Preoperative Preparation With Lugol Solution in Patients With Graves-Basedow Disease. (LIGRADIS)
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|ClinicalTrials.gov Identifier: NCT03980132|
Recruitment Status : Not yet recruiting
First Posted : June 10, 2019
Last Update Posted : August 7, 2019
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.
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.
- 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.
- 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.
- 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
|Condition or disease||Intervention/treatment||Phase|
|Hyperthyroidism, Autoimmune||Drug: Lugols Strong Iodine||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||270 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Care Provider, Investigator)|
|Official 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.|
|Estimated Study Start Date :||November 1, 2019|
|Estimated Primary Completion Date :||January 31, 2021|
|Estimated Study Completion Date :||September 30, 2021|
Experimental: Preoperative Lugol Solution preparation
Patients will receive Lugol Solution preparation for 10 days before thyroidectomy
Drug: Lugols Strong Iodine
5 L.I. drops / 8 hours for 10 days before surgery
No Intervention: No preparation
Patients will not receive preparation before thyroidectomy
- 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.
- Surgical difficulty [ Time Frame: Intraoperatively ]Score of the difficulty of the surgery by the surgeon through the Thyroidectomy Difficulty Scale.
- Intraoperative hemorrhage [ Time Frame: Intraoperatively ]Amount of blood lost during the thyroidectomy in dL.
- Surgical time. [ Time Frame: Intraoperatively. ]Time from surgical incision to skin closure in minutes.
- Intraoperative neuromonitoring. [ Time Frame: Intraoperatively. ]Rate of patients with loss of electromyographic signal during intraoperative neuromonitoring.
- Postoperative Long of Stay [ Time Frame: 30 days after surgery ]Days to hospital discharge after surgery.
- Readmissions [ Time Frame: 30 days after surgery. ]Rate of readmissions.
- Permanent complications [ Time Frame: 180 days after surgery ]Rate of patients with permanent complications, including hypoparathyroidism or recurrent laryngeal nerve injury.
- Adverse events [ Time Frame: 180 days after surgery ]Number of patients with an adverse event after administration of Lugol solution.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03980132
|José Luis Muñoz de Nova||Not yet recruiting|
|Madrid, Spain, 28028|
|Contact: José Luis Muñoz de Nova +34915202447 firstname.lastname@example.org|