Graves Disease, Hashimoto Disease
Conditions
Brief summary
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.
Interventions
DRUGDexamethasone
Will take Dexamethasone pre-operatively
DRUGPlacebo
Will take Placebo pre-operatively
Sponsors
Indiana University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Inclusion Criteria: ■ Graves' disease or Hashimoto's disease with positive thyroid autoantibodies (TgAb, TPO, TSI, and/or TRAb) undergoing total thyroidectomy for their disease. *
Exclusion criteria
* Pediatric patients \< 18 * Prior treatment with RAI * Prior neck surgeries * Known diagnosis of thyroid cancer * Diabetic patients on medications * A history of adverse reactions to corticosteroids. * Patients on any immunosuppressive regimen (such as organ transplant patients or patients treated for other autoimmune conditions). This includes patients with recent history of steroid therapy, or a history of adverse reactions to corticosteroids.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Thyroid difficulty Scale score | Day of Surgery | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in blood flow / vascularity | Pre-operative visit and Day of Surgery | 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. |
| Surgical complication of transient hypocalcemia | Two weeks post-operative and six weeks post-operative | Number of subjects with transient hypocalcemia (calcium \<8.5) |
| Surgical complication of permanent hypocalcemia | through study completion, or 6 months | Number of subjects with permanent hypocalcemia (calcium \<8.5) |
| Surgical complication of transient hypoparathyroidism | Two weeks post-operative and six weeks post-operative | Number of subjects with Post-op PTH \<10 |
| Surgical complication of permanent hypoparathyroidism | through study completion, or 6 months | Number of subjects with Post-op PTH \<10 |
| Surgical complication of recurrent laryngeal nerve palsy | Two weeks post-operative and six-weeks post-operative, if clinically indicated | Vocal cord dysfunction will be evaluated through voice assessment and/or flexible laryngoscopy |
| Change in SF-20 at 6 weeks | Six weeks post-operative | score ranges from 0 to 100, higher scores indicate better functioning or quality of life |
| Change in SF-20 at 6 months | through study completion, an average of 6 months | score ranges from 0 to 100, higher scores indicate better functioning or quality of life |
| Tg | through study completion, an average of 6 months | Tg, 1.3-31.8 ng/mL; |
| TgAB | through study completion, an average of 6 months | TgAB, 0-4.0 IU/mL; |
| TPO | through study completion, an average of 6 months | TPO AB 0-9.0 IU/mL; |
| TSI | through study completion, an average of 6 months | TSI 0-0.54 IU/L; |
| TRAb | through study completion, an average of 6 months | TRAb 0-1.75 IU/L |
| ThyPRO | through study completion, an average of 6 months | 0 points (best outcome) - 340 points (worst outcome) |
Countries
United States
Contacts
CONTACTAlexandria McDow, MD
CONTACTHannah Allison, MA
PRINCIPAL_INVESTIGATORAlexandria McDow, MD
Indiana University
Outcome results
None listed