Pneumatic Dilatation or Surgical Myotomy for Achalasia
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|ClinicalTrials.gov Identifier: NCT02086669|
Recruitment Status : Completed
First Posted : March 13, 2014
Last Update Posted : April 5, 2016
|Condition or disease||Intervention/treatment||Phase|
|Achalasia||Procedure: Pneumatic dilatation Procedure: Laparoscopic myotomy||Phase 2|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||56 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Randomized Study to Compare Pneumatic Dilatation With Surgical Myotomy for Treatment of Achalasia - Long Term Follow up|
|Study Start Date :||January 2000|
|Actual Primary Completion Date :||January 2009|
|Actual Study Completion Date :||January 2014|
Experimental: Pneumatic dilatation
Repetitive pneumatic dilatation as the initial treatment followed by repetitive dilatation in case of dysphagia recurrence.
Procedure: Pneumatic dilatation
Active Comparator: Surgical myotomy
Laparoscopic myotomy and subsequent follow up.
Procedure: Laparoscopic myotomy
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02086669
|Sahlgrenska University Hospital|
|Göteborg, Sweden, 41132|
|Study Chair:||Lars Lundell, Professor||Karolinska University Hospital|