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

NCT ID: NCT00629694

Last Updated: 2012-01-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-09-30
• Study Completion Date: 2009-05-31

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

Conditions

Otitis Media With Effusion

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

A-T

Group Type: ACTIVE_COMPARATOR

adenoidectomy, myringotomy, tubes insertion

Intervention Type: PROCEDURE

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

A-M

Group Type: EXPERIMENTAL

A-M

Intervention Type: PROCEDURE

adenoidectomy and myringotomy alone

Interventions

adenoidectomy, myringotomy, tubes insertion

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

Intervention Type: PROCEDURE

A-M

adenoidectomy and myringotomy alone

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aghia Sophia Children's Hospital of Athens

OTHER

Sponsor Role: lead

Responsible Party

Ioannis Vlastos

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ioannis M Vlastos, MD

Role: PRINCIPAL_INVESTIGATOR

Aghia Sophia Children's Hospital of Athens

Locations

Department of Otolaryngology-Head and Neck Surgery, Aghia Sophia Children's Hospital of Athens

Athens, , Greece

Countries

Greece

Other Identifiers

12-01-07

Identifier Type: -

Identifier Source: org_study_id