Tracheal Anatomy After Thyroidectomy

Goiter, Nodular Clinical Trial

Official title:

Thyroidectomy Improves Tracheal Anatomy and Airflow in Patients With Nodular Goiter: A Prospective Cohort Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03072654
• Other study ID #: S-20130096
• Status: Completed
• Phase: N/A
• First received: March 2, 2017
• Last updated: March 6, 2017
• Start date: November 1, 2014
• Est. completion date: March 2, 2017

Study information

• Verified date: March 2017
• Source: University of Southern Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: March 2, 2017
• Est. primary completion date: March 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

• Reads and write Danish

Exclusion Criteria:

• Suspected or present malignancy

• Neuromuscular disease

• Prior surgery to the neck

Related Conditions & MeSH terms

• Goiter
• Goiter, Nodular

Intervention

Procedure:
• Thyroidectomy
Remove the nodular goiter on the neck by thyroidectomy (standard procedure)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Southern Denmark

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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