Intervention in Single Thyroid Nodule.
Primary Purpose
Thyroid Nodule
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
thyroidectomy
Sponsored by
About this trial
This is an interventional treatment trial for Thyroid Nodule
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
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
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
background
Learn more about this trial
Intervention in Single Thyroid Nodule.
We'll reach out to this number within 24 hrs