Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:58 PM
Ignite Modification Date:
2025-12-24 @ 9:58 PM
NCT ID:
NCT03980132
Eligibility Criteria:
Inclusion Criteria:
Patients who meet all of the following criteria will be eligible:
* The age of the patient must be over 18 years of age.
* The patient or his / her tutor, in cases where this is the case, has the capacity to understand the study and agrees to participate in it, by signing the corresponding informed consent document.
* Patients who have been diagnosed with GD, defined as the existence of hyperthyroidism (TSH \< lower limit of laboratory normality associated with TSI \> upper limit of laboratory normality) that present ultrasonographic data (diffuse vascularization increase) and / or scintigraphy (diffuse uptake of the radioisotope) compatible with GD.
* Euthyroid patients (free T4 and / or free T3 within the normal range of the laboratory) at the time of randomization, and under treatment with AT drugs (propylthiouracil, carbimazole or methimazole).
* The patient must be proposed for total thyroidectomy, using a transcervical approach.
Exclusion Criteria:
The participant can not participate in the study if he / she presents any of the following circumstances:
* Prior cervicotomy by surgical intervention on the thyroid or parathyroid gland.
* Associated hyperparathyroidism that requires associating a parathyroidectomy in the same surgical act.
* Associated thyroid cancer that requires adding a lymph node dissection of the central or lateral compartment in the same surgical time.
* Iodine allergy.
* Consumption of lithium or amiodarone between randomization and administration of LS.
* Patients with category IV of the anesthetic risk classification of the American Society of Anesthesiologists (ASA).
* Women who breastfeed during the administration of the LS or in the month after it.
* Preoperative palsy of a vocal cord verified by laryngoscopy.
* Surgery performed by training specialists, or by staff not specifically dedicated to endocrine surgery.
* Surgery not performed under general anesthesia.
* Endoscopic surgery, video assisted or by remote approach.
* Surgery performed in out-patient settings.
* Current drug consumption or alcohol abuse that could interfere with meeting the study requirements.
* Participation in any other trial with medications in the month prior to randomization.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03980132
Study Brief:
Protocol Section:
NCT03980132