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

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ClinicalTrials.gov Identifier: NCT03980132
Recruitment Status : Not yet recruiting
First Posted : June 10, 2019
Last Update Posted : August 7, 2019
Sponsor:
Collaborators:
José Luis Muñoz de Nova - H. U. La Princesa
Guzmán Franch Arcas - C. A. U. Salamanca
Nuria Muñoz Pérez - H. U. Virgen de las Nieves
Aitor de la Quintana Basarrate - H. U. Cruces
Oscar Vidal Pérez - H. Clinic Barcelona
José Manuel Rodríguez González - H. C. U. Virgen de la Arrixaca
Pablo Moreno Llorente - H. U. Bellvitge
María Isabel Gutiérrez Giner - H. U. Insular de Gran Canaria
Francisco Javier Guadarrama González - H. U. 12 de Octubre
Irene Osorio Silla - H. U. Fundación Jiménez Díaz
Enrique Mercader Cidoncha - H. G. U. Gregorio Marañón
Joaquín Gómez Ramírez - H. U. Ramón y Cajal
Mariano Artés Caselles - H. U. Puerta de Hierro
Lander Gallego Otaegui - H. U. Donostia
Elena Gamborino Caramés - H. C. U. Santiago de Compostela
Juan Manuel Martos Martínez - H. U. Virgen del Rocío
Joaquín Ortega Serrano - H. C. U. Valencia
Susana Ros López - H. C. U. Lozano Blesa
Information provided by (Responsible Party):
Jesús María Villar del Moral, Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

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

Condition or disease Intervention/treatment Phase
Hyperthyroidism, Autoimmune Drug: Lugols Strong Iodine Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 270 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: 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.
Estimated Study Start Date : November 1, 2019
Estimated Primary Completion Date : January 31, 2021
Estimated Study Completion Date : September 30, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Preoperative Lugol Solution preparation
Patients will receive Lugol Solution preparation for 10 days before thyroidectomy
Drug: Lugols Strong Iodine
5 L.I. drops / 8 hours for 10 days before surgery

No Intervention: No preparation
Patients will not receive preparation before thyroidectomy



Primary Outcome Measures :
  1. Postoperative complications [ Time Frame: 30 days after surgery ]
    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.


Secondary Outcome Measures :
  1. Surgical difficulty [ Time Frame: Intraoperatively ]
    Score of the difficulty of the surgery by the surgeon through the Thyroidectomy Difficulty Scale.

  2. Intraoperative hemorrhage [ Time Frame: Intraoperatively ]
    Amount of blood lost during the thyroidectomy in dL.

  3. Surgical time. [ Time Frame: Intraoperatively. ]
    Time from surgical incision to skin closure in minutes.

  4. Intraoperative neuromonitoring. [ Time Frame: Intraoperatively. ]
    Rate of patients with loss of electromyographic signal during intraoperative neuromonitoring.

  5. Postoperative Long of Stay [ Time Frame: 30 days after surgery ]
    Days to hospital discharge after surgery.

  6. Readmissions [ Time Frame: 30 days after surgery. ]
    Rate of readmissions.

  7. Permanent complications [ Time Frame: 180 days after surgery ]
    Rate of patients with permanent complications, including hypoparathyroidism or recurrent laryngeal nerve injury.

  8. Adverse events [ Time Frame: 180 days after surgery ]
    Number of patients with an adverse event after administration of Lugol solution.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03980132


Locations
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Spain
José Luis Muñoz de Nova Not yet recruiting
Madrid, Spain, 28028
Contact: José Luis Muñoz de Nova    +34915202447    jmunoz@salud.madrid.org   
Sponsors and Collaborators
Jesús María Villar del Moral
José Luis Muñoz de Nova - H. U. La Princesa
Guzmán Franch Arcas - C. A. U. Salamanca
Nuria Muñoz Pérez - H. U. Virgen de las Nieves
Aitor de la Quintana Basarrate - H. U. Cruces
Oscar Vidal Pérez - H. Clinic Barcelona
José Manuel Rodríguez González - H. C. U. Virgen de la Arrixaca
Pablo Moreno Llorente - H. U. Bellvitge
María Isabel Gutiérrez Giner - H. U. Insular de Gran Canaria
Francisco Javier Guadarrama González - H. U. 12 de Octubre
Irene Osorio Silla - H. U. Fundación Jiménez Díaz
Enrique Mercader Cidoncha - H. G. U. Gregorio Marañón
Joaquín Gómez Ramírez - H. U. Ramón y Cajal
Mariano Artés Caselles - H. U. Puerta de Hierro
Lander Gallego Otaegui - H. U. Donostia
Elena Gamborino Caramés - H. C. U. Santiago de Compostela
Juan Manuel Martos Martínez - H. U. Virgen del Rocío
Joaquín Ortega Serrano - H. C. U. Valencia
Susana Ros López - H. C. U. Lozano Blesa

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Responsible Party: Jesús María Villar del Moral, Head of General and Digestive Surgery - H. U. Virgen de las Nieves, Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
ClinicalTrials.gov Identifier: NCT03980132     History of Changes
Other Study ID Numbers: LIGRADIS
First Posted: June 10, 2019    Key Record Dates
Last Update Posted: August 7, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Jesús María Villar del Moral, Fundación de Investigación Biomédica - Hospital Universitario de La Princesa:
Thyroid Surgery
Grave' Disease
Lugol Solution
Additional relevant MeSH terms:
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Graves Disease
Thyroid Diseases
Endocrine System Diseases
Orbital Diseases
Eye Diseases
Autoimmune Diseases
Immune System Diseases
Hyperthyroidism
Exophthalmos
Goiter
Lugol's solution
Pharmaceutical Solutions
Hemostatics
Coagulants