The Therapeutic Effect of BET in COM With ETD

E

Eye & ENT Hospital of Fudan University

Status

Unknown

Conditions

Balloon Eustachian Tuboplasty

Treatments

Procedure: BET

Study type

Interventional

Funder types

Other

Identifiers

NCT03440710
The Effect of BET in COM

Details and patient eligibility

About

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?

Enrollment

60 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

60 participants in 2 patient groups

with BET
Experimental group
Description:
with BET and Tympanoplast
Treatment:
Procedure: BET
without BET
Other group
Description:
with Tympanoplast only
Treatment:
Procedure: BET

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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