voice disorder, glottic insufficiency
Conditions
Interventions
assess the change in Gore-Tex® volume and position after bilateral medialization thyroplasty by post-operative imaging (MRI).
Sponsors
Prof. Dr. P.P.G. van Benthem Head of department of ENT Head- and Neck surgery
Eligibility
Inclusion criteria
Inclusion criteria: - Adult >18 years old - Glottic insufficiency caused by atrophy with or without sulcus - Consented for bilateral medialization thyroplasty with Gore-Tex® under local anaesthesia - No contraindication for MRI (see addendum 1) - To be able and willing of giving informed consent
Exclusion criteria
Exclusion criteria: - Patients undergoing unilateral medialization thyroplasty - Patients with medical history of phonosurgery - patients with revision thyroplasty - patients with medical history of head and neck malignancy - patient with other causes of glottic insufficiency (paralysis, hypomobility, paresis, vocal fold scar) - patients with a contra-indication to MRI (see addendum 1)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assessment of change in Gore-Tex® volume and position after bilateral medialization thyroplasty .The volume and position of the implants will be visually rated on fused MRIs at post-operative day 1 and 3 months. Change in volume of Gore-Tex® implant will be quantified in ml and in %. Overlap of the segmented volumes in MRI images will be quantified using the Jaccard index (representing the percentage overlap between two volumes). | — |
Secondary
| Measure | Time frame |
|---|---|
| subjective and objective voice parameters: VHI-30 [8], maximum phonation time (MPT), dynamic range, fundamental frequency (F0), melodic range. | — |
Contacts
Public ContactEmke Van den Broek
UMC/LUMC
Outcome results
None listed