Health TrialsbyHealthPanel

Preoperative Corticosteroids in Autoimmune Thyroid Disease

ConditionsGraves DiseaseHashimoto Disease
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorIndiana University

About this trial

This study proposes to randomize patients about to undergo surgery for their autoimmune, inflammatory thyroid disease, and determine if a short course of corticosteroids decreases the inflammation of the gland and makes surgery less difficult.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

Pediatric patients < 18

Prior treatment with RAI

Prior neck surgeries

Known diagnosis of thyroid cancer

Trial design

Design model

Parallel

Treatments tested in this trial

  • Dexamethasone

    Drug

    Will take Dexamethasone pre-operatively

  • Placebo

    Drug

    Will take Placebo pre-operatively

Treatment groups

76 Participants
are divided into 2 treatment groups
Group A: SteroidsExperimental treatment 1 intervention
Group B: placeboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Thyroid difficulty Scale score

This scale is completed by the surgeon to assess the difficulty of a thyroid operation, and includes 4 parameters (vascularity, friability, mobility/fibrosis, and gland size). The scale ranges from 4 points (best outcome) - 20 points (worst outcome). Higher scores indicate a more difficult operation.

Time frame
Day of Surgery

Secondary outcomes

1

Change in blood flow / vascularity

The surgeon will use ultrasound to assess the vascularity of the surgical area. Scoring is dependent on thyroid gland size, whether there is substernal extension, and the level of vascularity. The minimum score (2) indicates normal vascularity and normal gland size with no substernal extension. The maximum score (11) indicates extensive vascularity and large gland size with substernal extension.

Time frame
Pre-operative visit and Day of Surgery
2

Surgical complication of transient hypocalcemia

Number of subjects with transient hypocalcemia (calcium \<8.5)

Time frame
Two weeks post-operative and six weeks post-operative
3

Surgical complication of permanent hypocalcemia

Number of subjects with permanent hypocalcemia (calcium \<8.5)

Time frame
through study completion, or 6 months
4

Surgical complication of transient hypoparathyroidism

Number of subjects with Post-op PTH \<10

Time frame
Two weeks post-operative and six weeks post-operative

Other outcomes

Sponsors and contacts

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

Indiana University

Lead sponsor

Source ClinicalTrials.gov
Apply now