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Very Long Term VHI Voice Outcome After MTIS

Primary Purpose

Laryngeal Paralysis

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Questionnaires
Sponsored by
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Laryngeal Paralysis

Eligibility Criteria

16 Years - 80 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • patients presenting UVFP of neurogenic origin treated by MTIS > 2 years before inclusion.
  • No superior limit in terms of years.
  • Age 18-80 years at the time of MTIS
  • No other treatment before MTIS other than resorbing material injection laryngoplasty (maximum twice)
  • No further voice treatment after MTIS except speech therapy.
  • VHI or VHI-10 performed before MTIS and within the 6 months after MTIS. In case of multiple post-op VHI tests, only the earliest post-op. VHI test will be taken into account
  • VHI tests validated for the utilized language

Exclusion Criteria:

  • patient not able to answer VHI questionnaire personally
  • Post MTIS new health condition affecting the voice tract and/ or the respiratory function.
  • Post MTIS appearance of other voice/ vocal cord pathology

Sites / Locations

  • Cliniques universitaires Saint-Luc
  • CHU Namur -Mont-Godinne
  • Valencia Medical School - Hospital General Universitario

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Questionnaire

Arm Description

Questionnaire to previously operated patients

Outcomes

Primary Outcome Measures

Voice handicap index
Questionnaire

Secondary Outcome Measures

Full Information

First Posted
November 18, 2016
Last Updated
March 19, 2018
Sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
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1. Study Identification

Unique Protocol Identification Number
NCT02969993
Brief Title
Very Long Term VHI Voice Outcome After MTIS
Official Title
Very Long Term VHI Voice Outcome After MTIS
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
December 2016 (undefined)
Primary Completion Date
October 17, 2017 (Actual)
Study Completion Date
October 19, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Long term assesment of voice outcome after Montgomery Thyroplastie by performing a Survey of operated patients using the voice handicap index scale

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Laryngeal Paralysis

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
53 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Questionnaire
Arm Type
Experimental
Arm Description
Questionnaire to previously operated patients
Intervention Type
Other
Intervention Name(s)
Questionnaires
Intervention Description
evaluating the voice outcome by the fullfilment of the voice handicap index
Primary Outcome Measure Information:
Title
Voice handicap index
Description
Questionnaire
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: patients presenting UVFP of neurogenic origin treated by MTIS > 2 years before inclusion. No superior limit in terms of years. Age 18-80 years at the time of MTIS No other treatment before MTIS other than resorbing material injection laryngoplasty (maximum twice) No further voice treatment after MTIS except speech therapy. VHI or VHI-10 performed before MTIS and within the 6 months after MTIS. In case of multiple post-op VHI tests, only the earliest post-op. VHI test will be taken into account VHI tests validated for the utilized language Exclusion Criteria: patient not able to answer VHI questionnaire personally Post MTIS new health condition affecting the voice tract and/ or the respiratory function. Post MTIS appearance of other voice/ vocal cord pathology
Facility Information:
Facility Name
Cliniques universitaires Saint-Luc
City
Brussels Capital Region
State/Province
Brussels
ZIP/Postal Code
1200
Country
Belgium
Facility Name
CHU Namur -Mont-Godinne
City
Yvoir
State/Province
Namur
ZIP/Postal Code
5530
Country
Belgium
Facility Name
Valencia Medical School - Hospital General Universitario
City
Valencia
State/Province
Levante
ZIP/Postal Code
46014
Country
Spain

12. IPD Sharing Statement

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Very Long Term VHI Voice Outcome After MTIS

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