Condition category
Ear, Nose and Throat
Date applied
17/10/2000
Date assigned
17/10/2000
Last edited
19/09/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Professor MP Haggard

ORCID ID

Contact details

Institute of Hearing Research
University Park
Nottingham
NG7 2RD
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

E203/85

Study information

Scientific title

Acronym

TRIAL

Study hypothesis

To assess the benefit of the three main treatments for Otitis Media with Effusion (OME), i.e. Ventilation tube insertion alone, Ventilation tube insertion plus adenoidectomy, Observation + medical management- in terms of:
1. The impact upon the child's life including hearing ability, general health, behaviour and quality of life
2. The relative cost effectiveness of treatment to the NHS particularly in terms of additional benefit conferred by adenoidectomy

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Hearing research

Intervention

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

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

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

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/04/1994

Overall trial end date

01/12/1997

Reason abandoned

Eligibility

Participant 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.

Participant type

Patient

Age group

Senior

Gender

Not Specified

Target number of participants

590

Participant 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.

Recruitment start date

01/04/1994

Recruitment end date

01/12/1997

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Institute of Hearing Research
Nottingham
NG7 2RD
United Kingdom

Sponsor information

Organisation

Medical Research Council (MRC) (UK)

Sponsor details

20 Park Crescent
London
W1B 1AL
United Kingdom
+44 20 7636 5422
clinical.trial@headoffice.mrc.ac.uk

Sponsor type

Research council

Website

http://www.mrc.ac.uk

Funders

Funder type

Research council

Funder name

Medical Research Council (MRC) (UK)

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2001 protocol in http://www.ncbi.nlm.nih.gov/pubmed/11678951
2. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22443163

Publication citations

  1. Protocol

    Surgery for persistent otitis media with effusion: generalizability of results from the UK trial (TARGET). Trial of Alternative Regimens in Glue Ear Treatment., Clin Otolaryngol Allied Sci, 2001, 26, 5, 417-424.

  2. Results

    Adjuvant adenoidectomy in persistent bilateral otitis media with effusion: hearing and revision surgery outcomes through 2 years in the TARGET randomised trial., Clin Otolaryngol, 2012, 37, 2, 107-116, doi: 10.1111/j.1749-4486.2012.02469.x.

Additional files

Editorial Notes