METHODS AND ANALYSIS: A feasibility study to test the practicality of running a multicentre, randomised clinical trial of surgery for UVFP, including: (1) a qualitative study to understand the recruitment process and how it operates in clinical centres and (2) a small randomised trial of 30 participants recruited at 3 UK sites comparing non-selective laryngeal reinnervation to type I thyroplasty. Participants will be followed up for 12 months. The primary outcome focuses on recruitment and retention, with secondary outcomes covering voice, swallowing and quality of life.
ETHICS AND DISSEMINATION: Ethical approval was received from National Research Ethics Service-Committee Bromley (reference 11/LO/0583). In addition to dissemination of results through presentation and publication of peer-reviewed articles, results will be shared with key clinician and patient groups required to develop the future large-scale randomised controlled trial.
TRIAL REGISTRATION NUMBER: ISRCTN90201732; 16 December 2015.
METHODS: This prospective observational study comprised 34 newly diagnosed unilateral vocal fold paralysis patients undergoing surgical interventions: injection laryngoplasty or medialisation thyroplasty. Voice assessments, including maximum vocal intensity and other acoustic parameters, were performed at baseline and at one and three months post-intervention. Maximum vocal intensity was also repeated within two weeks before any surgical interventions were performed. The results were compared between different time points and between the two intervention groups.
RESULTS: Maximum vocal intensity showed high internal consistency. Statistically significant improvements were seen in maximum vocal intensity, Voice Handicap Index-10 and other acoustic analyses at one and three months post-intervention. A significant moderate negative correlation was demonstrated between maximum vocal intensity and Voice Handicap Index-10, shimmer and jitter. There were no significant differences in voice outcomes between injection laryngoplasty and medialisation thyroplasty patients at any time point.
CONCLUSION: Maximum vocal intensity can be applied as a treatment outcome measure in unilateral vocal fold paralysis patients; it can demonstrate the effectiveness of treatment and moderately correlates with self-reported outcome measures.
METHODS: CT scans of the neck of two hundred patients were analysed by two groups of raters. For thyrohyoid approach, mean distance from the superior border of the thyroid cartilage to the laryngeal cavity (THd) and mean angle from the superior border of the thyroid cartilage to mid-true cords (THa) were measured. For transthyroid approach, mean distance from mid-thyroid cartilage to mid-true cords (TTd) and Hounsfield unit (HU) at mid-thyroid cartilage (TTc) were measured. For cricothyroid approach, mean distance from the inferior border of the thyroid cartilage to the laryngeal cavity (CTd) and mean angle from the inferior border of the thyroid cartilage to mid-true cords (CTa) were measured.
RESULTS: There were statistically significant differences between males and females for all measurements except for CTa (p 0.05). There was a significant fair positive correlation between age and TTc (p = 0.0002). For all measurements obtained, there were moderate to excellent inter-group consistency and intra-rater reliability.
CONCLUSION: This study demonstrated a significant sex dimorphism that may influence the three TIL approaches except for needle angulation in the cricothyroid approach. The knowledge of laryngeal dimension is important to increase success in TIL procedure.