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…
ID
Bron
Verkorte titel
Aandoening
voice disorder, glottic insufficiency
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
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).
Achtergrond van het onderzoek
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.
Doel van het onderzoek
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.
Onderzoeksopzet
Observational study. Patients will undergo two MRI scans (without intravenous (iv) contrast administration), first MRI one day postoperative and second MRI three months postoperative.
Onderzoeksproduct en/of interventie
assess the change in Gore-Tex® volume and position after bilateral medialization thyroplasty by post-operative imaging (MRI).
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
- 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
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
- 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)
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL9731 |
| Ander register | METC LLD : METC NL 72655.058.20 |