Randomized clinical trial, blinded for the researcher and multicenter, to evaluate the efficacy and safety of preoperative preparation with Lugol solution in euthyroid patients with Graves-Basedow disease.

Phase 1

• Conditions: Graves-Basedow disease; MedDRA version: 20.0 Level: LLT Classification code 10065624 Term: Graves-Basedow disease System Organ Class: 100000004860; Therapeutic area: Diseases [C] - Hormonal diseases [C19]

• Registration Number: EUCTR2019-001237-14-ES
• Lead Sponsor: Dr. Jesús María Villar del Moral and Dr. José Luis Muñoz de Nova

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-04-30
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 270

Inclusion Criteria

-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 EG.
-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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 200
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 70

Exclusion Criteria

-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 SL.
-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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified