VOCALIST: Does Laryngeal Reinnervation or Type I Thyroplasty give better voice results for patients with Unilateral Vocal Fold Paralysis?
VOCALIST Scientific Summary:
The aim of the study is to establish the feasibility of a multi-centre, randomised phase III clinical trial of surgical treatment for UVFP.
Main objectives are to test the feasibility of:
- The multicentre recruitment process, including continuous improvement technology based on qualitative methodology
- Recruiters being able to present true equipoise with the treatment arms
- The randomisation process and investigate reasons for any difficulties that affect recruitment
- 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
- Process of follow up visits
- Means of gathering health economics and health-related quality of life data suitable for measuring cost effectiveness
The trial will be recruiting at four hospitals;
- Royal National Throat Nose and Ear Hospital, London - CI Professor Martin Birchall
- Manchester Royal Infirmary , Manchester – PI Dr Yakubu Karagama
- Poole Hospital, Dorset - PI Dr Kate Heathcote
- Lewisham Hospital, London - PI Mr Nick Gibbins
Should you wish to receive more information on the scientific aspects of this study, please contact the lead Researcher Dr Helen Blackshaw firstname.lastname@example.org.