An interventional study of tympanostomy tube placement and adenoidectomy in Otitis Media With Effusion in Children, sponsored by Eye & ENT Hospital of Fudan University. Not yet recruiting. Open to participants aged 4 Years to 12 Years. Per ClinicalTrials.gov, last updated 2022-09-19.
Sponsored by Eye & ENT Hospital of Fudan University · Not applicable, Interventional, and Treatment
This study aims to verify the efficacy of adjuvant adenoidectomy for children with chronic OME who become candidates for tympanostomy tube placement, and explore potential factors associated with the efficacy of adjuvant adenoidectomy.
Otitis media with effusion is a common condition in children, and tympanostomy tube placement is the first-line treatment for those who requires surgical interventions. Adenoidectomy proves to be helpful to children over 4 years old, but the risks of adjuvant surgery is believed to somehow offset its benefits. This study is meant to verify if concurrent adenoidectomy provides extra benefits in resolving MEE, reducing AOM, and improving hearing and patients' quality of life to children who become candidates for TT.
88 studies on the registry are indexed under Otitis Media with Effusion; 17 are open to participants now.
This study's planned enrollment of 380 is above the median of 80 across 61 interventional studies indexed under Otitis Media with Effusion.
Browse Otitis Media with Effusion studies →Eye & ENT Hospital of Fudan University is the lead sponsor of 126 studies on the registry; 70 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants only receive tympanostomy tube placement.
Procedure: tympanostomy tube placement
Participants will receive tympanostomy tube placement and concurrent adenoidectomy.
Procedure: tympanostomy tube placement · Procedure: adenoidectomy
An incision will be made in the the tympanic membrane, through which a ventilation tube will be inserted.
The adenoid is resected transorally under a 70° endoscope with microdebrider or coblator until torus tubarius and choanae are completely revealed.
Recurrence rate
Rate of OME recurrence
Time frame: 1 year after tube removal
Rate of repeated tube placement
proportion of patients who need repeated tube insertion
Time frame: 1 year after tube removal
AOM attacks
The number of acute otitis media attacks
Time frame: 1 year after tube removal
Otorrhea
Rate of Otorrhea
Time frame: 2 years after tube insertion
Pure tone audiometry
Change of pure tone audiometry thresholds compared with baseline
Time frame: 2 years after tube insertion
Otitis Media-6 and Pediatric Sleep Questionnaire
Change of questionnaire score. Otitis Media-6 score ranges from 6 to 42, and higher scores mean worse outcomes. Pediatric Sleep Questionnaire score ranges from 0 to 22, and higher scores mean worse outcomes.
Time frame: 2 years after tube insertion
Complications
Complications related to interventions of this study
Time frame: 2 years after tube insertion
Costs of OME-related visits and treatment
Medical expenses associated with OME
Time frame: Through study completion, an average of 2 years
No study locations are listed for this record.
Start is estimated for Sep 2022; primary completion for Sep 2025, 36 months later.
Of 16 interventional studies with no phase under Otitis Media with Effusion, half reached primary completion within 48 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 65. This study's planned 36 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.
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