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Clinical Trials/NCT02969993
NCT02969993
Completed
Not Applicable

Very Long Term VHI Voice Outcome After MTIS

Cliniques universitaires Saint-Luc- Université Catholique de Louvain3 sites in 2 countries53 target enrollmentDecember 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Laryngeal Paralysis
Sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Enrollment
53
Locations
3
Primary Endpoint
Voice handicap index
Status
Completed
Last Updated
8 years ago

Overview

Brief Summary

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

Registry
clinicaltrials.gov
Start Date
December 2016
End Date
October 19, 2017
Last Updated
8 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Voice handicap index

Time Frame: 2 years

Questionnaire

Study Sites (3)

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