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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
76
Will take Dexamethasone pre-operatively
Will take Placebo pre-operatively
IU Health North Hospital
Indianapolis, Indiana, United States
RECRUITINGIU Health Methodist Hospital
Indianapolis, Indiana, United States
RECRUITINGIU Health University Hospital
Indianapolis, Indiana, United States
RECRUITINGThyroid 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
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
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
Surgical complication of permanent hypocalcemia
Number of subjects with permanent hypocalcemia (calcium \<8.5)
Time frame: through study completion, or 6 months
Surgical complication of transient hypoparathyroidism
Number of subjects with Post-op PTH \<10
Time frame: Two weeks post-operative and six weeks post-operative
Surgical complication of permanent hypoparathyroidism
Number of subjects with Post-op PTH \<10
Time frame: through study completion, or 6 months
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Surgical complication of recurrent laryngeal nerve palsy
Vocal cord dysfunction will be evaluated through voice assessment and/or flexible laryngoscopy
Time frame: Two weeks post-operative and six-weeks post-operative, if clinically indicated
Change in SF-20 at 6 weeks
score ranges from 0 to 100, higher scores indicate better functioning or quality of life
Time frame: Six weeks post-operative
Change in SF-20 at 6 months
score ranges from 0 to 100, higher scores indicate better functioning or quality of life
Time frame: through study completion, an average of 6 months
Tg
Tg, 1.3-31.8 ng/mL;
Time frame: through study completion, an average of 6 months
TgAB
TgAB, 0-4.0 IU/mL;
Time frame: through study completion, an average of 6 months
TPO
TPO AB 0-9.0 IU/mL;
Time frame: through study completion, an average of 6 months
TSI
TSI 0-0.54 IU/L;
Time frame: through study completion, an average of 6 months
TRAb
TRAb 0-1.75 IU/L
Time frame: through study completion, an average of 6 months
ThyPRO
0 points (best outcome) - 340 points (worst outcome)
Time frame: through study completion, an average of 6 months