RecruitingPhase 3NCT04856488

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


Sponsor

Jan Calissendorff

Enrollment

182 participants

Start Date

Nov 18, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria2

  • Hyperthyroidism accepted for thyroidectomy due to toxic nodular goiter with free T4 \<30 pmol/L or Graves' disease
  • Signed informed consent

Exclusion Criteria17

  • 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

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Interventions

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

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


Locations(1)

Department of Endocrinology, Karolinska University Hospital

Solna, Stockholm County, Sweden

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NCT04856488


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