Laparoscopic Dor Versus Toupet Fundoplication for the Treatment of Idiopathic Esophageal Achalasia
This trial is active, not recruiting.
|Treatments||dor fundoplication, toupet fundoplication|
|Sponsor||Washington University School of Medicine|
|Collaborator||University of Washington|
|Start date||March 2003|
|End date||August 2011|
|Trial size||200 participants|
|Trial identifier||NCT00490750, 03-0241|
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.
|Endpoint classification||bio-equivalence study|
|Intervention model||single group assignment|
|Masking||single blind (subject)|
Primary outcomes are 24 hour pH testing results
time frame: pH testing at 6-12 months after surgical treatment
Symptomatic response measured by detailed patient questionnaire and results of barium swallow radiographs
time frame: 6-12 months after surgical intervention
Male or female participants at least 18 years old.
Inclusion Criteria: - Diagnosis of Achalasia Exclusion Criteria: - Prior heller myotomy
|Official title||Randomized Prospective Trial of Laparoscopic Heller Myotomy and Partial Fundoplication for the Treatment of Idiopathic Esophageal Achalasia|
|Principal investigator||L. Michael Brunt, MD|
|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.|
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