Preoperative Preparation With Lugol Solution in Patients With Graves-Basedow Disease.

NCT03980132 | Completed Phase 4

• 1 other identifier: LIGRADIS
• Study Type: interventional
• Target: 184
• Locations: 1 country
• Sites: 21

Brief Summary

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

• Demographic variables: birthdate, gender and ethnicity.
• Drugs allergies. Allergy to iodine.
• Personal history and usual treatment.
• Aspects related to the GD: date of diagnosis, use of AT drugs and/or radioiodine, existence of ophthalmopathy, existence of cervical compression symptoms and indication of surgery.
• Physical exploration: body mass index, pulse at rest and blood pressure and cervical palpation.
• Laboratory tests: hematocrit, leukocytes, neutrophils, platelets, international normalized ratio(INR), creatinine, potassium, total calcium, albumin, total proteins, parathormone (PTH), 25-hydroxide-vitamin D, free T4 and / or free T3, TSH, thyroid stimulating immunoglobulin (TSI).
• Classification of the anesthetic risk of ASA.
• Cervical ultrasound: existence of thyroid nodules and volume of the thyroid.
• Mobility of the vocal cords evaluated by laryngoscopy.
• Compliance with assigned treatment: the patient assigned to the LS arm must have consumed at least 80% of the total dose indicated. Intraoperative variables
• Surgical time.
• Antibiotic prophylaxis
• Intraoperative hemorrhage.
• Thyroidectomy Difficulty Scale.
• Loss of electromyographic signal during neural intraoperative monitorization.
• Accidental parathyroidectomy.
• Section or obvious lesion of the recurrent laryngeal nerve.
• Trachea or esophagus perforation.
• Weight of the gland.
• Electrosurgical hemostasis system used during the intervention.
• Maneuvers used to check hemostasis.
• Hemostats used during the intervention.
• Use of drainage.
• Definitive surgical technique: TT, unilateral or bilateral subtotal thyroidectomy or hemithyroidectomy. Postoperative variables
• Early complications: hypoparathyroidism, paralysis of the recurrent laryngeal nerve, postoperative hematoma, surgical site infection or death.
• Debit for surgical drains.
• Postoperative hospital long of stay.
• Anatomopathological variables: histological diagnosis compatible with GD and existence of parathyroid glands in the surgical specimen.
• Long-term complications: hypocalcemia and/or permanent vocal cord paralysis longer than 6 months

Conditions

Hyperthyroidism, Autoimmune

Keywords

Thyroid Surgery; Grave' Disease; Lugol Solution

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (8)

• Surgical difficulty

  Intraoperatively

• Intraoperative hemorrhage

  Intraoperatively

• Surgical time.

  Intraoperatively.

• Intraoperative neuromonitoring.

  Intraoperatively.

• Postoperative Long of Stay

  30 days after surgery

Study Arms (2)

Preoperative Lugol Solution preparation

EXPERIMENTAL

Patients will receive Lugol Solution preparation for 10 days before thyroidectomy

Drug: Lugols Strong Iodine

No preparation

NO INTERVENTION

Patients will not receive preparation before thyroidectomy

Interventions

Lugols Strong Iodine DRUG

5 L.I. drops / 8 hours for 10 days before surgery

Preoperative Lugol Solution preparation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who meet all of the following criteria will be eligible:
• The age of the patient must be over 18 years of age.
• The patient or his / her tutor, in cases where this is the case, has the capacity to understand the study and agrees to participate in it, by signing the corresponding informed consent document.
• Patients who have been diagnosed with GD, defined as the existence of hyperthyroidism (TSH \< lower limit of laboratory normality associated with TSI \> upper limit of laboratory normality) that present ultrasonographic data (diffuse vascularization increase) and / or scintigraphy (diffuse uptake of the radioisotope) compatible with GD.
• Euthyroid patients (free T4 and / or free T3 within the normal range of the laboratory) at the time of randomization, and under treatment with AT drugs (propylthiouracil, carbimazole or methimazole).
• The patient must be proposed for total thyroidectomy, using a transcervical approach.

You may not qualify if:

• The participant can not participate in the study if he / she presents any of the following circumstances:
• Prior cervicotomy by surgical intervention on the thyroid or parathyroid gland.
• Associated hyperparathyroidism that requires associating a parathyroidectomy in the same surgical act.
• Associated thyroid cancer that requires adding a lymph node dissection of the central or lateral compartment in the same surgical time.
• Iodine allergy.
• Consumption of lithium or amiodarone between randomization and administration of LS.
• Patients with category IV of the anesthetic risk classification of the American Society of Anesthesiologists (ASA).
• Women who breastfeed during the administration of the LS or in the month after it.
• Preoperative palsy of a vocal cord verified by laryngoscopy.
• Surgery performed by training specialists, or by staff not specifically dedicated to endocrine surgery.
• Surgery not performed under general anesthesia.
• Endoscopic surgery, video assisted or by remote approach.
• Surgery performed in out-patient settings.
• Current drug consumption or alcohol abuse that could interfere with meeting the study requirements.
• Participation in any other trial with medications in the month prior to randomization.

Sponsors & Collaborators

• Jesús María Villar del Moral: lead

Study Sites (21)

Hospital Universitario de Bellvitge

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

Location

Hospital Universitario Donostia

San Sebastián, Guipúzcoa, 20014, Spain

Location

Hospital Clínico Universitario

Santiago de Compostela, La Coruña, 15706, Spain

Location

Hospital Universitario Insular de Gran Canaria

Las Palmas de Gran Canaria, Las Palmas, 35016, Spain

Location

Hospital Universitario Puerta de Hierro

Majadahonda, Madrid, 28222, Spain

Location

Hospital Clínico Universitario Virgen de la Arrixaca

El Palmar, Murcia, 30120, Spain

Location

Hospital Universitario de Cruces

Barakaldo, Vizcaya, 48903, Spain

Location

Hospital Universitario de Basurto

Bilbao, Vizcaya, 48013, Spain

Location

Hospital Universitario del Mar

Barcelona, 08003, Spain

Location

Hospital Clinic

Barcelona, 08036, Spain

Location

Hospital Universitario Virgen de las Nieves

Granada, 18014, Spain

Location

Hospital Universitario de La princesa

Madrid, 28006, Spain

Location

Hospital General Universitario Gregorio Marañón

Madrid, 28007, Spain

Location

Hospital Universitario Ramón y Cajal

Madrid, 28034, Spain

Location

Hospital Universitario Fundación Jiménez Díaz

Madrid, 28040, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Location

Complejo Asistencial Universitario de Salamanca

Salamanca, 37007, Spain

Location

Hospital Universitario Virgen Macarena

Seville, 41009, Spain

Location

Hospital Universitario Virgen del Rocío

Seville, 41013, Spain

Location

Hospital Clínico Universitario

Valencia, 16010, Spain

Location

Hospital Clínico Universitario Lozano Blesa

Zaragoza, 50009, Spain

Location

Related Publications (1)

• 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.

  PMID: 34195471 RESULT

MeSH Terms

Conditions

Graves Disease

Interventions

iodine potassium iodide

Condition Hierarchy (Ancestors)

Exophthalmos; Orbital Diseases; Eye Diseases; Goiter; Thyroid Diseases; Endocrine System Diseases; Hyperthyroidism; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of General and Digestive Surgery - H. U. Virgen de las Nieves

Study Record Dates

• First Submitted: May 30, 2019
• First Posted: June 10, 2019
• Study Start: November 25, 2019
• Primary Completion: November 30, 2023
• Study Completion: November 30, 2023
• Last Updated: March 6, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (21)