This trial is active, not recruiting.

Condition esophageal achalasia
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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification bio-equivalence study
Intervention model single group assignment
Masking single blind (subject)
Primary purpose treatment
(Active Comparator)
Heller myotomy followed by Dor fundoplication
dor fundoplication
Subjects are randomized to undergo Heller myotomy followed by Laparoscopic Dor fundoplication
(Active Comparator)
Heller myotomy followed by Toupet fundoplication
toupet fundoplication
Subjects are randomized to undergo Heller myotomy followed by Laparoscopic Toupet fundoplication

Primary Outcomes

Primary outcomes are 24 hour pH testing results
time frame: pH testing at 6-12 months after surgical treatment

Secondary Outcomes

Symptomatic response measured by detailed patient questionnaire and results of barium swallow radiographs
time frame: 6-12 months after surgical intervention

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Diagnosis of Achalasia Exclusion Criteria: - Prior heller myotomy

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2011.
Information provided to ClinicalTrials.gov by Washington University School of Medicine.