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

Otitis Media With Effusion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00629694
• Other study ID #: 12-01-07
• Status: Completed
• Phase: Phase 2
• First received: February 27, 2008
• Last updated: January 20, 2012
• Start date: September 2007
• Est. completion date: May 2009

Study information

• Verified date: January 2012
• Source: Aghia Sophia Children's Hospital of Athens
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: Ministry of Health and Welfare
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: May 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Years to 12 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertrophy
• Otitis
• Otitis Media
• Otitis Media with Effusion

Intervention

Procedure:
• adenoidectomy, myringotomy, tubes insertion
adenoidectomy, myringotomy and tubes insertion (A-T)against adenoidectomy and myringotomy alone (A-M)
• A-M
adenoidectomy and myringotomy alone

Locations

Country	Name	City	State
Greece	Department of Otolaryngology-Head and Neck Surgery, Aghia Sophia Children's Hospital of Athens	Athens

Sponsors (1)

Lead Sponsor	Collaborator
Aghia Sophia Children's Hospital of Athens

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	OM-6		one year post operative	No
Secondary	tympanogram type B		one year	No