Thyroid removal for Graves' disease or amiodarone-induced thyrotoxicosis
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)
The study will try to see if adults having their thyroid removed for Graves' disease or amiodarone-induced thyrotoxicosis have different complication rates depending on how active their thyroid is before or during surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 486 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Kantonsspital Winterthur KSW Academic / other |
| Locations | 15 sites (Aalst and 14 other locations) |
| Trial ID | NCT06963203 on ClinicalTrials.gov |
What this trial studies
This observational study will prospectively register adults undergoing thyroidectomy for Graves' disease or amiodarone-induced thyrotoxicosis in the EUROCRINE registry with an added module for study-specific routine data. It will compare surgical complication rates according to preoperative or perioperative thyroid metabolic status without changing standard preoperative, operative, or postoperative care. Collected data will include biochemical thyroid status, medications, surgical details, and postoperative outcomes across multiple European centers. The approach is registry-based and aims to identify whether patients who are not fully euthyroid at the time of surgery experience higher morbidity than those who are euthyroid.
Who should consider this trial
Good fit: Adults (18+) undergoing thyroidectomy for Graves' disease or amiodarone-induced thyrotoxicosis with biochemical hyperthyroidism or on specific antithyroid medications who can give informed consent.
Not a fit: Children, pregnant women, those unable to consent, patients undergoing concurrent parathyroid or other neck procedures, or those not having thyroidectomy are not included and are unlikely to benefit from these findings.
Why it matters
Potential benefit: If successful, the results could help doctors choose timing and preparation for thyroidectomy that lower complication risks.
How similar studies have performed: Previous registry and retrospective studies have reported mixed results on perioperative outcomes in thyrotoxicosis, and randomized evidence is limited, so a prospective registry-based analysis addresses a recognized evidence gap.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Aalst and 14 other locations
- OLV Ziekenhuis — Aalst, Belgium (Recruiting)
- Universite de Lorraine, Cru Nancy — Nancy, France (Recruiting)
- Evgenidion Hospital Athens — Athens, Greece (Recruiting)
- Universitario Virgen de las Nieves — Granada, Spain (Recruiting)
- Hospital Costa del Sol — Marbella, Spain (Recruiting)
- Kantonsspital Winterthur — Zurich, Winterthur, Switzerland (Recruiting)
- Clarunis St. Clara Spital — Basel, Switzerland (Not_yet_recruiting)
- Universitätsspital Bern, Inselspital — Bern, Switzerland (Recruiting)
- University Hospitals of Geneva — Geneva, Switzerland (Recruiting)
- University Hospital of Lausanne CHUV — Lausanne, Switzerland (Recruiting)
- Kantonsspital Basel Land — Liestal, Switzerland (Not_yet_recruiting)
- Spital Männedorf — Männedorf, Switzerland (Recruiting)
- Ospedale Regionale di Mendrisio — Mendrisio, Switzerland (Recruiting)
- HOCH Kantonsspital St. Gallen — Sankt Gallen, Switzerland (Recruiting)
- Spital Limmattal — Schlieren, Switzerland (Recruiting)
Study contacts
- Principal investigator: Andrea Goldmann, MD — Kantonsspital Winterthur KSW
- Study coordinator: Andrea Goldmann, MD
- Email: andrea.goldmann@ksw.ch
- Phone: 052 266 21 21
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.