Preoperative Corticosteroids in Autoimmune Thyroid Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Dexamethasone, Placebo.
- Who it may be relevant to
- Registry conditions: Graves Disease, Hashimoto Disease. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Randomized Controlled Trial of Preoperative Corticosteroids in Autoimmune ThyroidDisease
Overview
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
- Drug Dexamethasone
Will take Dexamethasone pre-operatively - Drug Placebo
Will take Placebo pre-operatively
Primary outcome measures
- Thyroid difficulty Scale score [Time frame: Day of Surgery]
Secondary outcome measures (12)
- Change in blood flow / vascularity [Time frame: Pre-operative visit and Day of Surgery]
- Surgical complication of transient hypocalcemia [Time frame: Two weeks post-operative and six weeks post-operative]
- Surgical complication of permanent hypocalcemia [Time frame: through study completion, or 6 months]
- Surgical complication of transient hypoparathyroidism [Time frame: Two weeks post-operative and six weeks post-operative]
- Surgical complication of permanent hypoparathyroidism [Time frame: through study completion, or 6 months]
- Surgical complication of recurrent laryngeal nerve palsy [Time frame: Two weeks post-operative and six-weeks post-operative, if clinically indicated]
- Change in SF-20 at 6 weeks [Time frame: Six weeks post-operative]
- Change in SF-20 at 6 months [Time frame: through study completion, an average of 6 months]
- Tg [Time frame: through study completion, an average of 6 months]
- TgAB [Time frame: through study completion, an average of 6 months]
- TPO [Time frame: through study completion, an average of 6 months]
- TSI [Time frame: through study completion, an average of 6 months]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
United States · 3 centers
- IU Health North Hospital — Indianapolis
- IU Health Methodist Hospital — Indianapolis
- IU Health University Hospital — Indianapolis
Identifiers
NCT: NCT05435547 · 10009