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

Sponsor

Mansoura University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04847700

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

1.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Ménière	Procedure: Surgical treatment Procedure: Surgical treatment	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

May 1, 2021

Anticipated Primary Completion Date :

Jan 1, 2023

Anticipated Study Completion Date :

Jun 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Minimally invasive vestibular neurectomy	Procedure: Surgical treatment Endoscopic retrosigmoid minimally invasive vestibular neurectomy
Active Comparator: Tenotomy of the stapedius and tensor tympani muscles	Procedure: Surgical treatment Endoscopic tenotomy of middle ear muscles

Arm

Intervention/Treatment

Active Comparator: Minimally invasive vestibular neurectomy

Procedure: Surgical treatment

Endoscopic retrosigmoid minimally invasive vestibular neurectomy

Active Comparator: Tenotomy of the stapedius and tensor tympani muscles

Procedure: Surgical treatment

Endoscopic tenotomy of middle ear muscles

Outcome Measures

Primary Outcome Measures

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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	ORL-HNS department,Mansoura University Hospital, Faculty of Medicine, Mansoura University	Mansoura	ElDakahlia	Egypt	35516

Sponsors and Collaborators

Mansoura University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Noha A.Elkholy, Principle investigator, Mansoura University

ClinicalTrials.gov Identifier:

NCT04847700

Other Study ID Numbers:

MD.21.02.418.R1

First Posted:

Apr 19, 2021

Last Update Posted:

Jul 7, 2021

Last Verified:

Jul 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Meniere Disease

Study Results

No Results Posted as of Jul 7, 2021