Correlation Analysis Between ETF and Prognosis of Tympanoplasty

Sponsor

Eye & ENT Hospital of Fudan University (Other)

Overall Status

Unknown status

CT.gov ID

NCT03424369

Collaborator

(none)

1,000

Enrollment

Location

Anticipated Duration (Months)

34.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Eustachian Tube Dysfunction	Procedure: Tympanoplasty

Study Design

Study Type:

Observational

Anticipated Enrollment :

1000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Correlation Analysis Between Eustachian Tube Function and Prognosis of Tympanoplasty

Actual Study Start Date :

Aug 1, 2017

Anticipated Primary Completion Date :

Dec 20, 2018

Anticipated Study Completion Date :

Dec 31, 2019

Arms and Interventions

Arm	Intervention/Treatment
Eustachian tube unobstructed	Procedure: Tympanoplasty Tympanoplasty
Eustachian tube dysfunction	Procedure: Tympanoplasty Tympanoplasty

Arm

Intervention/Treatment

Eustachian tube unobstructed

Procedure: Tympanoplasty

Tympanoplasty

Eustachian tube dysfunction

Procedure: Tympanoplasty

Tympanoplasty

Outcome Measures

Primary Outcome Measures

Eustachian tube function status were evaluated using TUBOMANOMETRY (TMM) [before the surgery, and 6months after the surgery]
Eustachian tube functional status in patients with chronic otitis media before/after tympanoplasty were evaluated using TUBOMANOMETRY (TMM)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Otorhinolaryngology Department of Affiliated Eye and ENT Hospital, Fudan University, Shanghai, China	Shanghai	Shanghai	China	200031

Sponsors and Collaborators

Eye & ENT Hospital of Fudan University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Eye & ENT Hospital of Fudan University

ClinicalTrials.gov Identifier:

NCT03424369

Other Study ID Numbers:

ETF and tympanoplasty

First Posted:

Feb 7, 2018

Last Update Posted:

Feb 23, 2018

Last Verified:

Jan 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Feb 23, 2018