Trial of alternative regimens in glue ear treatment - effectiveness of surgery for otitis media with effusion in 3.5-7 year olds using multiple developmental and economic measures combined with classical clinical measures

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN35793977

Enrollment

590

Registered

2000-10-17

Start date

1994-04-01

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hearing research Ear, Nose and Throat Glue ear

Interventions

1. Ventilation tube insertion alone 2. Ventilation insertion plus adenoidectomy 3. Observation + medical management

Eligibility

Inclusion criteria

Inclusion criteria: Children aged 3.5-7 years having had no previous ear or adenoid surgery, having B+B or B+C2 tympanograms and a bilateral average hearing threshold greater than 20 dB, plus an air-bone gap greater than 10 dB HL.

Exclusion criteria

Exclusion criteria: Children with severe general disease, cranio-facial abnormalities, sensori-neural losses, parents with language or literacy problems. A few children are also excluded if a consultant feels it would be unethical to randomise them into the study.

Design outcomes

Primary

Measure	Time frame
Clinical measures - Otoscopy, audiometry, tympanometry and questionnaire measures, (hearing and predictive factors, general health, economic impact, behavioural assessment and quality of life)	—

Secondary

Measure	Time frame
Not provided at time of registration	—

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026