The Therapeutic Effect of BET in COM With ETD

Study Overview
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Brief Summary
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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?

Official Title
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The Therapeutic Effect of Balloon Eustachian Tuboplasty (BET) in Chronic Otitis Media (COM) With Eustachian Tube Dysfunction (ETD)

Conditions
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Balloon Eustachian Tuboplasty

Intervention / Treatment
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* Procedure: BET


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who need tympanoplasty, with clear diagnosis of chronic otitis media, middle ear cholesteatoma; Patients with eustachian tube dysfunction using TMM; 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: Secondary chronic otitis media (after head and neck cancer radiotherapy); Ipsilateral ear recurrence after surgical treatment, requiring secondary surgery; Two tympanoplasty surgery; 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; poor general health, with severe liver and kidney dysfunction, coagulation disorders, cardiovascular disease, neurological diseases can not tolerate surgery.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: with BET<br>with BET and Tympanoplast | Procedure: BET<br>* Balloon Eustachian Tuboplasty<br>|
| Other: without BET<br>with Tympanoplast only | Procedure: BET<br>* Balloon Eustachian Tuboplasty<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence rate in chronic otitis media with eustachian tube dysfunction | Recurrence rate in chronic otitis media with eustachian tube dysfunction: with BET vs without BET | 6months after the surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hearing change in chronic otitis media with eustachian tube dysfunction | Hearing outcome in chronic otitis media with eustachian tube dysfunction: with BET vs without BET | before the surgery, and 6months after the surgery | 
| The change of Eustachian tube function using TUBOMANOMETRY (TMM) | Eustachian tube function before and after surgery using TUBOMANOMETRY (TMM) | before the surgery, and 6months after the surgery |