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 Details — Status: Completed

Administrative data

• NCT number: NCT00490750
• Other study ID #: 03-0241
• Status: Completed
• Phase: N/A
• First received: June 21, 2007
• Last updated: December 7, 2015
• Start date: March 2003
• Est. completion date: August 2011

Study information

• Verified date: December 2015
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis of Achalasia

Exclusion Criteria:

• Prior heller myotomy

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

• Esophageal Achalasia

Intervention

Procedure:
• Dor fundoplication
Subjects are randomized to undergo Heller myotomy followed by Laparoscopic Dor fundoplication
• Toupet fundoplication
Subjects are randomized to undergo Heller myotomy followed by Laparoscopic Toupet fundoplication

Locations

Country	Name	City	State
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (5)

Lead Sponsor	Collaborator
L. Michael Brunt	Duke University, Northwestern University, University of Oregon, University of Washington

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary outcomes are 24 hour pH testing results		pH testing at 6-12 months after surgical treatment	No
Secondary	Symptomatic response measured by detailed patient questionnaire and results of barium swallow radiographs		6-12 months after surgical intervention	No