D33.3
Conditions
Interventions
Group 1: The first arm will hold 25 patients who will be routinely monitored electrophysiologically (B- AEP and Facial-EMG), as well as using ICG- Videoangiography and the recording of D-AEPs during A
Sponsors
Universitätsklinikum Düsseldorf
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: o For patients still to be operated: ? Adults able to give consent (= 18 years) ? Presence of an acoustic neuroma with indication for surgical resection ? Complete recording of examination parameters during the operation and in the postoperative course o For patients who have already been operated: ? Adults able to give consent (= 18 years) ? Previous acoustic neuroma resection at the UKD ? Complete recording of the examination parameters
Exclusion criteria
Exclusion criteria: For patients still to be operated: ? Known ICG allergy, iodine allergy, chronic renal failure, hyperthyroidism, pregnancy o For patients who have already been operated: ? Incomplete data set
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total duration of the project: 1.5 years o The study is to include 25 prospective patients. ? For 4 tumor stages (corresponding to tumor size according to Koos I- IV), at least 6 patients per category should be included. ? With an average of 1 patient/week the study inclusion of n= 25 patients in 6 months is to be achieved. Intraoperative measurements - Names of the target criteria and methods - Acoustically evoked potentials: Intraoperative measurement method of the functionality of the vestibulocochlear nerve-> Amplitude changes and latency time changes of the acoustically evoked potentials are to be measured - Facial EMG: Intraoperative measurement method of the functionality of the facial nerve -> spontaneous activity of the facial nerve is measured on the basis of amplitude height and occurrence pattern in the Facial EMG - Vascularization of the vasa nervorum: The vascularization of the Vasa nervorum is visualized by means of indocyanine green and recorded with a white-light camera. PC algorithms can then calculate the fluorescence intensity. These target criteria will be recorded during 25 operations. These 25 operations are to take place over a period of half a year | — |
Secondary
| Measure | Time frame |
|---|---|
| Total duration of the project: 1.5 years Postoperative measurements - Names of the target criteria and measurement methods - Hearing function: The hearing function should be quantified with the help of tone threshold audiograms and the Freiburg Speech Test. When testing hearing ability by means of sound threshold audiogram, the patients' hearing thresholds are determined at 0.5, 1.2.3 and 4 kHz. In the Freiburg Speech Test, the number of words understood and correctly reproduced out of a total of 200 words presented is counted. These results can then be classified according to the classification system of the hearing function according to Gardner & Robertson. - Facial muscle function: Facial muscle function is assessed during a physical examination that includes evaluation of the mobility of the eyebrows, forehead and the corners of the mouth. The facial muscle function is to be classified according to the House and Brackmann classification system. These examinations (tone threshold audiogram, Freiburg speech test, physical examination) are to take place at four points in time after surgery. These points in time are the day after surgery, 3 months after surgery, 6 months after surgery and 12 months after surgery. With a period of 6 months in which the operations take place and the last examination after 12 months of the last patient shot, the total duration of the study is 1.5 years. | — |
Countries
Germany
Contacts
Public ContactJan-Frederick Cornelius
Universitätsklinikum Düsseldorf
Outcome results
None listed