Thyroidectomy for Graves' Disease or Amiodarone-induced Thyrotoxicosis

NCT06963203 | Recruiting

• 1 other identifier: BASEC Nr 2024-01766
• Study Type: observational
• Target: 486
• Locations: 5 countries
• Sites: 15

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.

Conditions

Graves Disease; Amiodarone-Induced Thyrotoxicosis; Thyroidectomy

Keywords

GRATES; GRATE Study; thyreotoxicosis; euthyreoidism; Thyroid storm

Outcome Measures

Primary Outcomes (1)

• Complications

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

  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

Secondary Outcomes (12)

• Other complications

  From day 0= intraoperatively until last follow-up postoperatively (= through study completion, an average of 2 years)

• Duration of Surgery

  through study completion, an average of 2 years

• Estimated Blood Loss

  During procedure

• Intraoperative Tachycardia

  During the procedure

• Lenght of Hospital Stay

  From day 0= intraoperatively until last follow-up postoperatively (= through study completion, an average of 2 years)

Study Arms (2)

euthyreoid

Patients undergoing thyroidectomy in a euthyreoid state.

non-euthyreoid

Patients undegoing thyroidectomy in a non-euthyreoid state.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult, non- pregnant patients who underwent surgical management of Graves ' disease and AIT (Amiodarone induced thyreotoxicosis) in different functional states.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Andrea Goldmann: lead
• Spital Männedorf: collaborator
• Spital Limmattal Schlieren: collaborator
• Centre Hospitalier Universitaire Vaudois: collaborator
• Ospedale Regionale di Mendrisio: collaborator
• Cantonal Hospital of St. Gallen: collaborator
• Cantonal Hosptal, Baselland: collaborator
• St. Claraspital AG: collaborator
• University Hospital, Geneva: collaborator
• Insel Gruppe AG, University Hospital Bern: collaborator
• ASZ Aalst: collaborator
• University Hospital Virgen de las Nieves: collaborator
• University of Nancy: collaborator
• Hospital Costa del Sol: collaborator
• Evgenidion Hospital Athens, Greece: collaborator

Study Sites (15)

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, 8400, 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

MeSH Terms

Conditions

Graves Disease; Thyroid Crisis

Condition Hierarchy (Ancestors)

Exophthalmos; Orbital Diseases; Eye Diseases; Goiter; Thyroid Diseases; Endocrine System Diseases; Hyperthyroidism; Autoimmune Diseases; Immune System Diseases; Thyrotoxicosis

Study Officials

• Andrea Goldmann, MD

  Kantonsspital Winterthur KSW

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrea Goldmann, MD

CONTACT

052 266 21 21; andrea.goldmann@ksw.ch

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Fellow of the European Board of Surgery (FEBS) - Endocrine Surgery, Schwerpunkt Viszeralchirurgie, FMH Chirurgie, Kantonsspital Winterthur Klinik für Viszeral- und Thoraxchirurgie Stv. Chefärztin und Stv. Klinikleiterin, Teamleiterin Endokrine Chirurgie

Study Record Dates

• First Submitted: April 22, 2025
• First Posted: May 8, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: July 2, 2025

Record last verified: 2025-06

Locations

ES (2); CH (10); FR (1); BE (1); GR (1)