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To observe the prognostic difference of tympanocentesis in different kinds of otitis media effusion.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ON+ | Patients with OME after NPC with a Positive Result of Bacteria Culture of Middle Ear Effusion. | ||
| ON- | Patients with OME after NPC with a Negative Result of Bacteria Culture of Middle Ear Effusion. | ||
| O+ | Patients with OME with a Positive Result of Bacteria Culture of Middle Ear Effusion. | ||
| O- | Patients with OME with a Negative Result of Bacteria Culture of Middle Ear Effusion. |
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| Measure | Description | Time Frame |
|---|---|---|
| Positive Bacterial Culture Rate in Middle Ear Effusion | Up to 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Air Pressure (Tympanogram) | Tympanogram changed from type B to type A or type C. | Collected at 6, 12, 24 Weeks after Tympanocentesis |
| Eustachian Tube Dysfunction Questionnaire (ETDQ-7) |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Hao Xiong | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-sen Memorial Hospital, Sun Yat-sen University | Guangzhou | Guangdong | 510120 | China |
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| ID | Term |
|---|---|
| D010034 | Otitis Media with Effusion |
| D000077274 | Nasopharyngeal Carcinoma |
| ID | Term |
|---|---|
| D010033 | Otitis Media |
| D010031 | Otitis |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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middle ear effusion
The ETDQ-7 tool is used to assess the symptoms of Otitis Media With Effusion (OME), which consists of seven items with a scale of graduated responses ranging from 1 (No Problem) to 7 (Severe Problem), and 4 would correspond to a Moderate Problem. If the total score is more than 14, it is considered that there is eustachian tube dysfunction. The average post-operative ETDQ-7 score is less than 2.1 or decrease > 0.5 (minimal clinically important difference=0.5), it is considered that the eustachian tube function is improved.
| Collected at 6, 12, 24 Weeks after Tympanocentesis |
| D002277 |
| Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009303 | Nasopharyngeal Neoplasms |
| D010610 | Pharyngeal Neoplasms |
| D010039 | Otorhinolaryngologic Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
| D009302 | Nasopharyngeal Diseases |
| D010608 | Pharyngeal Diseases |
| D009057 | Stomatognathic Diseases |