2016 American Thyroid Association Guidelines for Diagnosis and Management of Hyperthyroidism and Other Causes of Thyrotoxicosis.
Douglas S Ross, Henry B Burch, David S Cooper...
https://pubmed.ncbi.nlm.nih.gov/27521067Actively Recruiting
Phase 3
Age: 18Years - 75Years
All Genders
ID04856488
Preoperative Lugol's Solution in Graves' Disease and Toxic Nodular Goiter to Reduce Surgical Complications
Led by Jan Calissendorff · Updated on 2026-02-10
182
Participants Needed
1
Research Sites
17 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research evaluates whether preoperative treatment with Lugol's 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 Lugol's 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
Brief Title
Preoperative Lugol's Solution in Graves' Disease and Toxic Nodular Goiter
Who Can Participate
Age: 18Years - 75Years
All Genders
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 75 years
- Hyperthyroidism accepted for thyroidectomy due to toxic nodular goiter with free T4 <30 pmol/L or Graves' disease
- Signed informed consent
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Treatment
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
Follow-up
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
Trial Site Locations
Total: 1 location
1
Department of Endocrinology, Karolinska University Hospital
Solna, Stockholm County, Sweden, 17176
Actively Recruiting
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Research Team
J
Jan Calissendorff, MD, PhD
F
Fredric Hedberg, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
Effect of preoperative iodine in patients with Graves' disease controlled with antithyroid drugs and thyroxine.
S Kaur, J H Parr, I D Ramsay...
https://pubmed.ncbi.nlm.nih.gov/2457351Impact of potassium iodide on thyroidectomy for Graves' disease: Implications for safety and operative difficulty.
Reese W Randle, Maria F Bates, Kristin L Long...
https://pubmed.ncbi.nlm.nih.gov/29108701Randomized trial of a short course of preoperative potassium iodide in patients undergoing thyroidectomy for Graves' disease.
Giles Whalen, Mary Sullivan, Louise Maranda...
https://pubmed.ncbi.nlm.nih.gov/27769543Lugol's iodine: its effect on thyroid blood flow in patients with thyrotoxicosis.
J H Marigold, A K Morgan, D J Earle...
https://pubmed.ncbi.nlm.nih.gov/3967130The effect of preoperative Lugol's iodine on intraoperative bleeding in patients with hyperthyroidism.
Yeliz Yilmaz, Kemal Erdinc Kamer, Orhan Ureyen...
https://pubmed.ncbi.nlm.nih.gov/27408715Effectiveness 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/26546192Rescue pre-operative treatment with Lugol's solution in uncontrolled Graves' disease.
Jan Calissendorff, Henrik Falhammar
https://pubmed.ncbi.nlm.nih.gov/28325735Lugol's solution and other iodide preparations: perspectives and research directions in Graves' disease.
Jan Calissendorff, Henrik Falhammar
https://pubmed.ncbi.nlm.nih.gov/29075974Adverse effects of iodine thyroid blocking: a systematic review.
L Spallek, L Krille, C Reiners...
https://pubmed.ncbi.nlm.nih.gov/22021061