Droplet and bone dust contamination from high-speed drilling during mastoidectomy.

OBJECTIVES: The aim of this study was to examine contamination from otolaryngologic procedures involving high-speed drilling, specifically mastoid surgery, and to assess the adequacy of PPE in such procedures. DESIGN AND SETTING: Mastoid surgery was simulated in a dry laboratory using a plastic temporal bone, microscope and handheld drill with irrigation and suction. Comparisons of distance of droplet and bone dust contamination and surgeon contamination were made under differing conditions. Irrigation speed, use of microscope and drill burr size and type were compared. MAIN OUTCOME MEASURES: Measurement of the distance of field contamination while performing simulated mastoidectomy and location of surgeon contamination. RESULTS: There was a greater distance field contamination and surgeon contamination without the use of the microscope. Contamination was reduced by using a smaller drill burr and by using a diamond burr when compared to a cutting burr. The use of goggles and a face mask provided good protection for the surgeon. However, the microscope alone may provide sufficient protection to negate the need for goggles. CONCLUSIONS: While the risks of performing mastoid surgery during the coronavirus pandemic cannot be completely removed, they can be mitigated. Such factors include using the microscope for all drilling, using smaller size drill burrs and creating a safe zone around the operating table.

One year into the COVID-19 pandemic: What do we know so far from studies assessing risk and mitigation of droplet aerosolisation during endonasal surgery? A systematic review.

OBJECTIVES: As we pass the anniversary of the declaration of a global pandemic by the World Health Organisation, it invites us to reflect upon the inescapable changes that coronavirus has wrought upon ENT and, in particular, rhinological practice. As it remains unclear when we will emerge from the shadow of COVID-19, a critical analysis of the evidence base on both the assessment and mitigation of risk is vital for ENT departments worldwide. This article presents a systematic review of the literature examining articles which consider either the quantification of risk or strategies to mitigate risk specifically in the setting of rhinological surgery. DESIGN: Systematic literature review. RESULTS: The literature search yielded a total of 3406 returns with 24 articles meeting eligibility criteria. A narrative synthesis stratified results into two broad themes: (1) those which made an assessment as to the aerosolisation of droplets during sinus surgery, further sub-divided into work which considered macroscopically visible droplets and that which considered smaller particles; (2) and those studies which examined the mitigation of this risk. CONCLUSION: Studies considering the aerosolisation of both droplets and smaller particles suggest endonasal surgery carries significant risk. While results both highlight a range of innovative adjunctive strategies and support suction as an important intervention to reduce aerosolisation, appropriate use of personal protective equipment (PPE) should be considered mandatory for all healthcare professionals involved in rhinological surgery. Studies have demonstrated that close adherence to PPE use is effective in preventing COVID-19 infection.

Reducing the risks of endoscopic sinonasal surgery in the Covid-19 era.

OBJECTIVES: Many routine sinonasal procedures utilising powered instruments are regarded as aerosol-generating. This study aimed to assess how different instrument settings affect detectable droplet spread and patterns of aerosolised droplet spread during simulated sinonasal surgery in order to identify mitigation strategies. DESIGN: Simulation series using three-dimensional (3-D) printed sinonasal model. Fluorescein droplet spread was assessed following microdebriding and drilling of fluorescein-soaked grapes and bones, respectively. SETTING: University dry lab. PARTICIPANTS: 3-D printed sinonasal model. MAIN OUTCOME MEASURES: Patterns of aerosolised droplet spread. RESULTS AND CONCLUSION: There were no observed fluorescein droplets or splatter in the measured surgical field after microdebridement of nasal polyps at aspecific irrigation rate and suction pressure. Activation of the microdebrider in the presence of excess fluid in the nasal cavity (reduced or blocked suction pressure, excessive irrigation fluid or bleeding) resulted in detectable droplet spread. Drilling with either coarse diamond or cutting burs resulted in detectable droplets and greater spread was observed when drilling within the anterior nasal cavity. High-speed drilling is a high-risk AGP but the addition of suction using a third hand technique reduces detectable droplet spread outside the nasal cavity. Using the instrument outside the nasal cavity inadvertently, or when unblocking, produces greater droplet spread and requires more caution.

Quality-of-life changes following three-dimensional printing of prosthesis for large nasal septal perforations-Our experience of 13 patients.

Nasal septal perforations can be caused by a number of aetiology including intra-nasal drug abuse, trauma and iatrogenic causes.

A Comparison between Mygind and Kaiteki positions in administration of drops to the olfactory cleft.

OBJECTIVES: Topical nasal steroids are a common treatment intervention for olfactory dysfunction. Penetration of topical treatment to the olfactory cleft (OC), such as nasal drops, is greatly dependent on the position of the head when the treatment is administered. We aimed to examine the penetrance of nasal drops to the OC in two different head positions: the Mygind (lying head back) position and the Kaiteki position. DESIGN AND SETTING: The specimens were firstly positioned in Mygind, and thereafter in Kaiteki positions. Nasal drops mixed with blue food dye were administered into the nostrils in each of the head position. Endoscopic videos were recorded, and two blinded observers scored the extent of olfactory cleft penetration (OCP) using a 4-point scale (0 = none, 3 = heavy). PARTICIPANTS: Twelve fresh-frozen cadaver specimens. MAIN OUTCOME MEASURES: Penetration of the dye into the OC. RESULTS: The mean score of nasal drops penetrance to the OC in the Mygind position was 1.34 (standard deviation, SD = 0.92), as compared to 1.76 (SD = 0.65) in the Kaiteki position. The difference in the OCP score between the two groups was not statistically significant (P > .05). CONCLUSION: Both Mygind and Kaiteki head positions are reasonable options for patients considering topical nasal drops for olfaction impairment. The preference of one position over the other should be determined by patient's preference and comfort.

Draf III frontal sinus surgery for the treatment of Pott's puffy tumour in adults: our case series and a review of frontal sinus anatomy risk factors.

PURPOSE: We present our case series of four adult patients with Pott's puffy tumour (PPT), successfully treated with Draf III over a mean period of 11 months. A critical review of the literature is also provided. METHODS: A retrospective review of patients undergoing Draf III for PPT from January 2018 to January 2019 was performed. RESULTS: Four consecutive male patients ranging from 26 to 62 years, with a mean age of 49.5 ± 16.3 years, undergoing Draf III for Pott's puffy tumour were included. Two patients had a Kuhn type IV frontal cell narrowing the frontonasal pathway and presented without previous sinus surgery, whereas the other two had previous sinus surgery. The success rate of the operation was 100% with an average length of follow-up of 11 months (range 5-18). CONCLUSION: In our experience, the Draf III procedure is a highly effective treatment of PPT. In particular, we have demonstrated it to be very effective in accessing highly positioned Kuhn type IV cells.

The impact of acoustic neuroma on long-term quality-of-life outcomes in the United Kingdom.

OBJECTIVE: To quantify the impact of acoustic neuroma on the quality-of-life (QOL) patients in the United Kingdom. STUDY DESIGN: Online questionnaire survey. PATIENTS: Members of the British Acoustic Neuroma Association received PANQOL questionnaires. RESULTS: Of the 880 BANA members contacted, 397 (45.1%) responded, although only 359 had complete datasets for analysis. Composite QOL scores were as follows: for microsurgery 58 (SD 35), for radiotherapy 56 (SD18), for combination of surgery and radiotherapy 49 (SD 14), and for the observation group 54 (SD 20). No statistical significance with ANOVA (p = 0.532). Mean (SD) composite QOL scores were as follows: for follow-up < 6 52 (SD 18), for follow-up 6-10 55 (SD 20) and follow-up > 10 years 65 (SD 45). Overall, these values were significantly different compared by ANOVA (p < 0.001). Patients with facial paralysis showed no statistical significant differences between the different treatment groups. CONCLUSIONS: Short- (< 6 years) and long-term (> 10 years) QOL outcomes show no significant differences between the different treatment groups.

What are the clinically important outcome measures in the surgical management of nasal obstruction?

OBJECTIVES: To assess the correlation between the Nasal Obstruction Symptom Evaluation (NOSE) scale and peak nasal inspiratory flow (PNIF) measurement, and to determine which outcome variable correlates with patient satisfaction and thereby, provide an indication of successful surgical outcome. DESIGN: Prospective case series SETTING: Tertiary rhinology service (Liverpool, U.K) PARTICIPANTS: Patients having surgery (septoplasty, turbinoplasty) for nasal obstruction. MAIN OUTCOME MEASURES: NOSE, PNIF, 5-point Likert scale (weighted from "very satisfied" to "not at all satisfied") and a 10-cm visual analogue scale (0 = not at all satisfied, 10 = very satisfied). RESULTS: Forty-five (15 female) had complete data sets available for analysis. The mean preoperative NOSE score was 78.4 (standard deviation, SD 14.8) and improved significantly to 23.0 (SD 19.1) postoperatively. A similar trend was observed where the mean preoperative PNIF improved significantly by 40% from 91.8 L/min (SD 28.2) to 139.9 (SD 27.9) following surgery. The mean improvement in NOSE score of the overall study cohort was 55.4 (SD 22.3) while the mean improvement in PNIF was 48.0 (SD 31.1). Although no correlation was observed between pre- and postoperative NOSE and PNIF, a significant (P = .01) but weak positive correlation (r = .39) was observed between the magnitude of change in NOSE and PNIF. The mean change in NOSE score of patients who were "very satisfied" with their nasal operation was 64.0 (SD 18.5), significantly higher compared to 39.2 (SD 17.9) in patients who were "satisfied." CONCLUSIONS: Patients who rate being either "satisfied" or "very satisfied" demonstrated significant improvement in NOSE and PNIF following their nasal surgery; the magnitude being twice the calculated minimal clinically important difference.

A meta-analysis of survival factors in rhino-orbital-cerebral mucormycosis-has anything changed in the past 20 years?

BACKGROUND: Rhino-orbital-cerebral mucormycosis (ROCM) is an uncommon yet potentially lethal fungal infection. Although most cases originate from developing countries, an ageing population and increased prevalence of chronic illness may mean some clinicians practicing in developed countries will encounter ROCM cases in their careers. Yohai et al published a systematic review of 145 case reports from 1970 to 1993 assessing prognostic factors for patients presenting with ROCM. We present an updated review of the literature and assess whether survival outcomes have changed in the two decades since that seminal paper. SEARCH STRATEGY: An extensive Medline literature search was performed for case reports published between 1994 and 2015. RESULTS: In total, 210 published cases were identified from the literature review, of which 175 patients from 140 papers were included in this review. Fifty-five were female, with an overall mean age of 43 years. Overall survival rate was 59.5%, which was not significantly better than the previous series reported (60%) reported by Yohai et al. Survival rates in patients with chronic renal disease had improved, from 19% to 52%, and in patients with leukaemia (from 13% to 50%). Facial necrosis and hemiplegia remained poor prognostic indicators (33% and 39% survival rates, respectively). Early commencement of medical treatment related to better survival outcomes (61% if commenced within first 12 days of presentation, compared to 33% if after 13 days). Timing of surgery had less of an effect on overall survival. However, in 28 cases that did not receive any surgical treatment, survival was only 21%. CONCLUSIONS: Although overall survival rates have not improved, survival in patients with renal disease were better, potentially due to the introduction of liposomal amphotericin B which is less nephrotoxic. Prompt recognition of ROCM, reversal of predisposing co-morbidities and aggressive medical treatment remain the cornerstone of managing this highly aggressive disease.

Validation of the facial dysfunction domain of the Penn Acoustic Neuroma Quality-of-Life (PANQOL) Scale.

The objective of this study is to evaluate the strength of content validity within the facial dysfunction domain of the Penn Acoustic Neuroma Quality-of-Life (PANQOL) Scale and to compare how it correlates with a facial dysfunction-specific QOL instrument (Facial Clinimetric Evaluation, FaCE). The study design is online questionnaire survey. Members of the British Acoustic Neuroma Association received both PANQOL questionnaires and the FaCE scale. 158 respondents with self-identified facial paralysis or dysfunction had completed PANQOL and FaCE data sets for analysis. The mean composite PANQOL score was 53.5 (range 19.2-93.5), whilst the mean total FaCE score was 50.9 (range 10-95). The total scores of the PANQOL and FaCE correlated moderate (r = 0.48). Strong correlation (r = 0.63) was observed between the PANQOL's facial dysfunction domain and the FaCE total score. Of all the FaCE domains, social function was strongly correlated with the PANQOL facial dysfunction domain (r = 0.66), whilst there was very weak-to-moderate correlation (range 0.01-0.43) to the other FaCE domains. The current study has demonstrated a strong correlation between the facial dysfunction domains of PANQOL with a facial paralysis-specific QOL instrument.

The Utility of the Sino-Nasal Outcome Test (SNOT) as a Treatment Outcome Measure in Nonsinogenic Facial Pain Syndrome.

INTRODUCTION: The purpose of this study was to assess the strength of correlation between the Sino-Nasal Outcome Test (SNOT) subdomains to determine which bore the greatest disease burden so that it could be used as a suitable measure of clinical response. METHODS: Prospective clinical audit of patients attending the Liverpool Multi-Disciplinary Facial Pain Clinic. The Brief Pain Inventory-Facial (BPI-F) was used as a comparator and surrogate measure of quality of life. RESULTS: Fifty patients (38 female) were reviewed, of whom 66% had midfacial segment pain. The total SNOT score was highly correlated with the BPI-F. Both the sleep function and psychological issues were the most highly correlated SNOT subdomains with the BPI-F, followed by ear-facial symptoms. The rhinologic symptom subdomain had a weak correlation with the BPI-F. The total SNOT score was most significantly correlated with the sleep function and psychological issues subdomains. CONCLUSION: This study supports the utility of the SNOT questionnaire as a measure of clinical outcome for nonsinogenic facial pain. The total SNOT score is highly correlated with the BPI-F, which has been used as a surrogate measure of quality of life. In addition, the sleep function and psychological issues subdomains are suitable variables to measure response to treatment.

Treatment outcomes of midfacial segment pain: experience from the Liverpool multi-disciplinary team facial pain clinic.

OBJECTIVES: Midfacial segment pain (MSP) has the characteristics of tension-type headache which is confined to the midface cor- responding to the second division of the trigeminal nerve. This review presents treatment outcomes of MSP patients managed at the Multi-disciplinary Team (MDT) Facial Pain Clinic in Liverpool. METHODOLOGY: Prospective clinical outcome performed in a tertiary referral centre for complex facial pain syndromes. MAIN OUTCOME MEASURES: Sino-Nasal Outcome Test (SNOT). Clinical "success" was defined as an improvement in total SNOT score of >9 points and a reduction of the ear-facial symptoms sub-domain score by ≥50% from baseline. RESULTS: The average age of the cohort was 49 years, with an average follow-up of 12 months. The overall pre-treatment total SNOT-22 score was 59.5 which improved significantly to 42 at latest follow-up. Although the average scores of all sub-domains improved, only the ear-facial symptoms and psychological issues sub-domains achieved statistical significance. When the criterion for success was applied, nine patients fulfilled this definition at an average of 12 months follow-up. The baseline total SNOT score in this cohort improved from 60.6 to 19.7. Half of these patients achieved success within 18 months of commencing treatment and the probability of attaining success at long-term follow-up was high. CONCLUSIONS: Treatment of midfacial segment facial pain is complex and requires follow-up to achieve any meaningful clinical outcome.

Infection with 2009 H1N1 influenza virus primes for immunological memory in human nose-associated lymphoid tissue, offering cross-reactive immunity to H1N1 and avian H5N1 viruses.

Influenza is a highly contagious mucosal infection in the respiratory tract. The 2009 pandemic H1N1 (pH1N1) influenza virus infection resulted in substantial morbidity and mortality in humans. Little is known on whether immunological memory develops following pH1N1 infection and whether it provides protection against other virus subtypes. An enzyme-linked immunosorbent spot assay was used to analyze hemagglutinin (HA)-specific memory B cell responses after virus antigen stimulation in nose-associated lymphoid tissues (NALT) from children and adults. Individuals with serological evidence of previous exposure to pH1N1 showed significant cross-reactive HA-specific memory B cell responses to pH1N1, seasonal H1N1 (sH1N1), and avian H5N1 (aH5N1) viruses upon pH1N1 virus stimulation. pH1N1 virus antigen elicited stronger cross-reactive memory B cell responses than sH1N1 virus. Intriguingly, aH5N1 virus also activated cross-reactive memory responses to sH1N1 and pH1N1 HAs in those who had previous pH1N1 exposure, and that correlated well with the memory response stimulated by pH1N1 virus antigen. These memory B cell responses resulted in cross-reactive neutralizing antibodies against sH1N1, 1918 H1N1, and aH5N1 viruses. The 2009 pH1N1 infection appeared to have primed human host with B cell memory in NALT that offers cross-protective mucosal immunity to not only H1N1 but also aH5N1 viruses. These findings may have important implications for future vaccination strategies against influenza. It will be important to induce and/or enhance such cross-protective mucosal memory B cells.

Extended vertical hemilaryngectomy and reconstruction with a neovascularised tracheal autograft for advanced unilateral laryngeal tumours: a learning curve.

Extended vertical hemilaryngectomy and reconstruction with a neovascularised tracheal autograft is a two-stage procedure for advanced unilateral tumours of the larynx. The purpose of this study was to review our early experience of this technique by reporting our clinical outcomes and highlighting some key learning points. Patients were identified from the Liverpool Head and Neck Cancer electronic database. Case notes were reviewed for demographic data, tumour stage, treatment, complications and outcomes. Eleven patients (all males) were identified. The mean age of the cohort was 58.2 years (range 37-78 years). The overall average follow-up period was 41.5 months (range 14 days-75 months). Of the 11 cases, 3 had completed stage 1 only. The most common complications following stage 1 procedure are related to the surgical neck wound (36% of cases). Of the remaining eight patients who completed the first two surgical stages, closure of tracheostomy stoma was possible in seven; all seven subsequently resumed a normal oral diet. All these patients have subsequently remained free of disease at latest follow-up. There were two cases of post-operative pneumonia and one case of radial forearm free-flap failure. In contrast, only one case of post-operative pneumonia was recorded following the stage 2 procedure. In total, three patients in this cohort were dead at follow-up. This technique has a role in the management of a select group of fit patients presenting with unilateral tumours of the glottis and who are otherwise destined for a total laryngectomy. Whilst the technique is complex, we have shown that its introduction is possible in a suitably specialised and motivated surgical unit.

Pediatric Inferior Turbinate Hypertrophy: Diagnosis and Management. A YO-IFOS Consensus Statement.

OBJECTIVE: Pediatric inferior turbinate hypertrophy (PedTH) is a frequent and often overlooked cause or associated cause of nasal breathing difficulties. This clinical consensus statement (CCS) aims to provide a diagnosis and management framework covering the lack of specific guidelines for this condition and addressing the existing controversies. METHODS: A clinical consensus statement (CCS) was developed by a panel of 20 contributors from 7 different European and North American countries using the modified Delphi method. The aim of the CCS was to offer a multidisciplinary reference framework for the management of PedTH on the basis of shared clinical experience and analysis of the strongest evidence currently available. RESULTS: A systematic literature review following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) criteria was performed. From the initial 96 items identified, 7 articles were selected based on higher-evidence items such as randomized-controlled trials, guidelines, and systematic reviews. A 34-statement survey was developed, and after three rounds of voting, 2 items reached strong consensus, 17 reached consensus or near consensus, and 15 had no consensus. CONCLUSIONS: Until further prospective data are available, our CCS should provide a useful reference for PedTH management. PedTH should be considered a nasal obstructive disease not necessarily related to an adult condition but frequently associated with other nasal or craniofacial disorders. Diagnosis requires clinical examination and endoscopy, whereas rhinomanometry, nasal cytology, and questionnaires have little clinical role. Treatment choice should consider the specific indications and features of the available options, with a preference for less invasive procedures. LEVEL OF EVIDENCE: 5 Laryngoscope, 134:1437-1444, 2024.

Characterisation of regulatory T cells in nasal associated lymphoid tissue in children: relationships with pneumococcal colonization.

Regulatory T cells (Treg) diminish immune responses to microbial infection, which may contribute to preventing inflammation-related local tissue damage and autoimmunity but may also contribute to chronicity of infection. Nasopharyngeal carriage of pneumococcus is common in young children and can persist for long periods but it is unknown whether the presence of Treg in the nasopharynx contributes to this persistence. We have investigated the numbers and activities of Foxp3+Treg in adenoidal tissues and their association with pneumococcal carriage in children. Expression of Treg cell-related markers including Foxp3, CD25, CD39, CD127 and CLTA4 were analysed by flow-cytometry in adenoidal mononuclear cells (MNC) and PBMC from children. Unfractionated MNC or Treg-depleted MNC were stimulated with a pneumococcal whole cell antigen (WCA) and T cell proliferation measured. Cytokine production by MNC was measured using a cytometric bead array. Higher numbers of CD25(high)Foxp3(high) Treg expressing higher CD39 and CTLA4 were found in adenoidal MNC than in PBMC. Children with pneumococcus positive nasopharyngeal cultures had higher proportions of Treg and expressed higher levels of CD39 and CTLA-4 than those who were culture negative (-). WCA induced adenoidal Treg proliferation which produce IL10 but not IL17, and CD4 T cell proliferation in Treg-depleted MNC was greater in pneumococcal culture positive than negative children. Significant numbers of Treg with an effector/memory phenotype which possess a potent inhibitory effect, exist in adenoidal tissue. The association of pneumococcal carriage with an increased frequency of adenoidal Treg suggests that Treg in nasal-associated lymphoid tissue (NALT) may contribute to the persistence of pneumococcus in children. Further studies to determine what component and mechanisms are involved in the promotion of Treg in NALT may lead to novel therapeutic or vaccination strategy against upper respiratory infection.

Long-term outcomes of facial nerve function in irradiated and nonirradiated nerve grafts.

OBJECTIVES: We reviewed the long-term results of facial nerve repair in a tertiary head and neck institution in the north of England. METHODS: We performed a case notes review of patients who had facial nerve repair over a 10-year period and had completed 24 months of follow-up. RESULTS: The study population comprised 18 female patients and 24 male patients, with an overall mean age of 53.2 years (range, 16 to 80 years). Of the 24 patients who had a cable nerve graft, the greater auricular nerve was used in 15 cases. The sural nerve was used as the donor in a cross-facial nerve graft in 9 patients. Sixteen patients had transposition nerve repair: hypoglossal and ansa cervicalis in 7 and 9 cases, respectively. Two patients had primary anastomosis after surgery for extensive malignant tumors. In this series, no patients achieved a House-Brackmann (HB) grade of II. Overall, the HB grades III, IV, and V were the best postoperative facial nerve functions achieved in 11.9%, 33.3%, and 26.2% of patients, respectively. Failure (HB grade VI) was observed in 28.6% of patients. More than half of patients (62.5%) who had either a sural nerve cable graft or a faciohypoglossal transposition had a good outcome (HB grade III or IV). CONCLUSIONS: In the present series, 45% of patients had an HB grade of III or IV at long-term follow-up. The best outcome (HB grade III) was observed after cross-facial grafting with the sural nerve.

Antisecretory factor-inducing therapy improves patient-reported functional levels in Meniere's disease.

OBJECTIVES: The aim of this study was to evaluate the effectiveness of specially processed cereal (SPC) as a suitable adjunctive treatment for Meniere's disease. METHODS: We performed a randomized double-blinded, placebo-controlled, crossover study in a tertiary referral center of patients who had a diagnosis of Meniere's disease based on the guidelines of the Committee on Hearing and Equilibrium of the American Academy of Otolaryngology-Head and Neck Surgery (AAO-HNS). The main outcome measure was the AAO-HNS Functional Level Scale (FLS). RESULTS: Thirty-nine patients completed the study without any reported complications. The mean pretreatment FLS score for the entire study cohort was 3.8 (median, 4; range, 1 to 6). The overall FLS score improved significantly (p < 0.001), to 2.8 (median, 3), after SPC treatment. No patients showed worsening on the FLS during SPC or placebo treatment. Of the 39 patients, 23 showed improvement on the FLS, and no change was observed in the remaining 16. The median improvement on the FLS in these 23 patients was 2 points (mean, 1.7; range, 1 to 4). The mean FLS score after placebo cereal treatment was not significantly different from baseline (p = 0.452), but was significantly higher than that after SPC treatment (mean, 3.7; p < 0.001). The marginal difference observed between the baseline FLS score and the placebo FLS score was due to the fact that 5 patients reported 1-point improvements on the FLS after placebo treatment. Nevertheless, significantly fewer patients improved on placebo than on SPC (p < 0.001). CONCLUSIONS: Treatment with SPC appears to be well tolerated by most patients (91%) without any complications. More than half (59%) of the study cohort reported subjective improvement in functional level.

Clinical effectiveness of septoplasty versus medical management for nasal airways obstruction: multicentre, open label, randomised controlled trial.

OBJECTIVE: To assess the clinical effectiveness of septoplasty. DESIGN: Multicentre, randomised controlled trial. SETTING: 17 otolaryngology clinics in the UK's National Health Service. PARTICIPANTS: 378 adults (≥18 years, 67% men) newly referred with symptoms of nasal obstruction associated with septal deviation and at least moderate symptoms of nasal obstruction (score >30 on the Nasal Obstruction and Symptom Evaluation (NOSE) scale). INTERVENTIONS: Participants were randomised 1:1 to receive either septoplasty (n=188) or defined medical management (n=190, nasal steroid and saline spray for six months), stratified by baseline symptom severity and sex. MAIN OUTCOME MEASURES: The primary outcome measure was patient reported score on the Sino-Nasal Outcome Test-22 (SNOT-22) at six months, with 9 points defined as the minimal clinically important difference. Secondary outcomes included quality of life and objective nasal airflow measures. RESULTS: Mean SNOT-22 scores at six months were 19.9 (95% confidence interval 17.0 to 22.7) in the septoplasty arm (n=152, intention-to-treat population) and 39.5 (36.1 to 42.9) in the medical management arm (n=155); an estimated 20.0 points lower (better) for participants randomised to receive septoplasty (95% confidence interval 16.4 to 23.6, P<0.001, adjusted for baseline continuous SNOT-22 score and the stratification variables sex and baseline NOSE severity categories). Greater improvement in SNOT-22 scores was predicted by higher baseline symptom severity scores. Quality of life outcomes and nasal airflow measures (including peak nasal inspiratory flow and absolute inhalational nasal partitioning ratio) improved more in participants in the septoplasty group. Readmission to hospital with bleeding after septoplasty occurred in seven participants (4% of 174 who had septoplasty), and a further 20 participants (12%) required antibiotics for infections. CONCLUSIONS: Septoplasty is a more effective intervention than a defined medical management regimen with a nasal steroid and saline spray in adults with nasal obstruction associated with a deviated nasal septum. TRIAL REGISTRATION: ISRCTN Registry ISRCTN16168569.