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Preoperative Administration of Lugols Solution in Toxic Thyroid Diseases (TD): A Prospective Study

A

Aristotle University Of Thessaloniki

Status

Active, not recruiting

Conditions

Toxic; Thyroid

Treatments

Dietary Supplement: Lugol's iodine solution 5%

Study type

Interventional

Funder types

Other

Identifiers

NCT06176976
LS trial

Details and patient eligibility

About

Lugol's solution and other preparations containing iodide have been used as an adjuvant treatment in patients with toxic disease planned for thyroidectomy. However, no conclusive evidence supporting the benefits of preoperative treatment with LS for patients with toxic goiters. This trial aims to provide new insights into future recommendations.

Enrollment

50 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Patients ≥18 years of age
  • Toxic thyroid disease, treated with antithyroid drugs, euthyroid and proposed for total thyroidectomy
  • Written informed consent

Exclusion criteria

  • prior thyroid or parathyroid surgery,
  • hyperparathyroidism that requires associated parathyroidectomy,
  • thyroid cancer that requires adding a lymph node dissection,
  • iodine allergy,
  • consumption of lithium or amiodarone,
  • medically unfit patients (ASA-IV),
  • breastfeeding women,
  • preoperative vocal cord palsy and
  • planned endoscopic, video-assisted or remote access surgery.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

50 participants in 2 patient groups

Thyroidectomy without lugols solution preparation
No Intervention group
Description:
euthyroid patients undergoing total thyroidectomy for toxic thyroid disease, no preoperative preparation with 5% lugols solution
Thyroidectomy with lugols solution preparation
Experimental group
Description:
euthyroid patients undergoing total thyroidectomy for toxic thyroid disease, preoperative preparation with 5% lugols solution for 10 days
Treatment:
Dietary Supplement: Lugol's iodine solution 5%

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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