Condition category
Ear, Nose and Throat
Date applied
06/03/2017
Date assigned
24/03/2017
Last edited
04/09/2017
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
A deviated septum is a condition where the thin wall separating the nostrils (nasual septum) is off-center or crooked (deviation). Most people only have a minor deviation, but it can lead to difficulty breathing, snoring and a blocked nose. A septoplasty is a type of operation that corrects a deviated septum by removing excess bone and cartilage to straighten the septum and nasal passages. Like any operation, there is a risk of complications. Most patients need to take at least 5 days off work or usual activities after the operation. Some patients seem not much better after the surgery. Practice varies around the country, and there is no good evidence about this operation or its alternatives, or about who might benefit most from treatment, to inform help patients and doctors decide when it should be carried out. The aim of this study is to compare the effectiveness septoplasty or non-surgical care (medical management), which consists of nasal sprays in the management of adults with deviated septums.

Who can participate?
Adults with have a deviated septum.

What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group are treated surgically using a septoplasty procedure. Those in the second group are given a six month supply of two different nasal sprays, each to use twice daily. At the start of the study and then again after six and 12 months, participants in both groups complete a number of questionnaire in order to assess their quality of life, nasal symptoms and how much they are using health care services as well as a test to measure how well they are breathing through their noses.

What are the possible benefits and risks of participating?
Participants may benefit from improvement in symptoms of nasal blockage, sleep disturbance and congestion/headache if these symptoms are related to blocked nose due to a deviated septum. For participants who receive the nasal spray, there is a risk of bleeding or irritation in the nose. For those who receive surgery, there is a risk of general complications from surgery, including minor bleeding, discomfort (common), heavy bleeding, temporary numbness of central upper teeth, hole in the septum (perforation) and cosmetic change in the appearance of nose (rare).

Where is the study run from?
Freeman Hospital (lead centre) and 15 other NHS hospitals in England, Scotland and Wales (UK)

When is the study starting and how long is it expected to run for?
March 2017 to November 2020

Who is funding the study?
National Institute for Health Research, Health Technology Assessment Programme (UK)

Who is the main contact?
1. Dr Sean Carrie (scientific)
2. Dr Ann Marie Hynes (public)
ann.hynes@newcastle.ac.uk

Trial website

www.nairos.co.uk

Contact information

Type

Scientific

Primary contact

Dr Sean Carrie

ORCID ID

Contact details

Freeman Hospital
High Heaton
Newcastle Upon Tyne
NE7 7DN
United Kingdom

Type

Public

Additional contact

Dr Ann Marie Hynes

ORCID ID

http://orcid.org/0000-0001-6308-5177

Contact details

Newcastle University Clinical Trials Unit
Newcastle University
1-4 Claremont Terrace
Newcastle Upon Tyne
NE2 4AE
United Kingdom
+44 191 208 2519
ann.hynes@newcastle.ac.uk

Additional identifiers

EudraCT number

2017-000893-12

ClinicalTrials.gov number

Protocol/serial number

8302

Study information

Scientific title

Multicentre RCT to determine the clinical and cost effectiveness of septoplasty compared with non-surgical strategy in the management of nasal septal deviation in adult patients with nasal airway obstruction in the presence of a deviated nasal septum, what is effectiveness of septal surgery with turbinate reduction compared with 6 months’ topical nasal treatment in improving nasal symptoms

Acronym

NAIROS

Study hypothesis

The aim of this study is to determine whether and to what extent septoplasty is superior to medical treatment in the management of adult patients with nasal obstruction in the presence of a septal deviation.

Ethics approval

North East – Newcastle & North Tyneside 2 Research Ethics Committee, 31/08/2017, ref: 17/NE/0239

Study design

Multi-centre randomised controlled trial with qualitative process and economic evaluation

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

No participant information sheet available

Condition

Deviated septum

Intervention

Patients will be randomised to one of two groups in a 1:1 ratio using a variable block stratified design stratified by severity (baseline self-report NOSE category – moderate 30-50; Severe 55-75; extreme 80-100) and gender.

Surgery: Participants will undergo septoplasty and turbinate reduction

Medical management: Participants receive medical management, which will comprise of regular use of a nasal saline spray (sterimar) followed by a fluorinated steroid spray Mometasone for 6 months.

All patients will be followed up at 6 and 12 months post randomisation.

Intervention type

Mixed

Phase

Drug names

Primary outcome measures

Patient reported assessment of nasal and general symptoms is assessed using the SNOT 22 questionnaire (Sinonasal Outcome Test) at baseline, 6 and 12 months.

Secondary outcome measures

1. Objective assessment nasal airflow is measured using rhinospirometry (nasal partitioning ratio and peak nasal airflow measurements) at baseline, 6 and 12 months
2. Quality of life is measured using the Short Form 36 Quality of Life Questionnaire at baseline, 6 and 12 months
3. Health utilisation is measured using a health utilisation questionnaire at baseline, 6 and 12 months

Overall trial start date

01/03/2017

Overall trial end date

30/11/2020

Reason abandoned

Eligibility

Participant inclusion criteria

1. Adults aged ≥ 18 years with a baseline NOSE score ≥30
2. Septal Deflection visible at naseondoscopy
3. Capacity to provide informed written consent and complete the study questionnaires.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

378

Participant exclusion criteria

1. Patients <18 years
2. Patients with a baseline NOSE score <30
3. Any prior septal surgery
4. Systemic inflammatory disease
5. Granulomatosis with poly angiitis
6. Naseondoscopic evidence of unrelated associated pathology eg. adenoid pad, septal perforation, chronic rhinosinusitis indicated by the prescence of polyposis or pus
7. Intranasal recreational drug use
8. Breast feeding, Pregnancy or intended pregnancy
9. Bleeding diathesis
10. Therapeutic anticoagulation
11. Known adverse reactions to general anaesthesia
12. Immuno- compromised patients

Recruitment start date

01/09/2017

Recruitment end date

30/04/2019

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Freeman Hospital
High Heaton
Newcastle Upon Tyne
NE7 7DN
United Kingdom

Trial participating centre

Aberdeen Royal Infirmary
Foresterhill
Aberdeen
AB25 2ZN
United Kingdom

Trial participating centre

Queen Elizabeth Hospital Birmingham
Mindelsohn Way Edgbaston
Birmingham
B15 2TH
United Kingdom

Trial participating centre

Bradford Royal Infirmary
Duckworth Lane
Bradford
BD9 6RJ
United Kingdom

Trial participating centre

Darlington Memorial Hospital
Hollyhurst Road
Darlington
DL3 6HX
United Kingdom

Trial participating centre

Ninewells Hospital
ENT Department (Ward 26)
Dundee
DD1 9SY
United Kingdom

Trial participating centre

Monklands Hospital
Monkscourt Avenue
Airdrie
ML6 OJS
United Kingdom

Trial participating centre

Leeds General Infirmary
Great George Street
Leeds
LS1 3EX
United Kingdom

Trial participating centre

Aintree Hosptial
Lower Lane
Liverpool
L9 7AL
United Kingdom

Trial participating centre

Royal Gwent Hospital
Cardiff Road
Newport
NP20 2UB
United Kingdom

Trial participating centre

Cumberland Infirmary
Newtown Road
Carlisle
CA2 7HY
United Kingdom

Trial participating centre

Derriford Hospital
Derriford Road
Plymouth
PL6 8DH
United Kingdom

Trial participating centre

Salisbury District Hospital
Odstock Road
Salisbury
SP2 8BJ
United Kingdom

Trial participating centre

Wrightington Hospital
Hall Lane Appley Bridge
Wigan
WN6 9EP
United Kingdom

Trial participating centre

Guy's Hospital
Great Maze Pond
London
SE1 9RT
United Kingdom

Trial participating centre

Norfolk and Norwich University Hospital
Colney Lane
Norwich
NR4 7UY
United Kingdom

Sponsor information

Organisation

Newcastle Upon Tyne NHS Foundation Trust

Sponsor details

Newcastle Joint Research Office
Regent Point
Regent Farm Road
Newcastle Upon Tyne
NE3 3HD
United Kingdom

Sponsor type

Research organisation

Website

http://www.newcastlejro.org.uk/

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Findings will be presented at international academic meetings and published in peer-reviewed journals. Publication of the results of the study will follow CONSORT guidelines for reporting clinical trials and NIHR guidance on communication research outcomes. Findings will also be distributed via ENTUK and ENT Scotland, and via primary care networks and conferences – including meetings of the Royal College of General Practitioners. The Royal Society of Medicine’s Sections also have a good track record of multidisciplinary meetings where the implications of NAIROS might usefully be discussed. The results will also be publicised in national media, with the aid of press releases from the Newcastle upon Tyne Hospitals Foundation Trust and Newcastle Universities. The domain name www.nairos.com has been purchases and will be used as a means of retaining stakeholder engagement and, thereafter, publicising the results.

IPD Sharing plan:
The current data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

31/10/2021

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

04/09/2017: Ethics approval information has been updated.