Nasal Airway Obstruction Study (NAIROS): a phase III, open-label, mixed-methods, multicentre randomised controlled trial of septoplasty versus medical management of a septal deviation with nasal obstruction.
Administration, Intranasal
Adult
Clinical Decision-Making
/ methods
Clinical Trials, Phase III as Topic
Conservative Treatment
/ economics
Cost-Benefit Analysis
Endoscopy
England
Female
Humans
Male
Multicenter Studies as Topic
Nasal Obstruction
/ diagnosis
Nasal Septum
/ diagnostic imaging
Nose Deformities, Acquired
/ complications
Patient Selection
Quality of Life
Randomized Controlled Trials as Topic
Rhinoplasty
/ economics
Saline Solution
/ administration & dosage
Scotland
Self Report
/ statistics & numerical data
Severity of Illness Index
Steroids, Fluorinated
/ administration & dosage
Treatment Outcome
Wales
Clinical trial
Cost-effectiveness
Mometasone furoate
Nasal obstruction
Nasal septum
Process evaluation
Septoplasty
Turbinates
Journal
Trials
ISSN: 1745-6215
Titre abrégé: Trials
Pays: England
ID NLM: 101263253
Informations de publication
Date de publication:
13 Feb 2020
13 Feb 2020
Historique:
received:
06
11
2019
accepted:
16
01
2020
entrez:
15
2
2020
pubmed:
15
2
2020
medline:
15
12
2020
Statut:
epublish
Résumé
Septoplasty (surgery to straighten a deviation in the nasal septum) is a frequently performed operation worldwide, with approximately 250,000 performed annually in the US and 22,000 in the UK. Most septoplasties aim to improve diurnal and nocturnal nasal obstruction. The evidence base for septoplasty clinical effectiveness is hitherto very limited. To establish, and inform guidance for, the best management strategy for individuals with nasal obstruction associated with a deviated septum. A multicentre, mixed-methods, open label, randomised controlled trial of septoplasty versus medical management for adults with a deviated septum and a reduced nasal airway. Eligible patients will have septal deflection visible at nasendoscopy and a nasal symptom score ≥ 30 on the NOSE questionnaire. Surgical treatment comprises septoplasty with or without reduction of the inferior nasal turbinate on the anatomically wider side of the nose. Medical management comprises a nasal saline spray followed by a fluorinated steroid spray daily for six months. The recruitment target is 378 patients, recruited from up to 17 sites across Scotland, England and Wales. Randomisation will be on a 1:1 basis, stratified by gender and severity (NOSE score). Participants will be followed up for 12 months post randomisation. The primary outcome measure is the total SNOT-22 score at 6 months. Clinical and economic outcomes will be modelled against baseline severity (NOSE scale) to inform clinical decision-making. The study includes a recruitment enhancement process, and an economic evaluation. The NAIROS trial will evaluate the clinical effectiveness and cost-effectiveness of septoplasty versus medical management for adults with a deviated septum and symptoms of nasal blockage. Identifying those individuals most likely to benefit from surgery should enable more efficient and effective clinical decision-making, and avoid unnecessary operations where there is low likelihood of patient benefit. EudraCT: 2017-000893-12, ISRCTN: 16168569. Registered on 24 March 2017.
Sections du résumé
BACKGROUND
BACKGROUND
Septoplasty (surgery to straighten a deviation in the nasal septum) is a frequently performed operation worldwide, with approximately 250,000 performed annually in the US and 22,000 in the UK. Most septoplasties aim to improve diurnal and nocturnal nasal obstruction. The evidence base for septoplasty clinical effectiveness is hitherto very limited.
AIMS
OBJECTIVE
To establish, and inform guidance for, the best management strategy for individuals with nasal obstruction associated with a deviated septum.
METHODS/DESIGN
METHODS
A multicentre, mixed-methods, open label, randomised controlled trial of septoplasty versus medical management for adults with a deviated septum and a reduced nasal airway. Eligible patients will have septal deflection visible at nasendoscopy and a nasal symptom score ≥ 30 on the NOSE questionnaire. Surgical treatment comprises septoplasty with or without reduction of the inferior nasal turbinate on the anatomically wider side of the nose. Medical management comprises a nasal saline spray followed by a fluorinated steroid spray daily for six months. The recruitment target is 378 patients, recruited from up to 17 sites across Scotland, England and Wales. Randomisation will be on a 1:1 basis, stratified by gender and severity (NOSE score). Participants will be followed up for 12 months post randomisation. The primary outcome measure is the total SNOT-22 score at 6 months. Clinical and economic outcomes will be modelled against baseline severity (NOSE scale) to inform clinical decision-making. The study includes a recruitment enhancement process, and an economic evaluation.
DISCUSSION
CONCLUSIONS
The NAIROS trial will evaluate the clinical effectiveness and cost-effectiveness of septoplasty versus medical management for adults with a deviated septum and symptoms of nasal blockage. Identifying those individuals most likely to benefit from surgery should enable more efficient and effective clinical decision-making, and avoid unnecessary operations where there is low likelihood of patient benefit.
TRIAL REGISTRATION
BACKGROUND
EudraCT: 2017-000893-12, ISRCTN: 16168569. Registered on 24 March 2017.
Identifiants
pubmed: 32054508
doi: 10.1186/s13063-020-4081-1
pii: 10.1186/s13063-020-4081-1
pmc: PMC7020359
doi:
Substances chimiques
Saline Solution
0
Steroids, Fluorinated
0
Types de publication
Clinical Trial Protocol
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
179Subventions
Organisme : Health Technology Assessment Programme
ID : 14/226/07
Investigateurs
Quentin Gardiner
(Q)
Paul Nix
(P)
Samuel Leong
(S)
Naveed Kara
(N)
Jillian Morrison
(J)
Sadie Khwaja
(S)
Sangeeta Maini
(S)
Jemima Dooley
(J)
Caroline Wilson
(C)
Ian Campbell
(I)
Maria Allen
(M)
Lyndsey Lindley
(L)
Joan Mackintosh
(J)
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