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| Name | Class |
|---|---|
| Ersta Hospital, Sweden | OTHER |
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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.
By the end of 2012 40 patients have been enrolled and passed the one year follow up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Toupet | Active Comparator | Laparoscopic Myotomy + Toupet 180 degree partial posterior fundoplication. |
|
| Dor | Experimental | Laparoscopic Myotomy + Dor anterior partial fundoplication. 90 degree partial fundoplication being the standard of care. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Toupet | Procedure | Laparoscopic posterior partial fundoplication plus myotomy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dysphagia symptoms according to Eckhardt | up to five years follow up |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lars R Lundell, Professor | Gastrocentrum Karolinska University Hospital, Stockholm Sweden | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Karolinska University Hospital | Stockholm | 14186 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24892729 | Derived | Kumagai K, Kjellin A, Tsai JA, Thorell A, Granqvist S, Lundell L, Hakanson B. Toupet versus Dor as a procedure to prevent reflux after cardiomyotomy for achalasia: results of a randomised clinical trial. Int J Surg. 2014;12(7):673-80. doi: 10.1016/j.ijsu.2014.05.077. Epub 2014 Jun 2. |
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| ID | Term |
|---|---|
| D004931 | Esophageal Achalasia |
| ID | Term |
|---|---|
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| D000074433 | Myotomy |
| D017465 | Receptors, Opioid, delta |
| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
| D011957 | Receptors, Opioid |
| D043562 | Receptors, G-Protein-Coupled |
| D011956 | Receptors, Cell Surface |
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| Dor | Procedure | Anterior partial fundoplication plus myotomy. |
|
|
| One and five years follow up |
| D004066 | Digestive System Diseases |
| D008565 | Membrane Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D018013 | Receptors, Neuropeptide |
| D017981 | Receptors, Neurotransmitter |
| D018000 | Receptors, Peptide |