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

Aghia Sophia Children's Hospital of Athens

Status and phase: Completed; Phase 2

Conditions: Otitis Media With Effusion

Treatments: Procedure: adenoidectomy, myringotomy, tubes insertion; Procedure: A-M

Study type: Interventional

Funder types: Other

Identifiers

NCT00629694

12-01-07

Details and patient eligibility

About

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

Enrollment: 52 patients

Sex: All

Ages: 3 to 12 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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52 participants in 2 patient groups

A-T

Active Comparator group

Treatment:

Procedure: adenoidectomy, myringotomy, tubes insertion

A-M

Experimental group

Treatment:

Procedure: A-M