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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 h.blackshaw@ucl.ac.uk.