Correlation Analysis Between ETF and Prognosis of Tympanoplasty

NCT03424369 | Unknown DMC

• 1 other identifier: ETF and tympanoplasty
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Eustachian Tube Dysfunction

Outcome Measures

Primary Outcomes (1)

• Eustachian tube function status were evaluated using TUBOMANOMETRY (TMM)

  Eustachian tube functional status in patients with chronic otitis media before/after tympanoplasty were evaluated using TUBOMANOMETRY (TMM)

  before the surgery, and 6months after the surgery

Study Arms (2)

Eustachian tube unobstructed

Procedure: Tympanoplasty

Eustachian tube dysfunction

Procedure: Tympanoplasty

Interventions

Tympanoplasty PROCEDURE

Tympanoplasty

Eustachian tube dysfunction; Eustachian tube unobstructed

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

According to the results of Eustachian tube manometry, the patients were divided into two groups: Eustachian tube function state and Eustachian tube dysfunction group. The prognosis of tympanoplasty was compared, and the eustachian tube function state was defined in tympanic cavity of chronic otitis media The value of postoperative recovery.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eye & ENT Hospital of Fudan University: lead

Study Sites (1)

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

Shanghai, Shanghai Municipality, 200031, China

RECRUITING

MeSH Terms

Interventions

Tympanoplasty

Intervention Hierarchy (Ancestors)

Otologic Surgical Procedures; Otorhinolaryngologic Surgical Procedures; Surgical Procedures, Operative

Central Study Contacts

Huawei Li, PhD, MD

CONTACT

+86-15821574627; huaweili2000@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2018
• First Posted: February 7, 2018
• Study Start: August 1, 2017
• Primary Completion: December 20, 2018
• Study Completion: December 31, 2019
• Last Updated: February 23, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)