Skip to main content
OpenTrials
Completed

NCT Number: NCT02086669

Pneumatic Dilatation or Surgical Myotomy for Achalasia

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Achalasia Deglutition Disorders Digestive System Diseases Esophageal Achalasia Esophageal Diseases Esophageal Motility Disorders Gastrointestinal Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Sahlgrenska University Hospital

Gothenburg, 41132, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Pneumatic dilatation

Procedure

Laparoscopic myotomy

Procedure

Primary outcomes

  1. Treatment failures

    Time frame: At least five years after intervention

    Treatment failure is defined as a Composite variabel containing a number of different Clinically relevant outcomes.

Secondary outcomes

  1. Dysphagia scoring

    Time frame: At least five years after intervention

    Dysphagia score according to standardized, validated scoring system.

  2. Health Related Quality of Life

    Time frame: At least five years after intervention.

    Universally adopted and validated instruments are used.

  3. Direct medical costs.

    Time frame: At least five years after intervention.

    Charges for the average hospital in respective countries.

Sponsors and collaborators

Lead sponsor

Karolinska University Hospital

Other

Collaborators

  • Sahlgrenska University Hospital

Registry information

Official study title

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

Important dates

Study start
2000
Primary completion
2009
Study completion
2014
First posted
Mar 13, 2014
Registry last updated
Apr 5, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.