000117407 001__ 117407 000117407 005__ 20220908120611.0 000117407 0247_ $$2doi$$a10.1016/j.conctc.2021.100806 000117407 0248_ $$2sideral$$a127886 000117407 037__ $$aART-2021-127886 000117407 041__ $$aeng 000117407 100__ $$aMuñoz de Nova J.L. 000117407 245__ $$aEfficacy 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 000117407 260__ $$c2021 000117407 5060_ $$aAccess copy available to the general public$$fUnrestricted 000117407 5203_ $$aBackground: 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. © 2021 000117407 540__ $$9info:eu-repo/semantics/openAccess$$aby-nc-nd$$uhttp://creativecommons.org/licenses/by-nc-nd/3.0/es/ 000117407 592__ $$a0.748$$b2021 000117407 594__ $$a2.7$$b2021 000117407 593__ $$aPharmacology$$c2021$$dQ2 000117407 593__ $$aMedicine (miscellaneous)$$c2021$$dQ2 000117407 655_4 $$ainfo:eu-repo/semantics/article$$vinfo:eu-repo/semantics/publishedVersion 000117407 700__ $$aFranch-Arcas G. 000117407 700__ $$aMejía-Abril G.P. 000117407 700__ $$aFlores-Ruiz M.E. 000117407 700__ $$aMuñoz-Pérez N. 000117407 700__ $$aPintos-Sánchez E. 000117407 700__ $$aGuadarrama González F.J. 000117407 700__ $$aValdés de Anca Á. 000117407 700__ $$aMercader-Cidoncha E. 000117407 700__ $$ade la Quintana-Basarrate A. 000117407 700__ $$aOsorio-Silla I. 000117407 700__ $$aRos-López S.$$uUniversidad de Zaragoza 000117407 700__ $$aGallego-Otaegui L. 000117407 700__ $$aSantos-Molina E. 000117407 700__ $$aMartínez-Nieto C. 000117407 700__ $$aGamborino-Caramés E. 000117407 700__ $$aArtés-Caselles M. 000117407 700__ $$aLorente-Poch L. 000117407 700__ $$aGarcía-Carrillo M. 000117407 700__ $$aMoreno-Llorente P. 000117407 700__ $$aMarín-Velarde C. 000117407 700__ $$aOrtega-Serrano J. 000117407 700__ $$aMartos-Martínez J.M. 000117407 700__ $$aVidal-Pérez O. 000117407 700__ $$aLuengo-Pierrard P. 000117407 700__ $$aVillar-del-Moral J.M. 000117407 7102_ $$11013$$2090$$aUniversidad de Zaragoza$$bDpto. Cirugía$$cÁrea Cirugía 000117407 773__ $$g22, 100806 (2021), [6 pp]$$tContemporary Clinical Trials Communications$$x2451-8654 000117407 8564_ $$s1613536$$uhttps://zaguan.unizar.es/record/117407/files/texto_completo.pdf$$yVersión publicada 000117407 8564_ $$s3101314$$uhttps://zaguan.unizar.es/record/117407/files/texto_completo.jpg?subformat=icon$$xicon$$yVersión publicada 000117407 909CO $$ooai:zaguan.unizar.es:117407$$particulos$$pdriver 000117407 951__ $$a2022-09-08-11:58:42 000117407 980__ $$aARTICLE