Clinical trial NCT06523933: Distribution of Bacteria in OME After Radiotherapy For NPC.
Official title: Distribution of Bacteria in Otitis Media With Effusion After Radiotherapy For Nasopharyngeal Carcinoma.
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Otitis Media Effusion
Nasopharyngeal Carcinoma
Keywords: Otitis Media Effusion
Nasopharyngeal Carcinoma
Bacteria
Lead sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2024-07-26
Enrollment: 234
Sex: ALL
Minimum age (years): 15
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with OME and OME after radiotherapy for NPC, who are given the treatment of tympanostomy only, including outpatient and inpatient patients, were included in the study.

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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Positive Bacterial Culture Rate in Middle Ear Effusion
timeFrame: Up to 24 weeks
Secondary outcomes:
measure: Changes in Air Pressure (Tympanogram)
timeFrame: Collected at 6, 12, 24 Weeks after Tympanocentesis
measure: Eustachian Tube Dysfunction Questionnaire (ETDQ-7)
timeFrame: Collected at 6, 12, 24 Weeks after Tympanocentesis
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen Memorial Hospital, Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
name: Hao Xiong
role: PRINCIPAL_INVESTIGATOR
References: