Dysphagia in Oculopharyngeal Muscular Dystrophy (OPMD)- Evaluation, Endoscopic Examination of Swallowing, Treatment and Long Term Follow up
Recruitment status was Recruiting
The investigators aimed to review the natural history of dysphagia and dysphonia in OPMD in order to identify the best candidates and the proper timing to perform dysphagia alleviating procedures in both heterozygote and homozygote patients from the large pool of cases with this disease in Israel.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
|Official Title:||Dysphagia in Oculopharyngeal Muscular Dystrophy. Evaluation, Endoscopic Examination of Swallowing, Treatment and Long Term Follow up.|
- Dysphagia, quality of life. Proper intervention timing in OPMD based on knowledge about the natural history of the feeding difficulty. [ Time Frame: at least 3 years ] [ Designated as safety issue: Yes ]Dysphagia, quality of life. Proper intervention timing in OPMD patients is very important and must be based on deep knowledge about the natural history of the feeding difficulty.
|Study Start Date:||July 2009|
|Estimated Primary Completion Date:||July 2011 (Final data collection date for primary outcome measure)|
|No Intervention: Mild dysphagia|
|Active Comparator: Severe dysphagia||
Procedure: Upper esophageal sphincter myotomy
Upper esophageal sphincter release operation to allow better swallowing. The intervention is done under GA and by extra-mucosal approach.
Clinical evaluation of patients suspected of having OPMD. Genetic confirmatory tests (diagnostic DNA test) at the genetic unit in Afula Hospital. Clinical follow-up with endoscopic fiber optic evaluation of swallowing. Pre-operative assessment. Crycopharyngeal myotomy intervention in selected patients. Nutrition follow-up.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01167439
|Contact: Sergiu C. Blumen, MD||972-4-630-4262|
|Israel National Center for OPMD and Dysphagia, HYMC||Recruiting|
|POB 169, Hadera, Israel, 38100|
|Contact: Sergiu C. Blumen, MD 972-52-2645938 firstname.lastname@example.org|