Actively Recruiting
Randomized Controlled Trial of Preoperative Dexamethasone in Autoimmune Thyroid Disease Including Graves and Hashimoto Disease
Led by Indiana University · Updated on 2025-05-01
76
Participants Needed
3
Research Sites
184 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating whether a short course of corticosteroids before surgery can reduce inflammation and make thyroid surgery easier in patients with autoimmune inflammatory thyroid diseases such as Graves' disease or Hashimoto's disease. This Phase 4 trial focuses on patients undergoing total thyroidectomy for their condition who have positive thyroid autoantibodies. Participants will be randomly assigned to receive either dexamethasone, a corticosteroid, or a placebo before their surgery. The study compares the effects of these treatments on thyroid inflammation and surgical difficulty. During the study, researchers will measure the thyroid difficulty scale score on the day of surgery to assess inflammation and surgical challenges. Participants are monitored closely for safety and treatment effects throughout the trial.
CONDITIONS
Official Title
Preoperative Corticosteroids in Autoimmune Thyroid Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of Graves' disease or Hashimoto's disease with positive thyroid autoantibodies (TgAb, TPO, TSI, and/or TRAb)
- Scheduled for total thyroidectomy for autoimmune thyroid disease
- Age 18 years or older
You will not qualify if you...
- Patients younger than 18 years
- Previous treatment with radioactive iodine (RAI)
- Previous neck surgeries
- Known diagnosis of thyroid cancer
- Diabetes treated with medications
- History of adverse reactions to corticosteroids
- Current use of immunosuppressive treatments, including recent steroid therapy or treatment for other autoimmune diseases
AI-Screening
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Trial Site Locations
Total: 3 locations
1
IU Health North Hospital
Indianapolis, Indiana, United States, 46032
Actively Recruiting
2
IU Health Methodist Hospital
Indianapolis, Indiana, United States, 46202
Actively Recruiting
3
IU Health University Hospital
Indianapolis, Indiana, United States, 46202
Actively Recruiting
Research Team
A
Alexandria McDow, MD
H
Hannah Allison, MA
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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