Efficacy of Oral Corticosteroid Therapy in Recurrent Paralyzes After Thyroidectomy
1 other identifier
interventional
156
1 country
1
Brief Summary
Thyroidectomy is a common surgical procedure in France. Recurrent paralysis is one of the main complications. Oral corticosteroid therapy are frequently used at a dosage of 1mg/kg for seven days, in case of recurrent paralysis to obtain remobilization as early as possible. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Sep 2018
Typical duration for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 23, 2018
CompletedFirst Posted
Study publicly available on registry
June 12, 2018
CompletedStudy Start
First participant enrolled
September 11, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 11, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
January 11, 2022
CompletedJanuary 29, 2021
January 1, 2021
3 years
May 23, 2018
January 28, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Evaluate the efficacy of oral corticosteroid in remobilization of vocal cords at seven days for patients with unilateral recurrent laryngeal nerve palsy after thyroidectomy
evaluated by naso fibroscope inspection
Seven days
Study Arms (2)
Corticoids
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Patients will receive corticosteroids therapy: 1mg/kg of prednisolone daily for seven days.
Eligibility Criteria
You may qualify if:
- Patients scheduled for simple total thyroidectomy or lobo-isthmectomy
- 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.
You may not qualify if:
- Patients operated on a total thyroidectomy with médiastino-recurrent dissection for cancer etiology
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Chu Poitiers
Poitiers, France
Related Publications (1)
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.
PMID: 40773211DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 23, 2018
First Posted
June 12, 2018
Study Start
September 11, 2018
Primary Completion
September 11, 2021
Study Completion
January 11, 2022
Last Updated
January 29, 2021
Record last verified: 2021-01