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NCT04458818 · OUTCOME

Change in Voice Quality on Visual Analogue Score

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.

Measure
MEAN
Unit
score on a scale
Interval / dispersion
Standard Deviation
Time frame
Preoperative and 14th Postoperative day

What was measured

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.

Groups in this outcome

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.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Prolene Mesh Implant39

Reported measurements

pre operative
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Prolene Mesh Implant4.771.224Not reportedNot reportedNot reported
post operative
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Prolene Mesh Implant7.641.308Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.224
        value
        4.77
    title
    pre operative
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.308
        value
        7.64
    title
    post operative
denoms
  1. counts
    1. group Id
      OG000
      value
      39
    units
    Participants
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.
dispersion Type
Standard Deviation
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
    OG000
    title
    Prolene Mesh Implant
param Type
MEAN
reporting Status
POSTED
time Frame
Preoperative and 14th Postoperative day
title
Change in Voice Quality on Visual Analogue Score
type
PRIMARY
unit Of Measure
score on a scale

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

Preserved source evidence · Not medical advice