Proportions of patients with at least a 50% reduction in nasal blockage visual analog scale scores at different intervals of follow-up.
Ho W, Yuen AP, Tang K, Wei WI, Lam PK. Time Course in the Relief of Nasal Blockage After Septal and Turbinate SurgeryA Prospective Study. Arch Otolaryngol Head Neck Surg. 2004;130(3):324-328. doi:10.1001/archotol.130.3.324
To evaluate prospectively the time course of the change in efficacy of septal and turbinate surgery in relieving nasal obstruction.
Interventional study, before-after trial.
Referral center, institutional practice, hospitalized care.
Thirty-four consecutive patients undergoing septal and turbinate surgery were recruited. Seven patients were unwilling to complete the follow-up after surgery. No patient withdrawal was because of adverse effects. Twenty-five normal subjects with no nasal obstruction were included as control subjects.
Functional nasal septal and turbinate surgery was performed to relieve nasal obstruction.
Main Outcome Measure
Patient assessment of severity of nasal blockage on a 0-mm (no blockage) to 100-mm (maximum blockage) visual analog scale before surgery and at fixed intervals after surgery.
The mean nasal blockage scores significantly decreased from the preoperative values at all intervals of follow-up. For the whole group, the nasal blockage score was on average 52% of the preoperative value at the last follow-up. The probability of having at least a 50% reduction in blockage decreased from 73%, to 60%, to 41%, and then to 27% at 3 months, 6 months, 1 year, and 2½ years, respectively.
Improvement in nasal blockage was found in patients after functional septal and turbinate surgery. However, the probability of substantial relief gradually decreased with time. Patients should be followed up after septal and turbinate surgery for possible recurring symptoms.
Severe nasal septal deviation results in blockage of the nasal airway. Septal surgery is commonly used to alleviate nasal obstruction in these patients. Various operations on the nasal septum have been described since the mid 1800s.1 The risks of septal operation include bleeding, infection, septal hematoma, septal perforation, and saddle-nose deformity. There are many septal surgery techniques described in the literature. The short- and long-term outcomes of the procedure are essential information that enables the surgeon and patient to make an appropriate decision on the plan of management. The American Academy of Otolaryngology–Head and Neck Surgery conducted a prospective study on the effectiveness of septoplasty with or without turbinate reduction, with follow-up at 6 months.2 There are otherwise few reports evaluating the efficacy of septal surgery. Most available studies on outcomes report the results at specific cutoff intervals after the procedure. Longitudinal studies3,4 on the efficacy of the procedure during extended follow-up are rare. Information on the changes in efficacy over time is particularly scarce. This study evaluates the results of septal and turbinate surgery at different postoperative follow-up intervals. This information is useful for the surgeon and the patient by providing realistic expectations on the outcomes of septal and turbinate surgery.
Consecutive patients with severe septal deviation with nasal obstruction undergoing septal and turbinate surgery were recruited prospectively for the study. The patients were required to assess the symptoms of nasal obstruction on a 0- to 100-mm visual analog scale (VAS) (0 mm, no blockage; and 100 mm, maximum obstruction). Patients were also required to note the number of days in a month during which they had rhinorrhea and hyposmia.
Most of the patients were prescribed medication for use as needed. The pattern of drug use before surgery was recorded as the mean number of days in a month during which the patient required a particular oral medication or corticosteroid nasal spray.
The nasal minimal cross-sectional area (MCA) was assessed using Rhinoklack RK 1000 acoustic rhinometry equipment (Stimotron, Wendelstein, Germany). The total MCA was obtained by adding the MCA of the 2 nasal fossae. To compare rhinometric values obtained from study subjects with those from normal individuals, normal subjects with no nasal obstruction were recruited for MCA and total MCA assessment with acoustic rhinometry.
Submucosal resection or septoplasty was performed depending on the configuration of the nasal septum. Submucosal resection was performed starting with a Killian incision. Septoplasty was performed when a caudal deviation was found. An incision was made at the caudal end of the septal cartilage. Inferior turbinectomy was performed by infracturing the inferior turbinate and by using turbinectomy scissors. The nose was packed for 2 days afterward. Patients usually returned 1 week later to undergo suction clearance of the nasal fossae.
The first postoperative assessment was done at 2 months, when the wound had completely healed. This assessment was performed again at 3 months, 6 months, 9 months, 1 year, 1½ years, 2 years, and 2½ years after surgery. To evaluate the trend of improvement in subjective nasal blockage VAS scores over time, a decrease of at least 50% in the preoperative nasal blockage VAS score was arbitrarily chosen as the criterion of acceptable improvement. The pattern of drug use at various intervals was also documented for each patient.
Statistical analysis was carried out using the Statistical Package for Social Sciences computer program (SPSS, version 9.0; SPSS Inc, Chicago, Ill). The paired t test was used to evaluate sequential changes in nasal symptom VAS scores. The actuarial probability of at least a 50% reduction in the VAS nasal blockage score over time was evaluated using the Kaplan-Meier method. To compare the sensitivity in detecting postoperative improvement after surgery between the subjective VAS score on nasal blockage assessment and the measurement of total MCA by acoustic rhinometry, the standardized response mean (SRM) of the 2 methods of assessment was obtained at different times during follow-up according to the method described by Liang et al.5 The SRM of a measuring method was calculated by dividing the mean of improvement by the SD of improvement. The SRM shows the degree of sensitivity of an assessment method to changes from baseline.
Thirty-four consecutive patients undergoing septal surgery in the Division of Otorhinolaryngology–Head and Neck Surgery were recruited for the study. These patients had poor response to the medication that was prescribed to alleviate nasal obstruction. Seven patients were unwilling to return for follow-up and were thus excluded from subsequent analysis. Twenty-five normal patients were recruited to obtain normal values of total MCA on acoustic rhinometry assessment.
Follow-up data from 27 patients (21 men and 6 women) were available for evaluation (mean follow-up, 17.4 months; range, 2-33 months). The mean age of the patients at presentation was 33 years (range, 18-62 years). The mean duration of history of nasal obstruction was 8.0 years (range, 0.5-40.0 years). The subjective symptom VAS scores, frequency of nasal symptoms, and preoperative total MCAs of these patients are shown in Table 1.
Twenty-five patients underwent submucosal resection of the deviated nasal septum. Two patients required a septoplasty with a hemitransfixion incision, for a more caudal septal deviation. Twenty-three patients underwent turbinectomy in the same session. Four (15%) of 27 patients reported secondary hemorrhage. All 4 patients underwent turbinectomy. Two of these patients required repacking of the nose for 2 days. None of the 4 patients required a transfusion, and all were discharged uneventfully afterward. No patient had complications of adhesion, septal perforation, or saddle-nose deformity at the last follow-up.
The nasal blockage VAS scores at the last follow-up were, on average, 52% of the preoperative values. At the last follow-up, 6 patients (22%) reported complete relief of nasal obstruction. Two patients (7%) had the same degree of nasal obstruction as before surgery. Two patients (7%) had a worse nasal blockage VAS score than before surgery. Not every patient completed all follow-up appointments. At all intervals of follow-up, the mean nasal obstruction VAS scores of patients showed a significant reduction from the mean preoperative values (P<.005 for all, paired t test) (Table 2).
The mean total MCA measurements at different follow-up intervals in the study patients are shown in Table 3. The mean ± SD total MCA measured in 25 normal subjects (15 men and 10 women) was 1.5 ± 0.5 cm2 (data not shown). For the study subjects, the mean total MCAs at all postoperative follow-up intervals were greater than the preoperative mean total MCAs. However, the differences were significant at 3 months, 6 months, and 2½ years only (Table 3).
The SRMs were calculated at different intervals of follow-up to show the sensitivity of the 2 methods in detecting postoperative improvement (Table 4). The SRMs of VAS nasal blockage scores were higher than the corresponding SRMs for the acoustic rhinometry measurements at all intervals except the 2½-year follow-up. Data from 5 patients only were available at 2½ years.
The improvement in subjective nasal obstruction over time was evaluated using the criterion of at least a 50% reduction in the preoperative nasal blockage VAS score. The actuarial probabilities of patients having at least a 50% reduction in the preoperative nasal blockage VAS scores at different intervals are shown in Figure 1 (Kaplan-Meier curve). The chance of having at least a 50% reduction in blockage at 3 months, 6 months, 1 year, and 2½ years was 73%, 60%, 41%, and 27%, respectively.
The frequency of attack of rhinorrhea decreased at all intervals of follow-up (statistically significant up to 12 months; P<.05 for all, paired t test). The number of days in a month during which patients had hyposmia showed a significant decrease for up to 18 months after surgery (P<.005 for all, paired t test). The VAS score of nasal pain and the number of days during which patients experienced postnasal drip were not different from the preoperative values at all intervals of follow-up.
The pattern of drug use was recorded as the number of days in a month during which the patient required oral medication or corticosteroid nasal spray for nasal blockage just before a specified follow-up (Table 5). There was a decrease in the use of both kinds of drugs at all intervals of follow-up, but the difference was not significant except for a decrease in the use of corticosteroid nasal spray at 2, 3, and 6 months.
This study evaluated the effectiveness of septal and turbinate surgery to relieve nasal obstruction over time. This is information that patients who are considering surgery need to know.
Secondary postoperative bleeding occurred in 15% (4/27) of our patients, of whom 7% (2/27) required nasal packing. This was higher than the 2.6% reported by Low and Willatt6 in patients with submucosal resection of the nasal septum. A probable contributing factor to this was the accompanying turbinectomy that was performed in our group of patients, rather than septal surgery alone. The bleeding rate observed in our study corresponded to the 6% to 20% reported by others, including Garth et al7 (6%), Maran and Lund8 (8%), and Fradis et al9 (20%). Septal surgery was otherwise proved to be safe, without complications of septal perforation, saddle nose, or secondary infection.
There are many reports on nasal septal surgery in the English literature.10- 14 However, most of these are on surgical techniques. Prospective investigations on the outcomes of nasal septal surgery with subjective and objective data are rare.15 There are a few retrospective studies on surgical outcomes. Schonsted-Madsen and Stoksted16 reported on the outcomes of combining functional septal surgery with aesthetic nasal pyramid surgery. This combination was effective in opening up the nasal passages in 233 (75%) of 312 patients, although opening up was not clearly defined. Fjermedal et al17 performed a retrospective study in which 63% of 478 patients expressed satisfaction with the results of their functional septal surgery. This study was based on the patients' subjective satisfaction rather than actual relief of nasal obstruction after the procedure. It is well known that a placebo effect from sham procedures can occur in up to 30% of patients,18 possibly contributed to by a good clinician-patient relationship. Therefore, patient satisfaction cannot be equated with adequate functional relief of nasal obstruction.
Attempts have been made to objectively monitor patient progress before and after surgery with rhinomanometry19,20 and acoustic rhinometry.21 However, these measurements had limitations. Holmstrom and Kumlien19 noted that improved rhinomanometry findings did not always correspond with the patients' perception of an improved airway. The quality of acoustic rhinometry measurements, like ultrasonography, is dependent on the skill and experience of the operator. In other studies, Yaniv22 and Kim23 and colleagues found discrepancies between subjective and objective results using acoustic rhinometry.
In our patients, objective assessment of the total MCA by acoustic rhinometry did not correspond with their subjective perception of a patent nasal airway. The SRMs of the VAS nasal blockage scores (Table 4) were higher than the corresponding SRMs of the acoustic rhinometry measurements at different intervals after surgery. This showed that the subjective VAS scores, compared with acoustic rhinometry measurements, were more sensitive to detect changes. This suggested that the subjective scores included other components, such as psychological factors or acuity of nasal airflow sensation, in addition to the changes in MCA of the nasal airway. The perception of a patent airway might not depend on the size of the nasal airway alone. The 2 methods of assessment of nasal blockage, VAS score and acoustic rhinometry, evaluated performance from different perspectives. In clinical practice, the patients' sensation of a patent nasal airway remains the most important factor when assessing surgical outcomes. Therefore, to measure improvement in the patency of the nasal airway in our patients, the subjective VAS nasal blockage score was used as the outcome measurement rather than the acoustic rhinometry results. The subsequent analysis based on change in nasal blockage VAS scores thus focused more on patients' perception of the airway rather than solely on a geometrical increase in the MCA of the nasal airway. This better reflects the patients' subjective perception of the patency of their nasal airway. This also minimizes any placebo effect inherent in assessing postoperative patient satisfaction alone.
Ideally, the operation should totally alleviate nasal blockage. However, this may not be realistic as there are multiple factors that contribute to a smooth nasal airflow. These include anatomical dimensions, sensitivity to airflow (trigeminal stimulation), and the presence of secretions that affect nasal airway patency temporarily. Exacerbation of symptoms is also expected when the patient has a common cold or an upper respiratory tract viral infection. Therefore, a reduction in nasal blockage to an acceptable degree during exacerbation, rather than complete eradication, would be a more practical goal. We thus arbitrarily assessed the outcomes of the procedure using the criterion of at least a 50% reduction in the baseline blockage VAS score on extended follow-up in the present study. At the last follow-up (mean, 17.4 months), this group of patients on average achieved a 52% reduction in nasal obstruction.
As in other clinical trials, this study had an increasing number of patient dropouts during extended follow-up. Therefore, the long-term probability of relief might have been overestimated due to the fact that patients with unsatisfactory results were more likely to be unwilling to complete the follow-up. The actuarial method used in the present study aimed to minimize this effect. The actuarial probability of obtaining at least a 50% reduction in the initial nasal blockage VAS score at 3 months of follow-up was 73%. This was similar to probabilities reported by Schonsted-Madsen and Stoksted16 (75%) and Fjermedal et al17 (63%). As in another reported series,6 the relief of nasal obstruction decreased during follow-up. We documented a gradual actuarial decrease in efficacy, defined as at least a 50% reduction in the original blockage, from 73% at 3 months to 27% at 2½ years. The return of symptoms during extended follow-up was probably the result of residual septal deviation and other contributing factors, such as accompanying hyperactive nasal mucosa leading to gradual turbinate hypertrophy, despite correction of the deviated septum. Jessen et al24 found that only 26% of their patients were symptomfree 9 years after septoplasty.
A confounding factor may be that in patients with long-standing nasal problems they are concerned about their nasal airways and they tend to complain about blockage. The preoperative total MCAs in our patients (range, 1.1-1.4 cm2, Table 3) were less than the mean of 1.5 cm2 in the 25 control subjects. However, at all postoperative follow-up intervals, the total MCAs (range, 1.4-2.0 cm2) showed improvement from baseline and became comparable to the norm. Some study patients complained of nasal obstruction even though their nasal airway had improved after surgery. As a result, the proportion of patients with at least a 50% reduction in nasal blockage decreased with longer follow-up after surgery (Figure 1). Nevertheless, our results show that obstructing symptoms recurred in a significant proportion of patients, and we do not agree with the claim by Murthy and Mckerrow,25 in their 12-month study of 95 patients, that routine follow-up of patients after uncomplicated septal surgery is unnecessary.
A significant decrease in the frequency of attacks of rhinorrhea was found in our patients. A contributing factor could be the accompanying turbinectomy, with a resultant reduction in the total mucosal surface area available for secretions. Improvement in hyposmia after septal and turbinate surgery was probably related to the opening up of the nasal airway and improved access in the olfactory area to chemicals in inspired air.
Trends of decrease in the use of oral medications and corticosteroid nasal sprays were found, although these were not statistically significant (Table 5) except for corticosteroid nasal spray at 2, 3, and 6 months. On the other hand, the relief of nasal blockage was at least not due to the increased use of prescribed medications. A decreased need for medications after surgery, if confirmed, is more convenient for the patients and could be considered a favorable outcome. A study design with an evaluation of the changes in generic and disease-specific quality-of-life factors would address the overall benefits of surgery.
In this study, the actuarial probability of obtaining at least a 50% reduction in the initial nasal blockage VAS score at 3 months' follow-up after septal and turbinate surgery was 73%. A gradual decrease in effectiveness was documented during follow-up, and the probability of at least a 50% reduction in nasal blockage score was 27% at 2½ years after surgery. These findings should be shared with prospective patients to avoid unrealistic expectations of surgery, and patients should be followed up after septal and turbinate surgery for possible recurring symptoms.
Corresponding author: Wai-kuen Ho, FRCS(Edin), Division of Otorhinolaryngology–Head and Neck Surgery, Department of Surgery, Queen Mary Hospital, University of Hong Kong Medical Centre, Hong Kong (e-mail: email@example.com).
Submitted for publication November 11, 2002; final revision received June 10, 2003; accepted July 1, 2003.
This study was supported by research grant 10203388/24333/21700/323/01 from the Committee on Research and Conference Grants, The University of Hong Kong.
We acknowledge the assistance of Daniel Y. T. Fong, PhD, BSc, for advice on medical statistics.