Pneumatic Dilatation or Surgical Myotomy for Achalasia

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02086669

Enrollment

Registered

2014-03-13

Start date

2000-01-31

Completion date

2014-01-31

Last updated

2016-04-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Achalasia

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.

Interventions

PROCEDUREPneumatic dilatation

PROCEDURELaparoscopic myotomy

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

* Newly diagnosed achalasia * Age 18-80 years * Informed consent

Exclusion criteria

* Previous treatment for achalasia. * Stage IV achalasia. * Unwillingness to participate.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026