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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Esophageal Achalasia

Intervention / Treatment
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* Procedure: Dor fundoplication
* Procedure: Toupet fundoplication


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of Achalasia Exclusion Criteria: Prior heller myotomy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Laparoscopic Dor fundoplication<br>Heller myotomy followed by Dor fundoplication | Procedure: Dor fundoplication<br>* Subjects are randomized to undergo Heller myotomy followed by Laparoscopic Dor fundoplication<br>|
| Active Comparator: Laparoscopic Toupet fundoplication<br>Heller myotomy followed by Toupet fundoplication | Procedure: Toupet fundoplication<br>* Subjects are randomized to undergo Heller myotomy followed by Laparoscopic Toupet fundoplication<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary outcomes are 24 hour pH testing results |  | pH testing at 6-12 months after surgical treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptomatic response measured by detailed patient questionnaire and results of barium swallow radiographs |  | 6-12 months after surgical intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Heller Dor, Heller Toupet, Myotomy