A Prospective Randomized Trial Comparing Two Reconstructive Operation Techniques After Myotomy of Achalasia. Comparing Toupet Versus DOR.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Dysphagia symptoms according to Eckhardt
研究概览
简要总结
Achalasia is a rare motor disorder of the gastroesophageal junction which is associated with an increased pressure of the esophageal sphincter. This leads to impairment to swallow and heartburn. Esophageal myotomy, which is a surgical longitudinal incision of the esophageal muscle layer extending over to the gastroesophageal junction is the treatment of choice for achalasia. In order to prevent reflux of stomach content into the esophagus this has to be combined with an antireflux procedure where the upper part of the stomach (fundus) is wrapped around the esophagus (fundoplication). This procedure can be performed with the wrapped fundus either in front of the esophagus (Dor procedure) or behind (Toupet). The latter introduces an angulation of the esophagus, which possibly may lead to an impairment of swallowing ability and passage of food to the stomach. On the other hand, the Toupet procedure may give a better control of reflux. The primary endpoint of the study is symptoms of impaired swallowing 1 year after treatment. Secondary outcomes include reflux (pH measurements in the esophagus), radiological imaging of swallowing and quality of life.
详细描述
By the end of 2012 40 patients have been enrolled and passed the one year follow up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •>18 years of age
- •Typical achalasia according to manometry
- •Eckhardt score >3
- •Informed consent
排除标准
- •Severe comorbidity precluding surgery
- •Pseudo achalasia
- •Inability to participate in follow-up
结局指标
主要结局
Dysphagia symptoms according to Eckhardt
时间窗: up to five years follow up
次要结局
- Ambulatory esophageal PH(One and five years follow up)
- Health-related quality of life according to Velanovich(One and five years follow up)
- Timed barium esophagogram at 1, 2 and 5 minutes(One and five years follow up)
研究者
Lars Lundell
Professor
Karolinska University Hospital
