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Recruiting NCT06963203

NCT06963203 Thyroidectomy for Graves' Disease or Amiodarone-induced Thyrotoxicosis

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Clinical Trial Summary
NCT ID NCT06963203
Status Recruiting
Phase
Sponsor Andrea Goldmann
Condition Graves Disease
Study Type OBSERVATIONAL
Enrollment 486 participants
Start Date 2025-07-01
Primary Completion 2027-06

Trial Parameters

Condition Graves Disease
Sponsor Andrea Goldmann
Study Type OBSERVATIONAL
Phase N/A
Enrollment 486
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2025-07-01
Completion 2027-06

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Brief Summary

The goal of this observational study is to learn about the potential differences in morbidity of thyroidectomy (removal of the thyroid gland) depending on the preoperative hormonal status. The main question it aims to answer is: Do patients undergoing thyroidectomy for thyreotoxicosis (thyroid hyperfunction) due to Graves' disease or Amiodarone induced thyreotoxicosis have comparable complication rates depending on their thyroid metabolic status prior or during the procedure. The data from participants undergoing a thyroidectomy at one of the study sites will be prospectively registered in the EUROCRINE registry, including an add-on module for additional study specific routine data. The operation itself, the preoperative or postoperative treatments are not altered in any way.

Eligibility Criteria

Inclusion Criteria: * Adult patients (≥ 18 years of age) undergoing surgical treatment for Graves' disease or Amiodarone-induced thyrotoxicosis (AIT) with biochemically confirmed hyperthyroidism or on specific medication for the treatment of Graves' disease or AIT. * Patients providing signed informed consent. Exclusion Criteria: * Children and minors (\<18 years). * Pregnant women. * Patients unable or unwilling to provide informed consent due to language barriers or intellectual limitations. * Patients undergoing concurrent parathyroidectomy for primary or secondary hyperparathyroidism, lymph node clearance, or redo surgery. * Surgical procedures performed for other reasons than Graves' disease or AIT

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