A Phase 2 interventional study of Pneumatic dilatation and Laparoscopic myotomy in Achalasia, sponsored by Karolinska University Hospital. Completed at 1 site in Sweden. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2016-04-05.
Sponsored by Karolinska University Hospital · Phase 2, Interventional, and Treatment
Patients with newly diagnosed achalasia have been submitted to either treatment with pneumatic dilatation or surgical myotomy. Minimal follow up five years.
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.
140 studies on the registry are indexed under Esophageal Achalasia; 44 are open to participants now.
This study's enrollment of 56 is close to the median of 60 across 93 interventional studies indexed under Esophageal Achalasia.
Browse Esophageal Achalasia studies →Karolinska University Hospital is the lead sponsor of 275 studies on the registry; 54 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Repetitive pneumatic dilatation as the initial treatment followed by repetitive dilatation in case of dysphagia recurrence.
Procedure: Pneumatic dilatation
Laparoscopic myotomy and subsequent follow up.
Procedure: Laparoscopic myotomy
Treatment failures
Treatment failure is defined as a Composite variabel containing a number of different Clinically relevant outcomes.
Time frame: At least five years after intervention
Dysphagia scoring
Dysphagia score according to standardized, validated scoring system.
Time frame: At least five years after intervention
Health Related Quality of Life
Universally adopted and validated instruments are used.
Time frame: At least five years after intervention.
Direct medical costs.
Charges for the average hospital in respective countries.
Time frame: At least five years after intervention.
This study is completed, as verified in Apr 2016. You cannot join it, but the record below documents what was studied.
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Karolinska University Hospital