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NIHR Signal Surgery for a deviated nasal septum improves quality of life more than non-surgical approaches

Published on 27 August 2019

doi: 10.3310/signal-000811

Surgery for adults who have a deviation, or bend, in the wall running through the centre of their nose improves quality of life more than non-surgical alternatives. The benefit was maintained for at least two years. The surgery, a septoplasty, also improves airflow through the nose.

The trial compared septoplasty to non-surgical alternatives, such as just monitoring the patient or giving treatments such as corticosteroid nasal sprays.

There has been a lack of good-quality evidence in managing this common condition, and so practice has been inconsistent. Some areas in England have put the procedure on a list of restricted treatments.

This study provides the first robust evidence about the effectiveness of the surgery and supports its use if conservative treatment is not working. A similar NIHR-funded trial is ongoing in the UK, and together, these trials may better guide practice.

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Why was this study needed?

A bend in the nasal septum, the central cartilage-like part of the nose, can obstruct the flow of air, and cause problems such as a blocked nose, snoring and sleep disturbance.

To reduce these problems, non-surgical methods such as steroid nasal sprays can be used, or the septum can be straightened surgically. This surgery is called septoplasty, and it is one of the most common ear, nose and throat operations in adults. In 2017-2018 there were 16,782 septoplasties carried out in England, and septoplasties are reported to cost the NHS about £18 million each year.

However, there has been no high-quality evidence that the operation improves symptoms. This has led to questions about whether it should be offered by the NHS, and there is variation in what is provided around the country.

This trial aimed to assess whether septoplasty benefits adults with a bent septum.

What did this study do?

This randomised controlled trial recruited 203 adults with a bent septum from 18 hospitals in the Netherlands. The bent septum had to be partly obstructing the airway and affecting breathing for a person to take part.

Participants were allocated to septoplasty or non-surgical management.

The study aimed to reflect usual practice, and the surgeons performing the septoplasties used their normal approaches. This could include an additional procedure called turbinoplasty if needed. Patients having surgery could also use medication.

Doctors reviewed the patients having non-surgical management and decided whether to monitor the patient without giving any treatment (watchful waiting) or to give medical treatment (usually a steroid nasal spray).

Patients knew which group they were in, which might have influenced how they perceived their outcomes. About 30% of participants in the non-surgical group ended up having surgery, but they were still analysed in the non-surgical group. This may make the difference in outcomes between treatments appear slightly smaller than in real life.

What did it find?

  • People allocated to surgery reported having better quality of life relating to their condition than those allocated to non-surgical approaches at 12 months (measured using the Glasgow Health Status Inventory, score range 0 to 100, higher score meaning better quality of life; mean scores: 72.2 in the septoplasty group versus 63.9 in the non-surgical group; mean difference 8.3 points, 95% confidence interval [CI] 4.5 to 12.1).
  • The improvement in quality of life with septoplasty was largest at six months, at which point the difference between the groups was large enough to be considered clinically important (mean difference: 11 points; a difference of 10 points or more was considered clinically important). The difference decreased slightly after this, but people who had septoplasty still experienced better quality of life than the non-surgical group at up to 2 years after the surgery.
  • Similar results were also found when using two different scales specifically designed for people with nasal problems — the Nasal Obstruction Symptom Evaluation (NOSE) scale and the Sino-Nasal Outcome Test-22 (SNOT-22).
  • Septoplasty also improved the flow of air through the nose more than non-surgical approaches at 12 months (peak nasal inspiratory flow before decongestion: 124.3 litres/minute [l/min] in the septoplasty group versus 95.0 l/min in the non-surgical group; mean difference: 29.3 l/min, 95% CI 16.9 to 41.8).
  • Of the people who had surgery, 18% experienced complications, including bleeding and infection. These were mild and occurred just after surgery. They either did not need treatment or could be treated outside of hospital. Two people (2.1%) developed a hole in their septum, and one person (1.0%) needed a second septoplasty because of continuing nasal problems. One person who had surgery (1.0%) developed an abscess on the septum, which was treated with intravenous antibiotics in hospital; this was the only serious adverse event.

What does current guidance say on this issue?

There is no national guidance available on the use of septoplasty. Several NHS Clinical Commissioning Groups (CCGs) in England only fund septoplasty for patients who meet specific criteria. For example, CCGs in and around Birmingham will only fund septoplasty in patients whose nasal airway obstruction is causing documented medical problems, such as continuing disruption to sleep and/or breathing, after all non-surgical treatments have been tried.

What are the implications?

This study suggests that septoplasty should be offered to adults with a bent septum whose symptoms don’t respond to non-surgical management.

The NAIROS study, funded by the NIHR, is also examining the effectiveness of septoplasty. Recruitment for NAIROS started in 2017 and is due to be completed in 2020. This study will include an economic analysis, which will help to assess whether the procedure provides good value for NHS money.

Citation and Funding

Van Egmond MMHT, Rovers MM, Hannink G et al. Septoplasty with or without concurrent turbinate surgery versus non-surgical management for nasal obstruction in adults with a deviated septum: a pragmatic, randomised controlled trial. Lancet. 2019;394:314-21;

This project was funded by the Netherlands Organisation for Health Research and Development (ZonMW).

Bibliography

Birmingham and Solihull CCG. Policy for cosmetic surgery rhinoplasty. [accessed 21.07.19].

ENT UK. About septal surgery. London: ENT UK; 2012.

Newcastle University. The NAIROS trial. Newcastle: Newcastle University; 2019.

NHS Digital. Hospital admitted patient care activity, 2017-18. Leeds: NHS Digital; 2018.

NIHR. Funding and Awards. NAIROS - Nasal AIRway Obstruction Study. London: National Institute for Health Research; 2019.

Why was this study needed?

A bend in the nasal septum, the central cartilage-like part of the nose, can obstruct the flow of air, and cause problems such as a blocked nose, snoring and sleep disturbance.

To reduce these problems, non-surgical methods such as steroid nasal sprays can be used, or the septum can be straightened surgically. This surgery is called septoplasty, and it is one of the most common ear, nose and throat operations in adults. In 2017-2018 there were 16,782 septoplasties carried out in England, and septoplasties are reported to cost the NHS about £18 million each year.

However, there has been no high-quality evidence that the operation improves symptoms. This has led to questions about whether it should be offered by the NHS, and there is variation in what is provided around the country.

This trial aimed to assess whether septoplasty benefits adults with a bent septum.

What did this study do?

This randomised controlled trial recruited 203 adults with a bent septum from 18 hospitals in the Netherlands. The bent septum had to be partly obstructing the airway and affecting breathing for a person to take part.

Participants were allocated to septoplasty or non-surgical management.

The study aimed to reflect usual practice, and the surgeons performing the septoplasties used their normal approaches. This could include an additional procedure called turbinoplasty if needed. Patients having surgery could also use medication.

Doctors reviewed the patients having non-surgical management and decided whether to monitor the patient without giving any treatment (watchful waiting) or to give medical treatment (usually a steroid nasal spray).

Patients knew which group they were in, which might have influenced how they perceived their outcomes. About 30% of participants in the non-surgical group ended up having surgery, but they were still analysed in the non-surgical group. This may make the difference in outcomes between treatments appear slightly smaller than in real life.

What did it find?

  • People allocated to surgery reported having better quality of life relating to their condition than those allocated to non-surgical approaches at 12 months (measured using the Glasgow Health Status Inventory, score range 0 to 100, higher score meaning better quality of life; mean scores: 72.2 in the septoplasty group versus 63.9 in the non-surgical group; mean difference 8.3 points, 95% confidence interval [CI] 4.5 to 12.1).
  • The improvement in quality of life with septoplasty was largest at six months, at which point the difference between the groups was large enough to be considered clinically important (mean difference: 11 points; a difference of 10 points or more was considered clinically important). The difference decreased slightly after this, but people who had septoplasty still experienced better quality of life than the non-surgical group at up to 2 years after the surgery.
  • Similar results were also found when using two different scales specifically designed for people with nasal problems — the Nasal Obstruction Symptom Evaluation (NOSE) scale and the Sino-Nasal Outcome Test-22 (SNOT-22).
  • Septoplasty also improved the flow of air through the nose more than non-surgical approaches at 12 months (peak nasal inspiratory flow before decongestion: 124.3 litres/minute [l/min] in the septoplasty group versus 95.0 l/min in the non-surgical group; mean difference: 29.3 l/min, 95% CI 16.9 to 41.8).
  • Of the people who had surgery, 18% experienced complications, including bleeding and infection. These were mild and occurred just after surgery. They either did not need treatment or could be treated outside of hospital. Two people (2.1%) developed a hole in their septum, and one person (1.0%) needed a second septoplasty because of continuing nasal problems. One person who had surgery (1.0%) developed an abscess on the septum, which was treated with intravenous antibiotics in hospital; this was the only serious adverse event.

What does current guidance say on this issue?

There is no national guidance available on the use of septoplasty. Several NHS Clinical Commissioning Groups (CCGs) in England only fund septoplasty for patients who meet specific criteria. For example, CCGs in and around Birmingham will only fund septoplasty in patients whose nasal airway obstruction is causing documented medical problems, such as continuing disruption to sleep and/or breathing, after all non-surgical treatments have been tried.

What are the implications?

This study suggests that septoplasty should be offered to adults with a bent septum whose symptoms don’t respond to non-surgical management.

The NAIROS study, funded by the NIHR, is also examining the effectiveness of septoplasty. Recruitment for NAIROS started in 2017 and is due to be completed in 2020. This study will include an economic analysis, which will help to assess whether the procedure provides good value for NHS money.

Citation and Funding

Van Egmond MMHT, Rovers MM, Hannink G et al. Septoplasty with or without concurrent turbinate surgery versus non-surgical management for nasal obstruction in adults with a deviated septum: a pragmatic, randomised controlled trial. Lancet. 2019;394:314-21;

This project was funded by the Netherlands Organisation for Health Research and Development (ZonMW).

Bibliography

Birmingham and Solihull CCG. Policy for cosmetic surgery rhinoplasty. [accessed 21.07.19].

ENT UK. About septal surgery. London: ENT UK; 2012.

Newcastle University. The NAIROS trial. Newcastle: Newcastle University; 2019.

NHS Digital. Hospital admitted patient care activity, 2017-18. Leeds: NHS Digital; 2018.

NIHR. Funding and Awards. NAIROS - Nasal AIRway Obstruction Study. London: National Institute for Health Research; 2019.

Septoplasty with or without concurrent turbinate surgery versus non-surgical management for nasal obstruction in adults with a deviated septum: a pragmatic, randomised controlled trial

Published on 23 June 2019

van Egmond, Mmht,Rovers, M. M.,Hannink, G.,Hendriks, C. T. M.,van Heerbeek, N.

Lancet , 2019

BACKGROUND: Septoplasty (surgical correction of the deviated nasal septum) is the most frequently performed ear, nose, and throat operation in adults, but no randomised controlled trials or non-randomised comparative studies on the effectiveness of septoplasty have been published. Consequently, health-care providers, health insurance companies, and policy makers are concerned about the effectiveness of the procedure. We aimed to assess the effectiveness of septoplasty for nasal obstruction in adults with a deviated septum. METHODS: We did this open, multicentre, pragmatic, randomised controlled trial in 16 secondary and two tertiary referral hospitals in the Netherlands. Adults (aged >/=18 years) with nasal obstruction, a deviated septum, and an indication to have septoplasty done were randomly allocated (1:1) to receive either septoplasty with or without concurrent turbinate surgery or non-surgical management. Patients were stratified by sex, age (<35 years or >/=35 years), and deviation severity (mild, moderate, or severe). The primary outcome was health-related quality of life, measured with the validated Glasgow Health Status Inventory at 12 months. Analyses were done on an intention-to-treat basis. The trial is registered with the Netherlands Trial Register, number NTR3868. FINDINGS: Between Sept 2, 2013, and Dec 12, 2016, we randomly assigned 203 participants to receive either septoplasty with or without concurrent turbinate surgery (n=102) or non-surgical management (n=101). 189 participants were analysed at 12 months. At 12 months, mean score on the Glasgow Health Status Inventory of patients assigned to septoplasty was 72.2 (SD 12.2) and for those assigned to non-surgical management was 63.9 (SD 14.5, mean difference 8.3 [95% CI 4.5-12.1], favouring septoplasty). Septal abscess occurred in one surgical patient and septal perforation in two surgical patients. No side-effects of nasal medication were reported. INTERPRETATION: Septoplasty is more effective than non-surgical management for nasal obstruction in adults with a deviated septum. This effect was sustained up to 24 months of follow-up. FUNDING: The Netherlands Organisation for Health Research and Development (ZonMw).

Turbinoplasty is a surgical procedure to reduce the size of the turbinates. The turbinates are structures in the nose that can become enlarged and contribute to blocking the airway in people with a bent septum.

Expert commentary

This pragmatic trial is the first study to demonstrate that surgery is more effective than conservative treatment in patients with a septal deviation. The patient population appears to be very similar to those considered for surgery in the UK, and therefore results are likely to be generalisable to NHS patients.

This study will help ensure appropriate access to surgery. Conservative treatment remains an alternative, as it provided some improvement. The trial will allow more informed discussion of both options, including the risks of surgery.

This study doesn't provide all of the answers. For example, one-third of patients had only a mild septal deviation, and it is not clear if they derived as much benefit from surgery. The NAIROS trial will add further to the evidence base, and hopefully the two trial teams will work together to address the remaining questions.

Claire Hopkins, Professor of Rhinology, King's College, London; President of the British Rhinological Society

The commentator is a principal investigator for the NAIROS trial