Abstract
Objectives
We wished to determine the feasibility of performing a multi-centre phase III randomized controlled trial that compares laryngeal reinnervation to type I thyroplasty for adults with unilateral vocal fold paralysis (UVFP) in the UK.
Methods
A feasibility study was designed; 27 participants were recruited at three UK sites. Trial procedures mirrored those intended for a full-scale trial. We assessed recruitment rates, acceptability of randomization, and dropout rates and conducted a qualitative study to understand the recruitment processes. Participants were followed up for up to 12 months to assess optimal outcome measures for the definitive trial covering voice, swallowing, and overall quality of life. A qualitative study was run in parallel with the quantitative clinical trial.
Results
Recruitment was successful with 23 patients with UVFP randomized to reinnervation (n = 12) and thyroplasty (n = 11). 96% (n = 22) of participants accepted the treatment to which they were allocated, of which 17 received their intervention before the study end date. The qualitative study identified minor recruitment challenges that could be addressed through in-trial training. The set of subjective and objective voice, swallowing, and quality of life outcome measures used demonstrated a responsiveness to change following interventions.
Conclusion
The results from this study have provided us with the assurance that conducting an adequately powered randomized controlled clinical trial of laryngeal reinnervation versus type I thyroplasty for adults with UVFP in the UK is feasible in terms of conduct, recruitment, outcome measurement, and completion.
Level of Evidence: 2.
Trial Registration: ISRCTN90201732
We wished to determine the feasibility of performing a multi-centre phase III randomized controlled trial that compares laryngeal reinnervation to type I thyroplasty for adults with unilateral vocal fold paralysis (UVFP) in the UK.
Methods
A feasibility study was designed; 27 participants were recruited at three UK sites. Trial procedures mirrored those intended for a full-scale trial. We assessed recruitment rates, acceptability of randomization, and dropout rates and conducted a qualitative study to understand the recruitment processes. Participants were followed up for up to 12 months to assess optimal outcome measures for the definitive trial covering voice, swallowing, and overall quality of life. A qualitative study was run in parallel with the quantitative clinical trial.
Results
Recruitment was successful with 23 patients with UVFP randomized to reinnervation (n = 12) and thyroplasty (n = 11). 96% (n = 22) of participants accepted the treatment to which they were allocated, of which 17 received their intervention before the study end date. The qualitative study identified minor recruitment challenges that could be addressed through in-trial training. The set of subjective and objective voice, swallowing, and quality of life outcome measures used demonstrated a responsiveness to change following interventions.
Conclusion
The results from this study have provided us with the assurance that conducting an adequately powered randomized controlled clinical trial of laryngeal reinnervation versus type I thyroplasty for adults with UVFP in the UK is feasible in terms of conduct, recruitment, outcome measurement, and completion.
Level of Evidence: 2.
Trial Registration: ISRCTN90201732
| Original language | English |
|---|---|
| Number of pages | 10 |
| Journal | Laryngoscope |
| Early online date | 5 May 2025 |
| DOIs | |
| Publication status | E-pub ahead of print - 5 May 2025 |
Bibliographical note
Publisher Copyright:© 2025 The Author(s). The Laryngoscope published by Wiley Periodicals LLC on behalf of The American Laryngological, Rhinological and Otological Society, Inc.
Keywords
- reinnervation
- voice
- dysphonia
- thyroplasty