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Minimally Invasive Vestibular Neurectomy Versus Tenotomy of the Stapedius and Tensor Tympani Muscles in the Management of Patients With Unilateral Meniere's Disease

M

Mansoura University

Status

Unknown

Conditions

Ménière

Treatments

Procedure: Surgical treatment

Study type

Interventional

Funder types

Other

Identifiers

NCT04847700
MD.21.02.418.R1

Details and patient eligibility

About

The distinctive symptoms of Meniere's disease (MD) include recurrent vertigo spells, fluctuating hearing loss, aural fullness and tinnitus. Conservative treatment in MD comprises lifestyle modifications, such as low-sodium diet, avoidance of caffeine, alcohol and stress, in addition to medication such as diuretics and betahistine. When conservative treatment fails, surgical management is attempted. Surgical interventions comprise transtympanic steroids or gentamicin, endolymphatic sac surgery (ES), ventilation tube placement, vestibular neurectomy, and labyrinthectomy. Recently, Loader et al. have presented encouraging results of the effectiveness of tenotomy of the stapedius and tensor tympani muscles (TSTM) in the management of patients with definite MD. Also, satisfactory results were obtained with endoscopic assisted minimally invasive vestibular neurectomy (MIVN). The aim of this study is to compare the clinical outcomes of MD patients who were submitted to either MIVN or TSTM in our department.

Enrollment

30 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion criteria

  • unilateral definite Meniere's disease.

Exclusion criteria

  • other peripheral or central vestibular disorders, bilateral MD and neurologic disorders.
  • Previous history of chronic otitis media or middle ear surgery.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

30 participants in 2 patient groups

Minimally invasive vestibular neurectomy
Active Comparator group
Treatment:
Procedure: Surgical treatment
Procedure: Surgical treatment
Tenotomy of the stapedius and tensor tympani muscles
Active Comparator group
Treatment:
Procedure: Surgical treatment
Procedure: Surgical treatment

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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