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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Toxic; Thyroid
• Intervention / Treatment: Dietary supplement: Lugol's iodine solution 5%

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Greece
  • Thessaloniki
    • Thessaloníki, Thessaloniki, Greece, 54352
      • 3rd Surgical Department of Aristotle University, AHEPA University Hospital, Thessaloniki

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Thyroidectomy without lugols solution preparation; euthyroid patients undergoing total thyroidectomy for toxic thyroid disease, no preoperative preparation with 5% lugols solution
Experimental: Thyroidectomy with lugols solution preparation; 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%; 4 drops of LS every 8 hours for 10 days preoperatively will be given

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: Aristotle University Of Thessaloniki
• Investigators: Principal Investigator: Styliani Laskou, 3rd Surgical Department of Aristotle University, AHEPA University Hospital, Thessaloniki

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2023
• Primary Completion (Estimated): January 1, 2025
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: November 29, 2023
• First Submitted That Met QC Criteria: December 17, 2023
• First Posted (Actual): December 20, 2023

Study Record Updates

• Last Update Posted (Actual): December 20, 2023
• Last Update Submitted That Met QC Criteria: December 17, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Thyroid Diseases; Hemostatics; Coagulants; Lugol's solution
• Other Study ID Numbers: LS trial

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No