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Goitres Influence on Voice Function - The Impact of Surgery (SOLOIST)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02468921
Recruitment Status : Unknown
Verified November 2016 by Jesper Roed Sorensen, University of Southern Denmark.
Recruitment status was:  Active, not recruiting
First Posted : June 11, 2015
Last Update Posted : November 8, 2016
Sponsor:
Collaborator:
Odense University Hospital
Information provided by (Responsible Party):
Jesper Roed Sorensen, University of Southern Denmark

Brief Summary:
The aim of the study is to investigate the influence benign non-toxic goitre and the surgical treatment hereof on the voice function before and 6 months following surgery.

Condition or disease Intervention/treatment
Goiter Procedure: Thyroidectomy

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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Impact of Surgical Treatment of Benign Non-toxic Goiter on the Voice Function
Study Start Date : November 2014
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : October 2018

Intervention Details:
  • Procedure: Thyroidectomy
    Regular thyroidectomy or hemithyroidectomy through Kocher's skin incision


Primary Outcome Measures :
  1. Number of patients with changed frequency range in voice function following thyroidectomy [ Time Frame: 6 months ]
    Change in frequency range (Hz) of the Voice Range Profiler Phonetogram from baseline to 6 months after surgery.



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients undergoing hemi- or total thyroidectomy at Odense University Hospital for benign symptomatic non-toxic goiter
Criteria

Inclusion criteria:

  • Patients undergoing hemi- or total thyroidectomy for benign non-toxic goiter with pressure symptoms
  • The patients must be able to understand, write and read Danish

Exclusion criteria:

  • Previous surgery to the neck
  • Diabetes or any neuromuscular disorders.
  • Present or previous head and neck malignancy, including malignancy found in the surgical thyroid specimen or suspicion hereof.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02468921


Locations
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Denmark
Odense University Hospital
Odense, Denmark, 5000
Sponsors and Collaborators
University of Southern Denmark
Odense University Hospital
Investigators
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Study Director: Christian Godballe, Professor University of Southern Denmark
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Responsible Party: Jesper Roed Sorensen, MD, University of Southern Denmark
ClinicalTrials.gov Identifier: NCT02468921    
Other Study ID Numbers: S-20131
First Posted: June 11, 2015    Key Record Dates
Last Update Posted: November 8, 2016
Last Verified: November 2016
Keywords provided by Jesper Roed Sorensen, University of Southern Denmark:
Goitre
thyroid disease
struma
Additional relevant MeSH terms:
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Goiter
Thyroid Diseases
Endocrine System Diseases