Effectiveness of oral corticosteroids in unilateral recurrent laryngeal nerve palsy after thyroidectomy

INTERVENTION: Trade Name: Solupred Product Name: solupred Pharmaceutical Form: Orodispersible tablet Pharmaceutical form of the placebo: Capsule Route of administration of the placebo: Oral use CONDITION: ; MedDRA version: 20.0 Level: LLT Classification code 10038130 Term: Recurrent laryngeal nerve palsy System Organ Class: 100000004852 Therapeutic area: Diseases [C] ‐ Ear, nose and throat diseases [C09] PRIMARY OUTCOME: ; Primary end point(s): Complete remobilization of laryngeal palsy, evaluated by naso fibroscope inspection at Day 7 after thyroidectomy; Complete response is definied by optimal contact of paralysed vocal fold with controlateral vocal fold; ; Secondary Objective: Study the incidence of unilateral recurrent laryngeal nerve palsy; Study the rate of complete remobilization at M1 and M3 between placebo and corticosteroids group; Study the rate of partial remobilization between at D7, M1 and M3 between placebo and corticosteroids group; Observance and tolerance of oral corticosteroids; Main Objective: Study the effectiveness of oral corticosteroids in vocal fold remobilization (at Day 7) for patients with unilateral recurrent laryngeal nerve palsy after thyroidectomy Timepoint(s) of evaluation of this end point: day 7 SECONDARY OUTCOME: ; Secondary end point(s): Percentage of recurrent laryngeal nerve palsy in studied population; Complete remobilization of laryngeal palsy at M1 and M3 between placebo and corticosteroids group; Partial remobilization of laryngeal palsy at D7, M1 and M3 between placebo and corticosteroids group (partial remobilization is definied by non optimal vocal fold movement); Observance and tolerance of oral corticosteroids evaluated by interrogation; Timepoint(s) of evaluation of this end point: Day 7, Month 1 and 3 INCLUSION CRITERIA: Patients undergoing total or partial thyroidectomy (no lymphe node dissection) Age = 18 yo Informed consent, and signed Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range 300 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 100