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NCT Number: NCT04856488

Preoperative Lugol's Solution in Graves' Disease and Toxic Nodular Goiter

The purpose of this study is to assess if preoperative treatment with Lugol's solution prior to thyroidectomy can reduce the surgical complications hypoparathyroidism and laryngeal nerve palsy

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Key information

Conditions

Hyperthyroidism Endocrine System Diseases Thyroid Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

About this study

Current practice in Sweden before thyroidectomy due to hyperthyroidism is preoperative treatment with antithyroid drugs (ATD) to all patients with Graves' disease and in cases of toxic nodular goiter with pronounced hyperthyroidism. Iodine solution is administered preoperatively in selected cases of Graves' disease where ATD is intolerable. In the cases where iodine is used it is in the form of extemporaneous prepared iodine potassium iodide solution (Lugol 5%). The dose varies in clinical studies. In American and Swedish guidelines the dose is 5-10 drops 3 times per day for 10 days prior to surgery. American guidelines recommend iodine as preoperative treatment i Graves' disease but this is based on sparse evidence. Iodine as preoperative treatment in toxic nodular goiter has yet not been studied.

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Iodine-Potassium Iodide 5%-10% Oral and Topical Solution

Drug

Iodine Potassium Iodide 5% oral solution, administered 3 times per day for 10 days

Other names: Lugol's solution

Primary outcomes

  1. Temporary hypoparathyroidism

    Time frame: 1 month postoperatively

    Numbers of participants with signs of hypoparathyroidism measured as hypocalcemia, low parathormone (PTH), supplementation with per oral vitamin D or calcium.

Secondary outcomes

  1. Temporary laryngeal nerve palsy

    Time frame: 1 month postoperatively

    Number of patients with postoperative signs of vocal chord damage via clinical assessment or laryngoscopy.

  2. Permanent laryngeal nerve palsy

    Time frame: 6 months postoperatively

    Number of patients with postoperative signs of vocal chord damage via clinical assessment or laryngoscopy.

  3. Permanent hypoparathyroidism

    Time frame: 6 months postoperatively

    Numbers of participants with signs of hypoparathyroidism measured as hypocalcemia, low PTH, supplementation with per oral vitamin D or calcium.

Other outcomes

  1. Change from Baseline in Quality of Life on the Thyroid Specific Patient Reported Outcome 39 (ThyPRO 29) questionnaire

    Time frame: 6 months postoperatively

    ThyPRO 39 is a validated thyroid specific Quality of Life form. Self reported questionnaire filled out before and after surgery. ThyPRO consists of 39 items grouped in 11 scales. Each item is is rated from 0 to 5 on a 5 point Likert scale. Increasing scores indicating decreasing quality of life. Lower scores indicating better quality of life.

Study contacts

Contact information is provided by the study sponsor or research team.

Fredric Hedberg, MD

CONTACT

[email protected]

+46(0)8 51770000

Jan Calissendorff, MD, PhD

CONTACT

[email protected]

+46(0)8 51770000

Sponsors and collaborators

Lead sponsor

Jan Calissendorff

Other

Registry information

Important dates

Study start
2021
Primary completion
2028
Study completion
2028
First posted
Apr 23, 2021
Registry last updated
Feb 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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