Using Lugol's solution before thyroid surgery for hyperthyroidism
Official title: Preoperative Lugol's Solution in Graves' Disease and Toxic Nodular Goiter
Run by Karolinska University Hospital · NCT04856488 · Data updated 2026-11-12
This study is testing if taking Lugol's solution before thyroid surgery can help reduce complications for people with hyperthyroidism.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 182 (estimated) |
| Sponsor | Karolinska University Hospital Academic / other |
| Locations | 1 site (Solna, Stockholm County) |
| Status | Recruiting |
| Started | November 18, 2021 |
| Main results expected | August 2028 |
| Study ends | December 2028 |
| Registry record updated | February 10, 2026 |
| Trial ID | NCT04856488 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include individuals with hyperthyroidism due to toxic nodular goiter or Graves' disease who are scheduled for thyroidectomy.
✕Probably not a fit
Patients with unstable coronary artery disease, previous thyroid surgery, or other significant health issues may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study evaluates the effectiveness of preoperative treatment with Lugol's solution in reducing surgical complications such as hypoparathyroidism and laryngeal nerve palsy in patients undergoing thyroidectomy for hyperthyroidism. The research involves administering Lugol's solution three times daily for ten days prior to surgery and monitoring thyroid hormone levels, heart rate, and patient-reported outcomes. A pilot study will first assess its effects on 20 patients with toxic nodular goiter before broader implementation. The study aims to provide evidence for a potentially beneficial alternative to current preoperative treatments.
Why it matters
Potential benefit: If successful, this approach could lead to fewer surgical complications for patients undergoing thyroidectomy due to hyperthyroidism.
How similar studies have gone: While the use of iodine as preoperative treatment in Graves' disease is recommended in guidelines, its application in toxic nodular goiter has not been extensively studied, making this approach relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Department of Endocrinology, Karolinska University Hospital
Solna, Stockholm County, Sweden Recruiting
Study contacts
- Principal investigator: Jan Calissendorff, MD, PhD — Department of Molecular Medicine and Surgery, Karolinska Institutet
- Study coordinator: Jan Calissendorff, MD, PhD
- Email: jan.calissendorff@regionstockholm.se
- Phone: +46(0)8 51770000
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.