Condition category
Surgery
Date applied
30/05/2007
Date assigned
30/05/2007
Last edited
21/01/2013
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

Dr Anne G.M. Schilder

ORCID ID

Contact details

University Medical Centre Utrecht (UMCU)
Wilhelmina Children's Hospital
Department of Otorhinolaryngology
P.O. Box 85090
Utrecht
3508 AB
Netherlands
+31 (0)30 250 4004
A.Schilder@umcutrecht.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

NOA (Nederlands Onderzoek Adenotomie)

Study hypothesis

This is a superiority trial testing the hypothesis that adenoidectomy is more effective than a watchful waiting strategy in children with recurrent upper respiratory tract infections.

Ethics approval

Approved by the Medical Ethical Committee UMC Utrecht on the 13th October 2006 (ref: NL14149.041.06).

Study design

Randomised, multicentre, active controlled, parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Adenoidectomy in children, common cold, upper respiratory tract infection, rhinosinusitis

Intervention

Adenoidectomy within six weeks versus watchful waiting.

Intervention type

Procedure/Surgery

Phase

Not Specified

Drug names

Primary outcome measures

Upper respiratory tract infection with or without fever (38°C or higher); this will be measured continuously by means of symptom diaries and daily temperature measurements.

Secondary outcome measures

1. Acute otitis media and otitis media with effusion episodes, measured continuously by means of symptom diaries
2. Health related quality of life, measured at inclusion (0 months), 3 months, 12 months and 24 months follow-up
3. Cost-effectiveness, measured continuously by means of symptom diaries
4. Nasopharyngeal flora, investigated at inclusion (0 months), 3 months and 12 months follow-up
5. Exhaled nitric oxide, measured at inclusion (0 months), 3 months, 12 months and 24 months follow-up

Overall trial start date

01/04/2007

Overall trial end date

01/02/2010

Reason abandoned

Eligibility

Participant inclusion criteria

Children aged 1 to 6 years selected for adenoidectomy primarily because of recurrent upper respiratory tract infections (common colds and rhinosinusitis).

Participant type

Patient

Age group

Child

Gender

Not Specified

Target number of participants

110

Participant exclusion criteria

1. Age younger than 1 year or older than 6 years
2. Previous adenoidectomy or adenotonsillectomy
3. Tympanostomy tubes present
4. Selected for adenoidectomy combined with tympanostomy tubes
5. Down’s syndrome
6. Craniofacial malformations (e.g. cleft lip or palate)

Recruitment start date

01/04/2007

Recruitment end date

01/02/2010

Locations

Countries of recruitment

Netherlands

Trial participating centre

University Medical Centre Utrecht (UMCU)
Utrecht
3508 AB
Netherlands

Sponsor information

Organisation

University Medical Centre Utrecht (UMCU) (The Netherlands)

Sponsor details

P.O. Box 85500
Utrecht
3508 GA
Netherlands

Sponsor type

Hospital/treatment centre

Website

http://www.umcutrecht.nl/zorg/#http://www.umcutrecht.nl/zorg/

Funders

Funder type

Research organisation

Funder name

The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22394446
2. 2013 economic evaluation in http://www.ncbi.nlm.nih.gov/pubmed/23329006

Publication citations

  1. Economic evaluation

    Boonacker CW, van den Aardweg MT, Broos PH, Hoes AW, Schilder AG, Rovers MM, Immediate adenoidectomy vs initial watchful waiting strategy in children with recurrent upper respiratory tract infections: an economic evaluation., JAMA Otolaryngol Head Neck Surg, 2013, 139, 2, 129-133, doi: 10.1001/jamaoto.2013.1324.

Additional files

Editorial Notes