Back to resultsMinimally Invasive Vestibular Neurectomy Versus Tenotomy of the Stapedius and Tensor Tympani Muscles in the Management of Patients With Unilateral Meniere's Disease
Primary Purpose
Ménière
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Surgical treatment
Surgical treatment
Sponsored by
About this trial
This is an interventional treatment trial for Ménière
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.
Sites / Locations
- ORL-HNS department,Mansoura University Hospital, Faculty of Medicine, Mansoura UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Minimally invasive vestibular neurectomy
Tenotomy of the stapedius and tensor tympani muscles
Arm Description
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04847700
Brief Title
Minimally Invasive Vestibular Neurectomy Versus Tenotomy of the Stapedius and Tensor Tympani Muscles in the Management of Patients With Unilateral Meniere's Disease
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
May 1, 2021 (Actual)
Primary Completion Date
January 1, 2023 (Anticipated)
Study Completion Date
June 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mansoura University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ménière
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Minimally invasive vestibular neurectomy
Arm Type
Active Comparator
Arm Title
Tenotomy of the stapedius and tensor tympani muscles
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Surgical treatment
Intervention Description
Endoscopic retrosigmoid minimally invasive vestibular neurectomy
Intervention Type
Procedure
Intervention Name(s)
Surgical treatment
Intervention Description
Endoscopic tenotomy of middle ear muscles
Primary Outcome Measure Information:
Title
dizziness handicap inventory (DHI)
Description
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).
Time Frame
6 months after surgery
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
ORL-HNS department,Mansoura University Hospital, Faculty of Medicine, Mansoura University
City
Mansoura
State/Province
ElDakahlia
ZIP/Postal Code
35516
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Noha A Elkholy
Phone
02-01065488097
Email
nohaaelkholy@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Minimally Invasive Vestibular Neurectomy Versus Tenotomy of the Stapedius and Tensor Tympani Muscles in the Management of Patients With Unilateral Meniere's Disease
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