Scoring System for Thyroid Gland Pathologies

• Conditions: Thyroid Nodule; Thyroid Cancer
• Interventions: Procedure: Thyroidectomy; Procedure: Lobectomy

• Registration Number: NCT04904159
• Lead Sponsor: Dr. Lutfi Kirdar Kartal Training and Research Hospital

Brief Summary

Although anamnesis and physical examination remain the place in the evaluation of patients today; laboratory values, imaging methods and pathology results have come to the fore in the decision-making of surgery for patients. As a result of all other criteria, a follow-up decision can be changed in a patient with a single fine needle aspiration biopsy result, or despite all the examinations the investigators have, a clear result cannot be achieved, and patient management may be disrupted. A holistic approach to thyroid gland pathologies is planned thanks to the scoring system that will be created in this study.

Detailed Description

In routine clinical practice, the criteria the investigators consider during the pre - op period in patients evaluated due to thyroid pathologies include anamnesis, physical examination, laboratory values, especially thyroid function, thyroid-neck ultrasonographies, fine needle aspiration biopsies, according to which decisions about operation or nonoperative follow-up are made with the patient. The investigators aim to create a common scoring system by taking into account the pathology results of patients who have undergone thyroidectomy and comparing these results with the results of pre-op examination and thus to address patient management in a more objective and comprehensive way.

Study Timeline

• Status Verified: 2021-05
• Study Start: 2021-05-01
• Study First Submitted: 2021-05-17
• Study First Submitted QC: 2021-05-22
• Study First Posted: 2021-05-27
• Last Update Submitted: 2021-05-27
• Last Update Posted: 2021-06-01
• Primary Completion: 2023-01-01
• Study Completion: 2023-05-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• patients who undergone surgery for thyroid gland pathologies

Exclusion Criteria

• patients who did not want to be involved in the study
• patients who missed in the follow-up period
• pregnant patients

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Malign	Thyroidectomy	Patients who have malign pathologies after thyroidectomy
Benign	Lobectomy	Patients who have benign pathologies after thyroidectomy

Primary Outcome Measures

Name	Time	Method
Thyroid Imaging Reporting and Data System ( TIRADS ) score	Before surgery	Radiological features of throid nodule ( minimum value is 1 maximum value is 5 ); thyroid nodule which has a higher value means a worse outcome
Age	Before Surgery	Years
History of Thyroiditis	Before Surgery	Yes or No
Radiation to the Neck Area	Before Surgery	Yes or No
Family History	Before Surgery	Presence of family members with any thyroid pathologies especially thyroid cancer
Bethesda classification system for thyroid fine needle aspirates	Before surgery	Histopathological features of thyroid nodule ( minimum value is 1 maximum value is 6 ) thyroid nodule which has higher value means a worse outcome
Smoking Status	Before Surgery	Yes or No
Complaint	Before Surgery	Months
Thyroid Stimulating Hormone ( TSH ) levels	Before surgery	it is a hormone secreted from the pituitary gland and triggers the functioning of the thyroid gland ( cut of values are 0.5 - 5.0 mIU / L )
Pathology results	Immediately after the surgery	The result of the throid gland part sent to the pathology unit after surgery ( the results can be benign or malign )
Gender	Before Surgery	Male - Female

Trial Locations

Locations (1)

Kartal Dr Lutfi Kirdar Tranining and Research Hospital; 🇹🇷 Istanbul, Turkey