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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
184
5 L.I. drops / 8 hours for 10 days before surgery
Hospital Universitario de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain
Hospital Universitario Donostia
San Sebastián, Guipúzcoa, Spain
Hospital Clínico Universitario
Santiago de Compostela, La Coruña, Spain
Hospital Universitario Insular de Gran Canaria
Las Palmas de Gran Canaria, Las Palmas, Spain
Hospital Universitario Puerta de Hierro
Majadahonda, Madrid, Spain
Hospital Clínico Universitario Virgen de la Arrixaca
El Palmar, Murcia, Spain
Hospital Universitario de Cruces
Barakaldo, Vizcaya, Spain
Hospital Universitario de Basurto
Bilbao, Vizcaya, Spain
Hospital Universitario del Mar
Barcelona, Spain
Hospital Clinic
Barcelona, Spain
...and 11 more locations
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.
Time frame: 30 days after surgery
Surgical difficulty
Score of the difficulty of the surgery by the surgeon through the Thyroidectomy Difficulty Scale.
Time frame: Intraoperatively
Intraoperative hemorrhage
Amount of blood lost during the thyroidectomy in dL.
Time frame: Intraoperatively
Surgical time.
Time from surgical incision to skin closure in minutes.
Time frame: Intraoperatively.
Intraoperative neuromonitoring.
Rate of patients with loss of electromyographic signal during intraoperative neuromonitoring.
Time frame: Intraoperatively.
Postoperative Long of Stay
Days to hospital discharge after surgery.
Time frame: 30 days after surgery
Readmissions
Rate of readmissions.
Time frame: 30 days after surgery.
Permanent complications
Rate of patients with permanent complications, including hypoparathyroidism or recurrent laryngeal nerve injury.
Time frame: 180 days after surgery
Adverse events
Number of patients with an adverse event after administration of Lugol solution.
Time frame: 180 days after surgery
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