Health TrialsbyHealthPanel

Preoperative Lugol's Solution in Graves' Disease and Toxic Nodular Goiter

ConditionHyperthyroidism
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorJan Calissendorff

About this trial

The purpose of this study is to assess if preoperative treatment with Lugol's solution prior to thyroidectomy can reduce the surgical complications hypoparathyroidism and laryngeal nerve palsy

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Hyperthyroidism accepted for thyroidectomy due to toxic nodular goiter with free T4 <30 pmol/L or Graves' disease

Signed informed consent

Disqualifiers

Unstable coronary artery disease

Previous thyroid surgery

Congestive heart failure

Renal insufficiency

Trial design

Design model

Parallel

Treatments tested in this trial

  • Iodine-Potassium Iodide 5%-10% Oral and Topical Solution

    Drug

    Iodine Potassium Iodide 5% oral solution, administered 3 times per day for 10 days

Treatment groups

182 Participants
are divided into 2 treatment groups
Group A: Iodine Potassium Iodide solutionExperimental treatment 1 intervention
Group B: No interventionNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Temporary hypoparathyroidism

Numbers of participants with signs of hypoparathyroidism measured as hypocalcemia, low parathormone (PTH), supplementation with per oral vitamin D or calcium.

Time frame
1 month postoperatively

Secondary outcomes

1

Temporary laryngeal nerve palsy

Number of patients with postoperative signs of vocal chord damage via clinical assessment or laryngoscopy.

Time frame
1 month postoperatively
2

Permanent laryngeal nerve palsy

Number of patients with postoperative signs of vocal chord damage via clinical assessment or laryngoscopy.

Time frame
6 months postoperatively
3

Permanent hypoparathyroidism

Numbers of participants with signs of hypoparathyroidism measured as hypocalcemia, low PTH, supplementation with per oral vitamin D or calcium.

Time frame
6 months postoperatively

Other outcomes

1

Change from Baseline in Quality of Life on the Thyroid Specific Patient Reported Outcome 39 (ThyPRO 29) questionnaire

ThyPRO 39 is a validated thyroid specific Quality of Life form. Self reported questionnaire filled out before and after surgery. ThyPRO consists of 39 items grouped in 11 scales. Each item is is rated from 0 to 5 on a 5 point Likert scale. Increasing scores indicating decreasing quality of life. Lower scores indicating better quality of life.

Time frame
6 months postoperatively

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Jan Calissendorff

Lead sponsor

Karolinska University Hospital

Sponsor institution

Source ClinicalTrials.gov
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