Tracheal Anatomy After Thyroidectomy

March 6, 2017 updated by: Jesper Roed Sorensen, University of Southern Denmark

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

72

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients referred for thyroidectomy for symptomatic benign nodular goiter

Description

Inclusion Criteria:

  • Reads and write Danish

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
6 months follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Southern Denmark

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 1, 2014

Primary Completion (ACTUAL)

March 1, 2017

Study Completion (ACTUAL)

March 2, 2017

Study Registration Dates

First Submitted

March 2, 2017

First Submitted That Met QC Criteria

March 6, 2017

First Posted (ACTUAL)

March 7, 2017

Study Record Updates

Last Update Posted (ACTUAL)

March 7, 2017

Last Update Submitted That Met QC Criteria

March 6, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S-20130096

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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