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

November 7, 2016 updated by: Jesper Roed Sorensen, University of Southern Denmark

The Impact of Surgical Treatment of Benign Non-toxic Goiter on the Voice Function

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Odense, Denmark, 5000
        • Odense University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients undergoing hemi- or total thyroidectomy at Odense University Hospital for benign symptomatic non-toxic goiter

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Southern Denmark

Collaborators

Odense University Hospital

Investigators

  • Study Director: Christian Godballe, Professor, University of Southern Denmark

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2014

Primary Completion (Anticipated)

October 1, 2018

Study Completion (Anticipated)

October 1, 2018

Study Registration Dates

First Submitted

January 19, 2015

First Submitted That Met QC Criteria

June 10, 2015

First Posted (Estimate)

June 11, 2015

Study Record Updates

Last Update Posted (Estimate)

November 8, 2016

Last Update Submitted That Met QC Criteria

November 7, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S-20131

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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