NCT03072654

Brief 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. 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2014

Typical duration for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2014

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

March 2, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 2, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 7, 2017

Completed
Last Updated

March 7, 2017

Status Verified

March 1, 2017

Enrollment Period

2.3 years

First QC Date

March 2, 2017

Last Update Submit

March 6, 2017

Conditions

Goiter, Nodular

Outcome Measures

Primary Outcomes (1)

  • 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)

    6 months follow-up

Interventions

ThyroidectomyPROCEDURE

Remove the nodular goiter on the neck by thyroidectomy (standard procedure)

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients referred for thyroidectomy for symptomatic benign nodular goiter

You may qualify if:

  • Reads and write Danish

You may not qualify if:

  • Suspected or present malignancy
  • Neuromuscular disease
  • Prior surgery to the neck

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 30800637DERIVED

MeSH Terms

Conditions

Goiter, Nodular

Interventions

Thyroidectomy

Condition Hierarchy (Ancestors)

GoiterThyroid DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Endocrine Surgical ProceduresSurgical Procedures, Operative

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD Fellow

Study Record Dates

First Submitted

March 2, 2017

First Posted

March 7, 2017

Study Start

November 1, 2014

Primary Completion

March 1, 2017

Study Completion

March 2, 2017

Last Updated

March 7, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share