To establish: 1) the effectiveness of adenoidectomy compared to a non-surgical strategy in children in terms of reduction of upper respiratory tract infections (with or without fever) and improvement in quality of life 2) the costs-effectiveness of…
ID
Source
Brief title
Condition
- Hepatobiliary neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Upper respiratory tract infections including common colds and episodes of
rhinosinusitis, with or without fever.
Secondary outcome
Health-related quality of life.
Background summary
Adenoidectomy is one of the most common operations in children in Western
countries. With 24,450 adenoidectomies carried out as a primary procedure in
2002, it is the third most common operation in children in the Netherlands.
Remarkably, the surgical rate in the Netherlands exceeds that in most other
Western countries. Whereas in our country the main indication for adenoidectomy
is recurrent upper respiratory tract infections, i.e. common colds or episodes
of rhinosinusitis, in other countries most adenoidectomies are carried out for
otitis media and upper airway obstruction. Convincing evidence regarding the
effectiveness of adenoidectomy in children with upper respiratory tract
infections is lacking.
Study objective
To establish:
1) the effectiveness of adenoidectomy compared to a non-surgical strategy in
children in terms of reduction of upper respiratory tract infections (with or
without fever) and improvement in quality of life
2) the costs-effectiveness of this procedure.
Study design
Multi-center randomized controlled trial.
Follow-up will be 2 years including symptom diaries and daily temperature
measurements and scheduled follow-up visits at 3, 6, 12, 18 and 24 months.
Intervention
Adenoidectomy within 6 weeks versus a non-surgical watchful waiting strategy.
Study burden and risks
Burden:
1 inclusion visit of 90 minutes at the participant's home, 5 follow-up visits
of 45 minutes at the practice of the local ENT-surgeon, 19 telephone contacts
of 10 minutes.
Risk:
Participants allocated to the adenoidectomy group carry the usual risks
associated with this operation (haemorrhage, aspiration, nausea, fever).
Participants allocated to the watchful waiting group carry the risk of
persistence or progression of their symptoms of upper respiratory tract
infections. Their parents are advised both in the information brochure and at
the follow-up visits to contact their general practitioner and/or local ENT
surgeon if symptoms grow worse. If both the doctor and parents agree that
adenoidectomy is indicated, they are free to have this operation performed.
Postbus 85090
3508 AB Utrecht
NL
Postbus 85090
3508 AB Utrecht
NL
Listed location countries
Age
Inclusion criteria
-age 1-8 years
-selected for adenoidectomy in current ENT practice because of recurrent upper respiratory tract infections
Exclusion criteria
-children selected for adenoidectomy primarily because of ear related symptoms or symptoms of upper airway obstruction
-children selected for a combined procedure including adenoidectomy and insertion of tympanostomy tubes
-Down syndrome
-craniofacial malformations
-immunodeficiencies
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL14149.041.06 |