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Very Long Term VHI Voice Outcome After MTIS

C

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Status

Completed

Conditions

Laryngeal Paralysis

Treatments

Other: Questionnaires

Study type

Interventional

Funder types

Other

Identifiers

NCT02969993
2016/394

Details and patient eligibility

About

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

Enrollment

53 patients

Sex

All

Ages

16 to 80 years old

Volunteers

No 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

Trial design

Primary purpose

Prevention

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

53 participants in 1 patient group

Questionnaire
Experimental group
Description:
Questionnaire to previously operated patients
Treatment:
Other: Questionnaires

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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