Hyperthyroidism
Conditions
Brief summary
The purpose of this study is to assess if preoperative treatment with Lugol's solution prior to thyroidectomy can reduce the surgical complications hypoparathyroidism and laryngeal nerve palsy
Detailed description
Current practice in Sweden before thyroidectomy due to hyperthyroidism is preoperative treatment with antithyroid drugs (ATD) to all patients with Graves' disease and in cases of toxic nodular goiter with pronounced hyperthyroidism. Iodine solution is administered preoperatively in selected cases of Graves' disease where ATD is intolerable. In the cases where iodine is used it is in the form of extemporaneous prepared iodine potassium iodide solution (Lugol 5%). The dose varies in clinical studies. In American and Swedish guidelines the dose is 5-10 drops 3 times per day for 10 days prior to surgery. American guidelines recommend iodine as preoperative treatment i Graves' disease but this is based on sparse evidence. Iodine as preoperative treatment in toxic nodular goiter has yet not been studied. The purpose of this study is to assess if preoperative treatment with Lugol's solution prior to thyroidectomy due to hyperthyroidism reduce the surgical complications hypoparathyroidism and laryngeal nerve palsy. Before including toxic nodular goiters accepted for surgery, a pilot study will be performed on 20 patients with toxic nodular goiter. They will receive Lugol solution 3 times per day for ten days and thyroid hormone levels will be measured day 0, day 3-4, day 6-7 and after 10 days of Lugol treatment. Heart rate assessed and ThyPRO39 filled out before and after treatment.
Interventions
DRUGIodine-Potassium Iodide 5%-10% Oral and Topical Solution
Iodine Potassium Iodide 5% oral solution, administered 3 times per day for 10 days
Sponsors
Jan Calissendorff
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Hyperthyroidism accepted for thyroidectomy due to toxic nodular goiter with free T4 \<30 pmol/L or Graves' disease * Signed informed consent
Exclusion criteria
* Unstable coronary artery disease * Previous thyroid surgery * Congestive heart failure * Renal insufficiency * Hepatic failure * Current infection * Treatment with steroids or anticoagulants * Thyroid associated orbitopathy CAS \> 2 * Diabetes mellitus type 1 * Active cancer * Severe psychiatric illness * Amiodarone treatment * Pregnancy * Breast feeding * Women of child bearing potential not using contraceptive * Inability to comprehend the meaning of the study * Iodine hypersensitivity
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Temporary hypoparathyroidism | 1 month postoperatively | Numbers of participants with signs of hypoparathyroidism measured as hypocalcemia, low parathormone (PTH), supplementation with per oral vitamin D or calcium. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Temporary laryngeal nerve palsy | 1 month postoperatively | Number of patients with postoperative signs of vocal chord damage via clinical assessment or laryngoscopy. |
| Permanent laryngeal nerve palsy | 6 months postoperatively | Number of patients with postoperative signs of vocal chord damage via clinical assessment or laryngoscopy. |
| Permanent hypoparathyroidism | 6 months postoperatively | Numbers of participants with signs of hypoparathyroidism measured as hypocalcemia, low PTH, supplementation with per oral vitamin D or calcium. |
Countries
Sweden
Contacts
CONTACTJan Calissendorff, MD, PhD
CONTACTFredric Hedberg, MD
PRINCIPAL_INVESTIGATORJan Calissendorff, MD, PhD
Department of Molecular Medicine and Surgery, Karolinska Institutet
Outcome results
None listed