Graves-Basedow disease MedDRA version: 20.0 Level: LLT Classification code 10065624 Term: Graves-Basedow disease System Organ Class: 100000004860
Conditions
Interventions
Trade Name: Solución de Lugol Fuerte
Pharmaceutical Form: Oral solution
INN or Proposed INN: Solución Fuerte de Lugol
CAS Number: 8500003-09-0
Sponsors
Dr. Jesús María Villar del Moral and Dr. José Luis Muñoz de Nova
Eligibility
Sex/Gender
All
Inclusion criteria
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 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To analyze whether, in euthyroid patients undergoing TT due to GD, preoperative non-preparation with LS increases the appearance of postoperative complications compared to the use of LS preparation.;Primary end point(s): The main variable will therefore be the appearance of at least one postoperative complication: hypoparathyroidism, RLN injury, postoperative hematoma, SSI or postoperative death.;Timepoint(s) of evaluation of this end point: 6 months; Secondary Objective: - To analyze whether, in patients undergoing TT, preoperative non-preparation with LS influences intraoperative results. - To analyze whether, in patients undergoing TT, preoperative non-preparation with LS influences the postoperative long of stay or the rate of readmissions, when compared with the group of patients who do receive such preparation. - To analyze if, in patients undergoing TT, preoperative non-preparation with LS does not increase the appearance of permanent complications, including hypoparathyroidism or RLN injury, when compared with the group of patients who do they receive this preparation. - Determine the safety profile of the use of the LS. - Detect if there are subgroups of patients undergoing TT, in which the non-preparation with LS is particularly beneficial or harmful. - Compare the results obtained according to the technical variations used by each unit. | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: 6 months; Secondary end point(s): Preoperative variables - Demographic variables: birthdate, gender and ethnicity. - Drugs allergies. Allergy to iodine. - Personal history and usual treatment. - Aspects related to the GD: date of diagnosis, use of AT drugs and/or RI, existence of ophthalmopathy, existence of cervical compression symptoms and indication of surgery. - Physical exploration: body mass index, pulse at rest and blood pressure and cervical palpation. - Laboratory tests: hematocrit, leukocytes, neutrophils, platelets, INR, creatinine, potassium, total calcium, albumin, total proteins, PTH, 25-OH-vitamin D, free T4 and / or free T3, TSH, TSI. - Classification of the anesthetic risk of ASA. - Cervical ultrasound: existence of thyroid nodules and volume of the thyroid. - Mobility of the vocal cords evaluated by laryngoscopy. - Compliance with assigned treatment: the patient assigned to the LS arm must have consumed at least 80% of the total dose indicated. Intraoperative variables - Surgical time. - Antibiotic prophylaxis. - Intraoperative hemorrhage. - Thyroidectomy Difficulty Scale. - Loss of electromyographic signal during neural intraoperative monitorization. - Accidental parathyroidectomy. - Section or obvious lesion of the NLR. - Trachea or esophagus perforation. - Weight of the gland. - Electrosurgical hemostasis system used during the intervention. - Maneuvers used to check hemostasis. - Hemostats used during the intervention. - Use of drainage. - Definitive surgical technique: TT, unilateral or bi | — |
Countries
Spain
Contacts
Public ContactPrincipal Investigator
Dr. José Luis Muñoz de Nova
Outcome results
None listed