<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02973152</url>
  </required_header>
  <id_info>
    <org_study_id>11/0107</org_study_id>
    <secondary_id>PB-PG-1013-32058</secondary_id>
    <nct_id>NCT02973152</nct_id>
  </id_info>
  <brief_title>Laryngeal Reinnervation Versus Thyroplasty in Patients With Vocal Fold Weakness.</brief_title>
  <acronym>VOCALIST</acronym>
  <official_title>Does Laryngeal Reinnervation or Type I Thyroplasty Give Better Voice Results for Patients With Unilateral Vocal Fold Paralysis (VOCALIST): a Feasibility Study.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Royal National Throat, Nose and Ear Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University College Joint Research Office</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University College London Hospitals</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>NIHR Research for Patient Benefit (RfPB)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Sealed Envelope: Redpill Online Application</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Royal National Throat, Nose and Ear Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to help determine the most effective treatment for participants&#xD;
      with Unilateral Vocal Fold Paralysis.&#xD;
&#xD;
      There are currently two types of operations used to treat this condition. One operation is&#xD;
      called thyroplasty. Doctors place a small piece of safe plastic into the side of the&#xD;
      participant's voice box to push the weak vocal cord into a position to enable better speech&#xD;
      and swallowing. In the other operation called laryngeal reinnervation, doctors repair the&#xD;
      neck nerve supply to the vocal cord using parts of other unaffected nerves to enable better&#xD;
      speech and swallowing. The investigators do not know which of these methods is better and are&#xD;
      conducting this study to start comparing the two operations so that a larger clinical trial&#xD;
      can be conducted in the future to tell us which operation is best.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Title: Does Laryngeal Reinnervation or Type I Thyroplasty give better voice results for&#xD;
      patients with Unilateral Vocal Fold Paralysis (VOCALIST): a feasibility study&#xD;
&#xD;
      Short title: VOCALIST&#xD;
&#xD;
      Trial medication: Not Applicable&#xD;
&#xD;
      Phase of trial: Phase IIb&#xD;
&#xD;
      Objectives: The aim of the study is to establish the feasibility of a multicentre, randomised&#xD;
      phase III clinical trial of surgical treatment for Unilateral Vocal Fold Paralysis (UVFP).&#xD;
&#xD;
      Main objectives are to test the feasibility of:&#xD;
&#xD;
        1. the multicentre recruitment process, including continuous improvement to the process&#xD;
           based on qualitative analysis;&#xD;
&#xD;
        2. recruiters being able to present true equipoise with the treatment arms;&#xD;
&#xD;
        3. the randomisation process and investigate reasons for any difficulties that affect&#xD;
           recruitment&#xD;
&#xD;
        4. the utility of the following characteristics of the proposed primary (voice handicap&#xD;
           index) and secondary outcomes: variability across patients, variability over time,&#xD;
           differences in outcome between randomised groups over time;&#xD;
&#xD;
        5. process of follow up visits and diary completion;&#xD;
&#xD;
        6. means of gathering health economics and health-related quality of life data suitable for&#xD;
           measuring cost effectiveness.&#xD;
&#xD;
      Type of trial: Quantitative and Qualitative Feasibility Study; multi-centre randomised&#xD;
      controlled trial&#xD;
&#xD;
      Trial design and methods: 30 patients will be randomised to receive the Laryngeal&#xD;
      Reinnervation or Type I Thyroplasty surgery.&#xD;
&#xD;
      Trial duration per participant: 12 months&#xD;
&#xD;
      Estimated total trial duration: 24 months&#xD;
&#xD;
      Planned trial sites: Multi-site; London, Poole and Manchester (3 sites).&#xD;
&#xD;
      Total number of participants planned: 30&#xD;
&#xD;
      Statistical methodology and analysis: The trial analysis will be descriptive and will be&#xD;
      performed on an intention to treat basis. Primary and secondary outcomes will be described&#xD;
      using proportions and means as appropriate, with confidence intervals. No formal comparisons&#xD;
      will be made. The correlations between the voice outcome measures will be calculated. There&#xD;
      is no planned interim analysis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>May 2016</start_date>
  <completion_date type="Actual">April 30, 2018</completion_date>
  <primary_completion_date type="Actual">April 30, 2018</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Whether the participant was randomised (yes/no)</measure>
    <time_frame>24 months</time_frame>
    <description>From those participants who were eligible to enter the study, whether the participant was randomised (yes/no)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Whether the participant successfully received the allocated operation (yes/no)</measure>
    <time_frame>24 months</time_frame>
    <description>From those participants who were eligible to enter the study, whether the participant successfully received the allocated operation (yes/no)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Whether the participant completed the trial (yes/no)</measure>
    <time_frame>24 months</time_frame>
    <description>From those participants who were eligible to enter the study, whether the participant completed the trial (yes/no)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>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.</measure>
    <time_frame>24 months</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>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</measure>
    <time_frame>24 months</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient views and beliefs on randomisation, recruitment and retention measured by Qualitative researcher via interviews. processes</measure>
    <time_frame>24 months</time_frame>
    <description>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).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient and surgeon/speech therapist views on utility of chosen outcome measure measured by Qualitative researcher via interviews. measures</measure>
    <time_frame>24 months</time_frame>
    <description>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).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Interaction between recruiter and patient during recruitment process measured by Qualitative researcher via interviews.</measure>
    <time_frame>24 months</time_frame>
    <description>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).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The validated EQ-5D-5L questionnaire will be used to evaluate the participants' health-related quality of life</measure>
    <time_frame>Baseline, 6 months and 12 month post surgery</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The validated VHI-10 [134] will be used to evaluate the psychosocial effects of voice disorder.</measure>
    <time_frame>Baseline, 6 months and 12 month post surgery</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The validated Eating Assessment Tool (EAT-10) [1920] will be used to evaluate the effects of swallowing.</measure>
    <time_frame>Baseline, 6 months and 12 month post surgery</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Stroboscopy Research Instrument (SRI) scale will be used to rate the Vocal cord vibration.</measure>
    <time_frame>Baseline, 6 months and 12 month post surgery</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Perceptual voice quality analysis will be determined using the GRBAS scale.</measure>
    <time_frame>Baseline, 6 months and 12 month post surgery</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The OperaVOX™ system will also be used to perform the acoustic voice analysis.</measure>
    <time_frame>Baseline, 6 months and 12 month post surgery</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The validated 100ml Water Swallow test will be used to measure the participants' swallowing.</measure>
    <time_frame>Baseline, 6 months and 12 month post surgery</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Laryngeal EMG will be used to detect laryngeal muscle activity.</measure>
    <time_frame>Baseline, 6 months and 12 month post surgery</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cost of laryngeal reinnervation versus thyroplasty procedures for unilateral vocal fold paralysis.</measure>
    <time_frame>24 months</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lifetime incremental cost per quality-adjusted life year QALY gained of laryngeal reinnervation versus thyroplasty.</measure>
    <time_frame>24 months</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">23</enrollment>
  <condition>Vocal Cord Paralysis Unilateral</condition>
  <arm_group>
    <arm_group_label>Thyroplasty</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Reinnervation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>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).</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Thyroplasty</intervention_name>
    <description>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.</description>
    <arm_group_label>Thyroplasty</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Reinnervation</intervention_name>
    <description>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).</description>
    <arm_group_label>Reinnervation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  UVFP due to unilateral recurrent laryngeal nerve paralysis of traumatic, iatrogenic or&#xD;
             idiopathic origin of between 6 and 60 months duration. Or symptoms that have not&#xD;
             sufficiently improved with speech therapy alone, as determined by the patient and&#xD;
             agreed by a multidisciplinary clinical team, after 6 months and pending a surgical&#xD;
             decision.&#xD;
&#xD;
          -  Age from 18 to 70 years old&#xD;
&#xD;
          -  Male or female&#xD;
&#xD;
          -  Able to provide informed consent&#xD;
&#xD;
          -  A significant voice disorder as measured by perceptual rating (Grade ≥2 GRBAS Scale)&#xD;
             and Voice Handicap Index (VHI-10 score &gt;16)&#xD;
&#xD;
          -  Common laryngeal electromyography (EMG, neurophysiological) criteria (Koufman Grades&#xD;
             2-5) in either the thyroarytenoid (TA) or posterior cricoarytenoid (PCA) muscle on the&#xD;
             paralysed side.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Impaired vocal fold mobility but a normal EMG (Koufman Grade I)&#xD;
&#xD;
          -  Severe lung disorders&#xD;
&#xD;
          -  Structural vocal fold lesions such as polyp&#xD;
&#xD;
          -  Previous laryngeal framework surgery&#xD;
&#xD;
          -  Cricoarytenoid joint fixation (CAJF)&#xD;
&#xD;
          -  Significant non-laryngeal speech abnormality (severe dysarthria determined by a panel&#xD;
             of trained speech therapists)&#xD;
&#xD;
          -  Previous Level 2, 3 or 4 thyroid neck dissection&#xD;
&#xD;
          -  Previous ipsilateral surgical neck dissection&#xD;
&#xD;
          -  Previous radiotherapy to the head and neck&#xD;
&#xD;
          -  Laryngeal injection of a rapidly absorbable material in the last 6 months.&#xD;
&#xD;
          -  Previous laryngeal injection of a non-rapidly absorbable material (e.g. bioplastics,&#xD;
             VOX)&#xD;
&#xD;
          -  Neuromuscular disease affecting the larynx or multiple cranial nerve palsies&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Professor Martin Birchall, FRCS,FMedSci</last_name>
    <role>Principal Investigator</role>
    <affiliation>University College London Hospitals</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Royal National Throat Nose and Ear Hospital, 330 Gray's Inn Road</name>
      <address>
        <city>London</city>
        <zip>WC1X 8DA</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>May 2018</verification_date>
  <study_first_submitted>November 3, 2016</study_first_submitted>
  <study_first_submitted_qc>November 21, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 25, 2016</study_first_posted>
  <last_update_submitted>May 25, 2018</last_update_submitted>
  <last_update_submitted_qc>May 25, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">May 29, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Royal National Throat, Nose and Ear Hospital</investigator_affiliation>
    <investigator_full_name>Professor Martin Birchall</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Type I Thyroplasty</keyword>
  <keyword>Reinnervation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vocal Cord Paralysis</mesh_term>
    <mesh_term>Paralysis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02973152
org study id: 11/0107
secondary id: PB-PG-1013-32058
nct id: NCT02973152
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
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:

        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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Whether the participant was randomised (yes/no)
time frame: 24 months
description: From those participants who were eligible to enter the study, whether the participant was randomised (yes/no)
measure: Whether the participant successfully received the allocated operation (yes/no)
time frame: 24 months
description: From those participants who were eligible to enter the study, whether the participant successfully received the allocated operation (yes/no)
measure: Whether the participant completed the trial (yes/no)
time frame: 24 months
description: From those participants who were eligible to enter the study, whether the participant completed the trial (yes/no)
measure: 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.
time frame: 24 months
description: 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.
measure: 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
time frame: 24 months
description: 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.
measure: Patient views and beliefs on randomisation, recruitment and retention measured by Qualitative researcher via interviews. processes
time frame: 24 months
description: 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).
measure: Patient and surgeon/speech therapist views on utility of chosen outcome measure measured by Qualitative researcher via interviews. measures
time frame: 24 months
description: 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).
measure: Interaction between recruiter and patient during recruitment process measured by Qualitative researcher via interviews.
time frame: 24 months
description: 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).
measure: The validated EQ-5D-5L questionnaire will be used to evaluate the participants' health-related quality of life
time frame: Baseline, 6 months and 12 month post surgery
description: 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.
measure: The validated VHI-10 [134] will be used to evaluate the psychosocial effects of voice disorder.
time frame: Baseline, 6 months and 12 month post surgery
description: 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.
measure: The validated Eating Assessment Tool (EAT-10) [1920] will be used to evaluate the effects of swallowing.
time frame: Baseline, 6 months and 12 month post surgery
description: 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.
measure: The Stroboscopy Research Instrument (SRI) scale will be used to rate the Vocal cord vibration.
time frame: Baseline, 6 months and 12 month post surgery
description: 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.
measure: Perceptual voice quality analysis will be determined using the GRBAS scale.
time frame: Baseline, 6 months and 12 month post surgery
description: 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.
measure: The OperaVOX™ system will also be used to perform the acoustic voice analysis.
time frame: Baseline, 6 months and 12 month post surgery
description: 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.
measure: The validated 100ml Water Swallow test will be used to measure the participants' swallowing.
time frame: Baseline, 6 months and 12 month post surgery
description: 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.
measure: Laryngeal EMG will be used to detect laryngeal muscle activity.
time frame: Baseline, 6 months and 12 month post surgery
description: 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.
measure: Cost of laryngeal reinnervation versus thyroplasty procedures for unilateral vocal fold paralysis.
time frame: 24 months
description: 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.
measure: Lifetime incremental cost per quality-adjusted life year QALY gained of laryngeal reinnervation versus thyroplasty.
time frame: 24 months
description: 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.
arm group label: Thyroplasty
arm group type: Active Comparator
description: 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.
arm group label: Reinnervation
arm group type: Active Comparator
description: 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).
intervention type: Procedure
intervention name: Thyroplasty
description: 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.
arm group label: Thyroplasty
intervention type: Procedure
intervention name: Reinnervation
description: 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).
arm group label: Reinnervation
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Professor Martin Birchall, FRCS,FMedSci
role: Principal Investigator
affiliation: University College London Hospitals
facility: 
country: United Kingdom
responsible party type: Principal Investigator
investigator affiliation: Royal National Throat, Nose and Ear Hospital
investigator full name: Professor Martin Birchall
investigator title: Professor
mesh term: Vocal Cord Paralysis
mesh term: Paralysis
sharing ipd: Undecided