A Prospective Study Comparing Two Reconstructive Operation Techniques After Myotomy of Achalasia

Study Overview
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Brief Summary
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Achalasia is a rare motor disorder of the gastroesophageal junction which is associated with an increased pressure of the esophageal sphincter. This leads to impairment to swallow and heartburn. Esophageal myotomy, which is a surgical longitudinal incision of the esophageal muscle layer extending over to the gastroesophageal junction is the treatment of choice for achalasia. In order to prevent reflux of stomach content into the esophagus this has to be combined with an antireflux procedure where the upper part of the stomach (fundus) is wrapped around the esophagus (fundoplication). This procedure can be performed with the wrapped fundus either in front of the esophagus (Dor procedure) or behind (Toupet). The latter introduces an angulation of the esophagus, which possibly may lead to an impairment of swallowing ability and passage of food to the stomach. On the other hand, the Toupet procedure may give a better control of reflux. The primary endpoint of the study is symptoms of impaired swallowing 1 year after treatment. Secondary outcomes include reflux (pH measurements in the esophagus), radiological imaging of swallowing and quality of life.

Detailed Description
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By the end of 2012 40 patients have been enrolled and passed the one year follow up.

Official Title
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A Prospective Randomized Trial Comparing Two Reconstructive Operation Techniques After Myotomy of Achalasia. Comparing Toupet Versus DOR.

Conditions
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Achalasia

Intervention / Treatment
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* Procedure: Toupet
* Procedure: Dor


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: >18 years of age Typical achalasia according to manometry Eckhardt score >3 Informed consent Exclusion Criteria: Severe comorbidity precluding surgery Pseudo achalasia Inability to participate in follow-up

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Toupet<br>Laparoscopic Myotomy + Toupet 180 degree partial posterior fundoplication. | Procedure: Toupet<br>* Laparoscopic posterior partial fundoplication plus myotomy.<br>* Other names: Laparascopic posterior partial fundoplication plus myotomy.;|
| Experimental: Dor<br>Laparoscopic Myotomy + Dor anterior partial fundoplication. 90 degree partial fundoplication being the standard of care. | Procedure: Dor<br>* Anterior partial fundoplication plus myotomy.<br>* Other names: Anterior partial fundoplication plus myotomy.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dysphagia symptoms according to Eckhardt |  | up to five years follow up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ambulatory esophageal PH |  | One and five years follow up | 
| Health-related quality of life according to Velanovich |  | One and five years follow up | 
| Timed barium esophagogram at 1, 2 and 5 minutes |  | One and five years follow up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dor, Randomized, Toupet, Achalasia