<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/NCT04458818</url>
  </required_header>
  <id_info>
    <org_study_id>Prolene mesh VC medialization</org_study_id>
    <nct_id>NCT04458818</nct_id>
  </id_info>
  <brief_title>A Novel Approach for Thyroplasty Type 1, With Prolene Mesh. A Prospective Study.</brief_title>
  <official_title>A Novel Approach for Thyroplasty Type 1, With Prolene Mesh. A Prospective Study.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Muhammad Rashid</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Pak Emirates Military Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Larynx performs important functions of the aero-digestive tract, it has vital role in control&#xD;
      of breathing, phonation, deglutition and protection of lower respiratory tract from&#xD;
      aspiration. Vocal cord paralysis is a common and at times debilitating laryngeal dysfunction&#xD;
      that has great social and economic impact on patients life. Medialization thyroplasty (MT),&#xD;
      if done accurately and up to the expectations of the patient is very rewarding. However&#xD;
      different materials with some modifications in the technique of the classical Isshiki type 1&#xD;
      thyroplasty is in practice, each with its own profile of benefits and disadvantages. Most of&#xD;
      them are costly and out of reach of general population. In this regard, we aim to test a&#xD;
      prolene mesh implant, which is easily available and can be placed with relative ease.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Introduction: Larynx performs important functions of the aero-digestive tract, it has vital&#xD;
      role in control of breathing, phonation, deglutition and protection of lower respiratory&#xD;
      tract from aspiration. The function of Vocal cord is central to all the Laryngeal functions,&#xD;
      even unilateral paralysis can have profound effect on overall laryngeal functionality&#xD;
      especially in sound production. Around 80% of all the jobs in the world are somehow dependent&#xD;
      upon social communication. Vocal cord paralysis is a common and at times debilitating&#xD;
      laryngeal dysfunction that has great social and economic impact on patients life.&#xD;
      Medialization thyroplasty (MT), if done accurately and up to the expectations of the patient&#xD;
      is very rewarding. However different materials with some modifications in the technique of&#xD;
      the classical Isshiki type 1 thyroplasty is in vogue, each with its own profile of benefits&#xD;
      and disadvantages. In this regard a large variety of complex materials are in use, which are&#xD;
      not routinely available in developing countries and some of them have not been cleared by the&#xD;
      host countries medical authorities. Most of them are costly and out of reach of general&#xD;
      population. In this regard, we aim to test a prolene mesh implant, which is easily available&#xD;
      and can be placed with relative ease. We recommend some modifications in the original&#xD;
      technique, which would not require the complex measurements and costly equipment. Even it can&#xD;
      be performed without fiber-optic laryngoscope guidance. Prolene is already in use in wide&#xD;
      range of procedures worldwide, approved by Federal drug administration in 1997 but it has&#xD;
      never been used in larynx. We intend to explore the efficacy of prolene mesh as an implant&#xD;
      for vocal cord medialization in terms of patient satisfaction and voice outcome.&#xD;
&#xD;
      Objective: To evaluate a new approach of vocal cord medialization using prolene mesh as an&#xD;
      implant material.&#xD;
&#xD;
      Study Design: Interventional, prospective study.. Place and Duration of study: Ent&#xD;
      departments of multiple tertiary care hospitals of Pakistan from Jun 2020 and onwards.&#xD;
&#xD;
      Materials and Methods: Patients of age 15 years onwards and with vocal cord paralysis/&#xD;
      paresis due to multiple causes would included in the study. Patients with neoplasm, trauma&#xD;
      and underlying muscular dystrophy are to be excluded. All patients will be counselled&#xD;
      properly and given the choice of intervention by prolene mesh implant. Consenting patients&#xD;
      will be subjected to routine blood investigations with fiber optic laryngoscopy and imaging&#xD;
      with Computerized Tomography scan (where applicable). Procedure will be performed under local&#xD;
      anesthesia with mild sedation, so that the patient will remain vocally responsive for the&#xD;
      assessment of voice and breathing intraoperatively. Pre and postoperative voices will be&#xD;
      recorded with a standard microphone at 15cm distance from the mouth in a quiet room. Maximum&#xD;
      phonation time (MPT) while vocalizing the vowel sound 'eee' and Maximum words count (MWC) in&#xD;
      a single breath (counting numbers) will be recorded pre and post operatively. Maximum three&#xD;
      attempts will be allowed to each patient and the better score of the three will be recorded&#xD;
      in the data. For subjective assessment of voice quality Visual (1-10) analogue score (VAS)&#xD;
      will be used both pre and postoperatively. For objective assessment of patients a customized&#xD;
      Voice Handicap Index (VHI-10) will be used.&#xD;
&#xD;
      Modified VHI-10 Questionnaire&#xD;
&#xD;
        1. My voice makes it difficult for people to hear me. 0 1 2 3 4 5&#xD;
&#xD;
        2. I run out of air when I talk. 0 1 2 3 4 5&#xD;
&#xD;
        3. People have difficulty understanding me in noisy room. 0 1 2 3 4 5&#xD;
&#xD;
        4. I use a great deal of effort to speak. 0 1 2 3 4 5&#xD;
&#xD;
        5. My family has difficulty hearing me when I call them throughout the house. 0 1 2 3 4 5&#xD;
&#xD;
        6. I use phone less often than I would like to. 0 1 2 3 4 5&#xD;
&#xD;
        7. I am tense when I am talking to others because of my voice. 0 1 2 3 4 5&#xD;
&#xD;
        8. I tend to avoid groups of people because of my voice. 0 1 2 3 4 5&#xD;
&#xD;
        9. People seem irritated with my voice. 0 1 2 3 4 5&#xD;
&#xD;
       10. People ask what's wrong with my voice. 0 1 2 3 4 5 VHI : Voice Handicap Index 0 = never,&#xD;
           1 = almost never (occasionally), 2 = sometimes, 3 = almost always, 4 = always Fig 1.1&#xD;
           Modified Voice Handicap Index (VHI-10)&#xD;
&#xD;
      Hospital ethical committee's approval will be obtained. The surgery will be performed under&#xD;
      local anesthesia (lignocaine with adrenaline 2%) and procedural sedation with propofol&#xD;
      25-100mcg/kg/min (only sedative dose) will be administered, so that the patient remains&#xD;
      vocally responsive during the procedure. Incision will be made at the lower border of thyroid&#xD;
      cartilage under aseptic measures. Skin flaps will be raised in sub-platysmal plane, strap&#xD;
      muscles will be separated in the midline to expose the laryngeal cartilaginous framework. A&#xD;
      simple laryngeal window approach will be used to place the Ethicon prolene mesh 6 x 6 cm&#xD;
      Swiss roll, secured with prolene 2/0 suture trimmed to the required size. Post op voice&#xD;
      analysis will be done on 14th post-operative day. Routine monthly follow up for 3 months will&#xD;
      be advised after that.&#xD;
&#xD;
      The results will be analyzed using Internal IBM SPSS Statistics version 20. Variables defined&#xD;
      would be compared between the preoperative and postoperative groups. For normal data paired&#xD;
      sample t-test would be used and for abnormally distributed data non parametric t-test would&#xD;
      be used. P-value of less than 0.05 will be taken as significant.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 1, 2020</start_date>
  <completion_date type="Actual">January 30, 2021</completion_date>
  <primary_completion_date type="Actual">January 30, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>The single group will be implanted with Prolene mesh made into Swiss rolls and placed in Laryngeal Window between the cartilage and inner periosteum,</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>No Masking. Patients in one arm are provided with prolene mesh implant, and is known by the patient, health care provider and the assessor.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Mean Phonation Time</measure>
    <time_frame>Preoperative and 14th Postoperative day</time_frame>
    <description>Pre and postoperative voices will be recorded with a standard microphone at 15cm distance from the mouth in a quiet room. Maximum phonation time (MPT) while vocalizing the vowel sound 'eee' will be measured in seconds. Maximum three attempts will be allowed to each patient and the better score of the three will be recorded in the data.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Maximum Words Count</measure>
    <time_frame>Preoperative and 14th Postoperative day</time_frame>
    <description>Pre and postoperative voices will be recorded with a standard microphone at 15cm distance from the mouth in a quiet room. Maximum words count (MWC) in a single breath (counting numbers) will be recorded pre and post operatively. Maximum three attempts will be allowed to each patient and the better score of the three will be recorded in the data.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Voice Quality on Visual Analogue Score</measure>
    <time_frame>Preoperative and 14th Postoperative day</time_frame>
    <description>For subjective assessment of voice quality Visual (1-10) analogue score (VAS) will be used both pre and postoperatively. Score 1 will be the score for lowest and 10 being the best score for voice quality.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">39</enrollment>
  <condition>Vocal Cord Paralysis</condition>
  <condition>Phonasthenia</condition>
  <condition>Presbylarynges</condition>
  <condition>Idiopathic Vocal Cord Paralysis</condition>
  <condition>Ca Larynx</condition>
  <arm_group>
    <arm_group_label>Prolene Mesh Implant</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The Group of Patients who were offered Prolene mesh Laryngeal implants for Vocal Cord Medialization.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Prolene Mesh Vocal Cord Medialization Implant</intervention_name>
    <description>The surgery will be performed under local anesthesia (lignocaine with adrenaline 2%) and procedural sedation with propofol 25-100mcg/kg/min (only sedative dose) will be administered, so that the patient remains vocally responsive during the procedure. Incision will be made at the lower border of thyroid cartilage under aseptic measures. Skin flaps will be raised in sub-platysmal plane, strap muscles will be separated in the midline to expose the laryngeal cartilaginous framework. A simple laryngeal window approach will be used to place the Ethicon prolene mesh 6 x 6cm Swiss roll, secured with prolene 2/0 suture trimmed to the required size. Post op voice analysis will be done on 7th day and 14th post-operative day. Monthly follow up will be advised after that.</description>
    <arm_group_label>Prolene Mesh Implant</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age more than 15 years&#xD;
&#xD;
          -  Vocal cord paralysis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with neoplasms&#xD;
&#xD;
          -  Trauma&#xD;
&#xD;
          -  Muscular dystrophies&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>15 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>ENT Departments</name>
      <address>
        <city>Kharian</city>
        <state>Punjab</state>
        <zip>500090</zip>
        <country>Pakistan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Pakistan</country>
  </location_countries>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>June 26, 2020</study_first_submitted>
  <study_first_submitted_qc>July 2, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 2020</study_first_posted>
  <results_first_submitted>March 22, 2021</results_first_submitted>
  <results_first_submitted_qc>April 28, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">April 29, 2021</results_first_posted>
  <last_update_submitted>April 28, 2021</last_update_submitted>
  <last_update_submitted_qc>April 28, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 29, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Pak Emirates Military Hospital</investigator_affiliation>
    <investigator_full_name>Muhammad Rashid</investigator_full_name>
    <investigator_title>Professor of ENT</investigator_title>
  </responsible_party>
  <keyword>Voice Rehabilitation</keyword>
  <keyword>Vocal Medialization</keyword>
  <keyword>Prolene mesh implant</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>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>March 3, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/18/NCT04458818/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>01 May 2020 - 30 Jan 2021</recruitment_details>
      <pre_assignment_details>Before inducting into the study, patients were tested with exclusion criteria i.e Neoplasia, trauma and muscular dystrophy cases, and inclusion criteria i.e.15 years and younger, vocal cord paralysis and voice disability.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Prolene Mesh Implant</title>
          <description>The Group of Patients who were offered Prolene mesh Laryngeal implants for Vocal Cord Medialization.&#xD;
Prolene Mesh Vocal Cord Medialization Implant: The surgery will be performed under local anesthesia (lignocaine with adrenaline 2%) and procedural sedation with propofol 25-100mcg/kg/min (only sedative dose) will be administered, so that the patient remains vocally responsive during the procedure. Incision will be made at the lower border of thyroid cartilage under aseptic measures. Skin flaps will be raised in sub-platysmal plane, strap muscles will be separated in the midline to expose the laryngeal cartilaginous framework. A simple laryngeal window approach will be used to place the Ethicon prolene mesh 6 x 6cm Swiss roll, secured with prolene 2/0 suture trimmed to the required size. Post op voice analysis will be done on 7th day and 14th post-operative day. Monthly follow up will be advised after that.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="39">May 01 2020</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="39">Jan 30 2021</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Prolene Mesh Implant</title>
          <description>The Group of Patients who were offered Prolene mesh Laryngeal implants for Vocal Cord Medialization.&#xD;
Prolene Mesh Vocal Cord Medialization Implant: The surgery will be performed under local anesthesia (lignocaine with adrenaline 2%) and procedural sedation with propofol 25-100mcg/kg/min (only sedative dose) will be administered, so that the patient remains vocally responsive during the procedure. Incision will be made at the lower border of thyroid cartilage under aseptic measures. Skin flaps will be raised in sub-platysmal plane, strap muscles will be separated in the midline to expose the laryngeal cartilaginous framework. A simple laryngeal window approach will be used to place the Ethicon prolene mesh 6 x 6cm Swiss roll, secured with prolene 2/0 suture trimmed to the required size. Post op voice analysis will be done on 7th day and 14th post-operative day. Monthly follow up will be advised after that.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="39"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="39"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="32"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="39"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="24"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Pakistan</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="39"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change in Mean Phonation Time</title>
        <description>Pre and postoperative voices will be recorded with a standard microphone at 15cm distance from the mouth in a quiet room. Maximum phonation time (MPT) while vocalizing the vowel sound 'eee' will be measured in seconds. Maximum three attempts will be allowed to each patient and the better score of the three will be recorded in the data.</description>
        <time_frame>Preoperative and 14th Postoperative day</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Prolene Mesh Implant</title>
            <description>The Group of Patients who were offered Prolene mesh Laryngeal implants for Vocal Cord Medialization.&#xD;
Prolene Mesh Vocal Cord Medialization Implant: The surgery will be performed under local anesthesia (lignocaine with adrenaline 2%) and procedural sedation with propofol 25-100mcg/kg/min (only sedative dose) will be administered, so that the patient remains vocally responsive during the procedure. Incision will be made at the lower border of thyroid cartilage under aseptic measures. Skin flaps will be raised in sub-platysmal plane, strap muscles will be separated in the midline to expose the laryngeal cartilaginous framework. A simple laryngeal window approach will be used to place the Ethicon prolene mesh 6 x 6cm Swiss roll, secured with prolene 2/0 suture trimmed to the required size. Post op voice analysis will be done on 7th day and 14th post-operative day. Monthly follow up will be advised after that.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Mean Phonation Time</title>
          <description>Pre and postoperative voices will be recorded with a standard microphone at 15cm distance from the mouth in a quiet room. Maximum phonation time (MPT) while vocalizing the vowel sound 'eee' will be measured in seconds. Maximum three attempts will be allowed to each patient and the better score of the three will be recorded in the data.</description>
          <units>seconds</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="39"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>pre operative</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.74" spread="1.712"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>post operative</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.08" spread="3.390"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change in Maximum Words Count</title>
        <description>Pre and postoperative voices will be recorded with a standard microphone at 15cm distance from the mouth in a quiet room. Maximum words count (MWC) in a single breath (counting numbers) will be recorded pre and post operatively. Maximum three attempts will be allowed to each patient and the better score of the three will be recorded in the data.</description>
        <time_frame>Preoperative and 14th Postoperative day</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Prolene Mesh Implant</title>
            <description>The Group of Patients who were offered Prolene mesh Laryngeal implants for Vocal Cord Medialization.&#xD;
Prolene Mesh Vocal Cord Medialization Implant: The surgery will be performed under local anesthesia (lignocaine with adrenaline 2%) and procedural sedation with propofol 25-100mcg/kg/min (only sedative dose) will be administered, so that the patient remains vocally responsive during the procedure. Incision will be made at the lower border of thyroid cartilage under aseptic measures. Skin flaps will be raised in sub-platysmal plane, strap muscles will be separated in the midline to expose the laryngeal cartilaginous framework. A simple laryngeal window approach will be used to place the Ethicon prolene mesh 6 x 6cm Swiss roll, secured with prolene 2/0 suture trimmed to the required size. Post op voice analysis will be done on 7th day and 14th post-operative day. Monthly follow up will be advised after that.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Maximum Words Count</title>
          <description>Pre and postoperative voices will be recorded with a standard microphone at 15cm distance from the mouth in a quiet room. Maximum words count (MWC) in a single breath (counting numbers) will be recorded pre and post operatively. Maximum three attempts will be allowed to each patient and the better score of the three will be recorded in the data.</description>
          <units>words</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="39"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>pre operative</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.33" spread="3.359"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>post operative</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.28" spread="5.047"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change in Voice Quality on Visual Analogue Score</title>
        <description>For subjective assessment of voice quality Visual (1-10) analogue score (VAS) will be used both pre and postoperatively. Score 1 will be the score for lowest and 10 being the best score for voice quality.</description>
        <time_frame>Preoperative and 14th Postoperative day</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Prolene Mesh Implant</title>
            <description>The Group of Patients who were offered Prolene mesh Laryngeal implants for Vocal Cord Medialization.&#xD;
Prolene Mesh Vocal Cord Medialization Implant: The surgery will be performed under local anesthesia (lignocaine with adrenaline 2%) and procedural sedation with propofol 25-100mcg/kg/min (only sedative dose) will be administered, so that the patient remains vocally responsive during the procedure. Incision will be made at the lower border of thyroid cartilage under aseptic measures. Skin flaps will be raised in sub-platysmal plane, strap muscles will be separated in the midline to expose the laryngeal cartilaginous framework. A simple laryngeal window approach will be used to place the Ethicon prolene mesh 6 x 6cm Swiss roll, secured with prolene 2/0 suture trimmed to the required size. Post op voice analysis will be done on 7th day and 14th post-operative day. Monthly follow up will be advised after that.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Voice Quality on Visual Analogue Score</title>
          <description>For subjective assessment of voice quality Visual (1-10) analogue score (VAS) will be used both pre and postoperatively. Score 1 will be the score for lowest and 10 being the best score for voice quality.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="39"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>pre operative</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.77" spread="1.224"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>post operative</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.64" spread="1.308"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>1 year follow up was kept for all the patients.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Prolene Mesh Implant</title>
          <description>The Group of Patients who were offered Prolene mesh Laryngeal implants for Vocal Cord Medialization.&#xD;
Prolene Mesh Vocal Cord Medialization Implant: The surgery will be performed under local anesthesia (lignocaine with adrenaline 2%) and procedural sedation with propofol 25-100mcg/kg/min (only sedative dose) will be administered, so that the patient remains vocally responsive during the procedure. Incision will be made at the lower border of thyroid cartilage under aseptic measures. Skin flaps will be raised in sub-platysmal plane, strap muscles will be separated in the midline to expose the laryngeal cartilaginous framework. A simple laryngeal window approach will be used to place the Ethicon prolene mesh 6 x 6cm Swiss roll, secured with prolene 2/0 suture trimmed to the required size. Post op voice analysis will be done on 7th day and 14th post-operative day. Monthly follow up will be advised after that.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="39"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="39"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>2</frequency_threshold>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="39"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>skin infection</sub_title>
                <description>Wound infection, post operatively</description>
                <counts group_id="E1" events="39" subjects_affected="1" subjects_at_risk="39"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>URTI</sub_title>
                <description>Upper respiratory tract infections</description>
                <counts group_id="E1" events="39" subjects_affected="4" subjects_at_risk="39"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr Muhammad Noman Karim</name_or_title>
      <organization>Combined Military Hospital Kharian, Punjab Pakistan</organization>
      <phone>+923313358884</phone>
      <email>f9noman@gmail.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT04458818
org study id: Prolene mesh VC medialization
nct id: NCT04458818
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Larynx performs important functions of the aero-digestive tract, it has vital role in control
      of breathing, phonation, deglutition and protection of lower respiratory tract from
      aspiration. Vocal cord paralysis is a common and at times debilitating laryngeal dysfunction
      that has great social and economic impact on patients life. Medialization thyroplasty (MT),
      if done accurately and up to the expectations of the patient is very rewarding. However
      different materials with some modifications in the technique of the classical Isshiki type 1
      thyroplasty is in practice, each with its own profile of benefits and disadvantages. Most of
      them are costly and out of reach of general population. In this regard, we aim to test a
      prolene mesh implant, which is easily available and can be placed with relative ease.
Introduction: Larynx performs important functions of the aero-digestive tract, it has vital
      role in control of breathing, phonation, deglutition and protection of lower respiratory
      tract from aspiration. The function of Vocal cord is central to all the Laryngeal functions,
      even unilateral paralysis can have profound effect on overall laryngeal functionality
      especially in sound production. Around 80% of all the jobs in the world are somehow dependent
      upon social communication. Vocal cord paralysis is a common and at times debilitating
      laryngeal dysfunction that has great social and economic impact on patients life.
      Medialization thyroplasty (MT), if done accurately and up to the expectations of the patient
      is very rewarding. However different materials with some modifications in the technique of
      the classical Isshiki type 1 thyroplasty is in vogue, each with its own profile of benefits
      and disadvantages. In this regard a large variety of complex materials are in use, which are
      not routinely available in developing countries and some of them have not been cleared by the
      host countries medical authorities. Most of them are costly and out of reach of general
      population. In this regard, we aim to test a prolene mesh implant, which is easily available
      and can be placed with relative ease. We recommend some modifications in the original
      technique, which would not require the complex measurements and costly equipment. Even it can
      be performed without fiber-optic laryngoscope guidance. Prolene is already in use in wide
      range of procedures worldwide, approved by Federal drug administration in 1997 but it has
      never been used in larynx. We intend to explore the efficacy of prolene mesh as an implant
      for vocal cord medialization in terms of patient satisfaction and voice outcome.

      Objective: To evaluate a new approach of vocal cord medialization using prolene mesh as an
      implant material.

      Study Design: Interventional, prospective study.. Place and Duration of study: Ent
      departments of multiple tertiary care hospitals of Pakistan from Jun 2020 and onwards.

      Materials and Methods: Patients of age 15 years onwards and with vocal cord paralysis/
      paresis due to multiple causes would included in the study. Patients with neoplasm, trauma
      and underlying muscular dystrophy are to be excluded. All patients will be counselled
      properly and given the choice of intervention by prolene mesh implant. Consenting patients
      will be subjected to routine blood investigations with fiber optic laryngoscopy and imaging
      with Computerized Tomography scan (where applicable). Procedure will be performed under local
      anesthesia with mild sedation, so that the patient will remain vocally responsive for the
      assessment of voice and breathing intraoperatively. Pre and postoperative voices will be
      recorded with a standard microphone at 15cm distance from the mouth in a quiet room. Maximum
      phonation time (MPT) while vocalizing the vowel sound 'eee' and Maximum words count (MWC) in
      a single breath (counting numbers) will be recorded pre and post operatively. Maximum three
      attempts will be allowed to each patient and the better score of the three will be recorded
      in the data. For subjective assessment of voice quality Visual (1-10) analogue score (VAS)
      will be used both pre and postoperatively. For objective assessment of patients a customized
      Voice Handicap Index (VHI-10) will be used.

      Modified VHI-10 Questionnaire

        1. My voice makes it difficult for people to hear me. 0 1 2 3 4 5

        2. I run out of air when I talk. 0 1 2 3 4 5

        3. People have difficulty understanding me in noisy room. 0 1 2 3 4 5

        4. I use a great deal of effort to speak. 0 1 2 3 4 5

        5. My family has difficulty hearing me when I call them throughout the house. 0 1 2 3 4 5

        6. I use phone less often than I would like to. 0 1 2 3 4 5

        7. I am tense when I am talking to others because of my voice. 0 1 2 3 4 5

        8. I tend to avoid groups of people because of my voice. 0 1 2 3 4 5

        9. People seem irritated with my voice. 0 1 2 3 4 5

       10. People ask what's wrong with my voice. 0 1 2 3 4 5 VHI : Voice Handicap Index 0 = never,
           1 = almost never (occasionally), 2 = sometimes, 3 = almost always, 4 = always Fig 1.1
           Modified Voice Handicap Index (VHI-10)

      Hospital ethical committee's approval will be obtained. The surgery will be performed under
      local anesthesia (lignocaine with adrenaline 2%) and procedural sedation with propofol
      25-100mcg/kg/min (only sedative dose) will be administered, so that the patient remains
      vocally responsive during the procedure. Incision will be made at the lower border of thyroid
      cartilage under aseptic measures. Skin flaps will be raised in sub-platysmal plane, strap
      muscles will be separated in the midline to expose the laryngeal cartilaginous framework. A
      simple laryngeal window approach will be used to place the Ethicon prolene mesh 6 x 6 cm
      Swiss roll, secured with prolene 2/0 suture trimmed to the required size. Post op voice
      analysis will be done on 14th post-operative day. Routine monthly follow up for 3 months will
      be advised after that.

      The results will be analyzed using Internal IBM SPSS Statistics version 20. Variables defined
      would be compared between the preoperative and postoperative groups. For normal data paired
      sample t-test would be used and for abnormally distributed data non parametric t-test would
      be used. P-value of less than 0.05 will be taken as significant.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: The single group will be implanted with Prolene mesh made into Swiss rolls and placed in Laryngeal Window between the cartilage and inner periosteum,
primary purpose: Treatment
masking: None (Open Label)
masking description: No Masking. Patients in one arm are provided with prolene mesh implant, and is known by the patient, health care provider and the assessor.
measure: Change in Mean Phonation Time
time frame: Preoperative and 14th Postoperative day
description: Pre and postoperative voices will be recorded with a standard microphone at 15cm distance from the mouth in a quiet room. Maximum phonation time (MPT) while vocalizing the vowel sound 'eee' will be measured in seconds. Maximum three attempts will be allowed to each patient and the better score of the three will be recorded in the data.
measure: Change in Maximum Words Count
time frame: Preoperative and 14th Postoperative day
description: Pre and postoperative voices will be recorded with a standard microphone at 15cm distance from the mouth in a quiet room. Maximum words count (MWC) in a single breath (counting numbers) will be recorded pre and post operatively. Maximum three attempts will be allowed to each patient and the better score of the three will be recorded in the data.
measure: Change in Voice Quality on Visual Analogue Score
time frame: Preoperative and 14th Postoperative day
description: For subjective assessment of voice quality Visual (1-10) analogue score (VAS) will be used both pre and postoperatively. Score 1 will be the score for lowest and 10 being the best score for voice quality.
arm group label: Prolene Mesh Implant
arm group type: Experimental
description: The Group of Patients who were offered Prolene mesh Laryngeal implants for Vocal Cord Medialization.
intervention type: Procedure
intervention name: Prolene Mesh Vocal Cord Medialization Implant
description: The surgery will be performed under local anesthesia (lignocaine with adrenaline 2%) and procedural sedation with propofol 25-100mcg/kg/min (only sedative dose) will be administered, so that the patient remains vocally responsive during the procedure. Incision will be made at the lower border of thyroid cartilage under aseptic measures. Skin flaps will be raised in sub-platysmal plane, strap muscles will be separated in the midline to expose the laryngeal cartilaginous framework. A simple laryngeal window approach will be used to place the Ethicon prolene mesh 6 x 6cm Swiss roll, secured with prolene 2/0 suture trimmed to the required size. Post op voice analysis will be done on 7th day and 14th post-operative day. Monthly follow up will be advised after that.
arm group label: Prolene Mesh Implant
criteria: 
gender: All
minimum age: 15 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Pakistan
responsible party type: Sponsor-Investigator
investigator affiliation: Pak Emirates Military Hospital
investigator full name: Muhammad Rashid
investigator title: Professor of ENT
mesh term: Vocal Cord Paralysis
mesh term: Paralysis
sharing ipd: Undecided
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 