Balloon Eustachian Tuboplasty
Conditions
Brief summary
Currently, surgical treatment of patients with chronic otitis media is one of the most important treatment methods. However, the current results show that some patients with eustachian tube dysfunction can't reconstruct the gas-containing structure of the middle ear after operation. This is a randomized controlled trial that aims to evaluate the therapeutic effect of balloon eustachian tuboplasty (BET) for the treatment in chronic otitis media (COM) with eustachian tube dysfunction (ETD). This future study will aim to address the question: Does BET gain better recovery of auditory function and lower recurrence rate in chronic otitis media with eustachian tube dysfunction?
Interventions
PROCEDUREBET
Balloon Eustachian Tuboplasty
Sponsors
Eye & ENT Hospital of Fudan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Patients who need tympanoplasty, with clear diagnosis of chronic otitis media, middle ear cholesteatoma; 2. Patients with eustachian tube dysfunction using TMM; 3. Subjects or their legal representatives can understand the purpose of the study, show sufficient compliance with the research protocol, and sign the informed consent form.
Exclusion criteria
1. Secondary chronic otitis media (after head and neck cancer radiotherapy); 2. Ipsilateral ear recurrence after surgical treatment, requiring secondary surgery; 3. Two tympanoplasty surgery; 4. Typical allergic rhinitis, nasal endoscopy or imaging studies suggest chronic rhinosinusitis, nasal polyps and other short-term eustachian tube function of a greater impact on the disease; 5. poor general health, with severe liver and kidney dysfunction, coagulation disorders, cardiovascular disease, neurological diseases can not tolerate surgery.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recurrence rate in chronic otitis media with eustachian tube dysfunction | 6months after the surgery | Recurrence rate in chronic otitis media with eustachian tube dysfunction: with BET vs without BET |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hearing change in chronic otitis media with eustachian tube dysfunction | before the surgery, and 6months after the surgery | Hearing outcome in chronic otitis media with eustachian tube dysfunction: with BET vs without BET |
| The change of Eustachian tube function using TUBOMANOMETRY (TMM) | before the surgery, and 6months after the surgery | Eustachian tube function before and after surgery using TUBOMANOMETRY (TMM) |
Countries
China
Outcome results
None listed