aryngeal reinnervation versus thyroplasty in patients with unilateral vocal fold paralysis

Phase 2

Completed

• Conditions: Topic: Ear, Nose and Throat; Subtopic: Ear, Nose and Throat; Disease: Ear, Nose and Throat; Ear, Nose and Throat; Unilateral vocal fold paralysis (UVFP)

• Registration Number: ISRCTN90201732
• Lead Sponsor: niversity College London Hospitals NHS Foundation Trust

Brief Summary

2017 protocol in https://pubmed.ncbi.nlm.nih.gov/28965097/ (added 30/11/2020)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-12-16
• Study Completion: 2018-05-01
• Last Update Posted: 5 January 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 30

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
11. Previous laryngeal injection of a non-rapidly absorbable material (e.g bioplastics, VOX)
12. Neuromuscular disease affecting the larynx or multiple cranial nerve palsies

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Recruitment rate.

Secondary Outcome Measures

Name	Time	Method
ot provided at time of registration