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临床试验/NCT01933373
NCT01933373已完成不适用

A Prospective Randomized Trial Comparing Two Reconstructive Operation Techniques After Myotomy of Achalasia. Comparing Toupet Versus DOR.

Karolinska University Hospital2 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2007年5月1日最近更新:
适应症

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

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

发起方
Karolinska University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Lars Lundell

Professor

Karolinska University Hospital

研究点 (2)

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