Ménière's disease Meniere's disease
Conditions
Interventions
- Surgical procedure in EDB group
First, a canal wall-up mastoidectomy is performed: the mastoid tegmen, sigmoid 
sinus, and sinodural angle are identified, and the posterior bony external ear 
canal wall is thinned. The posterior semi-circular canal (PSCC) and the dura 
mater of the posterior fossa are identified. Using the prominence of the 
horizontal semi-circular canal, Donaldson's line is identified to approximate 
the position of the endolymphatic sac. The bone over the sac and the dura are 
thinned with diamond burrs. The sac is completely skeletonized. The 
infralabyrinthine dura is exposed because the main body of the sac and its 
lumen often lie within this area. The bone of the vestibular aqueduct operculum 
is dissected. The posterior fossa dura from the retrolabyrinthine bone medial 
to the sac around the endolymphatic duct is exposed in order to identify the 
duct in its superior and inferior part in continuity from the endolymphatic 
sac, and to create a place to insert the tips of the instrument to clip the 
duct. At this level, care must be taken not to traumatize the dura, which is 
often thin. 
Finally, the dissected endolymphatic duct is blocked with an adequate titanium 
clip (Weck Horizon, size 'micro' to 'wide'). The size and numbers of clips used 
will be determined intraoperatively. The titanium clips are applied by using a 
clip applier (Weck Horizon) and a McGee bending forceps (Aesculap). In the case 
of tearing of the dura leading to liquor leakage, this will be treated with 
Sponsors
HagaZiekenhuis
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Definite unilateral MD according to diagnostic criteria of the Bárány Society (Lopez-Escamez, 2016) - More than 3 patient reported attacks in the 6 months prior to inclusion and at least 1 attack in the 2 months prior to inclusion - Age >= 18 years at the start of the trial - Non responding to a sufficient extent to conservative medical treatment including at least two sessions of at least one intra-tympanic injection (IT) each with corticosteroids (dexamethasone, methylprednisolone, triamcinolonacetonide) - Dutch health care insurance
Exclusion criteria
Exclusion criteria: - Severe disability (e.g. neurological, orthopedic, cardiovascular) according to the investigator, pregnancy or serious concurrent illness that might interfere with surgery or follow-up. - Active additional neuro-otologic disorders that may mimic MD (e.g. vestibular migraine (VM), recurrent vestibulopathy, phobic postural vertigo, vertebro-basilar TIAs, acoustic neuroma, congenital disorders, enlarged vestibular aquaduct (EVA)-like or genetic disorders (like DFNA9), cervicogenic dizziness), based on the complete clinical record. - Previous ear surgery for MD (IT injection is not an exclusion criterion) - Language difficulties - Active otitis media (with or without effusion) - Unable or unwilling to use DizzyQuest App - Unable to undergo MRI (such as gadolinium allergy, claustrophobia, implanted non-MRI compatible device of material, BMI) - Deafness of the contralateral ear
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main study parameter is the number of patients free of vertigo attacks at 12 months after surgery. This parameter was chosen because vertigo is the most invalidating symptom of MD. | — |
Secondary
| Measure | Time frame |
|---|---|
| We will determine if EDB has a beneficial effect on: • Cumulative incidence of vertigo bouts • Hearing • Use of escape medication (including intratympanic injections) • Co-interventions (ablative procedure) • Complications of surgery • FLS • DHI • THI • SF-36 • EQ-5D • CEA • iPCQ • iMCQ • BIA • Endolymphatic hydrops and perilymph signal intensity on MRI • Physiotherapeutical outcomes: balance, gait, visual acuity. | — |
Countries
Netherlands
Contacts
Public ContactHM Blom
HagaZiekenhuis
Outcome results
None listed