Pneumatic Dilatation or Surgical Myotomy for Achalasia

Phase 2

Completed

• Conditions: Achalasia
• Interventions: Procedure: Laparoscopic myotomy; Procedure: Pneumatic dilatation

• 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.

Study Timeline

• Study Start: 2000-01
• Primary Completion: 2009-01
• Study Completion: 2014-01
• Study First Submitted: 2014-03-03
• Study First Submitted QC: 2014-03-11
• Study First Posted: 2014-03-13
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-04
• Last Update Posted: 2016-04-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Surgical myotomy	Laparoscopic myotomy	Laparoscopic myotomy and subsequent follow up.
Pneumatic dilatation	Pneumatic dilatation	Repetitive pneumatic dilatation as the initial treatment followed by repetitive dilatation in case of dysphagia recurrence.

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