Preoperative Corticosteroids in Autoimmune Thyroid Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-16

Study Completion Date

2026-12-30

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.

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Detailed Description

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Conditions

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Graves Disease Hashimoto Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Steroids

Will be given pre-operative corticosteroid regimen

Group Type EXPERIMENTAL

Dexamethasone

Intervention Type DRUG

Will take Dexamethasone pre-operatively

placebo

Will be given Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Will take Placebo pre-operatively

Interventions

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Dexamethasone

Will take Dexamethasone pre-operatively

Intervention Type DRUG

Placebo

Will take Placebo pre-operatively

Intervention Type DRUG

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No