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NCT04458818 · BASELINE

Baseline characteristics

A Novel Approach for Thyroplasty Type 1, With Prolene Mesh. A Prospective Study. · Source last updated 2021-04-29

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

denoms
  1. counts
    1. group Id
      BG000
      value
      39
    units
    Participants
groups
  1. description
    The Group of Patients who were offered Prolene mesh Laryngeal implants for Vocal Cord Medialization. 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.
    id
    BG000
    title
    Prolene Mesh Implant
measures
  1. calculate Pct
    false
    classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          32
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          6
        title
        >=65 years
      denoms
      1. counts
        1. group Id
          BG000
          value
          39
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Categorical
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          24
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          15
        title
        Male
      denoms
      1. counts
        1. group Id
          BG000
          value
          39
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. denoms
      1. counts
        1. group Id
          BG000
          value
          0
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    Race and Ethnicity were not collected from any participant.
    title
    Race and Ethnicity Not Collected
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          39
      denoms
      1. counts
        1. group Id
          BG000
          value
          39
        units
        Participants
      title
      Pakistan
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Region of Enrollment
    unit Of Measure
    Participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      39
    units
    Participants
groups
  1. description
    The Group of Patients who were offered Prolene mesh Laryngeal implants for Vocal Cord Medialization. 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.
    id
    BG000
    title
    Prolene Mesh Implant
measures
  1. calculate Pct
    false
    classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          32
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          6
        title
        >=65 years
      denoms
      1. counts
        1. group Id
          BG000
          value
          39
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Categorical
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          24
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          15
        title
        Male
      denoms
      1. counts
        1. group Id
          BG000
          value
          39
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. denoms
      1. counts
        1. group Id
          BG000
          value
          0
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    Race and Ethnicity were not collected from any participant.
    title
    Race and Ethnicity Not Collected
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          39
      denoms
      1. counts
        1. group Id
          BG000
          value
          39
        units
        Participants
      title
      Pakistan
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Region of Enrollment
    unit Of Measure
    Participants

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Preserved source evidence · Not medical advice