRS (Gastrointestinal Symptom Rating Scale) and a dysphagia score (Eckardt score) are completed by all patients.
Follow-up with surveys 3, 6, 12, and 36 months (GSRS, RAND-36 and Eckardt score).
At 3,12 and 36 months an x-ray "time barium" is performed and after 12 months a gastroscopy and at 24 hours esophageal pH monitoring are performed.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
The randomization process is initiated after general anesthesia is induced and the group affiliation will be determined by opening of a sealed envelope specifying the group assignment. The information of group allocation is stored in a closed envelope kept in a locked archive until the study is completed.
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newly diagnosed achalasia
- •the patient should understand the nature and the purpose of the study and give informed consent
排除标准
- •previous surgical treatment of achalasia
- •inability to understand the contents of or follow the protocol
- •other pathology as an explanation for the obstruction of the esophageal transition
结局指标
主要结局
The proportion of patients who develop gastroesophageal reflux disease (GERD)
时间窗: 1 year
Measured as esophageal acid exposure (pH \<4) \> 4% of recorded time
次要结局
- Eckardt score(1 year)
- Esophageal emptying function(1 year)
- RAND-36(1 year)
- Dysmotility(1 year)
- Gastrointestinal Symptom Rating Scale (GSRS)(1 year)
研究者
Anders Thorell
Professor
Karolinska Institutet