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

Autor: José Luis Muñoz de Nova, Enrique Mercader-Cidoncha, Concepción Martínez-Nieto, Lander Gallego-Otaegui, Álvaro Valdés de Anca, Elena Santos-Molina, Mariano Artés-Caselles, Leyre Lorente-Poch, Nuria Victoria Muñoz-Pérez, Guzmán Franch-Arcas, María Eugenia Flores-Ruiz, Francisco Javier Guadarrama González, Juan Manuel Martos-Martínez, Elena Gamborino-Caramés, Susana Ros-López, Joaquín Ortega-Serrano, Irene Osorio-Silla, Maitane García-Carrillo, Oscar Vidal-Pérez, Aitor de la Quintana-Basarrate, Consuelo Marín-Velarde, Elena Pintos-Sánchez, Pablo Moreno-Llorente, Gina Mejía-Abril, Patricia Luengo-Pierrard, Jesús Villar-del-Moral
Přispěvatelé: UAM. Departamento de Cirugía
Rok vydání: 2021
Předmět:
Zdroj: Dipòsit Digital de la UB
Universidad de Barcelona
Zaguán. Repositorio Digital de la Universidad de Zaragoza
instname
Contemporary Clinical Trials Communications
Contemporary Clinical Trials Communications, Vol 22, Iss, Pp 100806-(2021)
Popis: "Artículo escrito por un elevado número de autores, solo se referencian el que aparece en primer lugar, el nombre del grupo de colaboración, si le hubiere, y los autores pertenecientes a la UAM"
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. Trial registration: ClinicalTrials.gov identifier: NCT03980132.
This project is funded by the Spanish Association of Surgeons by a competitive grant for multicenter studies. This Association has no influ- ence on any part of the design, data collection, analysis or interpreta- tion of the results, all of which will be carried out by the main investiga- tors (JLMN and JMVM)
Databáze: OpenAIRE
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