The Therapeutic Effect of BET in COM With ETD

Not Applicable

• Conditions: Balloon Eustachian Tuboplasty
• Interventions: Procedure: BET

• Registration Number: NCT03440710
• Lead Sponsor: Eye & ENT Hospital of Fudan University

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?

Detailed Description

Not available

Study Timeline

• Status Verified: 2018-02
• Study First Submitted: 2018-02-11
• Study First Submitted QC: 2018-02-19
• Last Update Submitted: 2018-02-19
• Study First Posted: 2018-02-22
• Last Update Posted: 2018-02-22
• Study Start: 2018-06-01
• Primary Completion: 2019-05-30
• Study Completion: 2019-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
with BET	BET	with BET and Tympanoplast
without BET	BET	with Tympanoplast only

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

Otorhinolaryngology Department of Affiliated Eye and ENT Hospital, Fudan University, Shanghai, China; 🇨🇳 Shanghai, Shanghai, China