Actively Recruiting
Randomized Controlled Trial of Preoperative Corticosteroids in Autoimmune Thyroid Disease
Led by Indiana University · Updated on 2025-05-01
76
Participants Needed
3
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research is focused on patients with autoimmune thyroid diseases, specifically Graves' disease or Hashimoto's disease, who are scheduled for total thyroidectomy surgery. The study aims to evaluate whether a short course of corticosteroids given before surgery can reduce inflammation of the thyroid gland and make the surgery easier. This is a randomized, quadruple-blinded, phase 4 trial sponsored by Indiana University. Participants will be randomly assigned to one of two groups: one group will receive a pre-operative corticosteroid regimen using Dexamethasone, while the other group will receive a placebo before their surgery. The treatment is given prior to surgery to assess its effect on thyroid inflammation and surgical difficulty. During the study, researchers will assess the difficulty of the thyroid surgery using a Thyroid Difficulty Scale on the day of surgery. Additional evaluations include measuring changes in blood flow and vascularity before surgery and on the day of surgery. Surgical complications such as transient or permanent hypocalcemia, hypoparathyroidism, and recurrent laryngeal nerve palsy will be monitored up to six months post-operation. Quality of life and thyroid-related antibody levels will also be tracked over approximately six months to understand the treatment's impact and safety.
CONDITIONS
Brief Title
Preoperative Corticosteroids in Autoimmune Thyroid Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Diagnosed with Graves' disease or Hashimoto's disease with positive thyroid autoantibodies (TgAb, TPO, TSI, and/or TRAb)
- Scheduled for total thyroidectomy surgery for their autoimmune thyroid disease
You will not qualify if you...
- Pediatric patients under 18 years old
- Previous treatment with radioactive iodine (RAI)
- Prior neck surgeries
- Known diagnosis of thyroid cancer
- Diabetes patients taking medications
- History of adverse reactions to corticosteroids
- Current use of immunosuppressive medications or recent steroid therapy, including organ transplant patients or those with other autoimmune conditions
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for screening and enrollment
Duration - Short period before surgery
Participants take either pre-operative corticosteroids or placebo before their total thyroidectomy surgery.
1 visit on the day of surgery
Duration - Up to 6 months
Participants are monitored for surgical complications and recovery over several months after surgery.
Visits at 2 weeks, 6 weeks, and additional assessments up to 6 months post-surgery
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
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here