Preoperative Corticosteroids in Autoimmune Thyroid Disease

Study Overview
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Brief Summary
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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.

Official Title
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Randomized Controlled Trial of Preoperative Corticosteroids in Autoimmune ThyroidDisease

Conditions
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Graves Disease, Hashimoto Disease

Intervention / Treatment
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* Drug: Dexamethasone
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Steroids<br>Will be given pre-operative corticosteroid regimen | Drug: Dexamethasone<br>* Will take Dexamethasone pre-operatively<br>|
| Placebo Comparator: placebo<br>Will be given Placebo | Drug: Placebo<br>* Will take Placebo pre-operatively<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Thyroid difficulty Scale score | 8 points (best outcome) - 41 points (worst outcome) | through study completion, an average of 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ultrasound doppler quantification of blood flow | 2 points (best outcome) -16 points (worst outcome) | through study completion, an average of 6 months | 
| Number of participants with the following surgical complications: | Number of subjects with: Transient hypocalcemia (calcium <8.5), Post-op PTH <10, Transient nerve injury/voice hoarseness (<6 months), Wound complication, Hematoma, Hypocalcemia (Calcium <8.5) >6 months, Permanent nerve injury > 6 months, Vocal cord dysfunction seen on flexible laryngoscopy, ED visit, Readmission, Reintubation, Tracheostomy | through study completion, an average of 6 months | 
| Calcium | Calcium, 8.5-10.5 mg/dL | through study completion, an average of 6 months | 
| SF-12 | 12 points (best outcome) to 48 points (worst outcome) | through study completion, an average of 6 months | 
| PTH | PTH, 10-65 pg/mL | through study completion, an average of 6 months | 
| TSH | TSH, 0.4-4.2 mcU/mL | through study completion, an average of 6 months | 
| FT4 | FT4, 0.6-1.5 ng/dL | through study completion, an average of 6 months | 
| TT3 | TT3, 82-179 ng/dL; | 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 |