Preoperative Lugol's Solution in Graves' Disease and Toxic Nodular Goiter

Study Overview
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Brief Summary
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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
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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.

Official Title
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Preoperative Lugol's Solution in Graves' Disease and Toxic Nodular Goiter

Conditions
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Hyperthyroidism

Intervention / Treatment
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* Drug: Iodine-Potassium Iodide 5%-10% Oral and Topical Solution


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Iodine Potassium Iodide solution<br>Participants receive Iodine Potassium Iodide solution oral drops 3 times per day for 10 Days prior to thyroidectomy in addition to standard preoperative treatment | Drug: Iodine-Potassium Iodide 5%-10% Oral and Topical Solution<br>* Iodine Potassium Iodide 5% oral solution, administered 3 times per day for 10 days<br>* Other names: Lugol's solution;|
| No Intervention: No intervention<br>Participants continue with standard preoperative treatment | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Temporary hypoparathyroidism | Numbers of participants with signs of hypoparathyroidism measured as hypocalcemia, low parathormone (PTH), supplementation with per oral vitamin D or calcium. | 1 month postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Temporary laryngeal nerve palsy | Number of patients with postoperative signs of vocal chord damage via clinical assessment or laryngoscopy. | 1 month postoperatively | 
| Permanent laryngeal nerve palsy | Number of patients with postoperative signs of vocal chord damage via clinical assessment or laryngoscopy. | 6 months postoperatively | 
| Permanent hypoparathyroidism | Numbers of participants with signs of hypoparathyroidism measured as hypocalcemia, low PTH, supplementation with per oral vitamin D or calcium. | 6 months postoperatively |