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Intervention in Single Thyroid Nodule.

NCT ID: NCT05658809

Last Updated: 2022-12-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-30

Study Completion Date

2023-12-30

Brief Summary

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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

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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

Conditions

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Thyroid Nodule

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Total thyroidectomy for single thyroid nodule

group of participants will be treated with total thyroidectomy

Group Type ACTIVE_COMPARATOR

thyroidectomy

Intervention Type PROCEDURE

Patients will be divided into 2 groups group will be treated with total thyroidectomy and the other group will be treated with hemithyroidectomy

Hemithyroidectomy for single thyroid nodule

2nd group of participants will be treated with hemithyroidectomy

Group Type ACTIVE_COMPARATOR

thyroidectomy

Intervention Type PROCEDURE

Patients will be divided into 2 groups group will be treated with total thyroidectomy and the other group will be treated with hemithyroidectomy

Interventions

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thyroidectomy

Patients will be divided into 2 groups group will be treated with total thyroidectomy and the other group will be treated with hemithyroidectomy

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Omar Anter Ali Abdelhamid

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Mohamed S. Shahine, Phd

Role: CONTACT

Phone: 01025555420

Email: [email protected]

References

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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.

Reference Type BACKGROUND
PMID: 15133637 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26462967 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26180765 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21221869 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31275541 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 22443979 (View on PubMed)

Other Identifiers

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THYSINGLE

Identifier Type: -

Identifier Source: org_study_id