Thyroidectomy for Graves' Disease or Amiodarone-induced Thyrotoxicosis

Sponsor
Andrea Goldmann
Study ID
NCT06963203
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Study Details

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.

Key Dates

Start date
Jul 1, 2025
Status verified
Jun 2025
Primary completion
Jun 30, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
486 participants (estimated)

Arms

  • Arm: euthyreoid
    Patients undergoing thyroidectomy in a euthyreoid state.
  • Arm: non-euthyreoid
    Patients undegoing thyroidectomy in a non-euthyreoid state.

Primary Outcome Measure

Complications [ Time Frame: Day 0= intraoperative until last follow-up postoperatively (e.g. for the recovery from a nerve palsy)= through study completion, an average of 2 years ]

Central Contacts

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