Pneumatic Dilatation or Surgical Myotomy for Achalasia

Achalasia Clinical Trial

Official title:

Randomized Study to Compare Pneumatic Dilatation With Surgical Myotomy for Treatment of Achalasia - Long Term Follow up

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02086669
• Other study ID #: S500-00
• Status: Completed
• Phase: Phase 2
• First received: March 3, 2014
• Last updated: April 4, 2016
• Start date: January 2000
• Est. completion date: January 2014

Study information

• Verified date: April 2016
• Source: Karolinska University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regionala Etikprövningsnämnden i Göteborg
• Study type: Interventional

Clinical Trial Summary

Patients with newly diagnosed achalasia have been submitted to either treatment with pneumatic dilatation or surgical myotomy. Minimal follow up five years.

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 information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: January 2014
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Newly diagnosed achalasia

• Age 18-80 years

• Informed consent

Exclusion Criteria:

• Previous treatment for achalasia.

• Stage IV achalasia.

• Unwillingness to participate.

Study Design

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

Related Conditions & MeSH terms

• Achalasia
• Esophageal Achalasia

Intervention

Procedure:
• Pneumatic dilatation

• Laparoscopic myotomy

Locations

Country	Name	City	State
Sweden	Sahlgrenska University Hospital	Göteborg

Sponsors (2)

Lead Sponsor	Collaborator
Karolinska University Hospital	Sahlgrenska University Hospital, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment failures	Treatment failure is defined as a Composite variabel containing a number of different Clinically relevant outcomes.	At least five years after intervention	No
Secondary	Dysphagia scoring	Dysphagia score according to standardized, validated scoring system.	At least five years after intervention	No
Secondary	Health Related Quality of Life	Universally adopted and validated instruments are used.	At least five years after intervention.	No
Secondary	Direct medical costs.	Charges for the average hospital in respective countries.	At least five years after intervention.	No