Very Long Term VHI Voice Outcome After MTIS

NCT ID: NCT02969993

Last Updated: 2018-03-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

53 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-31

Study Completion Date

2017-10-19

Brief Summary

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

Detailed Description

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Conditions

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Laryngeal Paralysis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Questionnaire

Questionnaire to previously operated patients

Group Type EXPERIMENTAL

Questionnaires

Intervention Type OTHER

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

Interventions

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Questionnaires

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cliniques universitaires Saint-Luc- Université Catholique de Louvain

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Cliniques universitaires Saint-Luc

Brussels Capital Region, Brussels Capital, Belgium

Site Status

CHU Namur -Mont-Godinne

Yvoir, Namur, Belgium

Site Status

Valencia Medical School - Hospital General Universitario

Valencia, Levante, Spain

Site Status

Countries

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Belgium Spain

Other Identifiers

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2016/394

Identifier Type: -

Identifier Source: org_study_id

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