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

NCT00629694 | Completed Phase 2

• 1 other identifier: 12-01-07
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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

Keywords

adenoidectomy, myringotomy, tubes insertion, otitis media, adenoid hyperthophy

Outcome Measures

Primary Outcomes (1)

• OM-6

  one year post operative

Secondary Outcomes (1)

• tympanogram type B

  one year

Study Arms (2)

A-T

ACTIVE COMPARATOR

Procedure: adenoidectomy, myringotomy, tubes insertion

A-M

EXPERIMENTAL

Procedure: A-M

Interventions

adenoidectomy, myringotomy, tubes insertion PROCEDURE

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

A-T

A-M PROCEDURE

adenoidectomy and myringotomy alone

A-M

Eligibility Criteria

• Age: 3 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• other health problems especially related with the condition eg cleft palate

Sponsors & Collaborators

• Aghia Sophia Children's Hospital of Athens: lead

Study Sites (1)

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

Athens, Greece

Location

MeSH Terms

Conditions

Otitis Media with Effusion; Otitis Media

Interventions

Adenoidectomy; Middle Ear Ventilation

Condition Hierarchy (Ancestors)

Otitis; Ear Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Otorhinolaryngologic Surgical Procedures; Surgical Procedures, Operative; Ostomy; Otologic Surgical Procedures

Study Officials

• Ioannis M Vlastos, MD

  Aghia Sophia Children's Hospital of Athens

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: February 27, 2008
• First Posted: March 6, 2008
• Study Start: September 1, 2007
• Primary Completion: May 1, 2009
• Study Completion: May 1, 2009
• Last Updated: January 23, 2012

Record last verified: 2012-01

Locations

GR (1)