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临床试验/NCT00490750
NCT00490750已完成不适用

Randomized Prospective Trial of Laparoscopic Heller Myotomy and Partial Fundoplication for the Treatment of Idiopathic Esophageal Achalasia

L. Michael Brunt2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2003年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
2
主要终点
Primary outcomes are 24 hour pH testing results

研究概览

简要总结

The primary aim of this study is to test the hypothesis that Heller myotomy and Toupet fundoplication result in a lower rate of reflux symptoms and positive 24-hour pH testing when compared to Heller myotomy and Dor fundoplication.

详细描述

Idiopathic achalasia is an uncommon motor disorder of the esophagus which occasionally requires surgical intervention. Although there are several controversial aspects of therapy for achalasia, laparoscopic myotomy is emerging as the procedure of choice. Several studies report having good to excellent outcomes following a laparoscopic procedure in approximately 90% of patients. However, a main deterrent to long-term success is the development of gastroesophageal reflux disease (GERD) despite the use of an antireflux procedure. For this reason, most surgeons add a partial fundoplication to the myotomy. The gastric fundus can either be wrapped anterior to the esophagus (Dor fundoplication), or posterior to the esophagus (Toupet fundoplication). Currently, the type of fundoplication is determined by surgeon's choice. There exists no systematic comparison of the two procedures. This multicenter, randomized study aims to evaluate patient outcomes following myotomy and Dor versus Toupet fundoplication.

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
Single (Participant)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosis of Achalasia

排除标准

  • Prior heller myotomy

结局指标

主要结局

Primary outcomes are 24 hour pH testing results

时间窗: pH testing at 6-12 months after surgical treatment

次要结局

  • Symptomatic response measured by detailed patient questionnaire and results of barium swallow radiographs(6-12 months after surgical intervention)

研究者

发起方
L. Michael Brunt
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

L. Michael Brunt

Professor of Surgery

Washington University School of Medicine

研究点 (2)

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