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

Background: Currently, both the American Thyroid Association and the European Thyroid Association recom mend 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 LIGRA...

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Autores: Muñoz de Nova, José Luis, Franch-Arcas, Guzmán, Mejía-Abril, Gina Paola, Flores-Ruiz, María Eugenia, Muñoz-Pérez, Nuria, Pintos-Sánchez, Elena, Martos Martínez, Juan Manuel, Villar-del-Moral, Jesús María
Tipo de recurso: artículo
Estado:Versión publicada
Fecha de publicación:2021
País:España
Institución:Universidad de Sevilla (US)
Repositorio:idUS. Depósito de Investigación de la Universidad de Sevilla
OAI Identifier:oai:idus.us.es:11441/139572
Acceso en línea:https://hdl.handle.net/11441/139572
https://doi.org/10.1016/j.conctc.2021.100806
Access Level:acceso abierto
Palabra clave:Thyroid surgery
Graves' disease
Lugol's solution
Hyperthyroidism
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spelling 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 trialMuñoz de Nova, José LuisFranch-Arcas, GuzmánMejía-Abril, Gina PaolaFlores-Ruiz, María EugeniaMuñoz-Pérez, NuriaPintos-Sánchez, ElenaMartos Martínez, Juan ManuelVillar-del-Moral, Jesús MaríaThyroid surgeryGraves' diseaseLugol's solutionHyperthyroidismBackground: Currently, both the American Thyroid Association and the European Thyroid Association recom mend 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 pro vide evidence either to support or refute the systematic use of LS in euthyroid patients undergoing thyroidec tomy 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 preoper ative 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 set ting. This trial aims to provide new insights into future Clinical Practice Guidelines recommendations. Trial registration: ClinicalTrials.gov identifier: NCT03980132.ElsevierCirugía2021info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionapplication/pdfapplication/pdfhttps://hdl.handle.net/11441/139572https://doi.org/10.1016/j.conctc.2021.100806reponame:idUS. Depósito de Investigación de la Universidad de Sevillainstname:Universidad de Sevilla (US)InglésContemporary Clinical Trials Communications, 22, 100806.https://www.sciencedirect.com/science/article/pii/S2451865421001071?via%3Dihubinfo:eu-repo/semantics/openAccessoai:idus.us.es:11441/1395722026-06-17T12:51:07Z
dc.title.none.fl_str_mv 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
title 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
spellingShingle 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
Muñoz de Nova, José Luis
Thyroid surgery
Graves' disease
Lugol's solution
Hyperthyroidism
title_short 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
title_full 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
title_fullStr 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
title_full_unstemmed 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
title_sort 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
dc.creator.none.fl_str_mv Muñoz de Nova, José Luis
Franch-Arcas, Guzmán
Mejía-Abril, Gina Paola
Flores-Ruiz, María Eugenia
Muñoz-Pérez, Nuria
Pintos-Sánchez, Elena
Martos Martínez, Juan Manuel
Villar-del-Moral, Jesús María
author Muñoz de Nova, José Luis
author_facet Muñoz de Nova, José Luis
Franch-Arcas, Guzmán
Mejía-Abril, Gina Paola
Flores-Ruiz, María Eugenia
Muñoz-Pérez, Nuria
Pintos-Sánchez, Elena
Martos Martínez, Juan Manuel
Villar-del-Moral, Jesús María
author_role author
author2 Franch-Arcas, Guzmán
Mejía-Abril, Gina Paola
Flores-Ruiz, María Eugenia
Muñoz-Pérez, Nuria
Pintos-Sánchez, Elena
Martos Martínez, Juan Manuel
Villar-del-Moral, Jesús María
author2_role author
author
author
author
author
author
author
dc.contributor.none.fl_str_mv Cirugía
dc.subject.none.fl_str_mv Thyroid surgery
Graves' disease
Lugol's solution
Hyperthyroidism
topic Thyroid surgery
Graves' disease
Lugol's solution
Hyperthyroidism
description Background: Currently, both the American Thyroid Association and the European Thyroid Association recom mend 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 pro vide evidence either to support or refute the systematic use of LS in euthyroid patients undergoing thyroidec tomy 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 preoper ative 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 set ting. This trial aims to provide new insights into future Clinical Practice Guidelines recommendations. Trial registration: ClinicalTrials.gov identifier: NCT03980132.
publishDate 2021
dc.date.none.fl_str_mv 2021
dc.type.none.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
format article
status_str publishedVersion
dc.identifier.none.fl_str_mv https://hdl.handle.net/11441/139572
https://doi.org/10.1016/j.conctc.2021.100806
url https://hdl.handle.net/11441/139572
https://doi.org/10.1016/j.conctc.2021.100806
dc.language.none.fl_str_mv Inglés
language_invalid_str_mv Inglés
dc.relation.none.fl_str_mv Contemporary Clinical Trials Communications, 22, 100806.
https://www.sciencedirect.com/science/article/pii/S2451865421001071?via%3Dihub
dc.rights.none.fl_str_mv info:eu-repo/semantics/openAccess
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
application/pdf
dc.publisher.none.fl_str_mv Elsevier
publisher.none.fl_str_mv Elsevier
dc.source.none.fl_str_mv reponame:idUS. Depósito de Investigación de la Universidad de Sevilla
instname:Universidad de Sevilla (US)
instname_str Universidad de Sevilla (US)
reponame_str idUS. Depósito de Investigación de la Universidad de Sevilla
collection idUS. Depósito de Investigación de la Universidad de Sevilla
repository.name.fl_str_mv
repository.mail.fl_str_mv
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