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

NCT ID: NCT04847700

Last Updated: 2021-07-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-01

Study Completion Date

2023-06-01

Brief Summary

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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

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Conditions

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Ménière

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Minimally invasive vestibular neurectomy

Group Type ACTIVE_COMPARATOR

Surgical treatment

Intervention Type PROCEDURE

Endoscopic retrosigmoid minimally invasive vestibular neurectomy

Tenotomy of the stapedius and tensor tympani muscles

Group Type ACTIVE_COMPARATOR

Surgical treatment

Intervention Type PROCEDURE

Endoscopic tenotomy of middle ear muscles

Interventions

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Surgical treatment

Endoscopic retrosigmoid minimally invasive vestibular neurectomy

Intervention Type PROCEDURE

Surgical treatment

Endoscopic tenotomy of middle ear muscles

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mansoura University

OTHER

Sponsor Role lead

Responsible Party

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Noha A.Elkholy

Principle investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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ORL-HNS department,Mansoura University Hospital, Faculty of Medicine, Mansoura University

Al Mansurah, ElDakahlia, Egypt

Site Status RECRUITING

Countries

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Egypt

Facility Contacts

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Noha A Elkholy

Role: primary

02-01065488097

Other Identifiers

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MD.21.02.418.R1

Identifier Type: -

Identifier Source: org_study_id

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