Nasal airway obstruction study - NAIROS

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

Registry ID
ISRCTN16168569
Source registry
ISRCTN
Status
No longer recruiting
Study type
INTERVENTIONAL
Sponsor
Newcastle Upon Tyne NHS Foundation Trust
Enrollment
378
Start date
2017-09-01
Completion date
2021-03-04
Last update
2026-08-17

Conditions

Summary

Deviated septum

Detailed description

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.

Interventions

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.

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. Breastfeeding, pregnancy or intended pregnancy 9. Bleeding diathesis 10. Therapeutic anticoagulation 11. Known adverse reactions to general anaesthesia 12. Immunocompromised patients

Locations

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