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Clinical Trials/NCT04847700
NCT04847700
Unknown
Not Applicable

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

Mansoura University1 site in 1 country30 target enrollmentMay 1, 2021
ConditionsMénière

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Ménière
Sponsor
Mansoura University
Enrollment
30
Locations
1
Primary Endpoint
dizziness handicap inventory (DHI)
Last Updated
4 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
May 1, 2021
End Date
June 1, 2023
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Noha A.Elkholy

Principle investigator

Mansoura University

Eligibility Criteria

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.

Outcomes

Primary Outcomes

dizziness handicap inventory (DHI)

Time Frame: 6 months after surgery

contains 25 questions divided into physical, emotional, and functional subgroups. Each question is to be answered using a scale with ''no'' (0 points), ''sometimes'' (2 points), or ''yes'' (4 points). The total score ranges from zero (no incapacity) to 100 (severe incapacity).

Study Sites (1)

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