GoiterSOLOISTNCT02468921
Goitres Influence on Voice Function - The Impact of Surgery
An observational study of Goiter, run by University of Southern Denmark at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Goiter
- What is being tested?
- Thyroidectomy
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteDenmark
- Study dates
- Nov 2014to Oct 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients undergoing hemi- or total thyroidectomy at Odense University Hospital for benign symptomatic non-toxic goiter
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Goiter
- Being tested
- Thyroidectomy
- Keywords
- Goitre, thyroid disease, struma
- Medical subject headings
- Goiter, Thyroid Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ThyroidectomyProcedure or surgery
Regular thyroidectomy or hemithyroidectomy through Kocher's skin incision
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2015 (estimated)
- Study startNov 2014
- Primary completionOct 2018 (estimated)
- Study completionOct 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GoiterStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Southern Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- Odense University Hospital
- Responsible party
- Principal investigator, Jesper Roed Sorensen, University of Southern Denmark
- Investigators
- Christian Godballe, Professor, Study director, University of Southern Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02468921
- Sponsor's protocol ID
- S-20131
- Acronym
- SOLOIST
- Status last verified
- Nov 2016
- First submitted
- 19 Jan 2015
- Last updated
- 8 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Surgical Treatment of Benign Non-toxic Goiter on the Voice Function
- ClinicalTrials.gov ID
- NCT02468921
- Acronym / sponsor ID
- SOLOIST / S-20131
- Conditions
- Goiter
- Keywords
- Goitre, thyroid disease, struma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of Southern DenmarkUniversity, hospital or other
- Collaborators
- Odense University Hospital
- Study start
- Nov 2014
- Primary completion
- Oct 2018 (estimated)
- Study completion
- Oct 2018 (estimated)
- First posted
- 11 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients undergoing hemi- or total thyroidectomy at Odense University Hospital for benign symptomatic non-toxic goiter
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ThyroidectomyRegular thyroidectomy or hemithyroidectomy through Kocher's skin incision | Procedure or surgery | – |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christian Godballe, Professor study director
University of Southern Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Goiter, run by University of Southern Denmark at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with changed frequency range in voice function following thyroidectomy (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2016.