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.
DESIGN AND SETTING: Descriptive cross-sectional study in a tertiary center.
PARTICIPANTS AND METHODS: The subjects are 274 audio files of voices of patients undergoing thyroid, parathyroid surgeries, and known VCP due to other neck surgeries. Voice assessments were done by three endocrine surgeons (A, B, and C) with 20, 12, and 4 years of surgical experience.
MAIN OUTCOME MEASURES: Sensitivity and specificity of surgeon documented voice assessment in patients with underlying VCP. Subjects' acoustic analysis and Voice Handicap Index (VHI-10) were analyzed.
RESULTS: Raters A, B, and C have sensitivity of 63.6%, 78.8%, and 66.7%, respectively. Inter-rater reliability shows substantial agreement (ƙ = 0.67). VHI-10 has sensitivity of 75.8% and strong correlation of 0.707 (p value <0.001) to VCP. Subjects with VCP have notably higher jitter, shimmer, and noise-to-harmonic ratio compared to normal subjects with sensitivity of 74.2%, 71.2%, and 72.7%, respectively.
CONCLUSIONS: The results for surgeons documented voice assessment did not reach the desired sensitivity for a screening tool for patients with underlying VCP. Other tools such as VHI-10 and acoustic analysis may not be used as standalone tools in screening patients with underlying VCP. Routine preoperative laryngeal examination may be recommended for all patients undergoing thyroid, parathyroid, or other surgeries that places the laryngeal nerves at risk.
METHODS: Two middle-aged women with vagal paraganglioma undergoing an excision operation underwent immediate selective laryngeal reinnervation using the phrenic nerve and ansa cervicalis as the donor nerve. Multidimensional outcome measures were employed pre-operatively, and at 1, 6 and 12 months post-operatively.
RESULTS: The voice handicap index-10 score improved from 23 (patient 1) and 18 (patient 2) at 1 month post-operation, to 5 (patient 1) and 1 (patient 2) at 12 months. The Eating Assessment Tool 10 score improved from 20 (patient 1) and 24 (patient 2) at 1 month post-operation, to 3 (patient 1) and 1 (patient 2) at 12 months. There was slight vocal fold abduction observed in patient one and no obvious abduction in patient two.
CONCLUSION: Selective reinnervation is safe to perform following vagal paraganglioma excision conducted on the same side. Voice and swallowing improvements were demonstrated, but no significant vocal fold abduction was achieved.