|- candidate number||14422|
|- NTR Number||NTR3868|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||21-feb-2013|
|- Secondary IDs||U1111-1139-7254 WHO: The Universal Trial Number (UTN) |
|- Public Title||Effectiveness of septoplasty.|
|- Scientific Title||Effectiveness of septoplasty.|
|- hypothesis||Nasal obstruction is one of the most common reasons for nasal surgery and a deviated nasal septum is the most common anatomical cause of nasal obstruction. Accordingly, septal surgery is one of the most common procedures in ENT practice. There is an urgent call for such guidelines. Both the UK and Dutch ENT-societies recently indicated the 'effectiveness of septoplasty' as one of their most important gaps in medical knowledge. The objective of the current proposal therefore is to study the effects of septoplasty as compared to watchful waiting. |
|- Healt Condition(s) or Problem(s) studied||Septoplasty, Nasal septum, Cost-effectiveness , Quality of life|
|- Inclusion criteria||Patients selected for septoplasty according to current medical practice, i.e. symptomatic impairment of the nasal passage due to a septal deviation. |
|- Exclusion criteria||1. Patients selected for septoplasty due to a septal perforation;|
2. Patients with previous septal surgery;
3. Patients who undergo a septoplasty as part of a cosmetic rhinoplasty procedure;
4. Patients with untreated allergic rhinitis or allergic rhinitis unresponsive to medical treatment.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-apr-2013|
|- planned closingdate||1-apr-2015|
|- Target number of participants||200|
|- Interventions||Septoplasty, i.e. surgical correction of a deviated nasal septum according to the current medical practice. The control group will be a watchfull waiting strategy.|
|- Primary outcome||Heath related quality of life measured with the validated Glasgow Benefit Inventory questionnaire.|
|- Secondary outcome||1. EQ-5D;|
3. Nasal patency measured with 4-phase rhinomanometry;
4. Symptom scores will be determined with the Nasal Obstruction Symptom Evaluation (NOSE) Scale;
|- Timepoints||1. Baseline;|
2. 3 months;
3. 6 months;
4. 12 months;
5. 24 months.
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES|| C. Hendriks|
|- CONTACT for SCIENTIFIC QUERIES||Dr. N. Heerbeek, van|
|- Sponsor/Initiator ||Radboud University Nijmegen Medical Centre|
(Source(s) of Monetary or Material Support)
|ZON-MW, The Netherlands Organization for Health Research and Development|
|- Brief summary||Rationale: |
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.
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?
Open multi-centre randomized controlled trial.
Two hundred adults selected for septoplasty according to current medical practice.
Septoplasty performed within 6 weeks after randomization versus a non-surgical or watchful waiting strategy.
Two years including symptom and cost diaries and scheduled follow-up visits at 0, 3, 6, 12 and 24 months.
Primary outcome measure:
Health related quality of life.
Secondary outcome measures:
Objective measurement of nasal patency, symptoms score, and costs.
Effects will be calculated as incidence rate differences and incidence rate ratios, with 95% confidence intervals. Quality of life data will be analyzed with Student T- tests and analyses of variance (ANOVA). All analyses will be performed on an intention-to-treat basis. Costs per QALY will be estimated. Incremental cost-effectiveness ratios with 95% CIs will be calculated, and a budget impact analysis will be performed.
|- Main changes (audit trail)||Change in inclusion criterium: ‘Patients selected for septoplasty with or without concurrent turbinate surgery according to current medical practice, i.e. symptomatic impairment of the nasal passage due to a septal deviation’.
|- RECORD||21-feb-2013 - 6-nov-2013|