Pneumatic Dilatation or Surgical Myotomy for Achalasia

Karolinska University Hospital

Status and phase: Completed; Phase 2

Conditions: Achalasia

Treatments: Procedure: Pneumatic dilatation; Procedure: Laparoscopic myotomy

Study type: Interventional

Funder types: Other

Identifiers

NCT02086669

S500-00

Details and patient eligibility

About

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

Full 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.

Enrollment: 56 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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56 participants in 2 patient groups

Pneumatic dilatation

Experimental group

Description:

Repetitive pneumatic dilatation as the initial treatment followed by repetitive dilatation in case of dysphagia recurrence.

Treatment:

Procedure: Pneumatic dilatation

Surgical myotomy

Active Comparator group

Description:

Laparoscopic myotomy and subsequent follow up.

Treatment:

Procedure: Laparoscopic myotomy