Vocal Cord Paralysis Unilateral Clinical Trial
Official title:
Does Laryngeal Reinnervation or Type I Thyroplasty Give Better Voice Results for Patients With Unilateral Vocal Fold Paralysis (VOCALIST): a Feasibility Study.
The purpose of this study is to help determine the most effective treatment for participants
with Unilateral Vocal Fold Paralysis.
There are currently two types of operations used to treat this condition. One operation is
called thyroplasty. Doctors place a small piece of safe plastic into the side of the
participant's voice box to push the weak vocal cord into a position to enable better speech
and swallowing. In the other operation called laryngeal reinnervation, doctors repair the
neck nerve supply to the vocal cord using parts of other unaffected nerves to enable better
speech and swallowing. The investigators do not know which of these methods is better and are
conducting this study to start comparing the two operations so that a larger clinical trial
can be conducted in the future to tell us which operation is best.
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.
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03790956 -
Silk Protein Microparticle-based Filler for Injection Augmentation
|
N/A |