Preoperative Preparation With Lugol Solution in Patients With Graves-Basedow Disease.
Status:
Recruiting
Trial end date:
2023-09-30
Target enrollment:
Participant gender:
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
Phase:
Phase 4
Details
Lead Sponsor:
Jesús María Villar del Moral
Collaborators:
Guzmán Franch Arcas - C. A. U. Salamanca José Luis Muñoz de Nova - H. U. La Princesa Nuria Muñoz Pérez - H. U. Virgen de las Nieves