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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01933373
Other study ID # 2007/595-32
Secondary ID
Status Completed
Phase N/A
First received June 19, 2013
Last updated August 30, 2013
Start date May 2007
Est. completion date December 2012

Study information

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

Clinical Trial Summary

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.


Description:

By the end of 2012 40 patients have been enrolled and passed the one year follow up.


Recruitment information / eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Procedure:
Toupet
Laparoscopic posterior partial fundoplication plus myotomy.
Dor
Anterior partial fundoplication plus myotomy.

Locations

Country Name City State
Sweden Karolinska University Hospital Stockholm

Sponsors (2)

Lead Sponsor Collaborator
Karolinska University Hospital Ersta Hospital, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome

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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