Chorda Tympani Disorder, Taste Disorders, Stapes Fixation
Conditions
Keywords
stapedectomy, taste, taste buds, chorda tympani, narrow band imaging, electrical stimulation, taste strips, two point discrimination, quality of life
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.
Interventions
DIAGNOSTIC_TESTNarrow Band Imaging
Testing the taste buds structure (blood vessels morphology- classified to 5 types) and the number of taste buds per 20mm2, by Narrow Band Imaging technique before and after the operation (one and six months)
DIAGNOSTIC_TESTTongue sensitivity testing
testing the tongue sensitivity change prior to surgery and after (1 and 6 months) the surgery with two point discrimination test in mm.
OTHERQualitiy of life
Testing the patients quality of life before and after (one and six months) the stapes surgery by SF 36 questionnaire
DIAGNOSTIC_TESTThreshold change
Measuring the intraoperative chorda tympani stimulation threshold change at the beginning and at the end of the procedure- surgery
DIAGNOSTIC_TESTTaste
Taste is measured by applying taste strips (sweet, sour, salty, bitter) in 4 concentrations prior to, 1 and 6 months after surgery.
Sponsors
University Medical Centre Ljubljana
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
otosclerosis surgery -
Exclusion criteria
smell disturbance, taking drugs that could have the influence on taste, diseases and injuries of the tongue \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The change of the count of the taste buds after stapes surgery mesured by NBI | 2 years | The evaluation of the influence of the manipulation of the chorda tympani nerve on the structure of the taste buds measured by Narrow Band Imaging technique prior to surgery and 1 month and 6 months after surgery. The number of the taste buds will be counted on the surface of 20 mm2 . |
| The change of the structure -blood vessel morphology of the taste buds after stapes surgery mesured by NBI | 2 years | The evaluation of the influence of the manipulation of the chorda tympani nerve on the structure of the taste buds measured by Narrow Band Imaging technique prior to surgery and 1 month and 6 months after surgery. The blood vessel morphology will be assessed by the 5-point scoring system. |
| The change of the function of the taste buds mesured by the test strips | 2 years | The evaluation of the influence of the chorda tympani intraoperative manipulation to the change of the chorda tympani function measured by the taste strips test. |
| The influence of the chorda tympani intraoperative manipulation on the patients quality of life | 2 years | The patients quality of life is measured by the SF 36 questionnaire |
| The change of the function of the chorda tympani nerve measured by the change of tongue sensitivity measured by two point discrimination test | 2 years | The evaluation of the influence of the chorda tympani intraoperative manipulation to the change of the chorda tympani function measured by the two pint dicrimination test ( in mm) |
Countries
Slovenia
Contacts
Primary ContactNina Božanić Urbančič, MD
Backup ContactSaba Battelino, MD. PhD
Outcome results
None listed