Effectiveness and Mechanism of Preoperative Lugol Solution for Reducing Thyroid Blood Flow in Patients with Euthyroid Graves' Disease.
Shih-Ming Huang, Wei-Ting Liao, Chiou-Feng Lin...
https://pubmed.ncbi.nlm.nih.gov/26546192/Actively Recruiting
Led by Jan Calissendorff · Updated on 2026-02-10
182
Participants Needed
1
Research Sites
17 weeks
Total Duration
This research evaluates whether preoperative treatment with Lugols solution before thyroidectomy can reduce surgical complications such as hypoparathyroidism and laryngeal nerve palsy in patients with hyperthyroidism caused by Graves disease or toxic nodular goiter. The study addresses a gap in evidence, particularly regarding the use of iodine in toxic nodular goiter cases, aiming to improve surgical outcomes for these conditions. Participants are randomly assigned to receive either Lugols solution oral drops three times daily for 10 days before surgery in addition to standard preoperative care, or standard preoperative treatment alone. A pilot study on patients with toxic nodular goiter will measure thyroid hormone levels and heart rate during the treatment period. The intervention involves an iodine potassium iodide 5% oral solution administered as the investigational drug. During the study, participants will be monitored for temporary and permanent complications such as hypoparathyroidism and laryngeal nerve palsy at 1 and 6 months postoperatively. Assessments include thyroid hormone measurements, heart rate, and patient-reported outcomes using ThyPRO39 questionnaires. The total follow-up period extends to at least 6 months after surgery to evaluate the primary and secondary surgical outcomes and ensure safety.
CONDITIONS
Preoperative Lugol's Solution in Graves' Disease and Toxic Nodular Goiter
J
Jan Calissendorff, MD, PhD
F
Fredric Hedberg, MD
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Jan Calissendorff
Lead Sponsor
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 10 days
Participants receive iodine potassium iodide solution oral drops 3 times per day for 10 days prior to thyroidectomy in addition to standard preoperative treatment or continue with standard preoperative treatment without iodine.
Multiple visits on day 0, day 3-4, day 6-7, and after 10 days of treatment
Duration - 6 months postoperatively
Participants are monitored for surgical complications such as hypoparathyroidism and laryngeal nerve palsy after thyroidectomy.
Visits at 1 month and 6 months postoperatively
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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