Minimally Invasive Vestibular Neurectomy Versus Tenotomy of the Stapedius and Tensor Tympani Muscles in the Management of Patients With Unilateral Meniere's Disease
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2021
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 26, 2021
CompletedFirst Posted
Study publicly available on registry
April 19, 2021
CompletedStudy Start
First participant enrolled
May 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2023
CompletedJuly 7, 2021
July 1, 2021
1.7 years
March 26, 2021
July 2, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
dizziness handicap inventory (DHI)
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).
6 months after surgery
Study Arms (2)
Minimally invasive vestibular neurectomy
ACTIVE COMPARATORTenotomy of the stapedius and tensor tympani muscles
ACTIVE COMPARATORInterventions
Endoscopic retrosigmoid minimally invasive vestibular neurectomy
Eligibility Criteria
You may qualify if:
- unilateral definite Meniere's disease.
You may not qualify if:
- other peripheral or central vestibular disorders, bilateral MD and neurologic disorders.
- Previous history of chronic otitis media or middle ear surgery.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
ORL-HNS department,Mansoura University Hospital, Faculty of Medicine, Mansoura University
Al Mansurah, ElDakahlia, 35516, Egypt
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principle investigator
Study Record Dates
First Submitted
March 26, 2021
First Posted
April 19, 2021
Study Start
May 1, 2021
Primary Completion
January 1, 2023
Study Completion
June 1, 2023
Last Updated
July 7, 2021
Record last verified: 2021-07
Data Sharing
- IPD Sharing
- Will not share