The Therapeutic Effect of Balloon Eustachian Tuboplasty (BET) in Chronic Otitis Media (COM) With Eustachian Tube Dysfunction (ETD)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Balloon Eustachian Tuboplasty
- Sponsor
- Eye & ENT Hospital of Fudan University
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Recurrence rate in chronic otitis media with eustachian tube dysfunction
- Last Updated
- 8 years ago
Overview
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?
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Recurrence rate in chronic otitis media with eustachian tube dysfunction
Time Frame: 6months after the surgery
Recurrence rate in chronic otitis media with eustachian tube dysfunction: with BET vs without BET
Secondary Outcomes
- Hearing change in chronic otitis media with eustachian tube dysfunction(before the surgery, and 6months after the surgery)
- The change of Eustachian tube function using TUBOMANOMETRY (TMM)(before the surgery, and 6months after the surgery)