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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?
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| with BET | Experimental | with BET and Tympanoplast |
|
| without BET | Other | with Tympanoplast only |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BET | Procedure | Balloon Eustachian Tuboplasty |
|
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Otorhinolaryngology Department of Affiliated Eye and ENT Hospital, Fudan University, Shanghai, China | Shanghai | Shanghai Municipality | 200031 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40008607 | Derived | Swords C, Smith ME, Patel A, Norman G, Llewellyn A, Tysome JR. Balloon dilatation of the Eustachian tube for obstructive Eustachian tube dysfunction in adults. Cochrane Database Syst Rev. 2025 Feb 26;2(2):CD013429. doi: 10.1002/14651858.CD013429.pub2. |
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Eustachian tube function before and after surgery using TUBOMANOMETRY (TMM) |
| before the surgery, and 6months after the surgery |