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.

Natural history of post-operative non-functioning pituitary adenomas - a single centre cohort analysis.

PURPOSE: To study behaviour of endonasally operated non-functioning pituitary adenomas (NFPA) and propose a cost-effective stratified follow-up regimen. METHODS: A single centre retrospective cohort analysis from June 2009 till December 2019. All endonasally operated pituitary adenomas were identified with sub-analysis of the NFPA's. Patients of all age groups with radiological follow-up more than 30 months were included. Patients with any kind of cranial intervention performed < within 30 months of surgery were excluded. The post-operative MRI for this cohort was evaluated until either any intervention was performed or until the last follow-up. The maximal tumour diameter in any plane (mm) was measured from the MRI scans. The annual growth rate and the statistical relationship between age, sex, IHC, Ki-67, resection %, residual tumour was calculated. RESULTS: Out of 610 pituitary adenomas identified in the dataset, 116 patients met the inclusion criteria. Follow-up period ranged from 30 to 142 months (mean 78.5 months). A strong relationship existed between predicting tumour progression with first post-operative residue size (p = .001). A statistically significant relationship was found to be present between tumour growth and a residue of less than 10 mm diameter and 11-20 mm in diameter (Log rank p value .0216). On average, each patient with a residue < 5mm had MRI scans costing 976 £. CONCLUSION: Based on statistical analysis and internal validation of the growth rate of the residue, we have proposed MRI follow-up scans. These recommendations have the potential to save more than 300 £per patient towards MRI costs and can lay down a marker for defining time interval of serial scans for post-operative NFPA's.

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.

Quantitative and functional visual field outcomes after endoscopic trans-sphenoidal pituitary adenectomy.

OBJECTIVE: Quantitative data on visual outcomes after trans-sphenoidal surgery is lacking in the literature. This study aims to address this by quantitatively assessing visual field outcomes after endoscopic trans-sphenoidal pituitary adenectomy using the capabilities of modern semi-automated kinetic perimetry. METHODS: Visual field area (deg2) calculated on perimetry performed before and after surgery was statistically analysed. Functional improvement was assessed against UK driving standards. RESULTS: Sixty-four patients (128 eyes) were analysed (May 2016-Nov 2019). I4e and I3e isopter area significantly increased after surgery (p < 0.0001). Of eyes with pre-operative deficits: 80.7% improved and 7.9% worsened; the median amount of improvement was 60% (IQR 6-246%). Median increase in I4e isopter was 2213deg2 (IQR 595-4271deg2) and in I3e isopter 1034 deg2 (IQR 180-2001 deg2). Thirteen out of fifteen (87%) patients with III4e data regained driving eligibility after surgery. Age and extent of resection (EOR) did not correlate with visual improvement. Better pre-operative visual field area correlated with a better post-operative area (p < 0.0001). However, the rate of improvement in the visual field area increased with poorer pre-operative vision (p < 0.0001). CONCLUSIONS: A median visual field improvement of 60% may be expected in over 80% of patients. Functionally, a significant proportion of patients can expect to regain driving eligibility. EOR did not impact on visual recovery. When the primary goal of surgery is alleviating visual impairment, optic apparatus decompression without the aim for gross total resection appears a valid strategy. Patients with the worst pre-operative visual field often experience the greatest improvement, and therefore, poor pre-operative vision alone should not preclude surgical intervention.

Is a Single-Dose, Single-Agent Perioperative Antibiotic Protocol Adequate for Endoscopic Endonasal Skull Base Surgery? A 10-Year Review of 422 Cases.

Objective Postoperative meningitis is a rare but potentially fatal complication of endoscopic endonasal skull base surgery. Prophylactic antibiotic use varies considerably worldwide. We sought to analyze the safety of a single-agent, single-dose protocol. Design, Setting, and Participants A retrospective review of 422 procedures performed during 404 admission episodes from 2009 to 2019, encompassing sella, parasella, and other anterior skull base pathologies. Main Outcome Measures Primary outcome measure was development of meningitis within 30 days of surgery. Additional information collected: underlying pathological diagnosis, intraoperative cerebrospinal fluid (CSF) leak, postoperative CSF leak, and primary or revision surgery. Results Of 404 admission episodes for endoscopic anterior skull base surgery, 12 cases developed meningitis. Seven had positive CSF cultures and all 12 recovered. For pathology centered on the sella (including pituitary adenoma), the rate of meningitis was 1.1% (3/283). For pathologies demanding an extended approach (including meningioma and craniopharyngioma), the rate of meningitis was 14.5% (9/62). Postoperative CSF leak requiring surgical repair increased the relative risk by 37-fold. There were no cases of meningitis following repair of long-standing CSF fistula or encephalocoele (0/26) and no cases following surgery for sinonasal tumors with skull base involvement (0/33). Conclusion For sella-centered pathologies, a single dose of intravenous co-amoxiclav (or teicoplanin) is associated with rates of meningitis comparable to those reported in the literature. Postoperative meningitis was significantly higher for extended, intradural transphenoidal approaches, especially when postoperative CSF leak occurred. Fastidious efforts to prevent postoperative CSF leak are crucial to minimizing risk of meningitis.

Enhanced recovery and accelerated discharge after endoscopic transsphenoidal pituitary surgery: safety, patient feedback, and cost implications.

BACKGROUND: Enhanced recovery after surgery (ERAS) is a constant motivation. There is growing evidence that an endoscopic (rather than microscopic) transsphenoidal approach to pituitary tumours can play a role, facilitating faster recovery and a commensurate reduction in length of stay (LOS). Reducing LOS is beneficial to both patients and healthcare systems. We sought to assess the safety, patient feedback, and resource implications of adopting an enhanced recovery and accelerated discharge policy for elective pituitary surgery. METHODS: We retrospectively assessed two consecutive cohorts of patients undergoing elective surgery for pituitary adenoma in a single UK centre between July 2016 and November 2019. The pre-ERAS cohort included 52 sequential patients operated prior to protocol change. The ERAS cohort included 55 sequential patients operated after a protocol change. Patient demographic data, tumour characteristics, intra- and post-operative CSF leak, the rate and cause of readmission (within 30 days), and the mean and median LOS were recorded. Patient feedback was collected from a subset of patients (n = 23) in the ERAS group. RESULTS: The two cohorts were well-matched with respect to their demographic, pathological, and operative characteristics. The rates of readmission within 30 days of discharge were similar between the two groups (8% pre-ERAS cohort, 9% ERAS cohort, p = 0.75). In the pre-ERAS cohort, the mean LOS was 4.5 days and median LOS was 3 days. This compares with significant reduction in LOS for the ERAS group: mean of 1.7 days and median of 1 day (p < 0.05). Thirty-nine of 55 patients in the ERAS group were discharged on post-operative day 1. Patient feedback was very positive in the ERAS group (mean patient satisfaction score of 9.7/10 using a Likert scale). CONCLUSIONS: An enhanced recovery protocol after elective endoscopic pituitary surgery is safe, reduces length of stay, and is associated with high patient satisfaction.

From above or from below? That is the question. Comparison of the supraorbital approach with the endonasal approach. A cadaveric study.

BACKGROUND: Nowadays the endoscopic endonasal approach is increasingly being used to remove craniopharyngiomas, tuberculum sellae meningiomas and other presellar and parasellar lesions and its value in anterior skull base surgery is undisputed. Herein, we assess the relative advantages, disadvantages and feasibility of the keyhole eyebrow approach and the endonasal endoscopic approach in four cadaveric heads for the removal of presellar and parasellar lesions. METHODS: We used four cadaveric heads for 12 surgical dissections. The specimens were embalmed with two different techniques. Two bilateral supraorbital endoscopic assisted approaches and one transnasal expanded endonasal approach were performed for each head. We evaluated the feasibility, maneuverability and safety of each approach. We measured the operating room obtained with each approach and the distance from the main structures we reached. RESULTS: The technical feasibility of the endoscopic endonasal transphenoidal approach and the supraorbital eyebrow approach was reproduced in all four cadaveric heads. The transnasal approach gave us a good operating field medial to the two optic nerves and the two carotid arteries anteriorly until the frontal sinus and, posteriorly, the basilar artery, the emergence of the superior cerebellar arteries and posterior cerebral arteries. After performing the supraorbital approach, we viewed a wider field of the anterior skull base and we were able to reach the ipsilateral carotid artery, the optico-carotid recess, the pituitary stalk, the lamina terminalis until the contra lateral optic nerve and carotid artery, keeping a wider angle of maneuverability. CONCLUSIONS: Although the endoscopic transnasal approach has developed in leaps and bounds in the last decade, other transcranial approaches maintain their value. The supraorbital endoscopic approach is a minimally invasive approach and seems to be optimal for those lesions wider than 2 cm in the lateral extension and for all the paramedian lesions.

Endoscopic repair of the anterior skull base -is there a learning curve?

INTRODUCTION: Endoscopic anterior skull base surgery is now established practice. For skull base teams to manage complex pathology a variety of good dural repair techniques are required. However repairing certain skull base defects can be challenging. We look to see if a learning curve is associated with different types of CSF leaks in the anterior skull base Methods: Analysis of a prospectively collected database, contain 383 cases, on all endoscopic anterior skull base operations at one UK institution looking at CSF repair. Chi squared statistical analysis was undertaken comparing results from 2009 to 2013 with the 2014 to 2017 results. CSF leaks were categorised as either low flow with defects less than 2cm in diameter or high flow with defects greater than 2cm in diameter associated with a CSF void. RESULTS: 137 cases requiring repair were identified. Overall 96% of cases underwent successful primary repair with low flow CSF defects. The primary repair rate was similar in the early and later years. Successful repair of large anterior skull base defects was statistically more likely in the 2014-2017 group 96% compare to the 2009-2013 group 65%. CONCLUSIONS: A learning curve for small defects was not seen. However a learning curve does exist in relation to large defects with high flow over the first 20 cases.

The learning curve for endoscopic trans-sphenoidal resection of pituitary macroadenomas. A single institution experience, Leeds, UK.

BACKGROUND: The object of this study was to assess whether increasing operative experience results in greater endoscopic trans-sphenoidal resection of pituitary macroadenomas and lower complications. METHODS: A retrospective single institution cohort study was performed. Subjects underwent endoscopic trans-sphenoidal resection of pituitary macroadenoma between July 2009 and July 2016 by three neurosurgeons. Following data collection, statistical analysis compared percentage of tumor resection and length of hospital stay (LOS) with experience. Complications including CSF leak are reported. RESULTS: In total, 142 patients (87 male, 55 female) mean age 55.1 were included. Surgeon 1 performed 106 cases; surgeon 2 performed 23 cases; and surgeon 3 performed 13 cases. Mean pre-operative tumor volumes were 8.18 cm3, 6.52 cm3, and 3.47 cm3 and post-operative volumes were 2.21, 1.74, and 1.93 cm3 for surgeons 1, 2, and 3, respectively. Respective percentage resections were 74.3, 77.2, and 52.1%. Analysis demonstrated no difference in tumor resection with increasing experience for all three surgeons (p = 0.11, p = 0.17, and p = 0.26). Tumor consistency and cavernous sinus involvement did not appear to affect tumor resection. Mean LOS was 5 days, 4 days, and 3 days, respectively, with no significant correlation with experience for all three surgeons. Intraoperative CSF leak incidence was 19/106 (18%) for surgeon 1, 6/23(26%) for surgeon 2, and 2/13(15%) for surgeon 3. Primary closure rate was 96.3% and only three other complications occurred. CONCLUSIONS: This study demonstrates that in our institution there is no statistically significant learning curve for the endoscopic resection of pituitary macroadenoma. However, there is a trend of improvement in tumor resection with experience for one surgeon. These findings suggest that the surgeons in our institution were capable of performing this procedure effectively with a low complication rate since adoption of the endoscopic technique in 2009.

Retrospective analysis of anterior skull base CSF leaks and endoscopic repairs at Leeds.

OBJECTIVES: Over the past 10 years, endoscopic endonasal anterior skull base surgery has become established practice. Surgeons carrying out this surgery need to be able to endoscopically repair primary and secondary CSF leaks. A growing number of techniques have been adopted to date. This article highlights one UK institution's experience in the management of anterior skull base leaks, and how surgeons there have identified leak defect types that are difficult to seal and how they have adopted a new way of repairing them, which uses a fat ring. METHODS: Seventy-six patients requiring CSF leak repairs were identified form a prospective data base of 240 endoscopic anterior skull base procedures at the General Infirmary at Leeds performed between July 2009 and October 2015. RESULTS: Fifty-one cases have undergone an endoscopic primary repair of a skull base defect following resection of a lesion and, of these, 10 (19%) cases required a secondary repair. This was particularly over the planum sphenoidale area. Twenty-five cases had undergone an endoscopic repair as the primary procedure. This was due to a spontaneous leak in 7 cases, trauma in 3 cases, following craniotomy in 3 cases and following pituitary surgery in 2 cases. The remaining 10 were the secondary repairs referred to above. CONCLUSIONS: A number of techniques are effective in CSF repair. Defects over the planum sphenoidale and clivus are associated with the highest recurrence, requiring specific repair techniques. Utilisation of a 5 "F" repair helps to prevent recurrence in high risk defect cases over the optic chiasm. The 5 "F" repair used takes the form of placing intradural Fat and Fascia; next a Fat sealing ring is used, followed by a nasoseptal Flap; finally a supporting fragmentable pack is applied.

Public disclosure of surgeon's results--pituitary surgery.

OBJECTIVE: There are few agreed quantifiable outcome measures in pituitary surgery. The goal of this study is to present the measurement of resection volume after surgery for pituitary tumours as a surgeon-specific outcome measure that may have use in illustrating the performance of individual surgeons internally and externally, and contribute to quality improvement in pituitary surgery. METHOD: The authors used an existing validated method to measure the volume of pituitary tumours. This method was used to retrospectively assess the extent of resection (EOR) in all patients undergoing pituitary surgery for tumour volume reduction over a 3-year period in Leeds, UK. Three surgeons and two techniques (endonasal transsphenoidal surgery and conventional microscopic surgery) were compared. The results are summarised using Funnel plot methodology. RESULTS: The overall mean EOR for the 3 years of study was 54%. There was no difference between endoscopic and microscopic techniques in terms of EOR. Significant differences were found between surgeons' case mix (as estimated by preoperative tumour size) and EOR. One surgeon had smaller tumour cases at operation than the other two surgeons (p = 0.004). One surgeon achieved larger resections than the two other surgeons (p = 0.038 and 0.005). CONCLUSIONS: Measuring pituitary volumes manually using segmentation methods and existing software is possible for surgeons and provides valuable information on individual surgeon performance and departmental practice. A simple retrospective review of 3 years of practice has demonstrated that surgeons have different case-mix and their EOR can vary within safe limits. During a period of transition when we changed personnel and technique, the EOR was little affected and this was reassuring from a governance perspective. Performance assessment for low-volume conditions is possible .

Maximal medical therapy for chronic rhinosinusitis: a survey of otolaryngology consultants in the United Kingdom.

BACKGROUND: The management of chronic rhinosinusitis is based on a trial of "maximal medical therapy" before surgery is considered. Ear-Nose-Throat (ENT) UK consultant members were surveyed to determine the role and variability of UK-wide practices. METHODS: A survey was posted to all ENT UK consultant members (n = 603). This assessed the frequency of prescription, duration, and type of oral antibiotics, steroids, and antihistamines for chronic rhinosinusitis. RESULTS: A total of 158 questionnaires (26.3%) were returned. Of these, 61% were primarily rhinologists. The use of decongestants, antifungals, and immunotherapy was generally limited. Oral antibiotics were often used, with clarithromycin of <5 weeks duration being the preferred choice. Sixty-one percent of consultants always prescribe a steroid spray, most commonly mometasone furoate (75%). CONCLUSION: Although most respondents use triple therapy of oral antibiotics, steroid nasal spray, and saline douching to some extent, "maximal medical therapy" for chronic rhinosinusitis seems to vary greatly among consultants and frequently does not reflect recent guidelines.