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ID
Source
Brief title
Health condition
loss of taste function; sensorineural hearing loss; deafness; conductive hearing loss; otosclerosis
Sponsors and support
Intervention
Outcome measures
Primary outcome
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.
Secondary outcome
• To compare the postoperative EGM threshold in uA for different locations of the tongue in patients between two types of CTN injury (stretching or sacrificing)
• To compare the presence of postoperative symptoms of taste disturbance in patients between two types of CTN injury (stretching or sacrificing).
• To compare the postoperative perception of appetite, hunger and sensory in patients between two types of CTN injury (stretching or sacrificing).
• To compare the postoperative quality of life in patients between two types of CTN injury (stretching or sacrificing).
• To compare the postoperative enjoyment of food in patients between two types of CTN injury (stretching or sacrificing).
• To compare the postoperative food preference in patients between two types of CTN injury (stretching or sacrificing).
• To compare the postoperative odour identification score in patients between two types of CTN injury (stretching or sacrificing)
Background summary
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.
Study objective
Sacrificing the chorda tympani causes less taste disfunction than stretching or damaging the chorda tympani nerve.
Study design
• Preoperative
• 1 week postoperative
• 6 weeks postoperative
• 6 months postoperative
Intervention
Not applicable
Inclusion criteria
• 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
Exclusion criteria
• 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
Design
Recruitment
IPD sharing statement
Plan description
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 | NL9791 |
| Other | METC UMC Utrecht : METC 21-466 |