The effectiveness of endolymphatic duct blockage versus endolymphatic sac decompression in patients with intractable Ménière’s disease
Meniere's disease
Current interventions as of 24/04/2023: 74 patients will be randomised using a computer to either the EDB group or the decompression group. Patients in both groups undergo mastoidectomy and identification of the endolymphatic duct. In the EDB group, the duct is then clipped using a titanium clip. This clip is not placed in the decompression group. Both patient and the follow-up researcher are blinded to treatment allocation. Surgery will take several hours +1 day hospital stay. All participants will be followed up for 1 year after their surgery. All patients undergo vestibular rehabilitation therapy after surgery. Previous interventions as of 26/04/2021: 84 patients will be randomised using a computer to either the EDB group or the decompression group. Patients in both groups undergo mastoidectomy and identification of the endolymphatic duct. In the EDB group, the duct is then clipped using a titanium clip. This clip is not placed in the decompression group. Both patient and the follow-up researcher are blinded to treatment allocation. Surgery will take several hours +1 day hospital stay. All participants will be followed up for 1 year after their surgery. All patients undergo vestibular rehabilitation therapy after surgery. Previous interventions: 84 patients will be randomised using a computer to either the EDB group or the control group. Patients in both groups undergo mastoidectomy and identification of the endolymphatic duct. In the EDB group, the duct is then clipped using a titanium clip. This clip is not placed in the control group. Both patient and the follow-up researcher are blinded to treatment allocation. Surgery will take several hours +1 day hospital stay. All participants will be followed up for 1 year after their surgery. All patients undergo vestibular rehabilitation therapy after surgery.
1. Definite unilateral MD according to diagnostic criteria of the Bárány Society (Lopez-Escamez, 2016) 2. 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 3. Age ≥18 years at the start of the trial 4. 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) 5. Dutch health care insurance
Current participant exclusion criteria as of 26/04/2021: 1. Severe disability (e.g. neurological, orthopedic, cardiovascular) according to the investigator, pregnancy or serious concurrent illness that might interfere with surgery or follow-up 2. 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 3. Previous ear surgery for MD (IT injection is not an exclusion criterion) 4. Language difficulties 5. Active otitis media (with or without effusion) 6. Unable or unwilling to use DizzyQuest App 7. Unable to undergo MRI (such as gadolinium allergy, claustrophobia, implanted non-MRI compatible device of material, BMI) 8. Deafness of the contralateral ear Previous participant exclusion criteria: 1. Severe disability (e.g. neurological, orthopedic, cardiovascular) according to the investigator, pregnancy or serious concurrent illness that might interfere with surgery or follow-up 2. 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 3. Previous ear surgery for MD (IT injection is not an exclusion criterion) 4. Language difficulties 5. Active otitis media (with or without effusion) 6. Unable or unwilling to use DizzyQuest App 7. Unable to undergo MRI (such as gadolinium allergy, claustrophobia, implanted non-MRI compatible device of material, BMI)