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

Not Applicable

Completed

• Conditions: Esophageal Achalasia
• Interventions: Procedure: Dor fundoplication; Procedure: Toupet fundoplication

• Registration Number: NCT00490750
• Lead Sponsor: L. Michael Brunt

Brief 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.

Detailed 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 Timeline

• Study Start: 2003-03
• Study First Submitted: 2007-06-21
• Study First Submitted QC: 2007-06-21
• Study First Posted: 2007-06-25
• Primary Completion: 2011-08
• Study Completion: 2011-08
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-07
• Last Update Posted: 2015-12-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Diagnosis of Achalasia

Exclusion Criteria

• Prior heller myotomy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Laparoscopic Dor fundoplication	Dor fundoplication	Heller myotomy followed by Dor fundoplication
Laparoscopic Toupet fundoplication	Toupet fundoplication	Heller myotomy followed by Toupet fundoplication

Primary Outcome Measures

Name	Time	Method
Primary outcomes are 24 hour pH testing results	pH testing at 6-12 months after surgical treatment

Secondary Outcome Measures

Name	Time	Method
Symptomatic response measured by detailed patient questionnaire and results of barium swallow radiographs	6-12 months after surgical intervention

Trial Locations

Locations (1)

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States