Hyperthyroidism, Autoimmune Clinical Trial
— LIGRADISOfficial 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.
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
| Status | Completed |
| Enrollment | 184 |
| Est. completion date | November 30, 2023 |
| Est. primary completion date | November 30, 2023 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| Spain | Hospital Universitario de Cruces | Baracaldo | Vizcaya |
| Spain | Hospital Clinic | Barcelona | |
| Spain | Hospital Universitario del Mar | Barcelona | |
| Spain | Hospital Universitario de Basurto | Bilbao | Vizcaya |
| Spain | Hospital Clínico Universitario Virgen de la Arrixaca | El Palmar | Murcia |
| Spain | Hospital Universitario Virgen de las Nieves | Granada | |
| Spain | Hospital Universitario de Bellvitge | Hospitalet de Llobregat | Barcelona |
| Spain | Hospital Universitario Insular de Gran Canaria | Las Palmas De Gran Canaria | Las Palmas |
| Spain | Hospital General Universitario Gregorio Marañón | Madrid | |
| Spain | Hospital Universitario 12 de Octubre | Madrid | |
| Spain | Hospital Universitario de La princesa | Madrid | |
| Spain | Hospital Universitario Fundación Jiménez Díaz | Madrid | |
| Spain | Hospital Universitario Ramón y Cajal | Madrid | |
| Spain | Hospital Universitario Puerta de Hierro | Majadahonda | Madrid |
| Spain | Complejo Asistencial Universitario de Salamanca | Salamanca | |
| Spain | Hospital Universitario Donostia | San Sebastián | Guipúzcoa |
| Spain | Hospital Clínico Universitario | Santiago De Compostela | La Coruña |
| Spain | Hospital Universitario Virgen del Rocío | Sevilla | |
| Spain | Hospital Universitario Virgen Macarena | Sevilla | |
| Spain | Hospital Clínico Universitario | Valencia | |
| Spain | Hospital Clínico Universitario Lozano Blesa | Zaragoza |
| Lead Sponsor | Collaborator |
|---|---|
| Jesús María Villar del Moral |
Spain,
Munoz de Nova JL, Franch-Arcas G, Mejia-Abril GP, Flores-Ruiz ME, Munoz-Perez N, Pintos-Sanchez E, Guadarrama Gonzalez FJ, Valdes de Anca A, Mercader-Cidoncha E, de la Quintana-Basarrate A, Osorio-Silla I, Ros-Lopez S, Gallego-Otaegui L, Santos-Molina E, — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. | 30 days after surgery | |
| Secondary | Surgical difficulty | Score of the difficulty of the surgery by the surgeon through the Thyroidectomy Difficulty Scale. | Intraoperatively | |
| Secondary | Intraoperative hemorrhage | Amount of blood lost during the thyroidectomy in dL. | Intraoperatively | |
| Secondary | Surgical time. | Time from surgical incision to skin closure in minutes. | Intraoperatively. | |
| Secondary | Intraoperative neuromonitoring. | Rate of patients with loss of electromyographic signal during intraoperative neuromonitoring. | Intraoperatively. | |
| Secondary | Postoperative Long of Stay | Days to hospital discharge after surgery. | 30 days after surgery | |
| Secondary | Readmissions | Rate of readmissions. | 30 days after surgery. | |
| Secondary | Permanent complications | Rate of patients with permanent complications, including hypoparathyroidism or recurrent laryngeal nerve injury. | 180 days after surgery | |
| Secondary | Adverse events | Number of patients with an adverse event after administration of Lugol solution. | 180 days after surgery |