Ireland
--:--IST
Recruiting Observational

Thyroidectomy for Graves' Disease or Amiodarone-induced Thyrotoxicosis

NCT06963203 · tracked via the Priya Life Science France tracker
Sponsor
Andrea Goldmann
Phase
Observational
Started
2025-07-01
Last updated
2025-07-02

Condition(s) studied

Graves DiseaseAmiodarone-Induced ThyrotoxicosisThyroidectomy

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Complications — 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
    transient and permanent nerve palsy, transient and permanent hypoparathyroidism, reoperation for postoperative hemorrhage, occurrence of a "thyroid storm"

Trial sites (15)

FacilityCityRegionStatus
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 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
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06963203 on ClinicalTrials.gov ↗ ← All trials in France