Thyroidectomy for Graves' Disease or Amiodarone-induced Thyrotoxicosis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAndrea Goldmann
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
Adult, non- pregnant patients who underwent surgical management of Graves ' disease and AIT (Amiodarone induced thyreotoxicosis) in different functional states.
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
486 Participants
are grouped into 2 trial groupsGroup A: euthyreoid
Group B: non-euthyreoid
Trial outcomes
Primary outcomes
1
Complications
transient and permanent nerve palsy, transient and permanent hypoparathyroidism, reoperation for postoperative hemorrhage, occurrence of a "thyroid storm"
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 yearsSecondary outcomes
1
Other complications
Any other intra- or postoperative complication.
Time frame
From day 0= intraoperatively until last follow-up postoperatively (= through study completion, an average of 2 years)2
Duration of Surgery
Time from start of the procedure until the end of the procedure
Time frame
through study completion, an average of 2 years3
Estimated Blood Loss
Estimated amount of blood lost during the procedure.
Time frame
During procedure4
Intraoperative Tachycardia
Elevated heart rate during the procedure
Time frame
During the procedureSponsors and contacts
Click on the lead sponsor to view all of their trials.
Andrea Goldmann
Lead sponsor
Kantonsspital Winterthur KSW
Sponsor institution
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
Source ClinicalTrials.gov