Status:
RECRUITING
Preoperative Lugol's Solution in Graves' Disease and Toxic Nodular Goiter
Lead Sponsor:
Jan Calissendorff
Conditions:
Hyperthyroidism
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief 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
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- Hyperthyroidism accepted for thyroidectomy due to toxic nodular goiter with free T4 \<30 pmol/L or Graves' disease
- Signed informed consent
Exclusion
- 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
Key Trial Info
Start Date :
November 18 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2025
Estimated Enrollment :
182 Patients enrolled
Trial Details
Trial ID
NCT04856488
Start Date
November 18 2021
End Date
August 1 2025
Last Update
October 22 2024
Active Locations (1)
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1
Department of Endocrinology, Karolinska University Hospital
Solna, Stockholm County, Sweden, 17176