Dataset Information

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.

ABSTRACT: 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:To establish, and inform guidance for, the best management strategy for individuals with nasal obstruction associated with a deviated septum. METHODS/DESIGN: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: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:EudraCT: 2017-000893-12, ISRCTN: 16168569. Registered on 24 March 2017.

SUBMITTER: Rennie KJ

PROVIDER: S-EPMC7020359 | biostudies-literature | 2020 Feb

REPOSITORIES: biostudies-literature

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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.

Rennie Katherine J KJ O'Hara James J Rousseau Nikki N Stocken Deborah D Howel Denise D Ternent Laura L Drinnan Mike M Bray Alison A Rooshenas Leila L Hamilton David W DW Steel Alison A Fouweather Tony T Hynes Ann-Marie AM Holstein Eva-Maria EM Oluboyede Yemi Y Abouhajar Alaa A Wilson Janet A JA Carrie Sean S

Trials 20200213 1

<h4>Background</h4>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.<h4>Aims</h4>To establish, and inform guidance for, the best management strategy for individuals with nasal obstruction associated ...[more]

PMID: 32054508

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Project description:Improtance:Correction of caudal septal deviation with a batten graft has been popularized recently. However, few reports have documented the surgical outcomes of this technique, especially the use of bony batten grafts in septoplasty. Objective:To evaluate the surgical outcomes of bony batten grafting for the management of caudal septal deviation in endonasal septoplasty. Design, Setting, and Participants:This retrospective cohort study evaluates the medical records of 141 patients with caudal septal deviation who underwent septoplasty using bony batten grafts from September 1, 2011, through February 29, 2016, at a tertiary referral hospital. Patients were divided into primary and secondary surgery groups. Patients were also divided into the septoplasty plus turbinate surgery and the septoplasty only group. Endoscopic assessment of deviation correction was performed, and postoperative complications were analyzed. Main Outcomes and Measures:Patient satisfaction and symptom improvement were evaluated via telephone interviews by using the Nasal Obstruction Symptoms Evaluation (NOSE) scores. Results:Of the 141 patients (24 women [17%] and 117 men [83%]; mean [SD] age, 32.8 [12.9] years), 86 (61%) rated their symptoms in the postoperative survey as much improved; 50 (35.5%), improved; 4 (2.8%), no change; and 1 (0.7%), worse. All patients had significantly improved mean (SD) postoperative NOSE scores (28.7 [22.0]; 95% CI, 25.0-32.4) compared with preoperative scores (70.5 [26.7]; 95% CI, 66.0-75.0; P?<?.001). No significant intergroup differences were observed in surgical outcome between the 116 patients undergoing primary surgery (mean [SD] NOSE score, 28.2 [21.9]) and 25 undergoing secondary surgery (mean [SD] NOSE score, 30.8 [24.3]; P?=?.34). No significant difference in surgical outcome was found between the 102 patients in the turbinate surgery group (mean [SD] NOSE score, 28.1 [20.8]) and 39 in the septoplasty only group (mean [SD] NOSE score, 30.4 [23.7]; P?=?.65). On endoscopic examination for surgical outcome, 128 patients (90.8%) had a straight septum and 13 (9.2%) had improved but residual caudal deviation. Postoperative complications included septal hematoma in 4 patients, hyposmia in 2, and chondritis in 1; all patients were treated successfully. Four patients required revision surgery because of incomplete functional correction or a desire for rhinoplasty. Conclusions and Relevance:Septoplasty using bony batten grafts is useful for correcting caudal septal deviation with favorable surgical outcomes and an acceptable complication rate. Level of Evidence:3.

Project description:Importance:While extracorporeal septoplasty (ECS) and its modifications have been previously studied, to our knowledge, no systematic review of surgical outcomes and complications of this technique has been performed. Objective:To evaluate the evidence of surgical outcomes and complications of ECS (including modified techniques) to treat severe L-strut septal deviation defined as deviation within 1.0 cm of the caudal or dorsal septum. Data Sources:MEDLINE, Embase, CINAHL, CENTRAL, Scopus, and Web of Science databases and reference lists were searched from inception to April 2018 for clinical and observational studies. Search terms included extracorporeal, septoplasty, and septum. Study Selection:Selection criteria were defined according to the population, intervention, comparison, and outcome framework. Relevant studies were selected by 2 independent reviewers based on abstracts and full texts. Data Extraction and Synthesis:Data were extracted using standardized lists chosen by the authors according to Cochrane Collaboration guidelines. Data were collected and synthesized with ranges reported, as well as assessment of bias and heterogeneity when applicable. Analysis started in February 2019. Main Outcomes and Measures:Outcomes assessed included functional nasal airway improvement by objective measurements and subjective measurements (Nasal Obstruction Symptom Evaluation [NOSE] and visual analog scale scores); complications including bleeding, infection, dorsal irregularities, and other functional or cosmetic deficits; and as revision surgery rates. Results:Of 291 records initially obtained, 31 were considered relevant after review according to PRISMA guidelines. All studies except 1 randomized clinical trial (3.2%) were observational in nature, with 21 retrospective studies (67.7%) and 9 prospective studies (29.0%). Conventional ECS was performed in 16 studies (51.6%), and modified ECS was performed in 15 studies (48.4%). The sample size varied from 10 to 567, and the mean age varied from 22.5 to 46 years. Of 31 studies, 14 (45%) were of good methodology. Meta-analysis was performed on 5 studies reporting change in NOSE scores, with pooled effect of -60.0 (95% CI, -67.8 to -52.2) points, but heterogeneity was high, with I2?=?96%. When comparing complications between modified and conventional ECS, the relative risk for infections was 0.95 (95% CI, 0.34-2.7); for bleeding, 0; for nasal dorsal irregularities, 0.29 (95% CI, 0.16-0.53); for other cosmetic complications, 4.3 (95% CI, 0.87-21.1); for other functional complications, 0.47 (95% CI, 0.20-1.1); and for revision operations, 1.4 (95% CI, 0.83-2.3). Conclusions and Relevance:Of the 31 studies included in this systematic review, less than half were of good methodology, and a significant level of heterogeneity was found regarding type of outcome measure used and reporting of complications. To improve the level of evidence, better study methodology, standardization of surgical outcomes measures, and reporting of complications are needed.

Dataset Information

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.

Publications

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.

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