Karolinska University Hospital
Stockholm, 14186, Sweden
NCT Number: NCT01933373
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.
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Notify Me18 year–80 year
All sexes
Interventional
Not applicable
Stockholm, 14186, Sweden
By the end of 2012 40 patients have been enrolled and passed the one year follow up.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Laparoscopic posterior partial fundoplication plus myotomy.
Other names: Laparascopic posterior partial fundoplication plus myotomy.
Anterior partial fundoplication plus myotomy.
Other names: Anterior partial fundoplication plus myotomy.
Time frame: up to five years follow up
Time frame: One and five years follow up
Time frame: One and five years follow up
Time frame: One and five years follow up
Karolinska University Hospital
Other
A Prospective Randomized Trial Comparing Two Reconstructive Operation Techniques After Myotomy of Achalasia. Comparing Toupet Versus DOR.
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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