Correlation Analysis Between ETF and Prognosis of Tympanoplasty

NCT ID: NCT03424369

Last Updated: 2018-02-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-08-01

Study Completion Date

2019-12-31

Brief Summary

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The regular opening of the eustachian tube plays an important role in maintaining normal pressure in middle ear cavity, hearing function and preventing the occurrence of middle ear inflammation. The current evaluation of Eustachian tube function mainly depends on the patient's history of auricular distention, occlusion, physical examination (Valsalva), acoustic impedance test. However, these tests can not accurately assess the eustachian tube function, the lack of quantitative analysis of eustachian tube function. 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 can not reconstruct the gas-containing structure of the middle ear after operation, which brings about the treatment of diseases and the recovery of auditory function Difficulties. Although domestic and foreign scholars believe that eustachian tube function in tympanoplasty in the reconstruction of the middle ear with air cavity plays an important role, but due to the lack of a reliable quantitative evaluation of eustachian tube function, eustachian tube function in the occurrence of chronic otitis media , There is a lack of reliable evidence-based medicine in the assessment of the value of development and prognosis. In recent years, a new eustachian tube function evaluation method - Eustachian tube manometry technique, began a quantitative objective assessment of Eustachian tube function, combined with physical examination and subjective symptom scales to conduct a comprehensive assessment of eustachian tube function . This study wants to evaluate the eustachian tube function preoperatively and postoperatively in patients with chronic otitis media who underwent surgery. Regular postoperative follow-ups were used to understand the importance of eustachian tube function in the prognosis of chronic otitis media surgery , In order to further improve the eustachian tube function and improve the surgical curative effect of chronic otitis media.

Detailed Description

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Conditions

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Eustachian Tube Dysfunction

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Eustachian tube unobstructed

Tympanoplasty

Intervention Type PROCEDURE

Tympanoplasty

Eustachian tube dysfunction

Tympanoplasty

Intervention Type PROCEDURE

Tympanoplasty

Interventions

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Tympanoplasty

Tympanoplasty

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1.18 to 75 years old, gender is not limited; 2.clear diagnosis of chronic otitis media, middle ear cholesteatoma need tympanoplasty patients; 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.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Eye & ENT Hospital of Fudan University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Huawei Li, PhD, MD

Role: CONTACT

+86-15821574627

Facility Contacts

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Huawei Li, Phd &MD

Role: primary

Lingjie Wu, MS &MD

Role: backup

Other Identifiers

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ETF and tympanoplasty

Identifier Type: -

Identifier Source: org_study_id

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