Outcomes of septoplasty

Abstract

A prospective nonrandomized study of consecutive patients presenting to the Massachusetts Eye and Ear Infirmary for septoplasty was conducted to evaluate patient-based outcome. Patients received statistically validated measures of general health status (Short Form-12) and nasal specific health (Nasal Health Survey) before and 6 and 12 months after surgery. Multiple perioperative patient- and surgeon-dependent treatment variables were also evaluated to determine the impact on outcome. A total of 161 patients were entered into the study, and 93 were available for statistical analysis. At 9 months the mean follow-up (range 6–12 months), both symptom and medication subscores of the Nasal Health Survey, and the total score demonstrated significant improvement (P < 0.05); 71% of patients had clinically significant improvement as determined by at least a 50% decrease in duration of nasal symptoms. Measures of general health did not differ significantly from normative values at baseline and did not change after surgical intervention. Predictor analysis revealed that female gender and a history of previous nasal surgery predicted worse outcome.

Septoplasty is the third most commonly performed surgical procedure by otolaryngologists in the United States and is generally performed to improve quality of life. 1 The outcome of this procedure and its impact on quality of life have never been clearly established. A number of studies have described both subjective and objective measures of outcome after septoplasty, but none has done so prospectively using a reliable and valid tool.

Outcomes research studies the impact of diverse therapies on a condition. 2 In other words, how effective are therapies at relieving distress, improving function, and decreasing disability? Appropriately designed and tested instruments enable researchers to determine outcomes with a high degree of confidence. The data provide important information to health care providers regarding the effectiveness of medical treatments and may be used to create treatment guidelines.

Researchers have proposed many methods of nasal airway evaluation including rhinomanometry, acoustic rhinometry, and nasal peak flow. 3 - 5 These methods can be inconsistent for predicting septoplasty outcome. Physical examination and measurements such as rhinometry do not consistently correlate with patient reports of nasal obstruction. 6 - 9 Therefore we believe there is a need for a sensitive, patient-based tool to assess the outcome of septoplasty.

The Nasal Health Survey (NHS; also known as the Chronic Sinusitis Survey) is a brief-duration-based monitor of nasal-specific health. It has demonstrated both validity and reliability. 10 , 11 The survey has both symptom- and medication-based sections for data collection. It is sensitive to change over time and has proved reliable in test-retest analysis, making it an excellent tool for patient monitoring. In this study, we used the Nasal Health Survey to study patients undergoing septoplasty.

The septoplasty procedure has many associated variables; some are surgeon dependent and others are patient dependent. In addition to looking at overall outcome, we have considered both patient- and surgeon-dependent variables as potential predictors of outcome.

This study had 2 main objectives: (1) to determine patient-based outcome in a population undergoing septoplasty; and (2) to assess potential predictors of outcome.

METHODS

A prospective nonrandomized longitudinal study was performed in consecutive patients presenting to the Massachusetts Eye and Ear Infirmary for septoplasty during a 12-month period. Patients undergoing rhinoplasty or nasal fracture reduction were included to represent a typical patient population undergoing nasal airway surgery for noninfectious indications. Patients with histories of sinus surgery or nasal polypectomy and those undergoing these procedures concomitantly were excluded because chronic infection may act as a confounding variable.

Table 1.

Multivariate analysis of predictors of outcome

Variable	P value
Sex	0.02
ASA class	NS
Previous nasal surgery	0.04
Asthma	NS
Smoking	NS
Environmental allergies	NS
Operating room time < 60 min	NS
Intraoperative use of antibiotics	NS
Intraoperative use of steroids	NS
Resident assistant	NS
Additional nasal surgery performed	NS
Turbinoplasty performed	NS
Septal support placed	NS
Nasal packing placed	NS
Discharged on oral antibiotics	NS
Complication	NS

NS, Nonsignificant at 0.05 level.

Table 2.

Preoperative and postoperative NHS and SF-12 scores (n = 93)

	Mean ± SD
Scale	Preoperative	Postoperative	P value
NHSs 49.1 ± 29.4	69.8 ± 29.4	0.001
NHSm	80.8 ± 20.6	85.8 ± 22.0	0.018
NHS	64.8 ± 21.2	78.1 ± 21.9	0.001
PCS 12	51.2 ± 8.1	52.5 ± 8.0	0.207
MCS 12	51.8 ± 7.1	50.8 ± 7.8	0.173

NHSs, Symptom subscore; NHSm, medication subscore.

Patients received a nasal-specific survey, the NHS, and a general health survey, the Medical Outcome Study Short-form 12-item Health Survey (SF-12), before and 6 and 12 months after surgery. The SF-12 is a well-established measure of general health that has been proved reliable and valid. It has both a physical component score (PCS) and a mental component score (MCS). The survey was administered with the permission of the Medical Outcomes Trust (Boston, MA) and scored as recommended. 12 An analogous algorithm was used for scoring the NHS, yielding 3 scores: a symptom-based score, a medication-based score, and a total score. According to convention, all scores were normalized to a 100-point scale, with 0 being the worst score and 100 the best. Mean scores for the NHS and SF-12 questionnaires were compared by the Student t test.

Hospital records and operative reports were reviewed retrospectively by a physician who was blinded to the results of the outcome analysis. Several variables were extracted from these records to evaluate predictors of outcome (Table 1). Certain variables were related to patient factors or comorbidities, and other factors were associated with the surgical procedure or perioperative management. We used univariate and multivariate regression analyses to determine the impact on outcome.

RESULTS

NHS and SF-12 surveys were distributed to 161 eligible patients. Ninety-three patients (58%) completed their follow-up surveys and were available for data analysis. The mean follow-up time was 9 ± 3 months.

Patient Characteristics

Fifty-seven percent of patients (53/93) who completed the survey were male. The average age was 40.1 years (range 22–78 years). A history of asthma was reported in 9 patients (10%). Ten patients (11%) were smokers, and 5 (5%) reported a history of environmental allergies requiring oral antihistamines. A subset of 8 patients (9%) had undergone previous nasal surgery including septoplasty, rhinoplasty, nasal fracture reduction, or cautery with outfracture of the inferior turbinate. Thirty-nine percent of patients used nasal sprays, and 42% took oral decongestants. The patients of 21 attending surgeons were included in the study. Surgeons had either hospital- or community-based practices. There were no statistically significant differences in general health, nasal specific health or demographics between the study group and those who did not complete their follow-up surveys.

Nineteen patients underwent additional nasal surgery at the time of septoplasty. The procedures included rhino-plasty (10), open nasal fracture reduction (6), closed nasal fracture reduction (2), and nasal valve repair (1). Sixty-five patients had some manipulation of their turbinates, and 62 patients had inferior turbinate reduction. Three patients had middle turbinate work alone.

SF-12

Postoperative SF-12 scores were virtually unchanged from preoperative scores (Table 2). SF-12 scores for this population were similar to normative scores as published by the Health Institute of Boston (PCS 50.12 ± 9.45, MCS 50.04 ± 9.59). 12

NHS

There was significant improvement in the symptom-based, medication-based, and total scores. Mean symptom-based scores increased from 49.1 to 69.8 (P < 0.001). Mean medication scores increased from 80.8 to 85.8 (P = 0.018), and total scores increased from 64.8 to 78.1 (P < 0.001) (Fig 1). Preoperative and postoperative scores on the NHS and SF-12 are presented in Table 2.

Fig 1.

Preoperative and postoperative NHS scores. NHSs, Symptom subscore; NHSm, medication subscore. ∗Statistically significant change.

Fig 2.

Total NHS scores for the normative group, preoperative and postoperative septoplasty patients, and preoperative and postoperative endoscopic sinus surgery patients. (∗Data from Gliklich RE, Metson R. Otolaryngol Head Neck Surg 1997;117:12–6.)

The subset of patients who underwent external nasal surgery (19) had improvement in both symptom sub-score and total score (mean improvements of 13.3 and 6.4, respectively). When patients who underwent external nasal surgery were excluded from the patient population, there was not a statistically significant change in total score (mean improvement of 15.1 vs 13.3). The subset of patients who had turbinate manipulation (62) had improvement in both symptom subscore and total score (mean improvements of 17.4 and 12.4, respectively). When patients who underwent turbinate manipulation were excluded from the patient population, there was not a statistically significant change in total score (mean improvement of 15.0 vs 13.3).

A change in NHS of 8 points requires a 4- of 8-week, or 50%, change in duration of nasal symptoms or medication usage. We used an improvement of 8 points or more to indicate clinical improvement. On the basis of this definition, 71% (66/93) of patients had improvement in nasal symptom score, and 48% (45/93) had improvement in medication score.

Analysis of patient- and surgeon-specific predictors revealed that in a univariate analysis, female gender and a history of previous nasal surgery predicted worse outcome (Fig 2). When a 4-variable multiple regression model was applied, again female gender and previous nasal surgery predicted worse outcome. Preoperative symptom, medication, and total scores were all significant predictors of postoperative scores. The higher the preoperative scores, the higher the postoperative scores. Correlation coefficients for symptom, medication, and total scores were 0.38, 0.46, and 0.49, respectively.

Comparison with Normative Data

Normative data for the NHS have been collected and reported for patients with no history of nasal and sinus disease. 13 The mean normative score for total NHS was 89.7, and the interquartile range (25th–75th percentile) was 83.3 to 100. Before surgery, 14% of patients were above the mean, and 42.7% were within the interquartile range. After surgery, 47% were above the mean, and 69% were within the interquartile range. For the symptom subscore, 35% of patients surpassed the mean after surgery, and 56% had scores within the normative interquartile range.

Complications

Complications occurred in 5 patients. Four patients required reoperation within 12 months. Two had repeat septoplasty, and 2 had additional external framework surgery. One patient had epistaxis that occurred approximately 3 hours after surgery. The epistaxis required packing placement in a treatment room but did not delay hospital discharge. This subgroup of 5 patients did not have a significantly worse outcome based on NHS scores.

DISCUSSION

An ideal tool for evaluation of septoplasty does not exist. Physical examination and various quantitative measures of the nasal airway do not necessarily correlate with symptoms. Because septoplasty is a procedure generally performed to improve nasal symptoms, a nasal-specific questionnaire provides a reasonable approach to the determination of outcome.

In this study, 71% of patients had at least a 50% decrease in duration of nasal symptoms, and 48% of patients had at least a 50% decrease in medication usage. The use of medications is an important potential confounding variable when determining outcome of nasal airway surgery. Therefore medication usage was also considered even though the vast majority of patients presented with a chief symptom of nasal obstruction. After septoplasty, large improvements in symptom scores were achieved, whereas changes in medication scores were smaller. Sixty-nine percent of patients achieved postoperative scores within a normative range. The literature has reported success rates between 63% and 85% with a variety of methods for determination of outcome. 3 , 9 , 14 - 18

Patients who underwent concomitant turbinate reduction or external nasal framework surgery were included to represent a typical population presenting with nasal airway symptoms. A feature of prospective observational outcome studies is that patients are studied in a natural clinical setting without an attempt to control or select environments. 2 When the subgroups of patients undergoing turbinate reduction or external nasal surgery were individually evaluated, there was no change in conclusions when compared with the remaining cohort. In addition, our conclusions did not change when these populations were excluded.

Baseline scores of general health were similar to those of a normative population and did not change with surgical intervention. This indicates that the burden of disease was low and that the general health status of this patient population was comparable with that of the general population. Surgical intervention had virtually no impact on overall health.

Patients with septal deviation achieved an intermediate score on the NHS between a normative group and those undergoing endoscopic sinus surgery 13 (Fig 2). The NHS establishes a ruler for nasal disease. It demonstrates where patients with isolated septal deviation fall in the spectrum of nasal health.

Predictor analysis revealed that female gender and a history of previous nasal surgery predicted worse outcome after septal surgery. Reasons for a difference in outcome based on gender may relate to differences in nasal airway anatomy or hormonal influences on nasal congestion. A worse outcome in patients with histories of previous nasal surgery may be caused by nasal airway alterations from a previous procedure that were not corrected at reoperation. 19 , 20

Predictor analysis also revealed trends toward worse outcome in nonsmokers, those with longer operating room times, patients who had turbinate work, and those who received intraoperative steroids. The sample size was inadequate to determine whether these trends are truly significant.

There was no consensus regarding the most appropriate way to determine outcome after septoplasty or other nasal airway surgery. Rhinometry is a commonly used measure of nasal patency. Because rhinometric findings may not correlate well with symptoms or examination, many have suggested that rhinometry has little value in a clinical setting. 7 , 8 , 21 , 22 Rhinometry testing demonstrated suboptimal test-retest consistency, which may be associated with the nasal cycle and affected by various mediators of nasal congestion. 21 In addition, clinical examination and CT of the nasal passages can suggest findings much different than those experienced by the patient. 6

Although this study aimed to evaluate septoplasty outcome in a natural clinical setting, the results of this study should be evaluated with some caution. First, only 58% of eligible patients had follow-up. Many patients were not willing to complete follow-up questionnaires. It is unclear if this unwillingness indicates either satisfaction or dissatisfaction with the results of the procedure. There were no statistically significant differences in general health, nasal-specific health, or demographics between the group with follow-up data and the group who did not complete their surveys. Second, a mean follow-up period of 9 months should be considered short-term. A 9-year follow-up study has shown that both subjective and objective changes in nasal airway patency take place over time. 23 Finally, the use of multiple t tests to compare preoperative and postoperative mean test scores might have increased the cumulative type I error or the probability of false identification of a significant difference.

CONCLUSIONS

Patients with septal deviation demonstrate subnormative levels of nasal-specific health and normative levels of general health.

After septoplasty, there was a significant improvement in nasal-specific health with no change in measures of general health.

Female gender and history of previous nasal surgery predicted worse outcome.

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