Intervention in Single Thyroid Nodule.

• Sponsor: Assiut University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05658809
• Collaborator: (none)
• Enrollment: 40
• Arms: 2
• Anticipated Duration (Months): 12

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Thyroid Nodule	Procedure: thyroidectomy	N/A

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

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Total Thyroidectomy Versus Hemithyroidectomy for Patients With Single Thyroid Nodule , Prospective Comparative Study
• Anticipated Study Start Date: Dec 30, 2022
• Anticipated Primary Completion Date: Dec 30, 2023
• Anticipated Study Completion Date: Dec 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Total thyroidectomy for single thyroid nodule group of participants will be treated with total thyroidectomy	Procedure: thyroidectomy; Patients will be divided into 2 groups group will be treated with total thyroidectomy and the other group will be treated with hemithyroidectomy
Active Comparator: Hemithyroidectomy for single thyroid nodule 2nd group of participants will be treated with hemithyroidectomy	Procedure: thyroidectomy; Patients will be divided into 2 groups group will be treated with total thyroidectomy and the other group will be treated with hemithyroidectomy

Outcome Measures

Primary Outcome Measures

1. Improvement in the management of single thyroid nodule to reduce the morbidity and mortality rates [one year]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Age from 20 to 60 years.

2. patients with single thyroid lesion

3. Fit for surgery

Exclusion Criteria:

1. patients with age less than 20 years and more than 60 years.

2. patients with multiple thyroid lesions.

3. patients with advanced and metastatic malignancy.

4. Unfit for surgery

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• Popoveniuc G, Jonklaas J. Thyroid nodules. Med Clin North Am. 2012 Mar;96(2):329-49. doi: 10.1016/j.mcna.2012.02.002.

• Responsible Party: Omar Anter Ali Abdelhamid, Principal Investigator, Assiut University
• ClinicalTrials.gov Identifier: NCT05658809
• Other Study ID Numbers: THYSINGLE
• First Posted: Dec 21, 2022
• Last Update Posted: Dec 21, 2022
• Last Verified: Dec 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Thyroid Nodule; Thyroid Diseases

Study Results

No Results Posted as of Dec 21, 2022