To measure the change in the volume and the position of Gore-Tex® after bilateral medialization thyroplasty in patients with vocal fold atrophy with or without sulcus by post-operative MRI.The results of this study will be used to 1) optimize the…
ID
Source
Brief title
Condition
- Other condition
- Head and neck therapeutic procedures
Synonym
Health condition
stemaandoening
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Change in implanted Gore-Tex® in volume and position.
Secondary outcome
voice parameters: VHI-30 questionnair, maximum phonation time (MPT), dynamic
range, fundamental frequency (F0), melodic range.
Background summary
Non-paralytic glottic insufficiency is a common form of dysphonia affecting
both voice quality as vocal function and causing substantial patient*s burden.
There are several underlying causes including hypomobility, paresis and atrophy
(with or without scarring) of the vocal folds. The surgical treatment to
improve glottic closure is medialization of the vocal folds. This may be
achieved by bilateral vocal fold injection with a filler, such as autologous
fat or calcium hydroxyapatite, or by bilateral medialization thyroplasty.
Several factors contribute to the optimal voice result after bilateral
medialization thyroplasty; an important factor is the underlying cause, but
also surgical factors play a major role, such as the optimal window position
and the amount of (over)correction of the implant.
Gore-Tex® is one of the most used implant materials for 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 objective
To measure the change in the volume and the position of Gore-Tex® after
bilateral medialization thyroplasty in patients with vocal fold atrophy with or
without sulcus by post-operative MRI.
The results of this study will be used to 1) optimize the peroperative
(over)correction, in order to 2) optimize the post-operative voice results.
Study design
Observational study
Patients will undergo two MRI-scans (no contrast); first MRI one day after
surgery and second MRI three months after surgery.
Study burden and risks
Burden associated with participation consists of undergoing a MRI without
contrast. The first MRI scan will take place on day 1 postoperatively during
admission. The second scan will be combined with regular outpatient control 3
months after surgery. Time investment per patient is estimated between 90 and
120 minutes. Serious adverse event that can occur with MRI-scanning is the
presence of magnetic sensitive materials. Patients will be screened according
to local guidelines in our hospital. Patients who are not able to undergo MRI
scanning will not be included in this study.
Albinusdreef 2
Leiden 2300 RC
NL
Albinusdreef 2
Leiden 2300 RC
NL
Listed location countries
Age
Inclusion criteria
- Adult >18 years old
- Glottic insufficiency caused by vocal fold atrophy with or without sulcus
- Consented for bilateral medialization thyroplasty with Gore-Tex® under local
anaesthesia
- No contraindication for MRI
- 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
- Patients with other causes of glottic insufficiency (paralysis, hypomobility,
paresis, vocal fold scar)
- Patients not fit for bilateral medialization thyroplasty under local
anesthesia
- Patients not able to undergo MRI scanning, e.g. metal implants,
claustrophobia
Design
Recruitment
metc-ldd@lumc.nl
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 |
|---|---|
| CCMO | NL72655.058.20 |