Distribution of Bacteria in OME After Radiotherapy For NPC.

Sun Yat-sen University

Status: Active, not recruiting

Conditions: Nasopharyngeal Carcinoma; Otitis Media Effusion

Study type: Observational

Funder types: Other

Identifiers

NCT06523933

SYSKY-2023-448-01

Details and patient eligibility

About

To observe the prognostic difference of tympanocentesis in different kinds of otitis media effusion.

Full description

This study is a prospective, observational clinical study to observe the difference in prognosis of tympanocentesis in different kinds of otitis media effusion (OME), especially OME after radiotherapy for nasopharyngeal carcinoma (NPC). A total of 234 patients diagnosed with OME who are given the treatment of tympanocentesis only, including outpatient and inpatient patients, were included in the study. The middle ear effusion collected during the tympanocentesis is sent for bacterial culture. The positive rate of the effusion and the recurrence rate within 24 weeks will be compared in order to figure out whether bacterial infection is an important influencing factor for some kinds of OME in addition to eustachian tube dysfunction, which is acknowledged.

Enrollment: 234 estimated patients

Sex: All

Ages: 15 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients clinical diagnosis of OME or OME after radiotherapy for NPC (Diagnostic criteria: fluid visible in the middle ear and a type B tympanogram).
• patients volunteered to participate in the study and signed the informed consent

Exclusion criteria

• NPC recurrence or other malignant tumor after radiotherapy.
• clear diagnosis of Eustachian ostium atresia or nasal obstruction diseases, such as severe deviated nasal septum, choanal atresia, osteoradionecrosis of skull base after radiotherapy, etc.
• pregnant and lactating women.
• patients with severe underlying diseases or with severe liver and kidney dysfunction.
• patients who could not cooperate (including poor hearing and radiation encephalopathy)
• patients with other middle ear diseases, such as middle ear cholesteatoma, osteoradionecrosis of temporal bone after radiotherapy, etc.
• severe deglutition disorders
• cleft palate

Trial design

234 participants in 4 patient groups

ON+

Description:

Patients with OME after NPC with a Positive Result of Bacteria Culture of Middle Ear Effusion.

ON-

Description:

Patients with OME after NPC with a Negative Result of Bacteria Culture of Middle Ear Effusion.

O+

Description:

Patients with OME with a Positive Result of Bacteria Culture of Middle Ear Effusion.

O-

Description:

Patients with OME with a Negative Result of Bacteria Culture of Middle Ear Effusion.