SOLOIST: Goitres Influence on Voice Function - The Impact of Surgery

• Sponsor: University of Southern Denmark (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02468921
• Collaborator: Odense University Hospital (Other)
• Enrollment: 60
• Location: 1
• Duration (Months): 47
• Patients Per Site Per Month: 1.3

Study Details

Study Description

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	Phase
Goiter	Procedure: Thyroidectomy

Study Design

• Study Type: Observational
• Anticipated 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: Nov 1, 2014
• Anticipated Primary Completion Date: Oct 1, 2018
• Anticipated Study Completion Date: Oct 1, 2018

Outcome Measures

Primary Outcome Measures

1. Number of patients with changed frequency range in voice function following thyroidectomy [6 months]

   Change in frequency range (Hz) of the Voice Range Profiler Phonetogram from baseline to 6 months after surgery.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Odense University Hospital	Odense		Denmark	5000

Sponsors and Collaborators

• University of Southern Denmark
• Odense University Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jesper Roed Sorensen, MD, University of Southern Denmark
• ClinicalTrials.gov Identifier: NCT02468921
• Other Study ID Numbers: S-20131
• First Posted: Jun 11, 2015
• Last Update Posted: Nov 8, 2016
• Last Verified: Nov 1, 2016

• Keywords provided by Jesper Roed Sorensen, MD, University of Southern Denmark: Goitre; thyroid disease; struma
• Additional relevant MeSH terms: Goiter

Study Results

No Results Posted as of Nov 8, 2016