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The impact of injury of the chorda tympani nerve during primary stapes surgery and primary cochlear implantation on taste function, quality of life and food preferences

The impact of injury of the chorda tympani nerve during primary stapes surgery and primary cochlear implantation on taste function, quality of life and food preferences - TACO study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON51173
Enrollment
154
Registered
2021-09-08
Start date
2021-10-26
Completion date
Unknown
Last updated
2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ageusia hypogeusia taste disturbance

Interventions

None listed

Sponsors

Universitair Medisch Centrum Utrecht
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Signed informed consent form - Age >= 18 years - Patients who are planned to undergo primary stapes surgery or primary cochlear implantation - Willingness and ability to participate in all scheduled procedures outlined in the research protocol - Good understanding of the Dutch language

Exclusion criteria

Exclusion criteria: - Previous middle ear surgery (with the exception of the placement of ventilation tubes in childhood) - History of chemotherapy and/or radiotherapy - History of facial nerve palsy - Cardiac pacemaker - Disability that could interfere with taste evaluation and/or questionnaire fulfilment - Pregnancy - History of orofacial pain - History of dysesthesia in the orofacial region - Local evidence of a pathological condition of the oral mucosa

Design outcomes

Primary

MeasureTime frame
The main study parameter will be the 6 weeks postoperative amount of identified taste strips of the ipsilateral tongue of the operated ear. The range for possible scores is 0 to 20.

Secondary

MeasureTime frame
- The difference between the preoperative and postoperative amount of identified sweet taste strips of the ipsilateral tongue of the operated ear - The difference between the preoperative and postoperative amount of identified salty taste strips of the ipsilateral tongue of the operated ear - The difference between the preoperative and postoperative amount of identified sour taste strips of the ipsilateral tongue of the operated ear - The difference between the preoperative and postoperative amount of identified bitter taste strips of the ipsilateral tongue of the operated ear - The difference between the preoperative and postoperative amount of identified umami taste strips of the ipsilateral tongue of the operated ear The difference between the preoperative and postoperative EGM thresholds in dB for different locations of the tongue - The postoperative existence of metallic taste sensation - The postoperative existence of dryness of the mouth - The postoperative existence of tingling sensations of the tongue - The postoperative existence of numbness of the tongue - The difference between the preoperative and postoperative score of the AHSP questionnaire- The difference between the preoperative and postoperative score of the health-related quality of life questionnaire - The difference between the preoperative and postoperative total and sub scores of the MTPRT - The difference between the preoperative and postoperative odour identification score

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)