Preoperative Administration of Lugols Solution in Toxic Thyroid Diseases (TD): A Prospective Study

Study Overview
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Brief Summary
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Lugol's solution and other preparations containing iodide have been used as an adjuvant treatment in patients with toxic disease planned for thyroidectomy. However, no conclusive evidence supporting the benefits of preoperative treatment with LS for patients with toxic goiters. This trial aims to provide new insights into future recommendations.

Official Title
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Preoperative Administration of Lugols Solution in Toxic Thyroid Diseases (TD): A Prospective Study

Conditions
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Toxic; Thyroid

Intervention / Treatment
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* Dietary Supplement: Lugol's iodine solution 5%


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients ≥18 years of age Toxic thyroid disease, treated with antithyroid drugs, euthyroid and proposed for total thyroidectomy Written informed consent Exclusion Criteria: prior thyroid or parathyroid surgery, hyperparathyroidism that requires associated parathyroidectomy, thyroid cancer that requires adding a lymph node dissection, iodine allergy, consumption of lithium or amiodarone, medically unfit patients (ASA-IV), breastfeeding women, preoperative vocal cord palsy and planned endoscopic, video-assisted or remote access surgery.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Thyroidectomy without lugols solution preparation<br>euthyroid patients undergoing total thyroidectomy for toxic thyroid disease, no preoperative preparation with 5% lugols solution | |
| Experimental: Thyroidectomy with lugols solution preparation<br>euthyroid patients undergoing total thyroidectomy for toxic thyroid disease, preoperative preparation with 5% lugols solution for 10 days | Dietary Supplement: Lugol's iodine solution 5%<br>* 4 drops of LS every 8 hours for 10 days preoperatively will be given<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Thyroidectomy complications rate | postoperative bleeding, hypoparathyroidism and recurrent laryngeal nerve palsy will be recorded | 24 hours postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Thyroid volume | via ultrasound | Pre-intervention and immediately after the intervention for the lugols solution group. Only preoperative measurement for the non lugols solutiongroup. | 
| Superior thyroid artery blood flow | via ultrasound | Pre-intervention and immediately after the intervention for the lugols solution group. Only preoperative measurement for the non lugols solutiongroup. | 
| Fibrinogen | Sera, stored at -80 C until they were used | Pre-intervention and immediately after the intervention for the lugols solution group. Only preoperative measurement for the non lugols solutiongroup. | 
| Vascular endothelial growth factor | Sera, stored at -80 C until they were used | Pre-intervention and immediately after the intervention for the lugols solution group. Only preoperative measurement for the non lugols solutiongroup. | 
| Interleukin-16 serum levels | Sera, stored at -80 C until they were used | Pre-intervention and immediately after the intervention for the lugols solution group. Only preoperative measurement for the non lugols solutiongroup. | 
| Thromboelastography | Thromboelastography assay | Pre-intervention and immediately after the intervention for the lugols solution group. Only preoperative measurement for the non lugols solutiongroup. |