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A randomized controlled clinical study comparing semicircular canal occlusion surgery and labyrinthectomy for advanced refractory Meniere's disease

A randomized controlled clinical study comparing semicircular canal occlusion surgery and labyrinthectomy for advanced refractory Meniere's disease

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100049239
Enrollment
Unknown
Registered
2021-07-28
Start date
2021-08-01
Completion date
Unknown
Last updated
2022-04-04

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

Conditions

Meniere's Disease

Interventions

Group 2:labyrinthectomy surgery performed

Sponsors

Shandong Second Provincial General Hospital (Shandong Provincial ENT Hospital)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Patients with unilateral Meniere's disease (2015 barany) with hearing loss, recurrent vertigo, and ineffective drug treatment for at least 6 months (vertigo episodes >=1 time/month). The contralateral ear should have normal, age-appropriate hearing. 2. Pure tone audiometry shows that the average threshold of the three frequencies of 500, 1k, and 2k Hz is >= 60dB HL, and (or) the speech recognition rate is <=50%.

Exclusion criteria

Exclusion criteria: 1. Cerebellopontine angle tumor or other intracranial space-occupying lesions; 2. Age: The patient was older than 70 years old at the beginning of the trial; 3. Severe disability (such as neurological, orthopedic, cardiovascular) or serious concurrent diseases, which may affect treatment or follow-up; 4. Concurrent middle ear disease (such as active middle ear disease) that may interfere with treatment; 5. Patients who cannot bear the risk of surgery; 6. Known history of adverse/allergic reactions to anesthetics.

Design outcomes

Primary

MeasureTime frame
vergito attack controlling rate;

Secondary

MeasureTime frame
hearing loss rate;speech recognition rate;one-sided weakening value of hot and cold test;caloric test DP value;vestibular evoked myogenic potential asymmetry;HIT gain;recovery time from imbalance;sensory organization test score;DHI scale score;vertigo symptom scale-shot form (VSS-sf);tinnitus disability scale score;aural fullness subjective improvement scale(AFSIS) score;function level scale (FLS);Me'nie`re’s disease outcome questionnaire (MDOQ);facial paralysis;cerebrospinal fluid leakage;infection;imbalance;

Countries

China

Contacts

Public ContactWang Haibo

Shandong Second Provincial General Hospital (Shandong Provincial ENT Hospital)

whboto11@163.com+86 531 83086678

Outcome results

None listed

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