Efficacy of Oral Corticosteroid Therapy in Recurrent Paralyzes After Thyroidectomy
NCT ID: NCT03553342
Last Updated: 2021-01-29
Study Results
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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UNKNOWN
PHASE3
156 participants
INTERVENTIONAL
2018-09-11
2022-01-11
Brief Summary
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The main objective is to evaluate the efficacy of oral corticosteroid therapy in remobilization of vocal cords at seven days in patients with unilateral recurrent paralysis after thyroidectomy.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Corticoids
Corticoids
Patients will receive corticosteroids therapy: 1mg/kg of prednisolone daily for seven days.
Placebo
Placebo
Patients will receive placebo for seven days.
Interventions
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Corticoids
Patients will receive corticosteroids therapy: 1mg/kg of prednisolone daily for seven days.
Placebo
Patients will receive placebo for seven days.
Eligibility Criteria
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Inclusion Criteria
* Patients over eighteen years old
* Free subject, whitout tutorship or curatorship or subordination
* Informed consent and signed by the patient after clear and fair information about the study.
Exclusion Criteria
* Patients with preoperative recurrent paralysis
* Patients with hypersensitivity to prednisolone or any of the excipients.
* Patients with contraindication to use Solupred
* Patients with anti-inflammatory of acetylsalicylic acid
* Patient with evolving virosis (hepatitis, herpes, chicken pox, zoster)
18 Years
ALL
No
Sponsors
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Poitiers University Hospital
OTHER
Responsible Party
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Locations
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Chu Poitiers
Poitiers, , France
Countries
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Central Contacts
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Facility Contacts
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References
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Carvajal-Alegria E, Girault N, Donatini G, Frasca D, Tonnerre D, Cosset T, Rulliere A, Lebreton JP, Dufour X, Carsuzaa F. Oral Corticosteroids in Vocal Fold Paralysis After Thyroid Surgery: A Randomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2025 Sep 1;151(9):874-880. doi: 10.1001/jamaoto.2025.2169.
Other Identifiers
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THYRCOR
Identifier Type: -
Identifier Source: org_study_id
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