Adjuvant Adenoidectomy for the Treatment of Chronic OME in Children
NCT ID: NCT05545345
Last Updated: 2022-09-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
380 participants
INTERVENTIONAL
2022-09-30
2025-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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TT
Participants only receive tympanostomy tube placement.
tympanostomy tube placement
An incision will be made in the the tympanic membrane, through which a ventilation tube will be inserted.
Ad+TT
Participants will receive tympanostomy tube placement and concurrent adenoidectomy.
tympanostomy tube placement
An incision will be made in the the tympanic membrane, through which a ventilation tube will be inserted.
adenoidectomy
The adenoid is resected transorally under a 70° endoscope with microdebrider or coblator until torus tubarius and choanae are completely revealed.
Interventions
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tympanostomy tube placement
An incision will be made in the the tympanic membrane, through which a ventilation tube will be inserted.
adenoidectomy
The adenoid is resected transorally under a 70° endoscope with microdebrider or coblator until torus tubarius and choanae are completely revealed.
Eligibility Criteria
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Inclusion Criteria
* 2\. Diagnosed with chronic OME. Diagnostic criteria: I. Middle ear effusion detected by otoscopy; II. Type B or C tympanograms; III. Symptoms/signs of OME persisted for \>3 months;
* 3\. Documented hearing loss ≥20dB (average threshold of 500Hz, 1000Hz and 2kHz in pure tone audiometry).
* 4\. Adenoid hypertrophy (A/N ratio\> 0.5 in lateral radiography of the nasopharynx).
* 5\. Informed consent given by the patients and their guardians.
Exclusion Criteria
2. Patients are diagnosed with other nose, sinuses or ear diseases that are eligible for surgical treatment.
3. Patients are diagnosed with OSAHS, tonsil hypertrophy ≥II° or scheduled for tonsillectomy.
4. History of tympanostomy tube placement.
5. Infection of the upper respiratory tract or acute rhinosinusitis over the past 7 days.
6. Sensorineural hearing loss.
7. Other situations that the investigators find unsuitable for the trial.
4 Years
12 Years
ALL
No
Sponsors
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Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
OTHER
Children's Hospital of Fudan University
OTHER
Eye & ENT Hospital of Fudan University
OTHER
Responsible Party
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Central Contacts
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Other Identifiers
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2022-AdOME
Identifier Type: -
Identifier Source: org_study_id
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