Clinical Trial: Pneumatic Dilatation or Surgical Myotomy for Achalasia

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 Summary:

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.


Sponsor: Karolinska University Hospital

Current Primary Outcome: 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.


Original Primary Outcome: Treatment failures [ Time Frame: At least five years after intervention ]

Current Secondary Outcome:

  • Dysphagia scoring [ Time Frame: At least five years after intervention ]
    Dysphagia score according to standardized, validated scoring system.
  • Health Related Quality of Life [ Time Frame: At least five years after intervention. ]
    Universally adopted and validated instruments are used.
  • Direct medical costs. [ Time Frame: At least five years after intervention. ]
    Charges for the average hospital in respective countries.


Original Secondary Outcome:

  • Dysphagia scoring [ Time Frame: At least five years after intervention ]
  • Health Related Quality of Life [ Time Frame: At least five years after intervention. ]
  • Direct medical costs. [ Time Frame: At least five years after intervention. ]


Information By: Karolinska University Hospital

Dates:
Date Received: March 3, 2014
Date Started: January 2000
Date Completion:
Last Updated: April 4, 2016
Last Verified: April 2016