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LIGRADIS
Randomized Clinical Trial, Blinded for the Researcher and Multicenter, to Evaluate the Efficacy and Safety of Preoperative Preparation With Lugol Solution in Euthyroid Patients With Graves-Basedow Disease.
Sponsor study identifier
interventional
184
1 country
21
Study Start
November 25, 2019
Actual (reported)Primary Completion
November 30, 2023
Actual (reported)Study Completion
November 30, 2023
Actual (reported)Currently, both the American Thyroid Association and the European Thyroid Association recommend the use of Lugol Solution (LS) in the preparation of patients undergoing thyroidectomy for Graves' disease (GD), but their recommendations are based on a low level of evidence. This means that its use is not generalized among the different endocrine surgery units. Methods: Study population: 270 patients (135 patients in each arms) undergoing total thyroidectomy (TT) due to GD in Spanish hospitals, which perform a minimum of 100 thyroidectomies a year, at least 10 of them for GD. Variables: Preoperative variables
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 30, 2023
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 30, 2019
Actual (reported)June 10, 2019
Actual (reported)November 25, 2019
Actual (reported)November 30, 2023
Actual (reported)November 30, 2023
Actual (reported)Postoperative complications
To analyze whether, in euthyroid patients undergoing TT due to GD, preoperative non-preparation with LS increases the appearance of postoperative complications compared to the use of LS preparation. The main variable will be the rate of postoperative complication: hypoparathyroidism, recurrent laryngeal nerve injury, hematoma, surgical site infection or death.
30 days after surgery
Surgical difficulty
Intraoperatively
Intraoperative hemorrhage
Intraoperatively
Surgical time.
Intraoperatively.
Intraoperative neuromonitoring.
Intraoperatively.
Postoperative Long of Stay
30 days after surgery
Patients will receive Lugol Solution preparation for 10 days before thyroidectomy
Patients will not receive preparation before thyroidectomy
5 L.I. drops / 8 hours for 10 days before surgery
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Hospital Universitario de Bellvitge
L'Hospitalet de Llobregat, Barcelona, 08907, Spain
Hospital Universitario Donostia
San Sebastián, Guipúzcoa, 20014, Spain
Hospital Clínico Universitario
Santiago de Compostela, La Coruña, 15706, Spain
Hospital Universitario Insular de Gran Canaria
Las Palmas de Gran Canaria, Las Palmas, 35016, Spain
Hospital Universitario Puerta de Hierro
Majadahonda, Madrid, 28222, Spain
Hospital Clínico Universitario Virgen de la Arrixaca
El Palmar, Murcia, 30120, Spain
Hospital Universitario de Cruces
Munoz de Nova JL, Franch-Arcas G, Mejia-Abril GP, Flores-Ruiz ME, Munoz-Perez N, Pintos-Sanchez E, Guadarrama Gonzalez FJ, Valdes de Anca A, Mercader-Cidoncha E, de la Quintana-Basarrate A, Osorio-Silla I, Ros-Lopez S, Gallego-Otaegui L, Santos-Molina E, Martinez-Nieto C, Gamborino-Carames E, Artes-Caselles M, Lorente-Poch L, Garcia-Carrillo M, Moreno-Llorente P, Marin-Velarde C, Ortega-Serrano J, Martos-Martinez JM, Vidal-Perez O, Luengo-Pierrard P, Villar-Del-Moral JM. 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. Contemp Clin Trials Commun. 2021 Jun 15;22:100806. doi: 10.1016/j.conctc.2021.100806. eCollection 2021 Jun.
184 participants (actual enrollment reported by the registry).
First Submitted
May 30, 2019
First Posted
June 10, 2019
Study Start
November 25, 2019
Actual (reported)Contact the study team to confirm eligibility.
Barakaldo, Vizcaya, 48903, Spain
Hospital Universitario de Basurto
Bilbao, Vizcaya, 48013, Spain
Hospital Universitario del Mar
Barcelona, 08003, Spain
Hospital Clinic
Barcelona, 08036, Spain
Hospital Universitario Virgen de las Nieves
Granada, 18014, Spain
Hospital Universitario de La princesa
Madrid, 28006, Spain
Hospital General Universitario Gregorio Marañón
Madrid, 28007, Spain
Hospital Universitario Ramón y Cajal
Madrid, 28034, Spain
Hospital Universitario Fundación Jiménez Díaz
Madrid, 28040, Spain
Hospital Universitario 12 de Octubre
Madrid, 28041, Spain
Complejo Asistencial Universitario de Salamanca
Salamanca, 37007, Spain
Hospital Universitario Virgen Macarena
Seville, 41009, Spain
Hospital Universitario Virgen del Rocío
Seville, 41013, Spain
Hospital Clínico Universitario
Valencia, 16010, Spain
Hospital Clínico Universitario Lozano Blesa
Zaragoza, 50009, Spain
Primary Completion
November 30, 2023
Actual (reported)Study Completion
November 30, 2023
Actual (reported)Last Updated
March 6, 2024
Record last verified: 2024-03
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Source: ClinicalTrials.gov.
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