Goitres Influence on Voice Function - The Impact of Surgery

Goiter Clinical Trial

— SOLOIST  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02468921
• Other study ID #: S-20131
• Status: Active, not recruiting
• Phase: N/A
• First received: January 19, 2015
• Last updated: November 7, 2016
• Start date: November 2014
• Est. completion date: October 2018

Study information

• Verified date: November 2016
• Source: University of Southern Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Health and Medicines Authority
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: October 2018
• Est. primary completion date: October 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Goiter

Intervention

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

Locations

Country	Name	City	State
Denmark	Odense University Hospital	Odense

Sponsors (2)

Lead Sponsor	Collaborator
University of Southern Denmark	Odense University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with changed frequency range in voice function following thyroidectomy	Change in frequency range (Hz) of the Voice Range Profiler Phonetogram from baseline to 6 months after surgery.	6 months	No