Effectiveness of oral corticosteroids in unilateral recurrent laryngeal nerve palsy after thyroidectomy
Phase 1
- Conditions
- MedDRA version: 20.0 Level: LLT Classification code 10038130 Term: Recurrent laryngeal nerve palsy System Organ Class: 100000004852Therapeutic area: Diseases [C] - Ear, nose and throat diseases [C09]
- Registration Number
- EUCTR2018-001231-48-FR
- Lead Sponsor
- CHU DE POITIERS
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Not specified
- Target Recruitment
- 400
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
Exclusion Criteria
Patients undergoing thyroid cancer surgery (with lymphe node dissection)
Patients with pre operative recurrent laryngeal nerve palsy
Patients with bilateral recurrent laryngeal nerve palsy
Patients with allergy to Prednisolone
Patients with ongoing infection
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br> Primary end point(s): Complete remobilization of laryngeal palsy, evaluated by naso fibroscope inspection at Day 7 after thyroidectomy<br> Complete response is definied by optimal contact of paralysed vocal fold with controlateral vocal fold<br> ;Timepoint(s) of evaluation of this end point: day 7;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;<br> Secondary Objective: Study the incidence of unilateral recurrent laryngeal nerve palsy<br> Study the rate of complete remobilization at M1 and M3 between placebo and corticosteroids group<br> Study the rate of partial remobilization between at D7, M1 and M3 between placebo and corticosteroids group<br> Observance and tolerance of oral corticosteroids<br>
- Secondary Outcome Measures
Name Time Method Timepoint(s) of evaluation of this end point: Day 7, Month 1 and 3;<br> Secondary end point(s): Percentage of recurrent laryngeal nerve palsy in studied population<br> Complete remobilization of laryngeal palsy at M1 and M3 between placebo and corticosteroids group<br> 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)<br> Observance and tolerance of oral corticosteroids evaluated by interrogation<br>