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Title: Efficacy and safety of preoperative with Lugol's iodine solution euthyroid patients with Graves' disease (LIGRADIS Trial): study protocol for a multicenter randomized trial
Author: 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
Quintana Basarrate, Aitor de la
Osorio, 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
Keywords: Malalties de la tiroide
Thyroid diseases
Issue Date: 12-Jun-2021
Publisher: Elsevier
Abstract: Background: 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. Methods: 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. Conclusions: 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.
Note: Versió postprint del document publicat a:
It is part of: Contemporary Clinical Trials, 2021, vol. 2021, num. 22, p. 100806
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ISSN: 1551-7144
Appears in Collections:Articles publicats en revistes (Ciències Clíniques)
Articles publicats en revistes (Institut d'lnvestigació Biomèdica de Bellvitge (IDIBELL))

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