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.

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.

Vascularized tissue to reduce fistula following salvage total laryngectomy: a systematic review.

OBJECTIVES/HYPOTHESIS: Pharyngocutaneous fistulae (PCF) are known to occur in nearly one-third of patients after salvage total laryngectomy (STL). PCF has severe impact on duration of admission and costs and quality of life and can even cause severe complications such as bleeding, infection and death. Many patients need further surgical procedures. The implications for functional outcome and survival are less clear. Several studies have shown that using vascularized tissue from outside the radiation field reduces the risk of PCFs following STL. This review and meta-analysis aims to identify the evidence base to support this hypothesis. DATA SOURCES: English language literature from 2004 to 2013 REVIEW METHODS: We searched the English language literature for articles published on the subject from 2004 to 2013. RESULTS: Adequate data was available to identify pooled incidence rates from seven articles. The pooled relative risk derived from 591 patients was 0.63 (95% CI: 0.47 to 0.85), indicating that patients who have flap reconstruction/reinforcement reduced their risk of PCF by one-third. CONCLUSION: This pooled analysis suggests that there is a clear advantage in using vascularized tissue from outside the radiation field in the laryngectomy defect. While some studies show a clear reduction in PCF rates, others suggest that the fistulae that occur are smaller and rarely need repair.

Oncologic outcomes of transoral laser microsurgery for radiorecurrent laryngeal carcinoma: a systematic review and meta-analysis of English-language literature.

BACKGROUND: The purpose of this systematic review and meta-analysis was to assess the oncological and functional outcomes of transoral laser microsurgery (TLM) in radiorecurrent laryngeal cancer. METHODS: The review was performed using search strategies including Medline, Embase, Zetoc, conference proceedings, and a manual search. Pooled estimates of local control at 24 months, disease-free survival (DFS), and overall survival (OS) rates were calculated. RESULTS: The pooled mean estimates were: local control rate at 24 months after first TLM (n = 249), 56.9% (95% confidence interval [CI], 47.4-66.1); local control after repeat TLM (n = 186), 63.8% (95% CI, 57.1-70.2); DFS (n = 174), 70.9% (95% CI, 60.8-80); and OS (n = 276), 74.8% (95% CI, 68.2-80.9). Pooled mean laryngeal preservation (n = 286) was 72.3% (95% CI, 68.4-76.1). CONCLUSION: TLM is oncologically sound in the salvage setting with high larynx-preservation rate, but there is a trend toward inferior local control rates compared to open partial laryngectomy techniques.

Open conservation partial laryngectomy for laryngeal cancer: a systematic review of English language literature.

BACKGROUND: Different modalities of treatment in early laryngeal cancer lead to equivalent oncological outcomes. Hence this systematic review was undertaken to synthesise the key oncological outcomes following primary open partial laryngectomy for laryngeal cancer. METHODS: A systematic review of the English literature with statistical pooling of outcomes, the main outcome measure being local control at 24 months. RESULTS: A total of 53 articles satisfied inclusion criteria and were included in the review. The pooled local control rate at 24 months from 5061 patients was 89.8% (95% CI 88.3-91.2), pooled overall survival was 79.7% (n = 3967; 95% CI 76.5-782.8) and pooled mean disease free survival was 84.8% (n = 2344; 95% CI 80.6-88.7). The pooled mean operative mortality, laryngectomy for function, tracheostomy decannulation and permanent gastrostomy rates were 0.7%, 1.7%, 96.3%, and 2.0%, respectively. CONCLUSIONS: Open conservation laryngectomy is a good option in selected primary laryngeal cancers with excellent oncological outcomes.

Oncologic outcomes of open conservation laryngectomy for radiorecurrent laryngeal carcinoma: a systematic review and meta-analysis of English-language literature.

BACKGROUND: The role of open conservation (partial) laryngeal surgery in radiorecurrent laryngeal cancers is unclear, and the procedure is not widely accepted or practiced. The objective of this review was to assess the oncologic and functional outcomes of partial laryngectomy in radiorecurrent tumors of the larynx reported in the literature. METHODS: The systematic review was performed using independently developed search strategies and included Medline, Embase, Zetoc, conference proceedings, and, when appropriate, a manual search. Inclusion criteria for the articles were set a priori. All included articles were subjected to quality assessment. Pooled estimates of local control at 24 months and of disease-free and overall survival rates were calculated using both a fixed-effects model (inverse square) and a random-effects model (DerSimonian-Laird). RESULTS: The search identified 401 publications, of which 26 studies satisfied all inclusion criteria. Ten studies had a quality score ≥6 (good), and 16 had a score of 4 or 5 (fair). The pooled estimates of oncologic outcomes using the random-effects model were as follows: The local control rate at 24 months for 560 patients was 86.9% (95% CI, 84%-89.5%), the disease-free survival rate for 352 patients was 91.2% (95% CI, 88.2%-93.9%), and the overall survival rate for 360 patients was 83.1% (95% CI, 79.1%-86.7%). Decannulation of tracheostomy occurred in 95.1% (95% CI, 92.6%-97.2%) of the patients who were analyzed (n = 315), whereas the pooled mean larynx preservation rate was 83.9% (95% CI, 80.7%-87%; n = 502) CONCLUSIONS: The current results indicated that open partial laryngectomies are oncologically sound procedures in the salvage setting and have a high larynx preservation rate.

Comparing health locus of control in patients with Spasmodic Dysphonia, Functional Dysphonia and Nonlaryngeal Dystonia.

Locus of Control (LoC) refers to an individuals' perception of whether they are in control of life events. Health Locus of Control refers to whether someone feels they have influence over their health. Health Locus of Control has not been studied in any depth in voice-disordered patients. The objective of this study was to examine Health Locus of Control in three patient groups: (1) Spasmodic Dysphonia, (2) Functional Dysphonia and (3) a nondysphonic group with Nonlaryngeal Dystonia. LoC was measured and compared in a total of 57 patients using the Multidimensional Health Locus of Control Scales (diagnostic specific) Form C. Internal, Chance, and Powerful others LoC were measured and comparisons were made using one-way analysis of variance. Contrary to expectations Internal LoC was found to be significantly higher in the Functional Dysphonia group when compared to the other two groups. There was no significant difference between the groups in Chance or Powerful others LoC. The two organic groups, Spasmodic Dysphonia and Nonlaryngeal Dystonia, were more alike in Internal Health Locus of Control than the Functional Dysphonia group. The diagnostic nature of the groups was reflected in their LoC scores rather than their voice loss. These results contribute to the debate about the etiology of Spasmodic Dysphonia and will be of interest to those involved in the psychology of voice and those managing voice-disordered patients.