ISRCTN90201732
Completed
Phase 2
Does Laryngeal Reinnervation or Type I Thyroplasty give better voice results for patients with Unilateral Vocal Fold Paralysis (VOCALIST): a feasibility study
niversity College London Hospitals NHS Foundation Trust0 sites30 target enrollmentDecember 16, 2015
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Topic: Ear, Nose and Throat
- Sponsor
- niversity College London Hospitals NHS Foundation Trust
- Enrollment
- 30
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
2017 protocol in https://pubmed.ncbi.nlm.nih.gov/28965097/ (added 30/11/2020)
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. UVFP due to unilateral recurrent laryngeal nerve paralysis of traumatic, iatrogenic or idiopathic origin of between 6 and 60 months duration. Or symptoms that have not sufficiently improved with speech therapy alone, as determined by the patient and agreed by a multidisciplinary clinical team, after 6 months and pending a surgical decision.
- •2\. Age from 18 to 70 years old.
- •3\. Male or female
- •4\. Able to provide informed consent
- •5\. A significant voice disorder as measured by perceptual rating (Grade \=2 GRBAS Scale) and Voice Handicap Index (VHI\-10 score \>16\)
- •6\. Common laryngeal electromyography (EMG, neurophysiological) criteria (Koufman Grades 2\-5\) in either the thyroarytenoid (TA) or posterior cricoarytenoid (PCA) muscle on the paralysed side
- •Original inclusion criteria 1\-2:
- •1\. UVFP due to unilateral recurrent laryngeal nerve paralysis of traumatic, iatrogenic or idiopathic origin
- •of between 6 and 36 months duration; or symptoms that have not sufficiently improved with speech therapy alone, as determined by the patient and agreed by a multidisciplinary clinical team, after 6 months and pending a surgical decision
- •2\. Aged between 18 and 60
Exclusion Criteria
- •1\. Impaired vocal fold mobility but a normal EMG (Koufman Grade I)
- •2\. Severe lung disorders
- •3\. Structural vocal fold lesions such as polyp
- •4\. Previous laryngeal framework surgery
- •5\. Cricoarytenoid joint fixation (CAJF)
- •6\. Significant non\-laryngeal speech abnormality (severe dysarthria determined by a panel of trained speech therapists)
- •7\. Previous Level 2,3 or 4 thyroid neck dissection
- •8\. Previous ipsilateral surgical neck dissection
- •9\. Previous radiotherapy to the head and neck
- •10\. Laryngeal injection of a rapidly absorbable material in the last 6 months
Outcomes
Primary Outcomes
Not specified
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