Does Laryngeal Reinnervation or Type I Thyroplasty Give Better Voice Results for Patients With Unilateral Vocal Fold Paralysis (VOCALIST): a Feasibility Study.
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Vocal Cord Paralysis Unilateral
- Sponsor
- Royal National Throat, Nose and Ear Hospital
- Enrollment
- 23
- Locations
- 1
- Primary Endpoint
- Whether the participant successfully received the allocated operation (yes/no)
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief 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.
Investigators
Professor Martin Birchall
Professor
Royal National Throat, Nose and Ear Hospital
Eligibility Criteria
Inclusion Criteria
- •UVFP due to unilateral recurrent laryngeal nerve paralysis of traumatic, iatrogenic or idiopathic origin of between 6 and 60 months duration. Or symptoms that have not sufficiently improved with speech therapy alone, as determined by the patient and agreed by a multidisciplinary clinical team, after 6 months and pending a surgical decision.
- •Age from 18 to 70 years old
- •Male or female
- •Able to provide informed consent
- •A significant voice disorder as measured by perceptual rating (Grade ≥2 GRBAS Scale) and Voice Handicap Index (VHI-10 score \>16)
- •Common laryngeal electromyography (EMG, neurophysiological) criteria (Koufman Grades 2-5) in either the thyroarytenoid (TA) or posterior cricoarytenoid (PCA) muscle on the paralysed side.
Exclusion Criteria
- •Impaired vocal fold mobility but a normal EMG (Koufman Grade I)
- •Severe lung disorders
- •Structural vocal fold lesions such as polyp
- •Previous laryngeal framework surgery
- •Cricoarytenoid joint fixation (CAJF)
- •Significant non-laryngeal speech abnormality (severe dysarthria determined by a panel of trained speech therapists)
- •Previous Level 2, 3 or 4 thyroid neck dissection
- •Previous ipsilateral surgical neck dissection
- •Previous radiotherapy to the head and neck
- •Laryngeal injection of a rapidly absorbable material in the last 6 months.
Outcomes
Primary Outcomes
Whether the participant successfully received the allocated operation (yes/no)
Time Frame: 24 months
From those participants who were eligible to enter the study, whether the participant successfully received the allocated operation (yes/no)
Whether the participant was randomised (yes/no)
Time Frame: 24 months
From those participants who were eligible to enter the study, whether the participant was randomised (yes/no)
Whether the participant completed the trial (yes/no)
Time Frame: 24 months
From those participants who were eligible to enter the study, whether the participant completed the trial (yes/no)
Secondary Outcomes
- Whether the Study Management Group (SMG) and recruiters are in clinical equipoise in relation to treatment arms (yes/no) measured by Qualitative researcher via interviews.(24 months)
- The Stroboscopy Research Instrument (SRI) scale will be used to rate the Vocal cord vibration.(Baseline, 6 months and 12 month post surgery)
- Perceptual voice quality analysis will be determined using the GRBAS scale.(Baseline, 6 months and 12 month post surgery)
- Patient and surgeon/speech therapist views on utility of chosen outcome measure measured by Qualitative researcher via interviews. measures(24 months)
- The validated VHI-10 [134] will be used to evaluate the psychosocial effects of voice disorder.(Baseline, 6 months and 12 month post surgery)
- The validated Eating Assessment Tool (EAT-10) [1920] will be used to evaluate the effects of swallowing.(Baseline, 6 months and 12 month post surgery)
- The validated 100ml Water Swallow test will be used to measure the participants' swallowing.(Baseline, 6 months and 12 month post surgery)
- Interaction between recruiter and patient during recruitment process measured by Qualitative researcher via interviews.(24 months)
- The validated EQ-5D-5L questionnaire will be used to evaluate the participants' health-related quality of life(Baseline, 6 months and 12 month post surgery)
- Laryngeal EMG will be used to detect laryngeal muscle activity.(Baseline, 6 months and 12 month post surgery)
- Whether surgeons and speech therapists are in clinical equipoise in relation to treatment arms (yes/no) measured by Qualitative researcher via interviews. between the two treatments(24 months)
- Patient views and beliefs on randomisation, recruitment and retention measured by Qualitative researcher via interviews. processes(24 months)
- The OperaVOX™ system will also be used to perform the acoustic voice analysis.(Baseline, 6 months and 12 month post surgery)
- Cost of laryngeal reinnervation versus thyroplasty procedures for unilateral vocal fold paralysis.(24 months)
- Lifetime incremental cost per quality-adjusted life year QALY gained of laryngeal reinnervation versus thyroplasty.(24 months)