Thyroidectomy for Graves' Disease or Amiodarone-induced Thyrotoxicosis: Is it Still Necessary to Achieve a Preoperative Euthyroid State? - A Prospective Observational Multicenter European Study (GRATES)

What this Trial Is About

This research aims to understand how thyroidectomy (removal of the thyroid gland) complications may differ depending on the thyroid hormone levels before surgery in patients with Graves' disease or Amiodarone-induced thyrotoxicosis (AIT). It focuses on whether patients with different thyroid metabolic states—controlled (normal hormone levels) or uncontrolled (elevated hormone levels)—have similar rates of complications such as nerve damage, hypoparathyroidism, bleeding, or severe heart events during and after surgery. The study is observational and uses data collected in the EUROCRINE registry from multiple centers in Europe. Patients who undergo thyroidectomy for Graves' disease or AIT are grouped based on their hormone levels before surgery, using free triiodothyronine (fT3) and free thyroxine (fT4) tests taken within one week prior to surgery. The study does not alter the surgery or treatment methods. Data are collected prospectively through the EUROCRINE registry and an additional module for study-specific routine data. The study plans to include about 25 centers over two years and will record details such as surgery duration, blood loss, medications, monitoring techniques, hospital stay, and any complications. Participants will provide informed consent, and their usual surgical care is not changed. Researchers will track outcomes from the day of surgery through an average of two years, including complications and recovery. Data include clinical information, operative details, and postoperative follow-up. The study aims to help refine surgical guidelines and determine if waiting for normal thyroid levels before surgery is necessary, potentially speeding up treatment and reducing risks and costs for patients.

Thyroidectomy for Graves' Disease or Amiodarone-induced Thyrotoxicosis