Scoring System for Thyroid Gland Pathologies

Sponsor
Dr. Lutfi Kirdar Kartal Training and Research Hospital (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT04904159
Collaborator
(none)
300
1
24
12.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Thyroidectomy
  • Procedure: Lobectomy

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 Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
300 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
A New Scoring System in the Diagnosis of Thyroid Gland Pathologies
Actual Study Start Date :
May 1, 2021
Anticipated Primary Completion Date :
Jan 1, 2023
Anticipated Study Completion Date :
May 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Benign

Patients who have benign pathologies after thyroidectomy

Procedure: Lobectomy
Lobectomy

Malign

Patients who have malign pathologies after thyroidectomy

Procedure: Thyroidectomy
total thyroidectomy

Outcome Measures

Primary Outcome Measures

  1. Age [Before Surgery]

    Years

  2. Gender [Before Surgery]

    Male - Female

  3. Smoking Status [Before Surgery]

    Yes or No

  4. Radiation to the Neck Area [Before Surgery]

    Yes or No

  5. History of Thyroiditis [Before Surgery]

    Yes or No

  6. Family History [Before Surgery]

    Presence of family members with any thyroid pathologies especially thyroid cancer

  7. Complaint [Before Surgery]

    Months

  8. 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

  9. 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

  10. 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 )

  11. 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 )

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Kartal Dr Lutfi Kirdar Tranining and Research Hospital Istanbul Turkey 34890

Sponsors and Collaborators

  • Dr. Lutfi Kirdar Kartal Training and Research Hospital

Investigators

  • Study Chair: Hasan Fehmi Küçük, Prof., Istanbul Dr. Lutfi Kirdar Kartal Training and Research Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Ramazan Sari, Principal Investigator, Dr. Lutfi Kirdar Kartal Training and Research Hospital
ClinicalTrials.gov Identifier:
NCT04904159
Other Study ID Numbers:
  • 2021/514/198/20
First Posted:
May 27, 2021
Last Update Posted:
Jun 1, 2021
Last Verified:
May 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Ramazan Sari, Principal Investigator, Dr. Lutfi Kirdar Kartal Training and Research Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 1, 2021