An interventional study of Toupet and Dor in Achalasia, sponsored by Karolinska University Hospital. Completed at 1 site in Sweden. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2013-09-02.
Sponsored by Karolinska University Hospital · Not applicable, Interventional, and Treatment
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.
By the end of 2012 40 patients have been enrolled and passed the one year follow up.
140 studies on the registry are indexed under Esophageal Achalasia; 44 are open to participants now.
This study's enrollment of 25 is below the median of 60 across 93 interventional studies indexed under Esophageal Achalasia.
Browse Esophageal Achalasia studies →Karolinska University Hospital is the lead sponsor of 275 studies on the registry; 54 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Laparoscopic Myotomy + Toupet 180 degree partial posterior fundoplication.
Procedure: Toupet
Laparoscopic Myotomy + Dor anterior partial fundoplication. 90 degree partial fundoplication being the standard of care.
Procedure: Dor
Laparoscopic posterior partial fundoplication plus myotomy.
Also known as: Laparascopic posterior partial fundoplication plus myotomy.
Anterior partial fundoplication plus myotomy.
Also known as: Anterior partial fundoplication plus myotomy.
Dysphagia symptoms according to Eckhardt
Time frame: up to five years follow up
Ambulatory esophageal PH
Time frame: One and five years follow up
Health-related quality of life according to Velanovich
Time frame: One and five years follow up
Timed barium esophagogram at 1, 2 and 5 minutes
Time frame: One and five years follow up
This study is completed, as verified in Aug 2013. You cannot join it, but the record below documents what was studied.
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Karolinska University Hospital