Clinical trial NCT04881513: The Change of the Structure and Function of Taste Buds After the Otosclerosis Surgery
Official title: The Structure and the Function of the Taste Buds After the Stapes Surgery and the Patients Quality of Life and it's Correlation to the Change of the Threshold of the Chorda Tympani Electrical Stimulation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chorda Tympani Disorder
Taste Disorders
Stapes Fixation
Keywords: stapedectomy
taste
taste buds
chorda tympani
narrow band imaging
electrical stimulation
taste strips
two point discrimination
quality of life
Lead sponsor: University Medical Centre Ljubljana
Sponsor class: OTHER
First posted: 2021-05-11
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Patients admitted for the otosclerosis operation are included in the study. The Narrow Band Imaging (NBI) of their taste buds is performed before the operation. The sensory function of the anterior 2/3 of the tongue is tested with the two point discrimination discs, the taste is tested with taste strips and the SF-36 questionnaire is applied. During the operation in local anesthesia the threshold for the tongue sensation (by the stimulation of the chorda tympani nerve) of the first 2/3 of the tongue at the beginning of the operation (when we first encounter the chorda tympani nerve) and at the end of the operation is measured.One month and six months after the operation the tests are being repeated (NBI, two-point discrimination and SF-36 questionnaire).

The study has the National Ethical Committee approval.

Detailed description: Patients admitted for otosclerosis operation 18 to 65 years old, not taking medications that could influence the taste and not having the problems with the smell are being recruited for the study.

The informed consent is signed by the patient. The Narrow Band Imaging (NBI) of their taste buds is performed before the operation. The number of taste buds in the 20mm2 size area and the blood vessel morphology is being recorded. For the blood vessel morphology the five point scoring system is used. Both sides of the tongue are tested separately.

The sensory function of the anterior 2/3 of the tongue is tested with the two point discrimination discs. Both sides of the tongue are tested separately.

The taste strips are used with 4 different concentrations of sweet, sour, salty and bitter applied to each side of the tongue separately.

SF-36 questionnaire adapted to Slovenian language is applied. During the operation in local anesthesia the threshold for the tongue sensation at the beginning of the operation (when the investigators first encounter the chorda tympani nerve) and at the end of the operation is measured. The investigators use the facial nerve monitoring system for the measurements and stimulate directly the chorda tympani with electrical current. After each operation the surgeon determines the grade of the intraoperative manipulation of the chorda tympani nerve.

One month and six months after the operation the tests are being repeated (NBI, two-point discrimination, taste testing with taste strips and SF-36 questionnaire).

The study has the National Ethical Committee approval.

Eligibility criteria: Inclusion Criteria: otosclerosis surgery -

Exclusion Criteria: smell disturbance, taking drugs that could have the influence on taste, diseases and injuries of the tongue

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Primary outcomes:
measure: The change of the count of the taste buds after stapes surgery mesured by NBI
timeFrame: 2 years
measure: The change of the structure -blood vessel morphology of the taste buds after stapes surgery mesured by NBI
timeFrame: 2 years
measure: The change of the function of the taste buds mesured by the test strips
timeFrame: 2 years
measure: The influence of the chorda tympani intraoperative manipulation on the patients quality of life
timeFrame: 2 years
measure: The change of the function of the chorda tympani nerve measured by the change of tongue sensitivity measured by two point discrimination test
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Ljubljana
country: Slovenia
facility: UMC Ljubljana
Study officials:
affiliation: UMC Ljubljana
name: Nina Božanić Urbančič, MD
role: PRINCIPAL_INVESTIGATOR
References: