Ear, Nose & Throat Journal2023, Vol. 102(7) 445–452© The Author(s) 2021Article reuse guidelines:sagepub.com/journals-permissionsDOI: 10.1177/01455613211015440journals.sagepub.com/home/ear
Background: Patients with nasal obstruction due to deviated nasal septum (DNS) often have allergic rhinitis (AR) as contributing factor. When optimal medical therapy for AR fails, septoplasty alone may not adequately treat nasal obstruction. Therefore, with bilateral inferior turbinate hypertrophy representing long-standing AR, adding bilateral inferior turbinoplasty (BIT) to septoplasty might be beneficial. Objective: To assess whether septoplasty with/without BIT alleviates nasal obstruction in the above patient cohort and whether adding BIT to septoplasty brings significant benefit. Methodology: In this interventional, prospective study, patients with nasal obstruction due to DNS and persistent, moderate-severe AR refractory to optimal medication were randomly allocated into group A (septoplasty alone) and group B (septoplasty with BIT). Nasal Obstruction and Symptom Evaluation (NOSE) score, along with Subjective Performance parameters (days-off/month; number of outdoor visits/month; overall satisfaction score [OSS]) were used to assess the symptom and quality of life, respectively, at follow-up. Results: Each group had 40 age/sex-matched patients. Friedman test, and subsequent pair-wise comparison within groups without Bonferroni correction, revealed that septoplasty with/without BIT elicited significant reduction in NOSE scores and in the Subjective Performance parameters (days-off/month; number of outdoor visits/month) at 3 and 6 months. Wilcoxon Signed Rank test revealed that the OSS within groups also improved significantly with time. Further, comparison between groups revealed significant improvement in NOSE scores at all levels of follow-up when BIT was included. However, there were no significant differences between groups in the Subjective Performance parameters at any level of follow-up. Improvement in OSS between groups was significant only at 3 months but not subsequently. Conclusion: Septoplasty with/without BIT is helpful in treating patients with DNS and refractory AR. However, although adding BIT brings significant benefit in decreasing nasal obstruction, it does not significantly improve the Subjective Performance parameters during follow-up, except for OSS at the third month.
Keywords
deviated nasal septum, allergic rhinitis, nasal obstruction, NOSE score, subjective performance parameters, septoplasty, inferior turbinoplasty
Symptomatic deviated nasal septum (DNS) most commonly presents with nasal obstruction. However, multiple coexistent pathologies like turbinate hypertrophy, allergic rhinitis (AR), and chronic rhinosinusitis might contribute, and thereby aggravate this symptom. Of these, the most prevalent one is AR.1 Many a times, patients with symptomatic DNS continue to experience nasal obstruction even after successful septal surgery with an acceptable anatomic correction of septum. In such situations, coexistent AR might explain persistence of the obstructive symptoms. It needs to be acknowledged that nasal obstruction might be a combined result of anatomic and physiologic factors. Because of the high prevalence of AR of varying severity within the urban population, it appears more logical to consider both AR and DNS as the targets for treatment rather than to isolate and treat only the anatomic factor. This implies that neither septal correction for DNS nor the optimal medical management for AR would independently result in satisfactory relief from nasal obstruction in patients where such symptom results from both. Therefore, if optimal medical management for AR fails, should an additional surgical procedure for AR be considered along with septoplasty to provide the expected benefit from symptoms? We consider bilateral mucosal hypertrophy of the inferior turbinates as the clinical representative of long-standing AR. In this context, the question arises, would adding bilateral inferior turbinoplasty (BIT) to septoplasty be further beneficial in reducing nasal obstruction in patients having both DNS and AR?
The outcome of septal surgery can be assessed with the Nasal Obstruction & Symptom Evaluation (NOSE) score (Figure 1).2,3 This is a validated, disease-specific subjective assessment questionnaire introduced by Stewart et al in 2004.4 It consists of 5 symptoms in increasing severity for assessing nasal obstruction. In the present study, we evaluated the outcome following septal surgery with/without BIT through the NOSE score along with a given set of Subjective Performance parameters in patients presenting with nasal obstruction and who have both DNS and AR, where the AR was refractory to the optimal conservative medication. The present study attempts to inquire whether an additional surgical procedure is warranted in this patient cohort. As the patients’ perception of nasal airflow is the primary concern, improvement in the subjective symptom score would be an important tool in managing nasal obstruction caused by DNS coexistent with AR.
This interventional, prospective study was conducted between January 2019 and December 2019 in a tertiary care teaching institute. The objectives were to find out whether surgery (septoplasty with/without BIT) would be beneficial in nasal obstruction due to DNS and AR (that is refractory to the optimal medical management) and whether adding BIT to septoplasty would bring significant benefit.
The change in symptom pre- and postintervention (improvement in nasal obstruction) was documented with NOSE score, and the subjective performance following surgery was assessed based on 3 parameters (vide infra).
Inclusion criteria for the study were the patients belonging to the urban area, age >18 years, and diagnosed as having DNS along with AR (persistent, moderate-severe; according to the Allergic Rhinitis and its Impact on Asthma [ARIA] guidelines [2016 revision])5 that is refractory to the optimum medical management. The patients with AR were selected following skin prick test for a set of known environmental antigens that elicited immediate hypersensitivity reaction for allergy. They had clinico-radiologically identifiable septal deviation along with bilateral turbinate hypertrophy, and their symptoms persisted for more than 3 months even after optimal medical management for AR (topical nasal decongestants and steroids, oral antihistamine). Bilateral turbinate hypertrophy is considered as the clinical indicator for long-standing AR and has been used in the present study as the target for surgical intervention, along with continuation of medical management.
Exclusion criteria included age <18 years, other factor(s) causing nasal obstruction besides DNS and AR having clinico-radiologic evidence, like chronic rhinosinusitis, sinonasal mass lesions, adenoid hypertrophy, and so on, along with history of radiation in the head-neck region, septal perforation, uncontrolled asthma, and previous history of septal surgery. Patients having unilateral and/or compensatory hypertrophy of the inferior turbinate (due to DNS) were also excluded from this study.
A detailed and comprehensive evaluation of every patient was made through history-taking and evaluation, both clinical (in-office nasal endoscopy) and radiologic (computed tomography scan of nose and paranasal sinuses, with contrast when required). Bilateral mucosal hypertrophy of the inferior turbinates was considered here as the clinical representative of long-standing AR. The patients were divided through simple randomization into 2 groups. Patients in group A underwent septoplasty alone while those in group B were subjected to both septoplasty and BIT. Although the patients selected for surgical intervention were refractory to the optimal medical management for AR, such treatment was being continued both before and after surgery.
NOSE scores were noted at the preoperative period and at postoperative weeks 12 and 24 to compare, both within and between the groups, the improvement of nasal obstruction following surgical intervention and continued medical attention. No translation of the NOSE questionnaire into the vernacular was needed because all the subjects included were conversant with the English language. Thus, subsequent validation as required for a translated questionnaire instrument was not needed for this study.
Further comparisons, both within and between the groups, were carried out with parameters defining the subjective performance, like (a) days-off/month from work/study; (b) number of visits in the outpatients department (OPD)/month; and (c) overall satisfaction score (OSS). The first 2 parameters were compared with values before and after surgical intervention, while OSS was evaluated on the basis of the responses recorded by each patient on a predesigned form following surgery (Figure 2). The OSS was meant to indicate improvement in symptom and work efficiency in day-to-day life, thus it could be considered equivalent to representing the quality of life status.
All the surgeries were performed by the same group of surgeons. The BIT was carried out following a uniform surgical technique, that is, endoscopic powered shaving of the hypertrophied mucosa with microdebrider (Straightshot M5; Medtronic). Informed consent in writing was obtained from each patient at the time of his/her inclusion in the study. The study obtained clearance from the institutional ethical committee. All investigations and interventions were carried out maintaining the standard protocol of ethical principles for medical research involving human subjects laid down by the Declaration of Helsinki 1964 and its subsequent modifications.
Data were entered into Microsoft Excel spreadsheets (Microsoft Corporation) and codified for analysis. Continuous variables were described either by mean and SD or median and interquartile range (IQR) and categorical ones by proportion. Data display was achieved by charts and tables. Normality of the data set was checked by Shapiro-Wilk test. Nonparametric statistical tests like Mann-Whitney U test, Friedman test and Wilcoxon Signed Rank test were used for drawing inferences. Statistical Package for Social Sciences (SPSS) Software version 22 (IBM Corporation) was used for data analysis. P value of .05 (2-tailed) at 95% CI was considered as significant. A level of evidence of 2b has been assigned to this study, following guidelines provided by the Oxford Centre of Evidence-Based Medicine.6
A total of 80 patients were included following the selection criteria. Their age ranged from 18 to 57 (mean: 38 years) years. Overall, there were 47 men and 33 women. The age- and sexmatched, randomly allocated patients of group A and B underwent septoplasty and septoplasty with BIT, respectively, with each group consisting of 40 patients (Figure 3).
Normality test showed that all the data set related to the NOSE scores, days off/month, and number of OPD visits/month at preoperative, 3 and 6 months’ postoperative periods as well as the patients’ satisfaction at 3 and 6 months postoperative periods had skewed distribution. The study was powered at 80%.
Friedman test determined that the mean NOSE score and the parameters of Subjective Performance (days off/month and number of OPD visits/month) differed significantly between time intervals (Table 1).
Pair-wise comparison within the groups without using the Bonferroni correction revealed that septoplasty with/without BIT elicited a significant reduction in NOSE scores as well as in the parameters of Subjective Performance (days off/month and number of OPD visits/month) from preoperative period to 3 and 6 months after operation (Table 2, Wing A; Figures 4 and 5). It is also evident from the analysis that in both groups, the NOSE scores, along with the parameters of Subjective Performance (days off/month and number of OPD visits/month) significantly decreased further at 6 month’s assessment compared to their 3 month’s values (Table 2, Wing A; Figures 4 and 5).
Comparison between the groups revealed that the NOSE scores reduced significantly in group B as reflected at both levels of follow-up (Table 2, Wing B). However, no significant difference was observed between the groups in the parameters of subjective performance (days off/month and number of OPD visits/month) at any level of follow-up (Table 2, Wing B).
The groups did not have any statistically significant difference between them with respect to the NOSE score and the parameters of subjective performance (days off/month and number of OPD visits/month) before surgical intervention, which implies that the groups were comparable as per their baseline data. Therefore, it could be concluded that in each group, an operative procedure (septoplasty with/without BIT) in patients with DNS along with persistent, moderate-severe AR that was refractory to the optimal medical management had a significant impact on the NOSE score and on the parameters of subjective performance (days off/month and number of OPD visits/month; Table 1 and Table 2, Wing A). However, the impact of adding BIT as an adjunct intervention was significant on NOSE scores, but not on the parameters of subjective performance (days off/month and number of OPD visits/month; Table 2, Wing B).
Data regarding overall patients’ satisfaction, that is, the OSS, were also analyzed in both within and between the groups. Estimates of the OSS were 3.0 versus 4.0 (median) and 1.75 versus 2.0 (IQR) at 3 months versus 6 months follow-up. Comparison within the groups with Wilcoxon Signed Rank test revealed that over the time after surgery (septoplasty with/without BIT), the OSS improved significantly (Table 3, Wing A). This reflected long-lasting benefit of surgical management. However, significant between the group differences in OSS were observed only at three months follow-up, suggesting the benefit of BIT as an adjunct procedure at the early period following surgery, but not at subsequent follow-up (Table 3, Wing B).
The ARIA guidelines classify AR into 2 major groups, ‘‘intermittent’’ and ‘‘persistent,’’ depending on the duration of symptoms.5 They are further classified into ‘‘mild’’ and ‘‘moderate-severe’’ according to the degree of their symptoms. Patients having mild, intermittent AR are relatively easier to treat; treatment is challenging in case of persistent, moderatesevere degree of AR. This affects the quality of life significantly. The mainstay of treatment of persistent, moderate-severe AR generally includes topical steroid spray and systemic antihistamines. There are multiple changes in the sinonasal mucosa in AR, both microscopic and gross (endoscopic). Bilateral inferior turbinate mucosal hypertrophy is one of the major changes noticed in the nasal lining on endoscopy in patients having long-standing persistent, moderate-severe AR, and this formed the basis why we considered bilateral inferior turbinate hypertrophy as the working indicator of persistent, moderate-severe AR in our study. In the process, we excluded patients with nasal obstruction having compensatory hypertrophy of the contralateral inferior turbinate due to DNS. Although the definitive etiology or an inciting event is unknown, there is evidence of associated bony enlargement in unilateral, compensatory turbinate hypertrophy, which is apparently to protect the nasal passage from excess airflow that would lead to desiccation of the mucosa and subsequent crusting.7-9 In contrast, bilateral inferior turbinate hypertrophy is mucosal, characterized by cellular hyperplasia, venous congestion and stromal edema, and associated with chronic inflammatory conditions (like chronic allergic/non-AR).9 In context to our selection protocol, bilateral turbinate hypertrophy due to nonallergic chronic rhinitis could be ignored because we considered only those patients who had clinically proven AR following the ARIA guidelines, aided by positive skin prick test.
In spite of the optimum medical management as advocated in the ARIA guidelines, it has been noticed in routine otolaryngology practice that many patients with persistent, moderate-severe AR having good compliance to medications still continue to have nasal obstruction. Many of them have coexistent, identifiable DNS. In this group of patients, it becomes difficult to control symptoms to their expected level of satisfaction with medical management as the sole intervention. Kim et al and Schwentner et al found in their respective studies a remarkable improvement in nasal symptoms, sleep, practical problems, and overall quality of life following septoplasty.10,11 The study by Kim et al specifically considered both AR and DNS as contributors to nasal obstruction and concluded, much like we have done here, that septoplasty is beneficial in alleviating the quality of life in patients having DNS as well as AR.10
In this study, we opted for those patients who were refractory to the optimum medical management and had persistent, moderate-severe AR along with DNS. Subsequently, they were subjected to septoplasty with/without BIT, while the medical management for AR continued prior to and following surgery. Their improvement in symptom and subjective performance were recorded, respectively, with the NOSE questionnaire and a predesigned set of parameters based on daily activities and overall satisfaction.
Our study revealed that the mean postoperative NOSE scores in these carefully selected candidate patients decreased significantly in each group at all levels of follow-up, which signifies that surgery (septoplasty with/without BIT) did have a beneficial role in alleviating the obstructive symptoms. There was also significant improvement of the mean NOSE scores throughout all levels of follow-up when the 2 groups were compared. Therefore, BIT as an adjunct to septoplasty resulted in significant benefit to the obstructive symptoms compared to when septoplasty was performed alone.
However, although surgery (septoplasty with/without BIT) brought significant improvement in the parameters of subjective performance (days off/month and number of OPD visits/month) in each group throughout the follow-up period, the results were not significantly beneficial when the 2 groups were compared. That is, adding BIT to septoplasty might not be specifically advantageous in improving the subjective performance parameters (days off/month and number of OPD visits/month). That a significantly improved nasal airflow after adding BIT could not appreciably decrease the number of OPD visits/month in the patients belonging to group B can be explained by good adherence to the follow-up schedule by the patients across groups. Similarly, there might be other nonsurgical factors like inconsistency in compliance to the medical management of AR following surgery that may play their role, independent of BIT, in accounting for the nonsignificant reduction in the days off/month when the groups were compared. Surgery (septoplasty with/without BIT) could improve the OSS significantly in each group throughout the follow-up period; however, the benefit brought about by adding BIT to septoplasty was appreciable only at 3-month follow-up but not thereafter. The role of BIT in significantly improving the quality of life in the early postoperative period could be because of the immediate effect of alleviation of nasal obstruction after surgery. That the outcome in the later period of follow-up was independent of BIT in the patients across groups (including those in group B who had significant improvement of nasal obstruction when BIT was added as an adjunct) can again be explained by nonsurgical, patient-related factors like poor compliance to medication for AR postsurgery. Also, it can be deduced that BIT might not be the only determinant for the improvement of OSS. Analyzing these extrinsic factors influencing the final outcome in our patients is not within our scope at present, but they have the potential to modify the study design so that the specific role of these additional factors can be recognized.
There are few limitations in our study. First, the results could have been further strengthened had the sample size been more. However, the patient cohort in our study was highly selective. It included 3 major conditions for eligibility: (a) patients who were symptomatic in having nasal obstruction; (b) had both DNS and AR (persistent, moderate-severe) as the etiology; and (c) in whom AR was refractory to the optimal medical management. Thus, the high selectivity limited the sample strength but nevertheless increased the statistical rigor necessary for a reproducible result. Second, the follow-up period could be increased such that the reliability of the outcome could be ensured. This is especially relevant because septal remodeling takes time following its correction that necessitates long-term follow-up for obtaining optimum benefit. However, our study does provide a distinct trend throughout the periodic follow-up and at the end of 6 months. From a practical point of view, the subjective performance parameters like days off/month and number of OPD visits/month are expected to drastically change soon after surgery as the patients tend to return to work/study after a brief period of sanctioned leave provided by the respective authorities. Thus, these parameters can be readily assessed following surgery, and their earlier improvement could actually suggest successful surgical intervention. Hence, the results of the periodic follow-up adopted in our study could be highly representative of the outcome trend in the long term.
We believe that this study would be beneficial for the otolaryngologists to decide when to opt for surgical intervention in patients presenting with nasal obstruction due to both DNS and AR, and whether BIT would suit the patients’ need. Since BIT, when added to septoplasty, provides statistically significant benefit to the patients’ symptom of nasal obstruction, but at the same time the subjective performance and quality of life indicators remain largely independent of BIT (except for OSS at third month follow-up), the choice of adding this surgical procedure would depend much on other factors, like the patients’ profile, their choice, severity of the symptoms, extent of turbinate hypertrophy, financial and insurance issues, and the risk–benefit ratio while increasing the morbidity of the patients. These are beyond the scope of this study’s objectives and would form the avenues for further research. But for now, this paper opens up the question whether BIT is actually necessary in AR refractory to the optimal medical management when the symptom of nasal obstruction is compounded by DNS as well.
Sanjoy Kumar Ghosh and Mainak Dutta are joint first authors for this article.
The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.
The author(s) received no financial support for the research, authorship, and/or publication of this article.
Mainak Dutta https://orcid.org/0000-0003-3977-3230
1 Department of Otorhinolaryngology and Head-Neck Surgery, Jagannath Gupta Institute of Medical Sciences and Hospital, Budge Budge, West Bengal, India
2 Department of Otorhinolaryngology and Head-Neck Surgery, Medical College and Hospital, Kolkata, West Bengal, India
3 Department of Community Medicine, Bankura Sammilani Medical College and Hospital, Bankura, West Bengal, India
Received: March 06, 2021; revised: April 12, 2021; accepted: April 16, 2021
Corresponding Author:
Mainak Dutta, MS, FACS, Department of Otorhinolaryngology and Head-Neck Surgery, Medical College and Hospital, Kolkata; 88, College Street, Kolkata 700073, West Bengal, India.
Email: duttamainak@yahoo.com
