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Adenoidectomy, Myringotomy and Tubes' Insertion vs Adenoidectomy and Myringotomy Alone in Children With Otitis Media With Effusion and Adenoid Hypertrophy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ioannis Vlastos, Aghia Sophia Children's Hospital of Athens
ClinicalTrials.gov Identifier:
NCT00629694
First received: February 27, 2008
Last updated: January 20, 2012
Last verified: January 2012
History of Changes
  Purpose

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


Condition Intervention Phase
Otitis Media With Effusion
 Procedure: adenoidectomy, myringotomy, tubes insertion
Procedure: A-M
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Adenoidectomy, Myringotomy and Tubes' Insertion vs Adenoidectomy and Myringotomy Alone in Children With Otitis Media With Effusion and Adenoid Hypertrophy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Aghia Sophia Children's Hospital of Athens:

Primary Outcome Measures:
  • OM-6 [ Time Frame: one year post operative ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • tympanogram type B [ Time Frame: one year ] [ Designated as safety issue: No ]

Enrollment: 52
Study Start Date: September 2007
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A-T Procedure: adenoidectomy, myringotomy, tubes insertion
adenoidectomy, myringotomy and tubes insertion (A-T)against adenoidectomy and myringotomy alone (A-M)
Experimental: A-M Procedure: A-M
adenoidectomy and myringotomy alone

  Eligibility

Ages Eligible for Study:   3 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00629694

Locations
Greece
Department of Otolaryngology-Head and Neck Surgery, Aghia Sophia Children's Hospital of Athens
Athens, Greece
Sponsors and Collaborators
Aghia Sophia Children's Hospital of Athens
Investigators
Principal Investigator: Ioannis M Vlastos, MD Aghia Sophia Children's Hospital of Athens
  More Information

No publications provided

Responsible Party: Ioannis Vlastos, MD, Aghia Sophia Children's Hospital of Athens
ClinicalTrials.gov Identifier: NCT00629694     History of Changes
Other Study ID Numbers: 12-01-07
Study First Received: February 27, 2008
Last Updated: January 20, 2012
Health Authority: Greece: Ministry of Health and Welfare

Keywords provided by Aghia Sophia Children's Hospital of Athens:
adenoidectomy, myringotomy, tubes insertion, otitis media, adenoid hyperthophy

Additional relevant MeSH terms:
Hypertrophy
Otitis
Otitis Media
Otitis Media with Effusion
 Pathological Conditions, Anatomical
Ear Diseases
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on June 18, 2013