Goiter, NodularNCT03072654
Tracheal Anatomy After Thyroidectomy
An observational study of Goiter, Nodular, run by University of Southern Denmark.
Trial summary
The investigators aimed at investigating the effects of thyroidectomy on tracheal anatomy and airflow in patients with benign nodular goiter, employing a prospective observational study. Magnetic resonance images of the neck and respiratory flow-volume curves were performed prior to and six months following surgery. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Goiter, Nodular
- What is being tested?
- Thyroidectomy
- Type of treatment
- Surgery or procedure
- How many people
- 72 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2014to 2 Mar 2017
- 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: Patients referred for thyroidectomy for symptomatic benign nodular goiter
Who may be able to join
- Reads and write Danish
Who cannot join
- Suspected or present malignancy
- Neuromuscular disease
- Prior surgery to the neck
About this study
Official title: Thyroidectomy Improves Tracheal Anatomy and Airflow in Patients With Nodular Goiter: A Prospective Cohort Study
The investigators aimed at investigating the effects of thyroidectomy on tracheal anatomy and airflow in patients with benign nodular goiter, employing a prospective observational study.
Magnetic resonance images of the neck and respiratory flow-volume curves were performed prior to and six months following surgery. Tracheal and thyroid volumes, smallest cross-sectional area of the trachea (SCAT), tracheal narrowing, tracheal deviation and tracheal encirclement by the thyroid were evaluated. Through flow-volume curves respiratory function, including both in- and expiration, was evaluated.
- Conditions
- Goiter, Nodular
- Being tested
- Thyroidectomy
- Medical subject headings
- Goiter, Nodular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ThyroidectomyProcedure or surgery
Remove the nodular goiter on the neck by thyroidectomy (standard procedure)
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in tracheal anatomy
Change in tracheal narrowing (cross sectional area of the trachea at the goiter level compared to cross-sectional area of the trachea at the carina)
Measured: 6 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2017
- Study start1 Nov 2014
- Primary completion1 Mar 2017
- Study completion2 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Goiter, NodularStudies 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
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern Denmark
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jesper Roed Sorensen, University of Southern Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03072654
- Sponsor's protocol ID
- S-20130096
- Status last verified
- Mar 2017
- First submitted
- 2 Mar 2017
- Last updated
- 7 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Brinch FA, Dossing H, Nguyen N, Bonnema SJ, Hegedus L, Godballe C, Sorensen JR. The Impact of Esophageal Compression on Goiter Symptoms before and after Thyroid Surgery. Eur Thyroid J. 2019 Jan;8(1):16-23. doi: 10.1159/000493542. Epub 2018 Oct 17.
PubMed 30800637
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thyroidectomy Improves Tracheal Anatomy and Airflow in Patients With Nodular Goiter: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT03072654
- Acronym / sponsor ID
- S-20130096
- Conditions
- Goiter, Nodular
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- University of Southern DenmarkUniversity, hospital or other
- Study start
- 1 Nov 2014 (actual)
- Primary completion
- 1 Mar 2017 (actual)
- Study completion
- 2 Mar 2017 (actual)
- First posted
- 7 Mar 2017 (actual)
- 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 investigators aimed at investigating the effects of thyroidectomy on tracheal anatomy and airflow in patients with benign nodular goiter, employing a prospective observational study.
Magnetic resonance images of the neck and respiratory flow-volume curves were performed prior to and six months following surgery. Tracheal and thyroid volumes, smallest cross-sectional area of the trachea (SCAT), tracheal narrowing, tracheal deviation and tracheal encirclement by the thyroid were evaluated. Through flow-volume curves respiratory function, including both in- and expiration, was evaluated.
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
- Patients referred for thyroidectomy for symptomatic benign nodular goiter
Key inclusion criteria (1 listed)
- Reads and write Danish
Key exclusion criteria (3 listed)
- Suspected or present malignancy
- Neuromuscular disease
- Prior surgery to the neck
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 |
|---|---|---|
| ThyroidectomyRemove the nodular goiter on the neck by thyroidectomy (standard procedure) | Procedure or surgery | – |
Primary outcome
Changes in tracheal anatomy
Time frame: 6 months follow-up
Change in tracheal narrowing (cross sectional area of the trachea at the goiter level compared to cross-sectional area of the trachea at the carina)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2017.
- Derived from this study: PubMed 30800637Brinch FA, Dossing H, Nguyen N, Bonnema SJ, Hegedus L, Godballe C, Sorensen JR. The Impact of Esophageal Compression on Goiter Symptoms before and after Thyroid Surgery. Eur Thyroid J. 2019 Jan;8(1):16-23. doi: 10.1159/000493542. Epub 2018 Oct 17.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Goiter, Nodular, run by University of Southern 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 1 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: finished, as of the sponsor's last update on 7 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Changes in tracheal anatomy (time frame: 6 months follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03072654, which also lists 1 linked publication.
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 7 Mar 2017.