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NCT Number: NCT03980132

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

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

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Key information

Conditions

Hyperthyroidism, Autoimmune Autoimmune Diseases Endocrine System Diseases Exophthalmos Eye Diseases Goiter Graves Disease Hyperthyroidism Immune System Diseases Orbital Diseases Thyroid Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital Universitario de Bellvitge, L'Hospitalet de Llobregat, Barcelona, Spain

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lugols Strong Iodine

Drug

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

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Jesús María Villar del Moral

Other

Registry information

Official study 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.

Acronym: LIGRADIS

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Jun 10, 2019
Registry last updated
Mar 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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