NCT05658809

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2022

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 23, 2022

Completed
28 days until next milestone

First Posted

Study publicly available on registry

December 21, 2022

Completed
9 days until next milestone

Study Start

First participant enrolled

December 30, 2022

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2023

Completed
Last Updated

December 21, 2022

Status Verified

December 1, 2022

Enrollment Period

1 year

First QC Date

November 23, 2022

Last Update Submit

December 17, 2022

Conditions

Thyroid Nodule

Outcome Measures

Primary Outcomes (1)

  • 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.

    one year

Study Arms (2)

Total thyroidectomy for single thyroid nodule

ACTIVE COMPARATOR

group of participants will be treated with total thyroidectomy

Procedure: thyroidectomy

Hemithyroidectomy for single thyroid nodule

ACTIVE COMPARATOR

2nd group of participants will be treated with hemithyroidectomy

Procedure: thyroidectomy

Interventions

thyroidectomyPROCEDURE

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 noduleTotal thyroidectomy for single thyroid nodule

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age from 20 to 60 years.
  • patients with single thyroid lesion
  • Fit for surgery

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (6)

  • 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.

    PMID: 15133637BACKGROUND

  • 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.

    PMID: 26462967BACKGROUND

  • 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.

    PMID: 26180765BACKGROUND

  • 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.

    PMID: 21221869BACKGROUND

  • 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.

    PMID: 31275541BACKGROUND

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

    PMID: 22443979BACKGROUND

MeSH Terms

Conditions

Thyroid Nodule

Interventions

Thyroidectomy

Condition Hierarchy (Ancestors)

Thyroid NeoplasmsEndocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsEndocrine System DiseasesThyroid Diseases

Intervention Hierarchy (Ancestors)

Endocrine Surgical ProceduresSurgical Procedures, Operative

Central Study Contacts

Mohamed S. Shahine, Phd

CONTACT

01025555420msafwat67@aun.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 23, 2022

First Posted

December 21, 2022

Study Start

December 30, 2022

Primary Completion

December 30, 2023

Study Completion

December 30, 2023

Last Updated

December 21, 2022

Record last verified: 2022-12