Toxic; ThyroidNCT06176976
Preoperative Administration of Lugols Solution in Toxic Thyroid Diseases (TD): A Prospective Study
A study testing Lugol's iodine solution 5% in people with Toxic; Thyroid, run by Aristotle University Of Thessaloniki at 1 site in Greece.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Toxic; Thyroid
- What is being tested?
- Lugol's iodine solution 5%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteGreece
- Study dates
- 15 Dec 2023to Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients ≥18 years of age
- Toxic thyroid disease, treated with antithyroid drugs, euthyroid and proposed for total thyroidectomy
- Written informed consent
Who cannot join
- 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),
Show all 9Show fewer
- breastfeeding women,
- preoperative vocal cord palsy and
- planned endoscopic, video-assisted or remote access surgery.
Trial locations and contacts
1 site in 1 country.
Greece1 site
3rd Surgical Department of Aristotle University, AHEPA University Hospital, Thessaloniki
Thessaloniki, Thessaloniki, 54352
About this study
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.
- Conditions
- Toxic; Thyroid
- Being tested
- Lugol's iodine solution 5%
- Medical subject headings
- Thyrotoxicosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lugol's iodine solution 5%Dietary supplement
4 drops of LS every 8 hours for 10 days preoperatively will be given
| Study group | Role | What they receive |
|---|---|---|
| Thyroidectomy without lugols solution preparation | No intervention | euthyroid patients undergoing total thyroidectomy for toxic thyroid disease, no preoperative preparation with 5% lugols solution |
| Thyroidectomy with lugols solution preparation | Experimental | euthyroid patients undergoing total thyroidectomy for toxic thyroid disease, preoperative preparation with 5% lugols solution for 10 days Receives: Dietary Supplement: Lugol's iodine solution 5% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Thyroidectomy complications rate
postoperative bleeding, hypoparathyroidism and recurrent laryngeal nerve palsy will be recorded
Measured: 24 hours postoperatively
Secondary outcomes (6)
Thyroid volume
via ultrasound
Measured: Pre-intervention and immediately after the intervention for the lugols solution group. Only preoperative measurement for the non lugols solutiongroup.
Superior thyroid artery blood flow
via ultrasound
Measured: Pre-intervention and immediately after the intervention for the lugols solution group. Only preoperative measurement for the non lugols solutiongroup.
Fibrinogen
Sera, stored at -80 C until they were used
Measured: Pre-intervention and immediately after the intervention for the lugols solution group. Only preoperative measurement for the non lugols solutiongroup.
Vascular endothelial growth factor
Sera, stored at -80 C until they were used
Measured: Pre-intervention and immediately after the intervention for the lugols solution group. Only preoperative measurement for the non lugols solutiongroup.
Interleukin-16 serum levels
Sera, stored at -80 C until they were used
Measured: Pre-intervention and immediately after the intervention for the lugols solution group. Only preoperative measurement for the non lugols solutiongroup.
Thromboelastography
Thromboelastography assay
Measured: Pre-intervention and immediately after the intervention for the lugols solution group. Only preoperative measurement for the non lugols solutiongroup.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2023
- Study start15 Dec 2023
- Primary completionJan 2025 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Toxic; ThyroidStudies of the same condition, open and under way.
- More trials run by Aristotle University Of ThessalonikiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aristotle University Of Thessaloniki
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Styliani Konstantinos Laskou, Aristotle University Of Thessaloniki
- Investigators
- Styliani Laskou, Principal investigator, 3rd Surgical Department of Aristotle University, AHEPA University Hospital, Thessaloniki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06176976
- Sponsor's protocol ID
- LS trial
- Status last verified
- Dec 2023
- First submitted
- 29 Nov 2023
- Last updated
- 20 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Administration of Lugols Solution in Toxic Thyroid Diseases (TD): A Prospective Study
- ClinicalTrials.gov ID
- NCT06176976
- Acronym / sponsor ID
- LS trial
- Conditions
- Toxic; Thyroid
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Aristotle University Of ThessalonikiUniversity, hospital or other
- Study start
- 15 Dec 2023 (actual)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 20 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Thyroidectomy without lugols solution preparation | No intervention | –euthyroid patients undergoing total thyroidectomy for toxic thyroid disease, no preoperative preparation with 5% lugols solution |
| Thyroidectomy with lugols solution preparation | Experimental | Dietary Supplement: Lugol's iodine solution 5%euthyroid patients undergoing total thyroidectomy for toxic thyroid disease, preoperative preparation with 5% lugols solution for 10 days |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients ≥18 years of age
- Toxic thyroid disease, treated with antithyroid drugs, euthyroid and proposed for total thyroidectomy
- Written informed consent
Key exclusion criteria (9 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lugol's iodine solution 5%4 drops of LS every 8 hours for 10 days preoperatively will be given | Dietary supplement | Thyroidectomy with lugols solution preparation |
Primary outcome
Thyroidectomy complications rate
Time frame: 24 hours postoperatively
postoperative bleeding, hypoparathyroidism and recurrent laryngeal nerve palsy will be recorded
6 secondary outcomes
Thyroid volume
Time frame: Pre-intervention and immediately after the intervention for the lugols solution group. Only preoperative measurement for the non lugols solutiongroup.
Superior thyroid artery blood flow
Time frame: Pre-intervention and immediately after the intervention for the lugols solution group. Only preoperative measurement for the non lugols solutiongroup.
Fibrinogen
Time frame: Pre-intervention and immediately after the intervention for the lugols solution group. Only preoperative measurement for the non lugols solutiongroup.
Vascular endothelial growth factor
Time frame: Pre-intervention and immediately after the intervention for the lugols solution group. Only preoperative measurement for the non lugols solutiongroup.
Interleukin-16 serum levels
Time frame: Pre-intervention and immediately after the intervention for the lugols solution group. Only preoperative measurement for the non lugols solutiongroup.
Thromboelastography
Time frame: Pre-intervention and immediately after the intervention for the lugols solution group. Only preoperative measurement for the non lugols solutiongroup.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Styliani Laskou principal investigator
3rd Surgical Department of Aristotle University, AHEPA University Hospital, Thessaloniki
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lugol's iodine solution 5% in people with Toxic; Thyroid, run by Aristotle University Of Thessaloniki at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Thyroidectomy complications rate (time frame: 24 hours postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2023.