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
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- The change of the count of the taste buds after stapes surgery mesured by NBI
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •otosclerosis surgery -
排除标准
- •smell disturbance, taking drugs that could have the influence on taste, diseases and injuries of the tongue
研究组 & 干预措施
Structure /function of the taste buds and QoL
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.
干预措施: Narrow Band Imaging (Diagnostic Test)
Structure /function of the taste buds and QoL
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.
干预措施: Tongue sensitivity testing (Diagnostic Test)
Structure /function of the taste buds and QoL
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.
干预措施: Qualitiy of life (Other)
Structure /function of the taste buds and QoL
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.
干预措施: Threshold change (Diagnostic Test)
Structure /function of the taste buds and QoL
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.
干预措施: Taste (Diagnostic Test)
结局指标
主要结局
The change of the count of the taste buds after stapes surgery mesured by NBI
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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)
次要结局
未报告次要终点
研究者
Nina Bozanic Urbancic
MD, ENT specialist
University Medical Centre Ljubljana