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| ID | Type | Description | Link |
|---|---|---|---|
| PB-PG-1013-32058 | Other Identifier | University College London Hospitals NHS Foundation Trust |
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| Name | Class |
|---|---|
| University College Joint Research Office | UNKNOWN |
| University College London Hospitals | OTHER |
| National Institute for Health Research, United Kingdom | OTHER_GOV |
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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Thyroplasty | Active Comparator | 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. |
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| Reinnervation | Active Comparator | 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Thyroplasty | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Whether the participant was randomised (yes/no) | From those participants who were eligible to enter the study, whether the participant was randomised (yes/no) | 24 months |
| Whether the participant successfully received the allocated operation (yes/no) | From those participants who were eligible to enter the study, whether the participant successfully received the allocated operation (yes/no) | 24 months |
| Whether the participant completed the trial (yes/no) | From those participants who were eligible to enter the study, whether the participant completed the trial (yes/no) | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Assessed by a Qualitative researcher via interviews with SMG members/recruiters which will explore views on the trial design and treatment groups ('arms'), perceptions of uncertainty/equipoise, views about eligibility criteria, and accounts of how the protocol is delivered in practice. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Professor Martin Birchall, FRCS,FMedSci | University College London Hospitals | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal National Throat Nose and Ear Hospital, 330 Gray's Inn Road | London | WC1X 8DA | United Kingdom |
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| ID | Term |
|---|---|
| D014826 | Vocal Cord Paralysis |
| ID | Term |
|---|---|
| D007818 | Laryngeal Diseases |
| D012140 | Respiratory Tract Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D020421 | Vagus Nerve Diseases |
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| ID | Term |
|---|---|
| D058753 | Laryngoplasty |
| ID | Term |
|---|---|
| D013517 | Otorhinolaryngologic Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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| Sealed Envelope: Redpill Online Application |
| UNKNOWN |
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| Reinnervation | Procedure | 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). |
|
| 24 months |
| 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 | Assessed by a Qualitative researcher via interviews with SMG members/recruiters which will explore views on the trial design and treatment groups ('arms'), perceptions of uncertainty/equipoise, views about eligibility criteria, and accounts of how the protocol is delivered in practice. | 24 months |
| Patient views and beliefs on randomisation, recruitment and retention measured by Qualitative researcher via interviews. processes | Assessed by a Qualitative researcher via interviews with patients will explore the acceptability of the trial interventions and trial processes and reasons for participation / non-participation (where applicable). | 24 months |
| Patient and surgeon/speech therapist views on utility of chosen outcome measure measured by Qualitative researcher via interviews. measures | Assessed by a Qualitative researcher via interviews with SMG members/recruiters which will explore views on the trial design and treatment groups ('arms'), perceptions of uncertainty/equipoise, views about eligibility criteria, and accounts of how the protocol is delivered in practice. Interviews with patients will explore the acceptability of the trial interventions and trial processes and reasons for participation / non-participation (where applicable). | 24 months |
| Interaction between recruiter and patient during recruitment process measured by Qualitative researcher via interviews. | Assessed by a Qualitative researcher via interviews with SMG members/recruiters which will explore views on the trial design and treatment groups ('arms'), perceptions of uncertainty/equipoise, views about eligibility criteria, and accounts of how the protocol is delivered in practice.Interviews with patients will explore the acceptability of the trial interventions and trial processes and reasons for participation / non-participation (where applicable). | 24 months |
| The validated EQ-5D-5L questionnaire will be used to evaluate the participants' health-related quality of life | The secondary outcome measures will be plotted against time, and outcome differences between the surgical groups will be estimated, with 95% confidence intervals, using ANCOVA methodology that adjusts for baseline outcome measures. | Baseline, 6 months and 12 month post surgery |
| The validated VHI-10 [134] will be used to evaluate the psychosocial effects of voice disorder. | The secondary outcome measures will be plotted against time, and outcome differences between the surgical groups will be estimated, with 95% confidence intervals, using ANCOVA methodology that adjusts for baseline outcome measures. | 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. | The secondary outcome measures will be plotted against time, and outcome differences between the surgical groups will be estimated, with 95% confidence intervals, using ANCOVA methodology that adjusts for baseline outcome measures. | Baseline, 6 months and 12 month post surgery |
| The Stroboscopy Research Instrument (SRI) scale will be used to rate the Vocal cord vibration. | The secondary outcome measures will be plotted against time, and outcome differences between the surgical groups will be estimated, with 95% confidence intervals, using ANCOVA methodology that adjusts for baseline outcome measures. | Baseline, 6 months and 12 month post surgery |
| Perceptual voice quality analysis will be determined using the GRBAS scale. | The secondary outcome measures will be plotted against time, and outcome differences between the surgical groups will be estimated, with 95% confidence intervals, using ANCOVA methodology that adjusts for baseline outcome measures. | Baseline, 6 months and 12 month post surgery |
| The OperaVOX™ system will also be used to perform the acoustic voice analysis. | The secondary outcome measures will be plotted against time, and outcome differences between the surgical groups will be estimated, with 95% confidence intervals, using ANCOVA methodology that adjusts for baseline outcome measures. | Baseline, 6 months and 12 month post surgery |
| The validated 100ml Water Swallow test will be used to measure the participants' swallowing. | The secondary outcome measures will be plotted against time, and outcome differences between the surgical groups will be estimated, with 95% confidence intervals, using ANCOVA methodology that adjusts for baseline outcome measures. | Baseline, 6 months and 12 month post surgery |
| Laryngeal EMG will be used to detect laryngeal muscle activity. | The secondary outcome measures will be plotted against time, and outcome differences between the surgical groups will be estimated, with 95% confidence intervals, using ANCOVA methodology that adjusts for baseline outcome measures. | Baseline, 6 months and 12 month post surgery |
| Cost of laryngeal reinnervation versus thyroplasty procedures for unilateral vocal fold paralysis. | A detailed cost analysis of laryngeal reinnervation and thyroplasty procedures will be undertaken, since these are likely to be major cost components affecting the relative cost-effectiveness of laryngeal reinnervation. This will include the costs of the index procedure (staff costs, theatre costs, costs of consumables, recovery costs), length of hospital stay for index procedure, post-operative ibuprofen, and speech and language therapy. Costs for the index procedure will be obtained from the hospital finance department. | 24 months |
| Lifetime incremental cost per quality-adjusted life year QALY gained of laryngeal reinnervation versus thyroplasty. | An analysis of the feasibility study for a full economic evaluation of laryngeal reinnervation versus thyroplasty that will accompany the Phase III trial. This will be based on the idea that we will be aiming estimate the lifetime incremental cost per quality-adjusted life year (QALY) gained of laryngeal reinnervation versus thyroplasty, the outcome measure recommended by NICE when evaluating the cost-effectiveness of health care programmes in the NHS. | 24 months |
| D003389 | Cranial Nerve Diseases |
| D009422 | Nervous System Diseases |
| D010243 | Paralysis |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |