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Laparoscopic Dor Versus Toupet Fundoplication for the Treatment of Idiopathic Esophageal Achalasia

Esophageal Achalasia Clinical Trial

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

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00490750
Study type Interventional
Source Washington University School of Medicine
Contact
Status Completed
Phase N/A
Start date March 2003
Completion date August 2011
View Details
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