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

  • STATUS
    Recruiting
  • End date
    Sep 30, 2023
  • participants needed
    270
  • sponsor
    Jesús María Villar del Moral
Updated on 16 July 2021
body mass index
calcium
potassium
antibiotic prophylaxis
eye disease
thyroidectomy
hyperthyroidism
methimazole
postoperative hematoma

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

Details
Condition GRAVES' DISEASE
Treatment Lugols Strong Iodine
Clinical Study IdentifierNCT03980132
SponsorJesús María Villar del Moral
Last Modified on16 July 2021

Eligibility

Yes No Not Sure

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
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