The Change of the Structure and Function of Taste Buds After the Otosclerosis Surgery

Not Applicable

• Conditions: Chorda Tympani Disorder; Taste Disorders; Stapes Fixation
• Interventions: Diagnostic Test: Narrow Band Imaging; Diagnostic Test: Tongue sensitivity testing; Other: Qualitiy of life; Diagnostic Test: Threshold change; Diagnostic Test: Taste

• Registration Number: NCT04881513
• Lead Sponsor: University Medical Centre Ljubljana

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.

Study Timeline

• Study Start: 2020-01-01
• Study First Submitted: 2021-01-07
• Study First Submitted QC: 2021-05-05
• Study First Posted: 2021-05-11
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-29
• Last Update Posted: 2021-09-30
• Primary Completion: 2021-12-30
• Study Completion: 2022-01-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

otosclerosis surgery -

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Structure /function of the taste buds and QoL	Qualitiy of life	The structure of the taste buds is measured by Narrow Band Imaging (NBI) technique prior to the operation, one month and six months after the surgery. The tongue sensation is measured by two point discrimination before the operation, one month and six months after the operation. The taste is tested by the taste strips prior to, on month and six month after the surgery. The quality of life is measured by the SF36 questionnaire. The threshold change is measured by the stimulating electrode at the beginning and at the end of the surgery.
Structure /function of the taste buds and QoL	Taste	The structure of the taste buds is measured by Narrow Band Imaging (NBI) technique prior to the operation, one month and six months after the surgery. The tongue sensation is measured by two point discrimination before the operation, one month and six months after the operation. The taste is tested by the taste strips prior to, on month and six month after the surgery. The quality of life is measured by the SF36 questionnaire. The threshold change is measured by the stimulating electrode at the beginning and at the end of the surgery.
Structure /function of the taste buds and QoL	Threshold change	The structure of the taste buds is measured by Narrow Band Imaging (NBI) technique prior to the operation, one month and six months after the surgery. The tongue sensation is measured by two point discrimination before the operation, one month and six months after the operation. The taste is tested by the taste strips prior to, on month and six month after the surgery. The quality of life is measured by the SF36 questionnaire. The threshold change is measured by the stimulating electrode at the beginning and at the end of the surgery.
Structure /function of the taste buds and QoL	Narrow Band Imaging	The structure of the taste buds is measured by Narrow Band Imaging (NBI) technique prior to the operation, one month and six months after the surgery. The tongue sensation is measured by two point discrimination before the operation, one month and six months after the operation. The taste is tested by the taste strips prior to, on month and six month after the surgery. The quality of life is measured by the SF36 questionnaire. The threshold change is measured by the stimulating electrode at the beginning and at the end of the surgery.
Structure /function of the taste buds and QoL	Tongue sensitivity testing	The structure of the taste buds is measured by Narrow Band Imaging (NBI) technique prior to the operation, one month and six months after the surgery. The tongue sensation is measured by two point discrimination before the operation, one month and six months after the operation. The taste is tested by the taste strips prior to, on month and six month after the surgery. The quality of life is measured by the SF36 questionnaire. The threshold change is measured by the stimulating electrode at the beginning and at the end of the surgery.

Primary Outcome Measures

Name	Time	Method
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 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 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 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)

Trial Locations

Locations (1)

UMC Ljubljana; 🇸🇮 Ljubljana, Slovenia