Surgical Versus Non Surgical Management of Thyroid Nodule

Not Applicable

• Conditions: Thyroid Nodule
• Interventions: Procedure: thyroidectomy

• Registration Number: NCT04580199
• Lead Sponsor: Mahmoud Fahd

Brief Summary

To compare between surgical (hemi thyroidectomy and total thyroidectomy) and non-surgical (medical, ethanol injection,thermal ablation and laser photo coagulation) management of simple thyroid nodule regarding:

* Outcome of every type of management

* Feasibility of minimally invasive technique in management of simple thyroid nodule in Asyut university

* Complication of every type of management

Detailed Description

Thyroid nodules are very common in clinical practice; they are discovered by palpation in 3-7% and by ultrasound (US) in about 50% of the general population. The majority of thyroid nodules are benign and asymptomatic. The main management of benign thyroid nodules is observation and follow-up; however, a minority of them (10-15%) increase in size over time and may induce symptoms or cosmetic issues. Surgical excision has been established as a treatment for symptomatic benign thyroid nodules. thyroidectomy for benign thyroid disease continues to remain controversial, as there are many conflicting data published in the literature regarding the risk of hypothyroidism and recurrent laryngeal nerve injury stratified to indications for surgery, extent of thyroid resection and surgical volume .It carries a 2-10% risk of complications and neck scarring .Thyroid surgery is also costly and may not be appropriate for patients who have a high risk of surgical morbidity.Therefore, image-guided nonsurgical procedures such as ethanol ablation (EA) and thermal ablation have been proposed as alternative and less invasive approaches for the management of benign symptomatic thyroid nodules .These so-called thermoablative methods induce local thermodestruction, leading to nodule shrinkage and improvement of local symptoms. Monopolar radiofrequency ablation (RFA) and EA is widely used as a nonsurgical treatment usually for cystic (i.e., pure cyst) or predominantly cystic benign thyroid nodules (i.e., cystic portion \> 50%). There is another method called US-guided percutaneous laser ablation (PLA) is a safe and effective therapeutic option as an alternative to surgery for benign symptomatic nodules

Study Timeline

• Status Verified: 2020-10
• Study First Submitted: 2020-10-02
• Study First Submitted QC: 2020-10-02
• Last Update Submitted: 2020-10-07
• Study First Posted: 2020-10-08
• Last Update Posted: 2020-10-09
• Study Start: 2020-12-01
• Primary Completion: 2021-12-01
• Study Completion: 2022-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• complicated thyroid nodule

Exclusion Criteria

• less than 18 malignant thyroid nodule

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
laser photocaugulation	thyroidectomy	using laser for ablation of thyroid nodule
monopolar radiofrequency	thyroidectomy	using radiofrequency for ablation of thyroid nodule
total thyroidectomy	thyroidectomy	excision of thyroid gland
hemi thyroidectomy	thyroidectomy	excision half of thyroid gland
ethanol ingection	thyroidectomy	ingection of ethanol into thyroid nodule under guidance of ultrasound

Primary Outcome Measures

Name	Time	Method
shrinkage of the thyroid nodule	2 years	decrease in the size of thyroid nodule