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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Steroids | Experimental | Will be given pre-operative corticosteroid regimen |
|
| placebo | Placebo Comparator | Will be given Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexamethasone | Drug | Will take Dexamethasone pre-operatively |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day of Surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
â– Graves' disease or Hashimoto's disease with positive thyroid autoantibodies (TgAb, TPO, TSI, and/or TRAb) undergoing total thyroidectomy for their disease.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alexandria McDow, MD | Contact | 317-944-4377 | amcdow@iu.edu | |
| Hannah Allison, MA | Contact | hralliso@iu.edu |
| Name | Affiliation | Role |
|---|---|---|
| Alexandria McDow, MD | Indiana University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IU Health North Hospital | Recruiting | Indianapolis | Indiana | 46032 | United States |
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| ID | Term |
|---|---|
| D006111 | Graves Disease |
| D050031 | Hashimoto Disease |
| ID | Term |
|---|---|
| D005094 | Exophthalmos |
| D009916 | Orbital Diseases |
| D005128 | Eye Diseases |
| D006042 | Goiter |
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| ID | Term |
|---|---|
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
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| Placebo |
| Drug |
Will take Placebo pre-operatively |
|
| Pre-operative visit and Day of Surgery |
| Surgical complication of transient hypocalcemia | Number of subjects with transient hypocalcemia (calcium <8.5) | Two weeks post-operative and six weeks post-operative |
| Surgical complication of permanent hypocalcemia | Number of subjects with permanent hypocalcemia (calcium <8.5) | through study completion, or 6 months |
| Surgical complication of transient hypoparathyroidism | Number of subjects with Post-op PTH <10 | Two weeks post-operative and six weeks post-operative |
| Surgical complication of permanent hypoparathyroidism | Number of subjects with Post-op PTH <10 | through study completion, or 6 months |
| Surgical complication of recurrent laryngeal nerve palsy | Vocal cord dysfunction will be evaluated through voice assessment and/or flexible laryngoscopy | 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 | 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 | through study completion, an average of 6 months |
| Tg | Tg, 1.3-31.8 ng/mL; | through study completion, an average of 6 months |
| TgAB | TgAB, 0-4.0 IU/mL; | through study completion, an average of 6 months |
| TPO | TPO AB 0-9.0 IU/mL; | through study completion, an average of 6 months |
| TSI | TSI 0-0.54 IU/L; | through study completion, an average of 6 months |
| TRAb | TRAb 0-1.75 IU/L | through study completion, an average of 6 months |
| ThyPRO | 0 points (best outcome) - 340 points (worst outcome) | through study completion, an average of 6 months |
| IU Health Methodist Hospital | Recruiting | Indianapolis | Indiana | 46202 | United States |
|
| IU Health University Hospital | Recruiting | Indianapolis | Indiana | 46202 | United States |
|
| D013959 |
| Thyroid Diseases |
| D004700 | Endocrine System Diseases |
| D006980 | Hyperthyroidism |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D013967 | Thyroiditis, Autoimmune |
| D013966 | Thyroiditis |
| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |