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

NCT03980132 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 184

Last updated 2024-03-06

No results posted yet for this study

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

Conditions

  • Hyperthyroidism, Autoimmune

Interventions

DRUG

Lugols Strong Iodine

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

Sponsors & Collaborators

  • Jesús María Villar del Moral

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-25
Primary Completion
2023-11-30
Completion
2023-11-30

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03980132 on ClinicalTrials.gov