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Intervention in Single Thyroid Nodule.

Primary Purpose

Thyroid Nodule

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
thyroidectomy
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Thyroid Nodule

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age from 20 to 60 years. patients with single thyroid lesion Fit for surgery Exclusion Criteria: patients with age less than 20 years and more than 60 years. patients with multiple thyroid lesions. patients with advanced and metastatic malignancy. Unfit for surgery

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Total thyroidectomy for single thyroid nodule

    Hemithyroidectomy for single thyroid nodule

    Arm Description

    group of participants will be treated with total thyroidectomy

    2nd group of participants will be treated with hemithyroidectomy

    Outcomes

    Primary Outcome Measures

    Improvement in the management of single thyroid nodule to reduce the morbidity and mortality rates
    Compare between total thyroidectomy and hemithyroidectomy in patients with single thyroid nodule to improve the management of single thyroid nodule in general surgery department , Assiut university hospital.

    Secondary Outcome Measures

    Full Information

    First Posted
    November 23, 2022
    Last Updated
    December 17, 2022
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05658809
    Brief Title
    Intervention in Single Thyroid Nodule.
    Official Title
    Total Thyroidectomy Versus Hemithyroidectomy for Patients With Single Thyroid Nodule , Prospective Comparative Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    December 30, 2022 (Anticipated)
    Primary Completion Date
    December 30, 2023 (Anticipated)
    Study Completion Date
    December 30, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Assiut University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    Thyroid nodules are common clinical problem. The incidence is 2-4 per 100,000 people per year, being more common in women and the elderly. thyroid nodule is a "discrete lesion within the thyroid gland that is radiologically distinct from the surrounding thyroid parenchyma. Most thyroid nodules are asymptomatic, may present as neck swelling
    Detailed Description
    Thyroid nodular disease comprises of a wide range of disorders. Benign forms such as colloid nodules,cysts and thyroiditis are more comman than benign follicular neoplasms and thyroid carcinomas. Incidence of malignancy ranges from 10% to 30% in solitary thyroid nodule(STN).Studies have shown that the occurrence of malignancy is higher in case of solitary thyroid nodule compared to multinodular goitres. Preoperative evaluation of thyroid nodules is important in distinguishing between benign and malignant thyroid nodules and also in treatment to avoid unnecessary extensive surgery and its complications. Fine needle aspiration biopsy (FNAB) is the most common method of examining solitary thyroid nodules today.Total thyroidectomy and lobectomy remain the main primary surgical interventions for single thyroid nodule. There is debat between total thyroidectomy and hemithyroidectomy for patients with single thyroid nodule. our study is for comparing between total thyroidectomy and hemi thyroidectomy in single thyroid nodule

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Thyroid Nodule

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Total thyroidectomy for single thyroid nodule
    Arm Type
    Active Comparator
    Arm Description
    group of participants will be treated with total thyroidectomy
    Arm Title
    Hemithyroidectomy for single thyroid nodule
    Arm Type
    Active Comparator
    Arm Description
    2nd group of participants will be treated with hemithyroidectomy
    Intervention Type
    Procedure
    Intervention Name(s)
    thyroidectomy
    Intervention Description
    Patients will be divided into 2 groups group will be treated with total thyroidectomy and the other group will be treated with hemithyroidectomy
    Primary Outcome Measure Information:
    Title
    Improvement in the management of single thyroid nodule to reduce the morbidity and mortality rates
    Description
    Compare between total thyroidectomy and hemithyroidectomy in patients with single thyroid nodule to improve the management of single thyroid nodule in general surgery department , Assiut university hospital.
    Time Frame
    one year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age from 20 to 60 years. patients with single thyroid lesion Fit for surgery Exclusion Criteria: patients with age less than 20 years and more than 60 years. patients with multiple thyroid lesions. patients with advanced and metastatic malignancy. Unfit for surgery
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Mohamed S. Shahine, Phd
    Phone
    01025555420
    Email
    msafwat67@aun.edu.eg

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    15133637
    Citation
    Hurtado-Lopez LM, Arellano-Montano S, Torres-Acosta EM, Zaldivar-Ramirez FR, Duarte-Torres RM, Alonso-De-Ruiz P, Martinez-Duncker I, Martinez-Duncker C. Combined use of fine-needle aspiration biopsy, MIBI scans and frozen section biopsy offers the best diagnostic accuracy in the assessment of the hypofunctioning solitary thyroid nodule. Eur J Nucl Med Mol Imaging. 2004 Sep;31(9):1273-9. doi: 10.1007/s00259-004-1544-7. Epub 2004 May 6.
    Results Reference
    background
    PubMed Identifier
    26462967
    Citation
    Haugen BR, Alexander EK, Bible KC, Doherty GM, Mandel SJ, Nikiforov YE, Pacini F, Randolph GW, Sawka AM, Schlumberger M, Schuff KG, Sherman SI, Sosa JA, Steward DL, Tuttle RM, Wartofsky L. 2015 American Thyroid Association Management Guidelines for Adult Patients with Thyroid Nodules and Differentiated Thyroid Cancer: The American Thyroid Association Guidelines Task Force on Thyroid Nodules and Differentiated Thyroid Cancer. Thyroid. 2016 Jan;26(1):1-133. doi: 10.1089/thy.2015.0020.
    Results Reference
    background
    PubMed Identifier
    26180765
    Citation
    Jena A, Patnayak R, Prakash J, Sachan A, Suresh V, Lakshmi AY. Malignancy in solitary thyroid nodule: A clinicoradiopathological evaluation. Indian J Endocrinol Metab. 2015 Jul-Aug;19(4):498-503. doi: 10.4103/2230-8210.159056.
    Results Reference
    background
    PubMed Identifier
    21221869
    Citation
    Lloyd RV, Buehler D, Khanafshar E. Papillary thyroid carcinoma variants. Head Neck Pathol. 2011 Mar;5(1):51-6. doi: 10.1007/s12105-010-0236-9. Epub 2011 Jan 8.
    Results Reference
    background
    PubMed Identifier
    31275541
    Citation
    Alwithenani R, DeBrabandere S, Rachinsky I, MacNeil SD, Badreddine M, Van Uum S. Performance of the American Thyroid Association Risk Classification in a Single Center Cohort of Pediatric Patients with Differentiated Thyroid Cancer: A Retrospective Study. J Thyroid Res. 2019 Jun 2;2019:5390316. doi: 10.1155/2019/5390316. eCollection 2019.
    Results Reference
    background
    PubMed Identifier
    22443979
    Citation
    Popoveniuc G, Jonklaas J. Thyroid nodules. Med Clin North Am. 2012 Mar;96(2):329-49. doi: 10.1016/j.mcna.2012.02.002.
    Results Reference
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    Intervention in Single Thyroid Nodule.

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