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

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ClinicalTrials.gov Identifier: NCT00629694
Recruitment Status : Completed
First Posted : March 6, 2008
Last Update Posted : January 23, 2012
Sponsor:
Information provided by (Responsible Party):
Ioannis Vlastos, Aghia Sophia Children's Hospital of Athens

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

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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
Study Start Date : September 2007
Actual Primary Completion Date : May 2009
Actual Study Completion Date : May 2009

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Arm Intervention/treatment
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




Primary Outcome Measures :
  1. OM-6 [ Time Frame: one year post operative ]

Secondary Outcome Measures :
  1. tympanogram type B [ Time Frame: one year ]


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Ages Eligible for Study:   3 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: March 6, 2008    Key Record Dates
Last Update Posted: January 23, 2012
Last Verified: January 2012

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

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