Preoperative Lugol's Solution in Graves' Disease and Toxic Nodular Goiter
NCT ID: NCT04856488
Last Updated: 2024-10-22
Study Results
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Basic Information
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RECRUITING
PHASE3
182 participants
INTERVENTIONAL
2021-11-18
2025-08-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Iodine Potassium Iodide solution
Participants receive Iodine Potassium Iodide solution oral drops 3 times per day for 10 Days prior to thyroidectomy in addition to standard preoperative treatment
Iodine-Potassium Iodide 5%-10% Oral and Topical Solution
Iodine Potassium Iodide 5% oral solution, administered 3 times per day for 10 days
No intervention
Participants continue with standard preoperative treatment
No interventions assigned to this group
Interventions
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Iodine-Potassium Iodide 5%-10% Oral and Topical Solution
Iodine Potassium Iodide 5% oral solution, administered 3 times per day for 10 days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Signed informed consent
Exclusion Criteria
* 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
18 Years
75 Years
ALL
No
Sponsors
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Jan Calissendorff
OTHER
Responsible Party
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Jan Calissendorff
MD, Senior Consultant, PhD, Associate Professor
Principal Investigators
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Jan Calissendorff, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Department of Molecular Medicine and Surgery, Karolinska Institutet
Locations
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Department of Endocrinology, Karolinska University Hospital
Solna, Stockholm County, Sweden
Countries
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Central Contacts
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Facility Contacts
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References
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Ross DS, Burch HB, Cooper DS, Greenlee MC, Laurberg P, Maia AL, Rivkees SA, Samuels M, Sosa JA, Stan MN, Walter MA. 2016 American Thyroid Association Guidelines for Diagnosis and Management of Hyperthyroidism and Other Causes of Thyrotoxicosis. Thyroid. 2016 Oct;26(10):1343-1421. doi: 10.1089/thy.2016.0229.
Kaur S, Parr JH, Ramsay ID, Hennebry TM, Jarvis KJ, Lester E. Effect of preoperative iodine in patients with Graves' disease controlled with antithyroid drugs and thyroxine. Ann R Coll Surg Engl. 1988 May;70(3):123-7.
Randle RW, Bates MF, Long KL, Pitt SC, Schneider DF, Sippel RS. Impact of potassium iodide on thyroidectomy for Graves' disease: Implications for safety and operative difficulty. Surgery. 2018 Jan;163(1):68-72. doi: 10.1016/j.surg.2017.03.030. Epub 2017 Nov 3.
Whalen G, Sullivan M, Maranda L, Quinlan R, Larkin A. Randomized trial of a short course of preoperative potassium iodide in patients undergoing thyroidectomy for Graves' disease. Am J Surg. 2017 Apr;213(4):805-809. doi: 10.1016/j.amjsurg.2016.07.015. Epub 2016 Aug 4.
Marigold JH, Morgan AK, Earle DJ, Young AE, Croft DN. Lugol's iodine: its effect on thyroid blood flow in patients with thyrotoxicosis. Br J Surg. 1985 Jan;72(1):45-7. doi: 10.1002/bjs.1800720118.
Yilmaz Y, Kamer KE, Ureyen O, Sari E, Acar T, Karahalli O. The effect of preoperative Lugol's iodine on intraoperative bleeding in patients with hyperthyroidism. Ann Med Surg (Lond). 2016 Jun 16;9:53-7. doi: 10.1016/j.amsu.2016.06.002. eCollection 2016 Aug.
Huang SM, Liao WT, Lin CF, Sun HS, Chow NH. Effectiveness and Mechanism of Preoperative Lugol Solution for Reducing Thyroid Blood Flow in Patients with Euthyroid Graves' Disease. World J Surg. 2016 Mar;40(3):505-9. doi: 10.1007/s00268-015-3298-8.
Calissendorff J, Falhammar H. Rescue pre-operative treatment with Lugol's solution in uncontrolled Graves' disease. Endocr Connect. 2017 May;6(4):200-205. doi: 10.1530/EC-17-0025. Epub 2017 Mar 21.
Calissendorff J, Falhammar H. Lugol's solution and other iodide preparations: perspectives and research directions in Graves' disease. Endocrine. 2017 Dec;58(3):467-473. doi: 10.1007/s12020-017-1461-8. Epub 2017 Oct 26.
Spallek L, Krille L, Reiners C, Schneider R, Yamashita S, Zeeb H. Adverse effects of iodine thyroid blocking: a systematic review. Radiat Prot Dosimetry. 2012 Jul;150(3):267-77. doi: 10.1093/rpd/ncr400. Epub 2011 Oct 20.
Nauman J, Wolff J. Iodide prophylaxis in Poland after the Chernobyl reactor accident: benefits and risks. Am J Med. 1993 May;94(5):524-532. doi: 10.1016/0002-9343(93)90089-8. No abstract available.
Hedberg F, Cramon PK, Branstrom R, Falhammar H, Calissendorff J. Assessing the impact of short-term Lugol's solution on toxic nodular thyroid disease: a pre-post-intervention study. Front Endocrinol (Lausanne). 2024 Jul 25;15:1420154. doi: 10.3389/fendo.2024.1420154. eCollection 2024.
Other Identifiers
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LugolProtocol001
Identifier Type: -
Identifier Source: org_study_id
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