NCT04248114

Brief Summary

We performed a retrospective observational-analytic study. Anatomical measurements were performed on 118 participants during an ultrasound exam, and demographic data was collected from their medical files. The data was stratified according to age, sex, patient's body mass index (BMI), and height.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
118

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2016

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, 2016

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2018

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

January 28, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 30, 2020

Completed
Last Updated

October 14, 2021

Status Verified

October 1, 2021

Enrollment Period

1.8 years

First QC Date

January 28, 2020

Last Update Submit

October 6, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • anatomical relations between the second neck skin crease and the thyroid gland isthmus and cricoid cartilage

    Several neck creases can be observed in normal adults. The first upper crease runs horizontally roughly along the thyroid notch and hyoid bone. A second lower neck crease runs parallel to it approximately at the height of the cricoid; the measurements, in centimeters, in our study relate to this crease.

    June 1st 2016 until August 31 2018

Interventions

Ultrasound of the NeckDIAGNOSTIC_TEST

Anatomical measurements were performed on participants during an ultrasound exam

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The data was collected during ultrasound exams of subjects who underwent assessment of the thyroid gland.

You may qualify if:

  • Subjects who underwent assessment of the thyroid gland

You may not qualify if:

  • Patients who had any neck surgical procedure prior to the test, patients with abnormalities in the anterior neck, and patients without clear second crease were excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Fancy T, Gallagher D 3rd, Hornig JD. Surgical anatomy of the thyroid and parathyroid glands. Otolaryngol Clin North Am. 2010 Apr;43(2):221-7, vii. doi: 10.1016/j.otc.2010.01.001.

  • Brunaud L, Zarnegar R, Wada N, Ituarte P, Clark OH, Duh QY. Incision length for standard thyroidectomy and parathyroidectomy: when is it minimally invasive? Arch Surg. 2003 Oct;138(10):1140-3. doi: 10.1001/archsurg.138.10.1140.

  • Choi Y, Lee JH, Kim YH, Lee YS, Chang HS, Park CS, Roh MR. Impact of postthyroidectomy scar on the quality of life of thyroid cancer patients. Ann Dermatol. 2014 Dec;26(6):693-9. doi: 10.5021/ad.2014.26.6.693. Epub 2014 Nov 26.

MeSH Terms

Conditions

Thyroid Nodule

Condition Hierarchy (Ancestors)

Thyroid NeoplasmsEndocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsEndocrine System DiseasesThyroid Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director Head and Neck Unit

Study Record Dates

First Submitted

January 28, 2020

First Posted

January 30, 2020

Study Start

November 1, 2016

Primary Completion

August 31, 2018

Study Completion

August 31, 2018

Last Updated

October 14, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share