Achalasia Clinical Trial
Official title:
A Prospective Randomized Trial Comparing Two Reconstructive Operation Techniques After Myotomy of Achalasia. Comparing Toupet Versus DOR.
Verified date | August 2013 |
Source | Karolinska University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | Sweden: Regional Ethical Review Board |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 25 |
Est. completion date | December 2012 |
Est. primary completion date | December 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 80 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Sweden | Karolinska University Hospital | Stockholm |
Lead Sponsor | Collaborator |
---|---|
Karolinska University Hospital | Ersta Hospital, Sweden |
Sweden,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Dysphagia symptoms according to Eckhardt | up to five years follow up | No | |
Secondary | Ambulatory esophageal PH | One and five years follow up | No | |
Secondary | Health-related quality of life according to Velanovich | One and five years follow up | No | |
Secondary | Timed barium esophagogram at 1, 2 and 5 minutes | One and five years follow up | No |
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