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.

Autor:	Muñoz de Nova JL; Department of General and Digestive Surgery, Hospital Universitario La Princesa, Instituto de Investigación Sanitaria La Princesa, Universidad Autónoma de Madrid, Diego de León 62, 28006, Madrid, Spain., Franch-Arcas G; Department of General and Digestive Surgery, Complejo Asistencial Universitario de Salamanca, Paseo San Vicente 58-182, 37007, Salamanca, Spain., Mejía-Abril GP; Department of Clinical Pharmacology, Hospital Universitario de La Princesa, Instituto de Investigación Sanitaria La Princesa, Universidad Autónoma de Madrid, Diego de León 62, 28006, Madrid, Spain., Flores-Ruiz ME; Department of Clinical Pharmacology, Hospital Universitario de La Princesa, Instituto de Investigación Sanitaria La Princesa, Universidad Autónoma de Madrid, Diego de León 62, 28006, Madrid, Spain., Muñoz-Pérez N; Department of General and Digestive Surgery, Hospital Universitario Virgen de las Nieves, Avda. de las Fuerzas Armadas 2, 18014, Granada, Spain., Pintos-Sánchez E; Department of Clinical Pharmacology, Hospital Universitario de La Princesa, Instituto de Investigación Sanitaria La Princesa, Universidad Autónoma de Madrid, Diego de León 62, 28006, Madrid, Spain., Guadarrama González FJ; Department of General and Digestive Surgery. Hospital Universitario 12 de Octubre, Av. de Córdoba s/n, 28041, Madrid, Spain., Valdés de Anca Á; Department of General and Digestive Surgery, Hospital Universitario La Princesa, Instituto de Investigación Sanitaria La Princesa, Universidad Autónoma de Madrid, Diego de León 62, 28006, Madrid, Spain., Mercader-Cidoncha E; Department of General and Digestive Surgery, Hospital General Universitario Gregorio Marañón, Doctor Esquerdo 46, 28007, Madrid, Spain., de la Quintana-Basarrate A; Department of General and Digestive Surgery, Hospital Universitario de Cruces, Universidad del Pais Vasco, Plaza de Cruces S/N, 48903, Baracaldo, Vizcaya, Spain., Osorio-Silla I; Department of General and Digestive Surgery, Hospital Universitario Fundación Jiménez Díaz, Av. de los Reyes Católicos 2, 28040, Madrid, Spain., Ros-López S; Department of General and Digestive Surgery, Hospital Clínico Universitario Lozano Blesa, Avda. San Juan Bosco 15, 50009, Zaragoza, Spain., Gallego-Otaegui L; Department of General and Digestive Surgery, Hospital Universitario Donostia, Begiristain Doktorea Pasealekua 109, 20014, San Sebastián, Guipúzcoa, Spain., Santos-Molina E; Department of Clinical Pharmacology, Hospital Universitario de La Princesa, Instituto de Investigación Sanitaria La Princesa, Universidad Autónoma de Madrid, Diego de León 62, 28006, Madrid, Spain., Martínez-Nieto C; Department of Pharmacy, Hospital Universitario de La Princesa, Instituto de Investigación Sanitaria La Princesa, Universidad Autónoma de Madrid, Diego de León 62, 28006, Madrid, Spain., Gamborino-Caramés E; Department of General and Digestive Surgery, Hospital Clínico Universitario, Rúa da Choupana s/n, 15706, Santiago de Compostela (La Coruña), Spain., Artés-Caselles M; Department of General and Digestive Surgery, Hospital Universitario Puerta de Hierro, Manuel de Falla 1, 28222, Majadahonda, Madrid, Spain., Lorente-Poch L; Department of General and Digestive Surgery. Hospital Universitario del Mar, Passeig Marítim de la Barceloneta 25-29, 08003, Barcelona, Spain., García-Carrillo M; Department of General and Digestive Surgery, Hospital Universitario de Basurto, Montevideo Etorb 18, 48013, Bilbao, Vizcaya, Spain., Moreno-Llorente P; Endocrine Surgery Unit, Hospital Universitario de Bellvitge, Feixa Llarga s/n, 08907, Hospitalet de Llobregat (Barcelona), Spain., Marín-Velarde C; Department of General and Digestive Surgery, Hospital Universitario Virgen Macarena, Dr. Fedriani 3, 41009, Sevilla, Spain., Ortega-Serrano J; Department of General and Digestive Surgery, Hospital Clínico Universitario, Universidad de Valencia, Av. de Blasco Ibáñez 17, 46010, Valencia, Spain., Martos-Martínez JM; Department of General and Digestive Surgery, Hospital Universitario Virgen del Rocío, Av. Manuel Siurot s/n, 41013, Sevilla, Spain., Vidal-Pérez O; Department of General and Digestive Surgery, Hospital Clinic, Villarroel 170, 08036, Barcelona, Spain., Luengo-Pierrard P; Department of General and Digestive Surgery, Hospital Universitario Ramón y Cajal, Ctra. Colmenar Viejo km. 9,100, 28034, Madrid, Spain., Villar-Del-Moral JM; Department of General and Digestive Surgery. Hospital Universitario 12 de Octubre, Av. de Córdoba s/n, 28041, Madrid, Spain.
Jazyk:	angličtina
Zdroj:	Contemporary clinical trials communications [Contemp Clin Trials Commun] 2021 Jun 15; Vol. 22, pp. 100806. Date of Electronic Publication: 2021 Jun 15 (Print Publication: 2021).
DOI:	10.1016/j.conctc.2021.100806
Abstrakt:	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. Competing Interests: The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper. The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: (© 2021 The Authors. Published by Elsevier Inc.)
Databáze:	MEDLINE
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