Endoscopic Esophageal Myotomy for the Treatment of Achalasia
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Improvement of quality of life and dysphagia symptoms
研究概览
简要总结
Endoscopic Esophageal Myotomy (POEM), the research procedure, splits the lower esophageal sphincter muscle fibers from the inside of the esophagus, avoiding several abdominal incisions (belly area cuts), by using an endoscope to create a small cut at the most inner layer of the esophagus to expose the esophageal sphincter muscle fibers from the inside of the esophagus. The investigators are studying whether subjects who undergo Endoscopic Esophageal Myotomy will have similar functional outcome, and at the same time less pain, scar formation and wound infection than with laparoscopic or open surgery.
详细描述
The purpose of this research study is to find out more about a less invasive way of doing the surgical procedure (esophageal myotomy) to treat Achalasia.
Achalasia is a disease of the esophagus, where the lower esophageal sphincter fails to relax, causing difficulty in swallowing.
Esophageal myotomy (Heller myotomy) is surgically cutting the muscle fibers of the esophageal sphincter to allow passage of food into the stomach.
Esophageal myotomy is routinely done either by laparoscopic or open surgery. Laparoscopic surgery requires several (about 4 to 5) small incisions in the abdomen to allow the camera and surgical instruments to be introduced into the abdominal cavity to perform the myotomy. In open surgery, a 6- to 8-inch abdominal incision is made to gain access to the abdominal cavity to perform the myotomy.
Endoscopic Esophageal Myotomy (POEM), the research procedure, splits the lower esophageal sphincter muscle fibers from the inside of the esophagus, avoiding several abdominal incisions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of achalasia
- •Age 18-65
- •ASA class 1-2
排除标准
- •Pregnant women
- •Any prior surgical or endoscopic treatment for achalasia except dilation less than 20 mm
- •Patients who are taking immunosuppressive medications or are immunocompromised Patients on blood thinners or aspirin or with history of bleeding disorders
- •ASA class III patients
结局指标
主要结局
Improvement of quality of life and dysphagia symptoms
时间窗: 6 months
Patients will be given a quality of life and dysphagia questionare before surgery and at 3 and 6 months after surgery
次要结局
未报告次要终点
研究者
David W. Rattner, MD
Professor of Surgery - Harvard Medical School
Massachusetts General Hospital