Efficacy of Oral Corticosteroid Therapy in Recurrent Paralyzes After Thyroidectomy
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|ClinicalTrials.gov Identifier: NCT03553342|
Recruitment Status : Recruiting
First Posted : June 12, 2018
Last Update Posted : August 26, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Recurrent Paralysis of Vocal Cords||Drug: Corticoids Other: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||156 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Efficacy of Oral Corticosteroid Therapy in Recurrent Paralyzes After Thyroidectomy|
|Actual Study Start Date :||September 11, 2018|
|Estimated Primary Completion Date :||September 11, 2021|
|Estimated Study Completion Date :||January 11, 2022|
Patients will receive corticosteroids therapy: 1mg/kg of prednisolone daily for seven days.
|Placebo Comparator: Placebo||
Patients will receive placebo for seven days.
- Evaluate the efficacy of oral corticosteroid in remobilization of vocal cords at seven days for patients with unilateral recurrent laryngeal nerve palsy after thyroidectomy [ Time Frame: Seven days ]evaluated by naso fibroscope inspection
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03553342
|Contact: Xavier DUFOUR, Pr||0549444328 ext +firstname.lastname@example.org|
|Contact: Véronique DE MONTAUDRY, ARCemail@example.com|
|Contact: Xavier DUFOUR, DR 05.49.44.60.38 firstname.lastname@example.org|
|Contact: Florent CARSUZAA email@example.com|