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

Not Applicable

• Conditions: Ménière
• Interventions: Procedure: Surgical treatment

• Registration Number: NCT04847700
• Lead Sponsor: Mansoura University

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2021-03-26
• Study First Submitted QC: 2021-04-15
• Study First Posted: 2021-04-19
• Study Start: 2021-05-01
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-02
• Last Update Posted: 2021-07-07
• Primary Completion: 2023-01-01
• Study Completion: 2023-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• unilateral definite Meniere's disease.

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Minimally invasive vestibular neurectomy	Surgical treatment	-
Tenotomy of the stapedius and tensor tympani muscles	Surgical treatment	-

Primary Outcome Measures

Name	Time	Method
dizziness handicap inventory (DHI)	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).

Trial Locations

Locations (1)

ORL-HNS department,Mansoura University Hospital, Faculty of Medicine, Mansoura University; 🇪🇬 Mansoura, ElDakahlia, Egypt