No registrations found.
ID
Source
Brief title
Health condition
voice disorder, glottic insufficiency
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
subjective and objective voice parameters: VHI-30 [8], maximum phonation time (MPT), dynamic range, fundamental frequency (F0), melodic range.
Background summary
Rationale:
Dysphonia caused by non-paralytic glottic insufficiency can be treated by surgical medialization of the vocal folds. Gore-Tex® is one of the most widely used implant materials for correcting the glottic gap in uni- or bilateral medialization thyroplasty. As it is a soft and malleable material, it is held to change in volume and position after implantation. This change in volume and position may lead to suboptimal post-operative voice outcome. In clinical practice surgeons tend therefore to introduce a surplus of material to (over)correct for this post-operative change.
Objective:
Main objective: to assess the change in Gore-Tex® volume and position after bilateral medialization thyroplasty by post-operative imaging (MRI).
Study design:
Observational study. Patients will undergo two MRI scans (without intravenous (iv) contrast administration), first MRI one day postoperative and second MRI three months postoperative.
Study population:
Patients undergoing bilateral medialization thyroplasty with Gore-Tex® (age 18-99) without contraindications for MRI. N=10
Intervention (if applicable):
No intervention.
Main study parameters/endpoints:
1. Change in implanted Gore-Tex® volume in ml and in %.
2. Shift in position of the implant in relation to thyroid cartilage.
Study objective
Dysphonia caused by non-paralytic glottic insufficiency can be treated by surgical medialization of the vocal folds. Gore-Tex® is one of the most widely used implant materials for correcting the glottic gap in uni- or bilateral medialization thyroplasty. As it is a soft and malleable material, it is held to change in volume and position after implantation. This change in volume and position may lead to suboptimal post-operative voice outcome.
Study design
Observational study. Patients will undergo two MRI scans (without intravenous (iv) contrast administration), first MRI one day postoperative and second MRI three months postoperative.
Intervention
assess the change in Gore-Tex® volume and position after bilateral medialization thyroplasty by post-operative imaging (MRI).
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
- 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
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL9731 |
| Other | METC LLD : METC NL 72655.058.20 |