A Prospective Study Comparing Two Reconstructive Operation Techniques After Myotomy of Achalasia
A Prospective Randomized Trial Comparing Two Reconstructive Operation Techniques After Myotomy of Achalasia. Comparing Toupet Versus DOR.
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.
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Primary Completion Date
- >18 years of age
- Typical achalasia according to manometry
- Eckhardt score >3
- Informed consent
- Severe comorbidity precluding surgery
- Pseudo achalasia
- Inability to participate in follow-up
18 Years - 80 Years
Accepts Healthy Volunteers
Lars R Lundell, Professor, ,
Karolinska University Hospital
Ersta Hospital, Sweden
Lars R Lundell, Professor, Principal Investigator, Gastrocentrum Karolinska University Hospital, Stockholm Sweden