Intervention in Single Thyroid Nodule.

December 17, 2022 updated by: Omar Anter Ali Abdelhamid, Assiut University

Total Thyroidectomy Versus Hemithyroidectomy for Patients With Single Thyroid Nodule , Prospective Comparative Study

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 56 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement in the management of single thyroid nodule to reduce the morbidity and mortality rates
Time Frame: 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.
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

December 30, 2022

Primary Completion (Anticipated)

December 30, 2023

Study Completion (Anticipated)

December 30, 2023

Study Registration Dates

First Submitted

November 23, 2022

First Submitted That Met QC Criteria

December 17, 2022

First Posted (Actual)

December 21, 2022

Study Record Updates

Last Update Posted (Actual)

December 21, 2022

Last Update Submitted That Met QC Criteria

December 17, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • THYSINGLE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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