Randomized, exploratory comparative study to investigate the effect of two different vocal fold augmentation materials on voice quality in unilateral vocal fold paresis.
Phase 1
Recruiting
- Conditions
- J38.01
- Registration Number
- DRKS00024026
- Lead Sponsor
- niversitätsklinikum Köln
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 24
Inclusion Criteria
Patients aged 18 to 80 years with symptomatic unilateral vocal fold paresis without sufficient improvement under conservative therapy for more than six months, in whom in principle both methods of vocal fold augmentation (autologous fat or aquamide) can be used, are eligible for inclusion.
Exclusion Criteria
- Incorrect or incomplete documentation
- Previous laryngeal surgery with the exception of previous augmentation with absorbable material (hyaluron)
- Laryngeal carcinoma
- Pulmonary diseases
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in subjective self-assessment of voice, 3,6 and 12 months after surgery, by questionnaire (VHI-30).
- Secondary Outcome Measures
Name Time Method Postoperative change in external evaluation of voice quality (HIRANO-score) over time.