ISRCTN16168569
Completed
未知
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
ewcastle Upon Tyne NHS Foundation Trust0 sites378 target enrollmentMarch 24, 2017
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Deviated septum
- Sponsor
- ewcastle Upon Tyne NHS Foundation Trust
- Enrollment
- 378
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
2020 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/32054508 protocol (added 17/02/2020) 2023 Results article in https://pubmed.ncbi.nlm.nih.gov/37852641/ (added 19/10/2023) 2024 Results article in https://pubmed.ncbi.nlm.nih.gov/38477237/ (added 13/03/2024)
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Not specified
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