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

NCT ID: NCT06176976

Last Updated: 2023-12-20

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-15
• Study Completion Date: 2025-06-30

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.

Conditions

Toxic; Thyroid

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Thyroidectomy without lugols solution preparation

euthyroid patients undergoing total thyroidectomy for toxic thyroid disease, no preoperative preparation with 5% lugols solution

Group Type: NO_INTERVENTION

No interventions assigned to this group

Thyroidectomy with lugols solution preparation

euthyroid patients undergoing total thyroidectomy for toxic thyroid disease, preoperative preparation with 5% lugols solution for 10 days

Group Type: EXPERIMENTAL

Lugol's iodine solution 5%

Intervention Type: DIETARY_SUPPLEMENT

4 drops of LS every 8 hours for 10 days preoperatively will be given

Interventions

Lugol's iodine solution 5%

4 drops of LS every 8 hours for 10 days preoperatively will be given

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Aristotle University Of Thessaloniki

OTHER

Sponsor Role: lead

Responsible Party

Styliani Konstantinos Laskou

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Styliani Laskou

Role: PRINCIPAL_INVESTIGATOR

3rd Surgical Department of Aristotle University, AHEPA University Hospital, Thessaloniki

Locations

3rd Surgical Department of Aristotle University, AHEPA University Hospital, Thessaloniki

Thessaloniki, Thessaloniki, Greece

Countries

Greece

Other Identifiers

LS trial

Identifier Type: -

Identifier Source: org_study_id