Back to resultsAdenoidectomy, Myringotomy and Tubes' Insertion vs Adenoidectomy and Myringotomy Alone in Children With Otitis Media With Effusion and Adenoid Hypertrophy
Primary Purpose
Otitis Media With Effusion
Status
Completed
Phase
Phase 2
Locations
Greece
Study Type
Interventional
Intervention
adenoidectomy, myringotomy, tubes insertion
A-M
Sponsored by
About this trial
This is an interventional treatment trial for Otitis Media With Effusion focused on measuring adenoidectomy, myringotomy, tubes insertion, otitis media, adenoid hyperthophy
Eligibility Criteria
Inclusion Criteria:
- children operated for their adenoid hyperthrophy with an adenoid size of 3 (measured in a scale of 1-3 intraoperatively or from lateral neck x-ray) and otitis media with effusion causing an average air-bone gap of greater than 20db. Children should be otherwise healthy with an ASA score of I and between 3-12 years old of age
Exclusion Criteria:
- other health problems especially related with the condition eg cleft palate
Sites / Locations
- Department of Otolaryngology-Head and Neck Surgery, Aghia Sophia Children's Hospital of Athens
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
A-T
A-M
Arm Description
Outcomes
Primary Outcome Measures
OM-6
Secondary Outcome Measures
tympanogram type B
Full Information
NCT ID
NCT00629694
First Posted
February 27, 2008
Last Updated
January 20, 2012
Sponsor
Aghia Sophia Children's Hospital of Athens
1. Study Identification
Unique Protocol Identification Number
NCT00629694
Brief Title
Adenoidectomy, Myringotomy and Tubes' Insertion vs Adenoidectomy and Myringotomy Alone in Children With Otitis Media With Effusion and Adenoid Hypertrophy
Official Title
Adenoidectomy, Myringotomy and Tubes' Insertion vs Adenoidectomy and Myringotomy Alone in Children With Otitis Media With Effusion and Adenoid Hypertrophy
Study Type
Interventional
2. Study Status
Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
May 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aghia Sophia Children's Hospital of Athens
4. Oversight
5. Study Description
Brief Summary
It is not unusual for several children operated for severe adenoid hyperthrophy causing breathing problems to have otitis media with effusion simultaneously. It is unknown whether adenoidectomy, myringotomy and tubes insertion is superior to adenoidectomy and myringotomy alone in terms of otitis media related quality of life and recurrence of otitis media several months after the operation. For this purpose a randomized trial is conducted including children operated for adenoid hyperthrophy and whose otitis media with effusion had caused minimal or no symptoms so far
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Otitis Media With Effusion
Keywords
adenoidectomy, myringotomy, tubes insertion, otitis media, adenoid hyperthophy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
52 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A-T
Arm Type
Active Comparator
Arm Title
A-M
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
adenoidectomy, myringotomy, tubes insertion
Intervention Description
adenoidectomy, myringotomy and tubes insertion (A-T)against adenoidectomy and myringotomy alone (A-M)
Intervention Type
Procedure
Intervention Name(s)
A-M
Intervention Description
adenoidectomy and myringotomy alone
Primary Outcome Measure Information:
Title
OM-6
Time Frame
one year post operative
Secondary Outcome Measure Information:
Title
tympanogram type B
Time Frame
one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
children operated for their adenoid hyperthrophy with an adenoid size of 3 (measured in a scale of 1-3 intraoperatively or from lateral neck x-ray) and otitis media with effusion causing an average air-bone gap of greater than 20db. Children should be otherwise healthy with an ASA score of I and between 3-12 years old of age
Exclusion Criteria:
other health problems especially related with the condition eg cleft palate
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ioannis M Vlastos, MD
Organizational Affiliation
Aghia Sophia Children's Hospital of Athens
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Otolaryngology-Head and Neck Surgery, Aghia Sophia Children's Hospital of Athens
City
Athens
Country
Greece
12. IPD Sharing Statement
Learn more about this trial
Adenoidectomy, Myringotomy and Tubes' Insertion vs Adenoidectomy and Myringotomy Alone in Children With Otitis Media With Effusion and Adenoid Hypertrophy
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