search
Back to results

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
Eye & ENT Hospital of Fudan University
About
Eligibility
Locations
Arms
Outcomes
Full info

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

4 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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:

  1. Cleft palate or other systemic disorders.
  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.

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

    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
    search

    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

    We'll reach out to this number within 24 hrs