| Eligibility |
Inclusion Criteria:
Patients fulfilling all of the following inclusion criteria are eligible for the study:
1. Patients with the capacity for discernment and who agree to participate in the study
and sign the consent.
2. Age =18 years.
3. Indication for thyroid surgery due to either nontoxic single thyroid nodule (WHO
disease classification 5A01.1) or nontoxic multinodular goitre (WHO disease
classification 5A01.2).
4. Normal thyroid function without anti-thyroid medication. This is ascertained by at
least one serum TSH value within the reference range in the three months before
surgery (if multiple values are available, the latest value should be normal). If no
TSH values are available, a blood draw will be performed to measure TSH.
Exclusion Criteria:
The presence of any one of the following exclusion criteria will lead to exclusion of the
patient:
1. Women who are pregnant or breastfeeding (a urine pregnancy test will be done at Visit
2 before randomization if applicable).
2. Intention to become pregnant during the course of the study.
3. Alcohol or drug abuse within the past 6 months.
4. Inability to follow the procedures of the study, e.g. due to language problems,
psychological disorders, dementia, etc. of the patient.
5. Participation in another study with investigational drug within the 30 days preceding
and during the present study.
6. Use, within the last month before the scheduled surgery, of iodine-containing
medications, i.e., iodine-containing anti-cough syrups or iodine-containing
disinfectants. Non-iodine-containing anti-cough syrups and non-iodine-containing
disinfectants are authorized.
7. Use, within the last month before the scheduled surgery, of iodine-containing
radiological contrast media. Non-iodine-containing radiological contrast media are
authorized.
8. Susceptibility to iodine-induced hyperthyroidism (i.e., toxic adenoma or toxic
multinodular goiter, or previous episode of iodine-induced hyperthyroidism according
to the medical history).
9. Serum TSH (thyroid-stimulating hormone) level below the lower limit of the reference
range.
10. Graves' disease.
11. Susceptibility to iodine-induced hypothyroidism (history of thyroid surgery,
Hashimoto's thyroiditis, history of subacute or destructive thyroiditis).
12. Titer of serum thyroid autoantibodies (anti-TSH receptor, anti-thyroperoxydase or
antithyroglobulin) above the reference range.
13. History of sialadenitis, regardless of etiology.
14. History of allergic reactions (any grade) to radiological contrast media,
iodine-containing disinfectants, anti-cough medications, or seafood; and known
hypersensitivity to iodine.
15. History of allergic reactions (any grade) to the excipients of the ""IODURE DE
POTASSIUM 65 AApot cpr 65 mg" drug: lactosum anhydricum, cellulosum microcristallinum,
magnesii stearas.
16. Severe intolerance to lactose or galactose (patients having been recommended by their
physician to adhere to a strict regime free of the offending agent).
17. Concurrent treatment with lithium.
18. Concurrent treatment with potassium-sparing diuretics.
19. Nodule diagnosed as thyroid carcinoma or suspicious for thyroid carcinoma based on the
results of a fine-needle aspiration biopsy or a tru-cut biopsy (if performed during
the routine patient work-up as per standard indications).
20. Patients with hyperkalemia.
21. Dermatitis herpetiformis.
22. Congenital myotonia.
23. Hypocomplementemic urticaria/vasculitis.
24. Chronic obstructive pulmonary disease
25. Asthma
26. Heart failure stage B, C or D
27. Impaired renal function (eGFR <60 ml/min/1.73 m2)
28. Normal urinary iodine concentration on the day of surgery (determined
retrospectively).
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