An observational study in Otitis Media Effusion and Nasopharyngeal Carcinoma, sponsored by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University. Status unknown at 1 site in China. Open to participants aged 15 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-07-26.
Sponsored by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Observational
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.
85 studies on the registry are indexed under Otitis Media with Effusion; 15 are open to participants now.
This study's planned enrollment of 234 is above the median of 125 across 20 observational studies indexed under Otitis Media with Effusion.
Browse Otitis Media with Effusion studies →Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University is the lead sponsor of 477 studies on the registry; 278 are open to participants now.
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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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Exclusion Criteria:
Patients with OME after NPC with a Positive Result of Bacteria Culture of Middle Ear Effusion.
Patients with OME after NPC with a Negative Result of Bacteria Culture of Middle Ear Effusion.
Patients with OME with a Positive Result of Bacteria Culture of Middle Ear Effusion.
Patients with OME with a Negative Result of Bacteria Culture of Middle Ear Effusion.
Positive Bacterial Culture Rate in Middle Ear Effusion
Time frame: Up to 24 weeks
Changes in Air Pressure (Tympanogram)
Tympanogram changed from type B to type A or type C.
Time frame: Collected at 6, 12, 24 Weeks after Tympanocentesis
Eustachian Tube Dysfunction Questionnaire (ETDQ-7)
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.
Time frame: Collected at 6, 12, 24 Weeks after Tympanocentesis
This study is status unknown, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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