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.

Dr. Jesús María Villar del Moral and Dr. José Luis Muñoz de Nova0 个研究点目标入组 270 人开始时间: 2019年4月30日最近更新: 2019年6月30日

试验速览

暂无简介。

•-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

•-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.

发起方

Dr. Jesús María Villar del Moral and Dr. José Luis Muñoz de Nova