Laryngeal Reinnervation Versus Thyroplasty in Patients With Vocal Fold Weakness.

Title: Does Laryngeal Reinnervation or Type I Thyroplasty give better voice results for patients with Unilateral Vocal Fold Paralysis (VOCALIST): a feasibility study Short title: VOCALIST Trial medication: Not Applicable Phase of trial: Phase IIb Objectives: The aim of the study is to establish the feasibility of a multicentre, randomised phase III clinical trial of surgical treatment for Unilateral Vocal Fold Paralysis (UVFP). Main objectives are to test the feasibility of: 1. the multicentre recruitment process, including continuous improvement to the process based on qualitative analysis; 2. recruiters being able to present true equipoise with the treatment arms; 3. the randomisation process and investigate reasons for any difficulties that affect recruitment 4. the utility of the following characteristics of the proposed primary (voice handicap index) and secondary outcomes: variability across patients, variability over time, differences in outcome between randomised groups over time; 5. process of follow up visits and diary completion; 6. means of gathering health economics and health-related quality of life data suitable for measuring cost effectiveness. Type of trial: Quantitative and Qualitative Feasibility Study; multi-centre randomised controlled trial Trial design and methods: 30 patients will be randomised to receive the Laryngeal Reinnervation or Type I Thyroplasty surgery. Trial duration per participant: 12 months Estimated total trial duration: 24 months Planned trial sites: Multi-site; London, Poole and Manchester (3 sites). Total number of participants planned: 30 Statistical methodology and analysis: The trial analysis will be descriptive and will be performed on an intention to treat basis. Primary and secondary outcomes will be described using proportions and means as appropriate, with confidence intervals. No formal comparisons will be made. The correlations between the voice outcome measures will be calculated. There is no planned interim analysis.