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Completed

NCT Number: NCT02969993

Very Long Term VHI Voice Outcome After MTIS

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

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Key information

Conditions

Laryngeal Paralysis Cranial Nerve Diseases Laryngeal Diseases Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Paralysis Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Signs and Symptoms Vagus Nerve Diseases Vocal Cord Paralysis

Age range

16 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cliniques universitaires Saint-Luc, Brussels Capital Region, Brussels Capital, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

questionnaires

Other

evaluating the voice outcome by the fullfilment of the voice handicap index

Primary outcomes

  1. Voice handicap index

    Time frame: 2 years

    Questionnaire

Sponsors and collaborators

Lead sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Other

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Nov 21, 2016
Registry last updated
Mar 20, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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