Effectiveness of septoplasty compared to medical management in adults with obstruction associated with a deviated nasal septum: the NAIROS RCT.

Background: The indications for septoplasty are practice-based, rather than evidence-based. In addition, internationally accepted guidelines for the management of nasal obstruction associated with nasal septal deviation are lacking. Objective: The objective was to determine the clinical effectiveness and cost-effectiveness of septoplasty, with or without turbinate reduction, compared with medical management, in the management of nasal obstruction associated with a deviated nasal septum. Design: This was a multicentre randomised controlled trial comparing septoplasty, with or without turbinate reduction, with defined medical management; it incorporated a mixed-methods process evaluation and an economic evaluation. Setting: The trial was set in 17 NHS secondary care hospitals in the UK. Participants: A total of 378 eligible participants aged > 18 years were recruited. Interventions: Participants were randomised on a 1: 1 basis and stratified by baseline severity and gender to either (1) septoplasty, with or without turbinate surgery (n = 188) or (2) medical management with intranasal steroid spray and saline spray (n = 190). Main outcome measures: The primary outcome was the Sino-nasal Outcome Test-22 items score at 6 months (patient-reported outcome). The secondary outcomes were as follows: patient-reported outcomes - Nasal Obstruction Symptom Evaluation score at 6 and 12 months, Sino-nasal Outcome Test-22 items subscales at 12 months, Double Ordinal Airway Subjective Scale at 6 and 12 months, the Short Form questionnaire-36 items and costs; objective measurements - peak nasal inspiratory flow and rhinospirometry. The number of adverse events experienced was also recorded. A within-trial economic evaluation from an NHS and Personal Social Services perspective estimated the incremental cost per (1) improvement (of ≥ 9 points) in Sino-nasal Outcome Test-22 items score, (2) adverse event avoided and (3) quality-adjusted life-year gained at 12 months. An economic model estimated the incremental cost per quality-adjusted life-year gained at 24 and 36 months. A mixed-methods process evaluation was undertaken to understand/address recruitment issues and examine the acceptability of trial processes and treatment arms. Results: At the 6-month time point, 307 participants provided primary outcome data (septoplasty, n = 152; medical management, n = 155). An intention-to-treat analysis revealed a greater and more sustained improvement in the primary outcome measure in the surgical arm. The 6-month mean Sino-nasal Outcome Test-22 items scores were -20.0 points lower (better) for participants randomised to septoplasty than for those randomised to medical management [the score for the septoplasty arm was 19.9 and the score for the medical management arm was 39.5 (95% confidence interval -23.6 to -16.4; p < 0.0001)]. This was confirmed by sensitivity analyses and through the analysis of secondary outcomes. Outcomes were statistically significantly related to baseline severity, but not to gender or turbinate reduction. In the surgical and medical management arms, 132 and 95 adverse events occurred, respectively; 14 serious adverse events occurred in the surgical arm and nine in the medical management arm. On average, septoplasty was more costly and more effective in improving Sino-nasal Outcome Test-22 items scores and quality-adjusted life-years than medical management, but incurred a larger number of adverse events. Septoplasty had a 15% probability of being considered cost-effective at 12 months at a £20,000 willingness-to-pay threshold for an additional quality-adjusted life-year. This probability increased to 99% and 100% at 24 and 36 months, respectively. Limitations: COVID-19 had an impact on participant-facing data collection from March 2020. Conclusions: Septoplasty, with or without turbinate reduction, is more effective than medical management with a nasal steroid and saline spray. Baseline severity predicts the degree of improvement in symptoms. Septoplasty has a low probability of cost-effectiveness at 12 months, but may be considered cost-effective at 24 months. Future work should focus on developing a septoplasty patient decision aid. Trial registration: This trial is registered as ISRCTN16168569 and EudraCT 2017-000893-12. Funding: This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: 14/226/07) and is published in full in Health Technology Assessment; Vol. 28, No. 10. See the NIHR Funding and Awards website for further award information.

Septoplasty is an operation to straighten the septum, which is the partition wall between the nostrils inside the nose. Septoplasty can be used as a treatment for people who have a bent septum and symptoms of a blocked nose, such as difficulty sleeping and exercising. Medical management (a saltwater spray to clear the nose followed by a nose steroid spray) is an alternative treatment to septoplasty. The Nasal AIRway Obstruction Study (NAIROS) aimed to find out whether septoplasty or medical management is a better treatment for people with a bent septum and symptoms of a blocked nose. We recruited 378 patients with at least moderately severe nose symptoms from 17 hospitals in England, Scotland and Wales to take part in the NAIROS. Participants were randomly put into one of two groups: septoplasty or medical management. Participants' nose symptoms were measured both when they joined the study and after 6 months, using a questionnaire called the Sino-nasal Outcome Test-22 items. This questionnaire was chosen because patients reported that it included symptoms that were important to them. Other studies have shown that a 9-point change in the Sino-nasal Outcome Test-22 items score is significant. After 6 months, on average, people in the septoplasty group improved by 25 points, whereas people in the medical management group improved by 5 points. We saw improvement after septoplasty among patients with moderate symptoms, and among those with severe symptoms. Most patients who we spoke to after a septoplasty were happy with their treatment, but some would have liked more information about what to expect after their nose surgery. In the short term, septoplasty is more costly than medical management. However, over the longer term, taking into account all the costs and benefits of treatment, suggests that septoplasty would be considered good value for money for the NHS.

Unusual Presentation of Pott's puffy tumour in a child: our recent experience and review of the literature.

Pott's puffy tumour (PPT) is a rarely seen, but highly important, complication of frontal sinusitis. Early recognition followed by prompt imaging and treatment of this condition are essential to improve patient outcomes and prevent complications. This case report describes an atypical presentation of radiologically confirmed PPT in a boy who presented with a 2.5-week history of progressive frontal headache and midline frontal swelling. Flexible nasendoscopy revealed no acute findings. Prompt CT imaging confirmed the diagnosis and early surgical intervention via endoscopic approach with aggressive antibiotic therapy led to good recovery. This case highlights the need to remember PPT in assessing any child or adolescent with a new forehead swelling, with or without sinusitis symptoms. If there is strong clinical suspicion, further imaging should not be delayed. Surgical intervention should be performed as early as possible to prevent intracranial complications; antibiotics alone are not sufficient.

Benefits of music on theatre staff in a paediatric theatre setting: a staff survey.

BACKGROUND: Music has a long-standing place in the operating theatre. Nonetheless, limited studies have investigated the role of music during Ear Nose and Throat (ENT) surgical procedures. AIMS: To evaluate the benefits of background music on ENT theatre staff. METHODS: A 10-question survey was distributed to ENT theatre staff over a four week period. RESULTS: A total of 36 ENT theatre staff responded to the survey, a response rate of 86%. Most participants (61%) enjoyed the calming effect of background music in ENT surgery. The majority of participants responded that music did not affect their communication with other staff (69%), and improved their concentration (61%). Most respondents agreed that music can produce a sense of comfort for the patients (69%), and reduce anxiety before anaesthesia (75%). CONCLUSIONS: Background music can have a calming effect on staff in paediatric elective ENT surgery. This is a decision to be made by the surgical team with direct patient care and, if there is any concern about communication and distraction, then it is to be avoided.

Anti-thrombotics and their impact on inpatient epistaxis management: a tertiary centre experience.

INTRODUCTION: Epistaxis represents a massive burden upon NHS resources. Despite being an extremely common reason for emergency ENT admissions, there remains significant variation in its management. Although the evidence base is continually growing, there appears to be a lack of guidance towards managing anti-coagulants and anti-platelet medications and identifying patient-specific outcomes in this setting. Epistaxis has long been associated with a multitude of risk factors but none have shown consistent, direct correlation. MATERIALS AND METHODS: We aimed to identify if the use of anti-thrombotic medication was associated with a longer length of hospital admission or conferred a higher requirement for nasal packing, re-packing, surgery or re-admission. We conducted a retrospective analysis of 100 consecutive adult patients admitted over a 6-month period. Statistical analysis was conducted using SPSS software. RESULTS: Sixty-five percent of patients were taking anti-thrombotic medication. The variability of admission INR values in those taking warfarin did not relate with any outcome measure. There was no statistical difference between patients taking anti-thrombotic medication and those who do not, with regards to our primary outcome measures. Re-admission rates within 28 days were found to be 13%, with anti-thrombotic medication use and pre-existing cardiovascular disease recognised as commonly encountered risk factors. Three percent of patients required surgical intervention. Eight percent of patients required re-packing, with a Rapid Rhino chosen in all instances. CONCLUSION: The use of anti-thrombotic medication is not associated with increased morbidity or increased rate of complications. Anti-thrombotic usage and more than one medical co-morbidity increase the risk of re-admission within 28 days.

Biodegradable Synthetic Polyurethane Foam Nasal Packing After Septoplasty.

OBJECTIVE: To determine the usefulness of biodegradable Synthetic Polyurethane Foam (SPF) nasal packing as an adjunct to day-case septoplasty. STUDY DESIGN: Comparative, observational case series. PLACE AND DURATION OF STUDY: Aberdeen Royal Infirmary, University of Aberdeen, Scotland, UK, in the year 2011. METHODOLOGY: One-hundred consecutive patients who underwent septoplasty and received SPF packing in 2010 were prospectively audited while one-hundred consecutive patients undergoing septoplasty in the year 2000 were studied retrospectively. Data collected include demographics, type of operation and duration of hospital stay. Excel and SPSS were used for data collection and analysis. RESULTS: In the year 2000, the average age of the patients was 40.6 years. There were 37 females and 63 males. One patient returned home the same day, 22 stayed one night, 69 spent two nights and 8 stayed more than two nights in hospital for their operation. The average length of stay was 1.84 nights. In 2010, the average age of patients was 37.86 years, with 31 patients being female and 69 male. All patients in this cohort received SPF packing postoperatively. Seventy-three patients went home the same day, 24 patients stayed one night and 3 patients spent two nights in hospital for their operation. Average length of hospital stay was 0.3 nights. Results were statistically significant (p < 0.001). CONCLUSION: SPF was a useful nasal packing option after septoplasty and inferior turbinate surgery, which enabled the surgeons to carry out this surgery safely as a day-case procedure.

Targeted therapy of the inner ear.

BACKGROUND: There is experimental evidence that targeted delivery of steroids to the inner ear can protect hearing during cochlear implant surgery. The best protection appears to be achieved through pre-treatment of the cochlea, but the time period required for treatment is long compared with the duration of surgery, and needs further optimization. The stability of hearing thresholds is determined over a 3-month period after hearing preservation cochlear implantation. METHODS: Adult guinea pigs were implanted with a miniature cochlear implant electrode, and pure tone auditory brainstem response (ABR) thresholds were estimated in response to pure tones of 2-32 kHz immediately after surgery and at 1 week, 1 month and 3 months. Spiral ganglion cell (SGC) densities were estimated from mid-modular histological sections of the cochlea. Thirty minutes prior to implantation, a polymeric sponge (Seprapack, Genzyme) was loaded with either a 2% solution of dexamethasone phosphate or normal saline (control) and placed onto the round window. RESULTS: Implantation was associated with an immediate elevation in thresholds across frequencies, with a full recovery below 2 kHz over the next week and a partial recovery of thresholds at higher frequencies. These thresholds remained unchanged for the next 3 months. There was an immediate and sustained reduction in the elevation of thresholds at 32 kHz in dexamethasone-treated animals. SGC densities were greater in steroid-treated animals than controls in the basal turn of the cochlea (at the region of implantation) 3 months after implantation. CONCLUSION: It is concluded that ABR thresholds remain stable for 3 months after cochlear implantation in the guinea pig, and that local application of steroids to the inner ear prior to implantation is an effective method of preserving SGC populations when there is residual hearing at the time of implantation.

Update on long-term results with auditory brainstem implants in NF2 patients.

This study reviews the long-term results of auditory brainstem implant (ABI) in neurofibromatosis type 2 (NF2) patients. Retrospective chart reviews of patients who received an ABI at the Melbourne Cochlear Implant Clinic since 1995. Ten patients with an average follow-up of five years were included. Three patients received the N22 ABI and seven received the N24. Two patients discontinued use of their devices. Users reported part-time use for approximately four to five hours per day, switching their implants off in noisy environments. Audiological analyses at one to seven years post-implantation indicate that N24 patients showed worse performance at one year post-implantation but they continued to improve and, in the long term, both N22 and N24 groups achieved similar results. In conclusion, ABI provides a safe and useful tool for aural rehabilitation in NF2 patients. This study confirms that gradual improvement in performance occurs beyond one year post-implantation, as speech perception scores continued to improve.

Melanoma in the masseter muscle.

This case report presents two very unusual cases of melanomas arising within the masseter muscle. Both were metastases of unknown origin arising in young, healthy patients and presenting as asymptomatic lesions. No primary lesions were found in either case. A comprehensive search of the world literature revealed no previous similar cases.

Temporomandibular joint dysfunction following tonsillectomy.

We report a prospective, controlled trial to assess temporomandibular joint (TMJ) dysfunction following the use of a Boyle-Davis mouth gag during tonsillectomy. TMJ function was evaluated in patients undergoing tonsillectomy and a control group undergoing nasal surgery preoperatively and 6 weeks postoperatively. The main outcome measures were symptoms and signs of TMJ dysfunction and interincisal distance. A mean reduction of 0.89 mm in interincisal distance (P < 0.01) was noted postoperatively in the tonsillectomy patients. There was no statistically significant reduction of interincisal distance in patients undergoing nasal surgery. There was a statistically significant reduction in interincisal distance in the post-tonsillectomy patients, caused by fibrous healing of the tonsillar bed or fibrous ankylosis of the TMJ.

Ischaemic necrosis and facial palsy in Warthin's tumour of the parotid gland.

A 72-year-old patient with a Warthin's tumor of the right parotid gland developed massive necrosis of the tumour associated with temporary facial palsy with subsequent macroscopic tumour disappearance.