Toxic; Thyroid
Conditions
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.
Interventions
DIETARY_SUPPLEMENTLugol's iodine solution 5%
4 drops of LS every 8 hours for 10 days preoperatively will be given
Sponsors
Aristotle University Of Thessaloniki
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Thyroidectomy complications rate | 24 hours postoperatively | postoperative bleeding, hypoparathyroidism and recurrent laryngeal nerve palsy will be recorded |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| Thyroid volume | 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 |
| Thromboelastography | Pre-intervention and immediately after the intervention for the lugols solution group. Only preoperative measurement for the non lugols solutiongroup. | Thromboelastography assay |
| 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 |
Countries
Greece
Outcome results
None listed