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Active, not recruitingNCT06176976Updated Dec 20, 2023

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

An interventional study of Lugol's iodine solution 5% in Toxic; Thyroid, sponsored by Aristotle University Of Thessaloniki. Active, not recruiting at 1 site in Greece. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-12-20.

Sponsored by Aristotle University Of Thessaloniki · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jan 2025, 1 year 9 months ago, but the record still lists the study as active, not recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
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Study summary

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.

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Conditions studied

  • Toxic; Thyroid

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03

In context

Thyroid Diseases

967 studies on the registry are indexed under Thyroid Diseases; 197 are open to participants now.

This study's planned enrollment of 50 is below the median of 60 across 544 interventional studies indexed under Thyroid Diseases.

Browse Thyroid Diseases studies →

Lead sponsor

Aristotle University Of Thessaloniki is the lead sponsor of 274 studies on the registry; 56 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
50 participants (estimated)

Study arms

  • No intervention
    Thyroidectomy without lugols solution preparation

    euthyroid patients undergoing total thyroidectomy for toxic thyroid disease, no preoperative preparation with 5% lugols solution

  • Experimental
    Thyroidectomy with lugols solution preparation

    euthyroid patients undergoing total thyroidectomy for toxic thyroid disease, preoperative preparation with 5% lugols solution for 10 days

    Dietary Supplement: Lugol's iodine solution 5%

Interventions

  • Dietary supplementLugol's iodine solution 5%

    4 drops of LS every 8 hours for 10 days preoperatively will be given

06

What researchers measure

Primary outcomes

  1. Thyroidectomy complications rate

    postoperative bleeding, hypoparathyroidism and recurrent laryngeal nerve palsy will be recorded

    Time frame: 24 hours postoperatively

Secondary outcomes

  1. Thyroid volume

    via ultrasound

    Time frame: Pre-intervention and immediately after the intervention for the lugols solution group. Only preoperative measurement for the non lugols solutiongroup.

  2. Superior thyroid artery blood flow

    via ultrasound

    Time frame: Pre-intervention and immediately after the intervention for the lugols solution group. Only preoperative measurement for the non lugols solutiongroup.

  3. Fibrinogen

    Sera, stored at -80 C until they were used

    Time frame: Pre-intervention and immediately after the intervention for the lugols solution group. Only preoperative measurement for the non lugols solutiongroup.

  4. Vascular endothelial growth factor

    Sera, stored at -80 C until they were used

    Time frame: Pre-intervention and immediately after the intervention for the lugols solution group. Only preoperative measurement for the non lugols solutiongroup.

  5. Interleukin-16 serum levels

    Sera, stored at -80 C until they were used

    Time frame: Pre-intervention and immediately after the intervention for the lugols solution group. Only preoperative measurement for the non lugols solutiongroup.

  6. Thromboelastography

    Thromboelastography assay

    Time frame: Pre-intervention and immediately after the intervention for the lugols solution group. Only preoperative measurement for the non lugols solutiongroup.

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Study locations

1 site
  • 3rd Surgical Department of Aristotle University, AHEPA University Hospital, Thessaloniki
    Thessaloníki, Thessaloniki 54352, Greece
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 20, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06176976
Lead sponsor
Aristotle University Of Thessaloniki
Responsible party
Styliani Konstantinos Laskou (Principal Investigator, Aristotle University Of Thessaloniki) — Principal investigator
First posted
Dec 20, 2023
Start date
Dec 15, 2023
Primary completion
Jan 2025 (estimated)
Completion
Jun 2025 (estimated)
Last update
Dec 20, 2023

Study contacts

Styliani Laskou
principal investigator · 3rd Surgical Department of Aristotle University, AHEPA University Hospital, Thessaloniki

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.

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