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Effectiveness of endolymphatic sac surgery in patients with intractable Ménière’s disease: a randomised controlled study

Effectiveness of endolymphatic sac surgery in patients with intractable Ménière’s disease: a randomised controlled study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200061169
Enrollment
Unknown
Registered
2022-06-15
Start date
2022-06-01
Completion date
Unknown
Last updated
2023-03-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Meniere’s disease

Interventions

Sponsors

Department of otolaryngology head and neck surgery, The Second affiliated Hospital, The Air Force Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Definite unilateral Ménières disease (MD) according to diagnostic criteria of the Bárány Society Age >=18 years and < 70 years at the start of the trial. 2. Not responding to a sufficient extent to conservative medical treatment 3. More than three patients reported attacks in the 6 months prior to inclusion and lasted at least 20 minutes.

Exclusion criteria

Exclusion criteria: 1. Bilateral Meniere's disease; 2. Active additional neuro-otological disorders (e.g., vestibular migraine, acoustic neuromacontralateral sensorineural deafness, etc.) 3. Middle ear diseases. 4. Family history of genetic disorders related to hearing loss. 5. Severe disability (e.g., neurological diseases, cardiovascular diseases, psychosocial disease and malignant tumor). 6. Serious concurrent illnesses that might interfere with surgery. 7. Pregnancy and lactation.

Design outcomes

Primary

MeasureTime frame
dizziness handicap inventory;

Secondary

MeasureTime frame
Tinnitus Handicap Inventory;pure-tone threshold;speech recognition score;

Contacts

Public ContactLianjun Lu

Department of otolaryngology head and neck surgery, The Second affiliated Hospital, The Air Force Medical University

lulianj@fmmu.edu.cn+86 29 84777446

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026