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

Sponsor
Jesús María Villar del Moral (Other)
Overall Status
Recruiting
CT.gov ID
NCT03980132
Collaborator
(none)
270
Enrollment
21
Locations
2
Arms
46.2
Anticipated Duration (Months)
12.9
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief 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

Condition or Disease Intervention/Treatment Phase
  • Drug: Lugols Strong Iodine
 Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
270 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Care Provider, Investigator)
Primary Purpose:
Treatment
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.
Actual Study Start Date :
Nov 25, 2019
Anticipated Primary Completion Date :
Jan 31, 2023
Anticipated Study Completion Date :
Sep 30, 2023

Arms and Interventions

Arm Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

  1. Postoperative complications [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.

Secondary Outcome Measures

  1. Surgical difficulty [Intraoperatively]

    Score of the difficulty of the surgery by the surgeon through the Thyroidectomy Difficulty Scale.

  2. Intraoperative hemorrhage [Intraoperatively]

    Amount of blood lost during the thyroidectomy in dL.

  3. Surgical time. [Intraoperatively.]

    Time from surgical incision to skin closure in minutes.

  4. Intraoperative neuromonitoring. [Intraoperatively.]

    Rate of patients with loss of electromyographic signal during intraoperative neuromonitoring.

  5. Postoperative Long of Stay [30 days after surgery]

    Days to hospital discharge after surgery.

  6. Readmissions [30 days after surgery.]

    Rate of readmissions.

  7. Permanent complications [180 days after surgery]

    Rate of patients with permanent complications, including hypoparathyroidism or recurrent laryngeal nerve injury.

  8. Adverse events [180 days after surgery]

    Number of patients with an adverse event after administration of Lugol solution.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hospital Universitario de Bellvitge Hospitalet de Llobregat Barcelona Spain 08907
2 Hospital Universitario Donostia San Sebastián Guipúzcoa Spain 20014
3 Hospital Clínico Universitario Santiago De Compostela La Coruña Spain 15706
4 Hospital Universitario Insular de Gran Canaria Las Palmas De Gran Canaria Las Palmas Spain 35016
5 Hospital Universitario Puerta de Hierro Majadahonda Madrid Spain 28222
6 Hospital Clínico Universitario Virgen de la Arrixaca El Palmar Murcia Spain 30120
7 Hospital Universitario de Cruces Baracaldo Vizcaya Spain 48903
8 Hospital Universitario de Basurto Bilbao Vizcaya Spain 48013
9 Hospital Universitario del Mar Barcelona Spain 08003
10 Hospital Clinic Barcelona Spain 08036
11 Hospital Universitario Virgen de las Nieves Granada Spain 18014
12 Hospital Universitario de La princesa Madrid Spain 28006
13 Hospital General Universitario Gregorio Marañón Madrid Spain 28007
14 Hospital Universitario Ramón y Cajal Madrid Spain 28034
15 Hospital Universitario Fundación Jiménez Díaz Madrid Spain 28040
16 Hospital Universitario 12 de Octubre Madrid Spain 28041
17 Complejo Asistencial Universitario de Salamanca Salamanca Spain 37007
18 Hospital Universitario Virgen Macarena Sevilla Spain 41009
19 Hospital Universitario Virgen del Rocío Sevilla Spain 41013
20 Hospital Clínico Universitario Valencia Spain 16010
21 Hospital Clínico Universitario Lozano Blesa Zaragoza Spain 50009

Sponsors and Collaborators

  • Jesús María Villar del Moral

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jesús María Villar del Moral, Head of General and Digestive Surgery - H. U. Virgen de las Nieves, Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
ClinicalTrials.gov Identifier:
NCT03980132
Other Study ID Numbers:
  • LIGRADIS
First Posted:
Jun 10, 2019
Last Update Posted:
Jul 8, 2021
Last Verified:
Jul 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Keywords provided by Jesús María Villar del Moral, Head of General and Digestive Surgery - H. U. Virgen de las Nieves, Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
Thyroid Surgery
Grave' Disease
Lugol Solution
Additional relevant MeSH terms:
Graves Disease
Hyperthyroidism

Study Results

No Results Posted as of Jul 8, 2021