What is the effectiveness of septoplasty compared to a watchful waiting strategy in adults interms of health related quality of life and nasal passage? What is the relation between costs and effects of this procedure?Which patients benefit most from…
ID
Source
Brief title
Condition
- Upper respiratory tract disorders (excl infections)
- Respiratory tract therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
health related quality of life
Secondary outcome
objective measurement of nasal patency, symptoms score, and costs.
Background summary
Surgical correction of a deviated nasal septum (septoplasty) is the most common
ENT operation in adults in the
Netherlands. Indications for this intervention are practice-based rather than
evidence-based and internationally accepted
guidelines are lacking. Subsequently, the Dutch rate of septoplasties appears
to be higher than that in most other Western countries.
Study objective
What is the effectiveness of septoplasty compared to a watchful waiting
strategy in adults in
terms of health related quality of life and nasal passage? What is the relation
between costs and effects of this procedure?
Which patients benefit most from the operation?
Study design
Open multi-centre randomized controlled trial.
Intervention
Septoplasty performed within 6 weeks after randomization versus a non-surgical
or watchful waiting strategy.
Study burden and risks
Participation to this trial does not have any extra risks for the patient.
Patients would have this surgery prescripted anyway by their ENT doctor, while
the beneficiary effect is not yet been proven. The 4 phase rhinomanometry is a
non invasive method which measures the nose passage (participant needs to
breathe in and out through the nose with a mask on the nose). Filling out
questionnaires en diaries is not considered as a burden. The participant pays
in total 4 extra visits to the hospital.
Philips van Leijdenlaan 15
Nijmegen 6525 EX
NL
Philips van Leijdenlaan 15
Nijmegen 6525 EX
NL
Listed location countries
Age
Inclusion criteria
adult patient (aged > 17 years) selected for septoplasty because of a septal deviation causing nasal obstruction
Exclusion criteria
Patients selected for septoplasty due to a septal perforation, patients with previous septal surgery as well as patients who undergo a septoplasty as part of a cosmetic rhinoplasty procedure will be excluded.
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 | NL43509.091.13 |
| Other | NTR TC3868 |