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

Not Applicable

Active, not recruiting

• Conditions: Toxic; Thyroid
• Interventions: Dietary Supplement: Lugol's iodine solution 5%

• Registration Number: NCT06176976
• Lead Sponsor: Aristotle University Of Thessaloniki

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-11-29
• Status Verified: 2023-12
• Study Start: 2023-12-15
• Study First Submitted QC: 2023-12-17
• Last Update Submitted: 2023-12-17
• Study First Posted: 2023-12-20
• Last Update Posted: 2023-12-20
• Primary Completion: 2025-01
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Thyroidectomy with lugols solution preparation	Lugol's iodine solution 5%	euthyroid patients undergoing total thyroidectomy for toxic thyroid disease, preoperative preparation with 5% lugols solution for 10 days

Primary Outcome Measures

Name	Time	Method
Thyroidectomy complications rate	24 hours postoperatively	postoperative bleeding, hypoparathyroidism and recurrent laryngeal nerve palsy will be recorded

Secondary Outcome Measures

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

Trial Locations

Locations (1)

3rd Surgical Department of Aristotle University, AHEPA University Hospital, Thessaloniki; 🇬🇷 Thessaloníki, Thessaloniki, Greece