Adjuvant Adenoidectomy for the Treatment of Chronic OME in Children
Primary Purpose
Otitis Media With Effusion in Children
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
tympanostomy tube placement
adenoidectomy
Sponsored by
About this trial
This is an interventional treatment trial for Otitis Media With Effusion in Children focused on measuring Otitis media with effusion, tympanostomy tube placement, adjuvant adenoidectomy, hearing outcome
Eligibility Criteria
Inclusion Criteria:
- 1. Children 4-12 years of age.
- 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:
- Cleft palate or other systemic disorders.
- Patients are diagnosed with other nose, sinuses or ear diseases that are eligible for surgical treatment.
- Patients are diagnosed with OSAHS, tonsil hypertrophy ≥II° or scheduled for tonsillectomy.
- History of tympanostomy tube placement.
- Infection of the upper respiratory tract or acute rhinosinusitis over the past 7 days.
- Sensorineural hearing loss.
- Other situations that the investigators find unsuitable for the trial.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
TT
Ad+TT
Arm Description
Participants only receive tympanostomy tube placement.
Participants will receive tympanostomy tube placement and concurrent adenoidectomy.
Outcomes
Primary Outcome Measures
Recurrence rate
Rate of OME recurrence
Rate of repeated tube placement
proportion of patients who need repeated tube insertion
Secondary Outcome Measures
AOM attacks
The number of acute otitis media attacks
Otorrhea
Rate of Otorrhea
Pure tone audiometry
Change of pure tone audiometry thresholds compared with baseline
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.
Complications
Complications related to interventions of this study
Costs of OME-related visits and treatment
Medical expenses associated with OME
Full Information
NCT ID
NCT05545345
First Posted
August 4, 2022
Last Updated
September 16, 2022
Sponsor
Eye & ENT Hospital of Fudan University
Collaborators
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Children's Hospital of Fudan University
1. Study Identification
Unique Protocol Identification Number
NCT05545345
Brief Title
Adjuvant Adenoidectomy for the Treatment of Chronic OME in Children
Official Title
Adjuvant Adenoidectomy Plus Tympanostomy Tube Placement for the Treatment of Chronic OME in Children
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 2022 (Anticipated)
Primary Completion Date
September 2025 (Anticipated)
Study Completion Date
September 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eye & ENT Hospital of Fudan University
Collaborators
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Children's Hospital of Fudan University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Otitis Media With Effusion in Children
Keywords
Otitis media with effusion, tympanostomy tube placement, adjuvant adenoidectomy, hearing outcome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
380 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
TT
Arm Type
Active Comparator
Arm Description
Participants only receive tympanostomy tube placement.
Arm Title
Ad+TT
Arm Type
Experimental
Arm Description
Participants will receive tympanostomy tube placement and concurrent adenoidectomy.
Intervention Type
Procedure
Intervention Name(s)
tympanostomy tube placement
Intervention Description
An incision will be made in the the tympanic membrane, through which a ventilation tube will be inserted.
Intervention Type
Procedure
Intervention Name(s)
adenoidectomy
Intervention Description
The adenoid is resected transorally under a 70° endoscope with microdebrider or coblator until torus tubarius and choanae are completely revealed.
Primary Outcome Measure Information:
Title
Recurrence rate
Description
Rate of OME recurrence
Time Frame
1 year after tube removal
Title
Rate of repeated tube placement
Description
proportion of patients who need repeated tube insertion
Time Frame
1 year after tube removal
Secondary Outcome Measure Information:
Title
AOM attacks
Description
The number of acute otitis media attacks
Time Frame
1 year after tube removal
Title
Otorrhea
Description
Rate of Otorrhea
Time Frame
2 years after tube insertion
Title
Pure tone audiometry
Description
Change of pure tone audiometry thresholds compared with baseline
Time Frame
2 years after tube insertion
Title
Otitis Media-6 and Pediatric Sleep Questionnaire
Description
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
Title
Complications
Description
Complications related to interventions of this study
Time Frame
2 years after tube insertion
Title
Costs of OME-related visits and treatment
Description
Medical expenses associated with OME
Time Frame
Through study completion, an average of 2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
1. Children 4-12 years of age.
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:
Cleft palate or other systemic disorders.
Patients are diagnosed with other nose, sinuses or ear diseases that are eligible for surgical treatment.
Patients are diagnosed with OSAHS, tonsil hypertrophy ≥II° or scheduled for tonsillectomy.
History of tympanostomy tube placement.
Infection of the upper respiratory tract or acute rhinosinusitis over the past 7 days.
Sensorineural hearing loss.
Other situations that the investigators find unsuitable for the trial.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Huiqian Yu, PhD
Phone
86-13636423139
Email
yhq925@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Fangzhou Yu, MD
Phone
86-18321719732
Email
13301050317@fudan.edu.cn
12. IPD Sharing Statement
Learn more about this trial
Adjuvant Adenoidectomy for the Treatment of Chronic OME in Children
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