Clinical Trials Directory

Trials / Unknown

UnknownNCT04847700

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

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
30 (estimated)
Sponsor
Mansoura University · Academic / Other
Sex
All
Age
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDURESurgical treatmentEndoscopic retrosigmoid minimally invasive vestibular neurectomy
PROCEDURESurgical treatmentEndoscopic tenotomy of middle ear muscles

Timeline

Start date
2021-05-01
Primary completion
2023-01-01
Completion
2023-06-01
First posted
2021-04-19
Last updated
2021-07-07

Locations

1 site across 1 country: Egypt

Source: ClinicalTrials.gov record NCT04847700. Inclusion in this directory is not an endorsement.