Clinical trial NCT05435547: Preoperative Corticosteroids in Autoimmune Thyroid Disease
Official title: Randomized Controlled Trial of Preoperative Corticosteroids in Autoimmune ThyroidDisease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Graves Disease
Hashimoto Disease
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2022-06-28
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


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.

Primary outcomes:
measure: Thyroid difficulty Scale score
timeFrame: Day of Surgery
Secondary outcomes:
measure: Change in blood flow / vascularity
timeFrame: Pre-operative visit and Day of Surgery
measure: Surgical complication of transient hypocalcemia
timeFrame: Two weeks post-operative and six weeks post-operative
measure: Surgical complication of permanent hypocalcemia
timeFrame: through study completion, or 6 months
measure: Surgical complication of transient hypoparathyroidism
timeFrame: Two weeks post-operative and six weeks post-operative
measure: Surgical complication of permanent hypoparathyroidism
timeFrame: through study completion, or 6 months
measure: Surgical complication of recurrent laryngeal nerve palsy
timeFrame: Two weeks post-operative and six-weeks post-operative, if clinically indicated
measure: Change in SF-20 at 6 weeks
timeFrame: Six weeks post-operative
measure: Change in SF-20 at 6 months
timeFrame: through study completion, an average of 6 months
measure: Tg
timeFrame: through study completion, an average of 6 months
measure: TgAB
timeFrame: through study completion, an average of 6 months
measure: TPO
timeFrame: through study completion, an average of 6 months
measure: TSI
timeFrame: through study completion, an average of 6 months
measure: TRAb
timeFrame: through study completion, an average of 6 months
measure: ThyPRO
timeFrame: through study completion, an average of 6 months
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: IU Health North Hospital
state: Indiana
city: Indianapolis
country: United States
facility: IU Health Methodist Hospital
state: Indiana
city: Indianapolis
country: United States
facility: IU Health University Hospital
state: Indiana
Study officials:
affiliation: Indiana University School of Medicine
name: Alexandria McDow, MD
role: PRINCIPAL_INVESTIGATOR
References: