Pneumatic Dilatation or Surgical Myotomy for Achalasia
- Conditions
- Achalasia
- Registration Number
- NCT02086669
- Lead Sponsor
- Karolinska University Hospital
- Brief Summary
Patients with newly diagnosed achalasia have been submitted to either treatment with pneumatic dilatation or surgical myotomy. Minimal follow up five years.
- Detailed Description
Patients with newly diagnosed achalasia have been submitted to either treatment with pneumatic dilatation or surgical myotomy. Minimal follow up five years.
During follow up patients have been interviewed with regular intervals, by use validated questionnaires. The level of symptom control has been assessed as well as the scoring cumulative incidence of treatment failures.
Health Related Quality of Life (HRQL) has been regularly checked.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 56
- Newly diagnosed achalasia
- Age 18-80 years
- Informed consent
- Previous treatment for achalasia.
- Stage IV achalasia.
- Unwillingness to participate.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Treatment failures At least five years after intervention Treatment failure is defined as a Composite variabel containing a number of different Clinically relevant outcomes.
- Secondary Outcome Measures
Name Time Method Dysphagia scoring At least five years after intervention Dysphagia score according to standardized, validated scoring system.
Health Related Quality of Life At least five years after intervention. Universally adopted and validated instruments are used.
Direct medical costs. At least five years after intervention. Charges for the average hospital in respective countries.
Trial Locations
- Locations (1)
Sahlgrenska University Hospital
🇸🇪Göteborg, Sweden
Sahlgrenska University Hospital🇸🇪Göteborg, Sweden