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NCT04458818 · FLOW

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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.

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
    FG000
    title
    Prolene Mesh Implant
periods
  1. milestones
    1. achievements
      1. comment
        May 01 2020
        group Id
        FG000
        num Subjects
        39
      type
      STARTED
    2. achievements
      1. comment
        Jan 30 2021
        group Id
        FG000
        num Subjects
        39
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Overall Study
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.
recruitment Details
01 May 2020 - 30 Jan 2021
Complete source fields
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
    FG000
    title
    Prolene Mesh Implant
periods
  1. milestones
    1. achievements
      1. comment
        May 01 2020
        group Id
        FG000
        num Subjects
        39
      type
      STARTED
    2. achievements
      1. comment
        Jan 30 2021
        group Id
        FG000
        num Subjects
        39
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Overall Study
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.
recruitment Details
01 May 2020 - 30 Jan 2021

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Preserved source evidence · Not medical advice