Laryngeal Reinnervation Versus Thyroplasty in Patients With Vocal Fold Weakness.
Condition: Vocal Cord Paralysis Unilateral
MeSH terms: Vocal Cord Paralysis; Paralysis
Study type: Interventional
Phase: Phase 2

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Thyroplasty; Reinnervation
Intervention type(s): Procedure; Procedure
Intervention description(s): This medialisation/augmentation technique is a static technique, performed under local anaesthesia that aims to improve the positioning of the paralysed vocal fold. It uses a silastic implant readily available in different sizes according to size of larynx and gender of the patient. The correct size can be determined intraoperatively by using a measuring device while listening and visualising the larynx with flexible fiberoptic scope simultaneously.; For laryngeal reinnervation, ansa cervicalis to recurrent laryngeal nerve repair technique will be used. In this technique, the functioning ansa cervicalis nerve that overlies the internal jugular vein and the distal stump of injured recurrent laryngeal nerve (RLN) will be identified and anastomosed without tension (Crumley RL. Teflon versus thyroplasty versus nerve transfer: a comparison. The Annals of otology, rhinology, and laryngology. 1990;99(10 Pt 1):759-63).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Type I Thyroplasty; Reinnervation