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NCT04458818 · ADVERSE EVENTS

Adverse events

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.

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame
1 year follow up was kept for all the patients.
Other-event reporting threshold
2%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Prolene Mesh Implant

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.

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Group identifiers: EG000: Prolene Mesh Implant

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

    Other reported adverse events

    Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

    1. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      notes
      Upper respiratory tract infections
      organ System
      Respiratory, thoracic and mediastinal disorders
      stats
      1. group Id
        EG000
        num Affected
        4
        num At Risk
        39
        num Events
        39
      term
      URTI
    2. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      notes
      Wound infection, post operatively
      organ System
      Infections and infestations
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        39
        num Events
        39
      term
      skin infection
    Complete source fields
    event Groups
    1. deaths Num Affected
      0
      deaths Num At Risk
      39
      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
      EG000
      other Num Affected
      5
      other Num At Risk
      39
      serious Num Affected
      0
      serious Num At Risk
      39
      title
      Prolene Mesh Implant
    frequency Threshold
    2
    other Events
    1. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      notes
      Upper respiratory tract infections
      organ System
      Respiratory, thoracic and mediastinal disorders
      stats
      1. group Id
        EG000
        num Affected
        4
        num At Risk
        39
        num Events
        39
      term
      URTI
    2. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      notes
      Wound infection, post operatively
      organ System
      Infections and infestations
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        39
        num Events
        39
      term
      skin infection
    time Frame
    1 year follow up was kept for all the patients.

    Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

    Preserved source evidence · Not medical advice