Sacrificing the chorda tympani causes less taste disfunction than stretching or damaging the chorda tympani nerve.
ID
Bron
Verkorte titel
Aandoening
loss of taste function; sensorineural hearing loss; deafness; conductive hearing loss; otosclerosis
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
To evaluate the prognostic effect of CTN injury on postoperative taste function measured using taste strips in patients undergoing primary stapes surgery or primary cochlear implantation.
Achtergrond van het onderzoek
The chorda tympani nerve (CTN) is a mixed nerve, which carries sensory and parasympathetic fibers. The sensory component supplies the taste sensation of the anterior two-thirds of the ipsilateral side of the tongue. During middle ear surgery the CTN is exposed and frequently stretched or sacrificed, because it lacks a bony covering as it passes the middle ear. The injury may cause hypogeusia, ageusia or altered taste sensation of the ipsilateral side of the tongue. Patients may also suffer from a dry mouth. To date, there is no consensus regarding which type of CTN injury, obtained during primary stapes surgery or primary cochlear implantation, gives the least burden. Some articles concluded that the taste outcome is better if the CTN is sacrificed instead of the CTN being preserved but damaged by stretching. Other articles report that sacrificing the CTN results in more taste disturbance compared to nerve preservation. A lack of high quality studies on the subject precludes firm evidence-based recommendations and demonstrates the need for a high-quality study. In order to accommodate this need, in the proposed double-blind prospective study we will investigate the prognostic effect of CTN injury on postoperative taste disturbance and quality of life.
Doel van het onderzoek
Sacrificing the chorda tympani causes less taste disfunction than stretching or damaging the chorda tympani nerve.
Onderzoeksopzet
• Preoperative
• 1 week postoperative
• 6 weeks postoperative
• 6 months postoperative
Onderzoeksproduct en/of interventie
Not applicable
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
• Signed Informed Consent form
• Age ≥ 18 years
• Scheduled or on the waiting list of primary stapes surgery or primary cochlear implantation
• Willingness and ability to participate in all scheduled procedures outlined in the study protocol
• Good understanding of the Dutch language
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
• Previous middle ear surgery (with the exception of the placement of ventilation tubes in childhood)
• Disability that could interfere with taste evaluation and/or questionnaire fulfilment
• History of chemotherapy and/or radiotherapy
• History of facial nerve palsy
• Cardiac pacemaker
• Pregnancy
• History of orofacial pain
• History of dysesthesia in the orofacial region
• Local evidence of a pathological condition of the oral mucosa
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
Toelichting
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL9791 |
| Ander register | METC UMC Utrecht : METC 21-466 |