The purpose of this study is to evaluate the efficacy of three different surgical treatments
(1. Bilateral myringotomy and tube insertion (M&T); 2. Adenoidectomy and bilateral
myringotomy (A&T); 3. Adenoidectomy with myringotomy and tympanostomy tube insertion
(A-M&T)) in reducing subsequent episodes of middle ear disease and hearing loss caused by
the fluid in the middle ear in children aged 24-47 months. The fluid in the middle ear is
of at least three months' duration and unresponsive to standardized, recent antimicrobial
treatment. The children are assigned to one of the three surgical treatments. After
surgery, they are followed with examinations monthly and at the time of intercurrent
infections for three years.
The specific aim of this study is to compare, by means of a randomized clinical trial, the
efficacy of three surgical treatment combinations: adenoidectomy with myringotomy (A-M),
adenoidectomy with myringotomy and tympanostomy tube insertion (A-M&T), and M&T alone, in
reducing subsequent middle ear disease in children aged 24-47 months with otitis media with
effusion (OME) of at least 3 months' duration unresponsive to standardized, recent
antimicrobial treatment. The children are randomly assigned to one of three treatment arms:
1. M&T; 2. A-M; and 3. A-M&T. Subjects are be stratified according to: 1. age; 2.
nasal obstruction; and 3. previous tubes. All subjects are scheduled for surgery according
to assignment within 4 weeks after entry. The first post-operative visit takes place 2
weeks after surgery, and a complete examination of the ears, nose, and throat (ENT exam)
including pneumatic otoscopy, tympanometry and audiometry is performed. Subjects are
followed with monthly evaluations (ENT-exam, pneumatic otoscopy, tympanometry) for three
years. Audiometry is performed every 6 months. All subjects are evaluated at any time
while still enrolled in the study if signs and symptoms of URI, acute otitis media (AOM,
including otorrhea), or OME occur and are treated appropriately. Subjects who develop OME
for 4 months bilaterally or 6 months unilaterally have M&T and continue to be followed in
the study. The primary outcome measure will be percentage of time with middle ear effusion
(MEE). Episodes of AOM, otorrhea, and OME, time to first recurrence, and number of surgical
procedures will be compared between the three treatment groups. Treatment failures,
complications and sequelae of treatments will also be recorded and compared among the three
- Males and females between 24 and 47 months of age, in good general health.
- Asymptomatic otitis media with effusion bilaterally for a minimum of 3 consecutive
- At least one 10-day course of a broad-spectrum antimicrobial agent in the last month.