NCT02969993

Brief Summary

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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
53

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2016

Geographic Reach
2 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 18, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 21, 2016

Completed
10 days until next milestone

Study Start

First participant enrolled

December 1, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 17, 2017

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 19, 2017

Completed
Last Updated

March 20, 2018

Status Verified

March 1, 2018

Enrollment Period

11 months

First QC Date

November 18, 2016

Last Update Submit

March 19, 2018

Conditions

Laryngeal Paralysis

Outcome Measures

Primary Outcomes (1)

  • Voice handicap index

    Questionnaire

    2 years

Study Arms (1)

Questionnaire

EXPERIMENTAL

Questionnaire to previously operated patients

Other: Questionnaires

Interventions

QuestionnairesOTHER

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

Questionnaire

Eligibility Criteria

Age16 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Cliniques universitaires Saint-Luc

Brussels Capital Region, Brussels Capital, 1200, Belgium

Location

CHU Namur -Mont-Godinne

Yvoir, Namur, 5530, Belgium

Location

Valencia Medical School - Hospital General Universitario

Valencia, Levante, 46014, Spain

Location

MeSH Terms

Conditions

Vocal Cord Paralysis

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Laryngeal DiseasesRespiratory Tract DiseasesOtorhinolaryngologic DiseasesVagus Nerve DiseasesCranial Nerve DiseasesNervous System DiseasesParalysisNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 18, 2016

First Posted

November 21, 2016

Study Start

December 1, 2016

Primary Completion

October 17, 2017

Study Completion

October 19, 2017

Last Updated

March 20, 2018

Record last verified: 2018-03

Locations

BE(2)ES(1)