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Actively Recruiting

Phase 4
Age: 18Years +
All Genders
ID05435547

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 Hashimotos 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 treatments impact and safety.

CONDITIONS

Brief Title

Preoperative Corticosteroids in Autoimmune Thyroid Disease

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

Research Team

A

Alexandria McDow, MD

H

Hannah Allison, MA

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