Clinical trial NCT06176976: Preoperative Administration of Lugols Solution in Toxic Thyroid Diseases (TD): A Prospective Study
Official title: Preoperative Administration of Lugols Solution in Toxic Thyroid Diseases (TD): A Prospective Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Toxic; Thyroid
Lead sponsor: Aristotle University Of Thessaloniki
Sponsor class: OTHER
First posted: 2023-12-20
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Thyroidectomy complications rate
timeFrame: 24 hours postoperatively
Secondary outcomes:
measure: Thyroid volume
timeFrame: Pre-intervention and immediately after the intervention for the lugols solution group. Only preoperative measurement for the non lugols solutiongroup.
measure: Superior thyroid artery blood flow
timeFrame: Pre-intervention and immediately after the intervention for the lugols solution group. Only preoperative measurement for the non lugols solutiongroup.
measure: Fibrinogen
timeFrame: Pre-intervention and immediately after the intervention for the lugols solution group. Only preoperative measurement for the non lugols solutiongroup.
measure: Vascular endothelial growth factor
timeFrame: Pre-intervention and immediately after the intervention for the lugols solution group. Only preoperative measurement for the non lugols solutiongroup.
measure: Interleukin-16 serum levels
timeFrame: Pre-intervention and immediately after the intervention for the lugols solution group. Only preoperative measurement for the non lugols solutiongroup.
measure: Thromboelastography
timeFrame: Pre-intervention and immediately after the intervention for the lugols solution group. Only preoperative measurement for the non lugols solutiongroup.
Other outcomes:
Locations:
city: Thessaloníki
country: Greece
facility: 3rd Surgical Department of Aristotle University, AHEPA University Hospital, Thessaloniki
state: Thessaloniki
Study officials:
affiliation: 3rd Surgical Department of Aristotle University, AHEPA University Hospital, Thessaloniki
name: Styliani Laskou
role: PRINCIPAL_INVESTIGATOR
References: