Efficacy and safety of preoperative preparation with Lugol's iodine solution in euthyroid patients with Graves’ disease (LIGRADIS Trial): Study protocol for a multicenter randomized trial

• Published in: Contemporary clinical trials communications Vol. 22; p. 100806
• Main Authors: Muñoz de Nova, José Luis, Franch-Arcas, Guzmán, Mejía-Abril, Gina Paola, Flores-Ruiz, María Eugenia, Muñoz-Pérez, Nuria, Pintos-Sánchez, Elena, Guadarrama González, Francisco Javier, Valdés de Anca, Álvaro, Mercader-Cidoncha, Enrique, de la Quintana-Basarrate, Aitor, Osorio-Silla, Irene, Ros-López, Susana, Gallego-Otaegui, Lander, Santos-Molina, Elena, Martínez-Nieto, Concepción, Gamborino-Caramés, Elena, Artés-Caselles, Mariano, Lorente-Poch, Leyre, García-Carrillo, Maitane, Moreno-Llorente, Pablo, Marín-Velarde, Consuelo, Ortega-Serrano, Joaquín, Martos-Martínez, Juan Manuel, Vidal-Pérez, Oscar, Luengo-Pierrard, Patricia, Villar-del-Moral, Jesús María
• Format: Journal Article
• Language: English
• Published: Netherlands Elsevier Inc 01-06-2021; Elsevier
• Subjects: Graves' disease; Hyperthyroidism; Lugol's solution; Thyroid surgery; Lugol's solution; Thyroid surgery; Graves' disease; Hyperthyroidism
• ISSN: 2451-8654; 2451-8654
• DOI: 10.1016/j.conctc.2021.100806

Currently, both the American Thyroid Association and the European Thyroid Association recommend preoperative preparation with Lugol's Solution (LS) for patients undergoing thyroidectomy for Graves’ Disease (GD), but their recommendations are based on low-quality evidence. The LIGRADIS trial aims to provide evidence either to support or refute the systematic use of LS in euthyroid patients undergoing thyroidectomy for GD.
A multicenter randomized controlled trial will be performed. Patients ≥18 years of age, diagnosed with GD, treated with antithyroid drugs, euthyroid and proposed for total thyroidectomy will be eligible for inclusion. Exclusion criteria will be prior thyroid or parathyroid surgery, hyperparathyroidism that requires associated parathyroidectomy, thyroid cancer that requires adding a lymph node dissection, iodine allergy, consumption of lithium or amiodarone, medically unfit patients (ASA-IV), breastfeeding women, preoperative vocal cord palsy and planned endoscopic, video-assisted or remote access surgery.
Between January 2020 and January 2022, 270 patients will be randomized for either receiving or not preoperative preparation with LS. Researchers will be blinded to treatment assignment. The primary outcome will be the rate of postoperative complications: hypoparathyroidism, recurrent laryngeal nerve injury, hematoma, surgical site infection or death. Secondary outcomes will be intraoperative events (Thyroidectomy Difficulty Scale score, blood loss, recurrent laryngeal nerve neuromonitoring signal loss), operative time, postoperative length of stay, hospital readmissions, permanent complications and adverse events associated to LS.
There is no conclusive evidence supporting the benefits of preoperative treatment with LS in this setting. This trial aims to provide new insights into future Clinical Practice Guidelines recommendations.
ClinicalTrials.gov identifier: NCT03980132.