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Eur Arch OtorhinolaryngolDOI 10.1007/s00405-014-3054-y

RhInOlOgy

Clinical outcomes and quality of life in patients with nasal polyposis after functional endoscopic sinus surgery

Vojko Djukic · Zoran Dudvarski · Nenad Arsovic · Milovan Dimitrijevic · Ljiljana Janosevic

Received: 30 December 2013 / Accepted: 8 April 2014 © Springer-Verlag Berlin heidelberg 2014

Endoscopic score was on average significantly lower after 6 and 12 months of FESS (p < 0.05), but the mean score value after 12 months of operation was significantly higher in relation to that after 6 months of surgery (p < 0.05). nev-ertheless, the recurrence of nP was observed in 28 patients (32.9 %) in the follow-up period. In conclusion, FESS in nP patients results in significant improvement of symp-tom intensity, Qol and endoscopic score. While the inten-sity of symptoms and Qol showed a tendency to maintain between 6 and 12 months after surgery, endoscopic score showed a tendency of exacerbation in the same period.

Keywords nasal polyposis · Quality of life · Functional endoscopic sinus surgery · Outcomes

Introduction

nasal polyposis (nP) is a chronic inflammatory disease of the nasal and sinus mucosa leading to protrusion of edem-atous polyps in the nasal cavity [1]. nP is considered to be a subgroup of chronic rhinosinusitis and it frequently develops within different diseases such as asthma, aspirin intolerance, and cystic fibrosis. According to some studies, prevalence of nP among the chronic rhinosinusitis patients is 25–30 % [2]. Recent studies have evidenced that nP may lead to significant limitations in physical, emotional and social aspects of life of the affected patients [3, 4]. There-fore, in addition to clinical measurements of the intensity of the disease based on symptoms, endoscopic and com-puterized tomography (CT) sinus findings, measurement of health-related quality of life (Qol) also represents an important additional aspect in global assessment of nP patients. Some authors have proved that Short Form-36 health Survey (SF-36) questionnaire is valid and reliable

Abstract The majority of studies have shown that the use of functional endoscopic sinus surgery (FESS) leads to symptomatic improvement in 73–98.4 % of patients with chronic rhinosinusitis and nasal polyposis (nP). The aim of the study is to evaluate clinical outcomes and quality of life (Qol) in patients with nP after FESS. The prospective study included 85 consecutive adult patients (≥18 years) with nP who were operated on using FESS after fail-ure of the medicamentous treatment and in certain cases of surgical treatment. Qol was assessed by Short Form-36 health Survey (SF-36) questionnaire, and the symp-tom intensity was presented using visual analogue scale (VAS). The objective finding was presented as endoscopic and computerized tomography (CT) score. The intensity of each symptom, the values of symptom scores (major, minor and total), the values of dimension scales and sum-mary scales of the Qol, as well as the values of endoscopic score through three periods of time (pre-surgery, 6 and 12 months after the surgery) were analyzed. Following the FESS, mean intensity values of all individual symptoms and symptom scores were significantly lower and the val-ues of all dimension scales and summary scales of Qol were significantly higher (p < 0.05). There was no statisti-cally significant difference in symptom intensity and Qol after 6 and 12 months of surgical treatment (p > 0.05).

V. Djukic · Z. Dudvarski · n. Arsovic · M. Dimitrijevic · l. Janosevic Faculty of Medicine, University of Belgrade, Belgrade, Serbia

V. Djukic · Z. Dudvarski (*) · n. Arsovic · M. Dimitrijevic · l. Janosevic Clinic of Otorhinolaryngology and Maxillofacial Surgery, Clinical Center of Serbia, 2, Pasterova Street, 11000 Belgrade, Serbiae-mail: zdudvarski@open.telekom.rs

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for assessment of Qol of nP patients [3, 4]. The failure of medicamentous treatment requires the use of functional endoscopic sinus surgery (FESS). So far, the majority of studies have shown that FESS results in symptomatic improvement in 73–98.4 % of patients with the chronic rhinosinusitis [5–7]. nP as a subgroup of chronic rhinosi-nusitis is characterized by higher preoperative intensity of disease and poorer postoperative results [8–10].

The aim of this study was to evaluate the clinical out-comes and Qol in patients with nP after FESS.

Materials and methods

Study design

This prospective study was carried out at the Clinic of Otorhinolaryngology and Maxillofacial Surgery, Clinical Center of Serbia in Belgrade in the period from December 2010 to March 2012. The study was approved by the Ethics Board of the Faculty of Medicine, University of Belgrade and informed consents for surgical treatment and participa-tion in the study were obtained from all patients. The study included 85 consecutive adult patients (≥18 years) with nP who were operated on using FESS after failure of the medicamentous treatment and in certain cases of surgical treatment. Diagnosis of nP was based on medical history, anterior rhinoscopy, endoscopic examination of the nose and CT findings of the paranasal sinuses. Inclusion criteria were the following: bilateral nasal polyposis detected upon anterior rhinoscopy or nasal endoscopy, bilateral opacifica-tion of the paranasal sinuses on CT scans and postoperative histopathological verification of the nasal polyposis. Exclu-sion criteria were as follows: unilateral nasal polyposis, antrochoanal polyp, and histopathological verification of the neoplasm.

The patients had their control visits on postoperative days 7, 14 and 28, and then these visits were on monthly basis. Other than regular postoperative nose toilet by saline, intranasal corticosteroid therapy was prescribed to all patients for 3 months. The intensity of each symptom, the values of symptom scores (major, minor and total), the val-ues of dimension scales and summary scales of the Qol, as well as the values of endoscopic score through three time periods (pre-surgery, 6 and 12 months after the surgery) were analyzed.

Subjective measurements and Qol

Based on recommendations of the task force on rhinosinus-itis, patient’s subjective symptoms were divided to major and minor factors [11]. Major factors were the following:

nasal obstruction, nasal/postnasal secretion, facial pain/pressure, facial congestion/fullness, and hyposmia. Minor factors were as follows: headache, malaise/fatigue, fetor ex ore, cough, dental pain, pain/pressure/fullness in the ears and fever. Intensity of each symptom was assessed by the patients themselves using visual analogue scale (VAS) with values ranging from 0 to 10, with higher value designat-ing more intensive symptoms. Scores of minor and major symptoms as well as total symptom score were obtained by summation of the individual symptom intensity.

Qol was presented by general health questionnaire SF-36 completed by patients themselves. The questionnaire included 36 questions and it was designed to measure eight major health domains, including: physical function (PF), physical role (RP), body pain (BP), general health (gh), vitality (VT), social function (SF), emotional role (RE), and mental health (Mh). Using certain methodology, scores of domain scales with their values ranging between 0 and 100 were obtained, with higher value designating better Qol. Based on domain scales, the summary scales for physical (PCS) and mental health (MCS) were obtained [12, 13].

Objective measurements

All patients were examined by the same otorhinolaryngolo-gist and in addition to routine anterior rhinoscopy, endo-scopic examination of the nose using 4.0 mm rigid endo-scope at the angle of 0° and 30° was also performed. The finding was expressed through endoscopic score accord-ing to recommendations given by lund and Kennedy [14]. Using three-stage scale, the following elements were graded: polyps (0-absent, 1-confined to middle meatus, 2-beyond the middle meatus), secretion (0-absent, 1-clear and thin, 2-thick and purulent), edema, crusts and adhe-sions (0-absent, 1-mild, 2-severe). Each side of the nose was separately assessed and their scores represented the total endoscopic score.

All patients underwent preoperative CT examination of the paranasal sinuses in two planes, coronal and axial, with 3 mm section intervals. The findings were presented through CT score based on recommendations given by lund and Mackay [15]. CT findings were evaluated by the same radiologist who had no insight into other clini-cal characteristics of patients. Maxillary, anterior and pos-terior ethmoid, frontal and sphenoid sinuses were graded using three-stage scale (0-no abnormality, 1-partial opaci-fication, 2-total opacification), while ostiomeatal com-plex was graded using two-stage scale (0-not obstructed, 2-obstructed). Each side of the nose was separately evalu-ated with their score representing total CT score. higher values of the endoscopic and CT scores designated higher intensity of the disease.

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Statistical analysis

All statistical analyses were performed by SPSS 12.0 (SPSS Inc., Chicago, Illinois) statistical package. Results were expressed as frequency, percent and mean ± SD. The Wilcoxon Signed Ranks test was used to compare values through three time periods (pre-surgery, 6 and 12 months after surgery). All p values <0.05 were considered significant.

Results

Demographic data, comorbidities, and objective findings of 85 patients with nP were illustrated in the following table (Table 1).

The intensity of all symptoms (VAS) was significantly lower 6 months after surgical intervention except for dental pain. A year after surgical treatment, the intensity of each symptom was significantly lower for all symptoms. There was no statistically significant difference in individual symptom intensity after 6 and 12 months of surgical treat-ment. Mean values of symptom scores (major, minor and total) were significantly lower after 6 and 12 months of surgical treatment in relation to preoperative values. There was no statistically significant difference in mean symptom score values after 6 and 12 months of surgical treatment (Table 2).

Qol of nP patients was significantly better for all dimension scales and summary scales of SF-36 after 6 and 12 months of surgical treatment. In the period 6–12 months of operation, there was no significant difference in the Qol for all dimension scales and summary scales of SF-36 (Table 3).

Mean value of preoperative CT score for all subjects was 18.3 ± 4.8. Endoscopic score was significantly lower after 6 (Z = −7.856; p < 0.001) and 12 months of surgi-cal treatment (Z = −7.522; p < 0.001). Mean endoscopic score after 12 months of operation was significantly higher than the score recorded after 6 months of operation (Z = −3.002; p = 0.003) (Fig. 1).

Discussion

In our study, mean values of the intensity of nasal obstruc-tion and hyposmia were highest before operation (VAS

Table 1 Preoperative characteristics of 85 patients with nP

a Mean ± SDb number of patients (%)

Agea 48.0 ± 14.3

Malesb 50 (58.8 %)

Femalesb 35 (41.2 %)

Previous surgeryb 38 (44.7 %)

Allergyb 29 (34.1 %)

Asthmab 33 (38.8 %)

Aspirin intoleranceb 22 (25.9 %)

Endoscopic scorea 8.4 ± 2.2

CT scorea 18.3 ± 4.8

Table 2 Intensity of symptoms and scores before and after surgery (X ± SD)

Test time Test results

0 month 6 months 12 months 0–6 months 0–12 months 6–12 months

nasal obstruction 7.9 ± 1.7 1.9 ± 2.2 2.1 ± 2.3 p < 0.001 p < 0.001 p = 0.222

nasal/postnasal secretion 6.7 ± 2.9 2.6 ± 2.2 2.9 ± 2.6 p < 0.001 p < 0.001 p = 0.065

Facial pain/pressure 2.2 ± 2.8 0.5 ± 1.2 0.5 ± 1.3 p < 0.001 p < 0.001 p = 0.984

Facial congestion 3.5 ± 3.6 0.7 ± 1.5 0.9 ± 1.8 p < 0.001 p < 0.001 p = 0.182

hyposmia 8.5 ± 2.3 5.1 ± 3.8 5.3 ± 3.9 p < 0.001 p < 0.001 p = 0.205

headache 2.6 ± 3.2 0.9 ± 1.8 0.8 ± 1.7 p < 0.001 p < 0.001 p = 0.373

Fetor ex ore 1.4 ± 2.4 0.5 ± 1.3 0.5 ± 1.4 p < 0.001 p < 0.001 p = 0.670

Malaise/fatigue 4.1 ± 3.2 2.0 ± 2.4 2.3 ± 2.4 p < 0.001 p < 0.001 p = 0.103

Dental pain 0.6 ± 1.5 0.2 ± 0.8 0.2 ± 0.6 p = 0.077 p = 0.038 p = 0.285

Cough 2.5 ± 2.9 1.1 ± 1.7 1.3 ± 1.9 p < 0.001 p < 0.001 p = 0.065

Pressure/fullness in the ears 2.3 ± 3.0 0.9 ± 2.0 0.7 ± 1.8 p < 0.001 p < 0.001 p = 0.495

Fever 0.6 ± 1.5 0.0 ± 0.0 0.1 ± 0.7 p = 0.001 p = 0.015 p = 0.317

Major score 28.9 ± 7.8 10.8 ± 6.9 11.8 ± 7.9 p < 0.001 p < 0.001 p = 0.116

Minor score 13.9 ± 10.5 5.6 ± 5.3 5.8 ± 5.5 p < 0.001 p < 0.001 p = 0.365

Total score 42.9 ± 15.9 16.4 ± 10.4 17.7 ± 11.4 p < 0.001 p < 0.001 p = 0.260

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≥7–10), and mean values of the intensity of nasal/postnasal secretion and facial congestion were moderate (VAS ≥3–7). As expected, the intensity of facial pain/pressure was lowest (VAS 0–3) because this symptom is the characteris-tic of the acute rhinosinusitis or exacerbation of the chronic rhinosinusitis. Out of minor symptoms, only fatigue was moderately intense (VAS ≥3–7), while mean values of the intensity of other symptoms were lower. nevertheless, it should be underscored that the mean intensity values of minor symptoms such as headache, cough and feeling of fullness and pressure in the ears corresponded to values of some major factors. Possible explanation lies in significant degree of inflammation and presence of certain comorbidi-ties, before all asthma, in patients with nP. For this reason, these symptoms have definitely clinical significance and therefore should be considered. given that the majority of nP patients have marked hyposmia, data related to fetor ex ore are not always reliable. Mean VAS score values of dental pain and fever were minimal (VAS <1). Therefore, it may be noted that the symptoms such as fetor ex ore, dental pain and fever are not characteristic for nP patients and not so clinically significant.

The studies by Damm et al. [16] and nair et al. [17] showed that, in patients with the chronic rhinosinusitis and nP, the highest prevalence and intensity were found for nasal obstruction, nasal secretion and hyposmia, as confirmed by our study as well. In study by Dufour et al. [18], which included 60 patients with diffuse nP, preopera-tive nasal obstruction was recorded in 88.3 % of patients, and hyposmia in 96.4 % of patients, with the intensity on VAS from 7 to 10. Rhinorrhea of the same intensity was recorded in 48.3 % of patients and headache in 33.3 % of patients. In study of Soler et al. [19], the highest preopera-tive VAS intensity was recorded for nasal congestion (6.5), followed by fatigue (6.0), headache (5.8), hyposmia (5.5), nasal secretion (5.5) and facial pain/pressure (5.5). Mean values of all analyzed symptoms were moderate because the research involved clinically heterogeneous group of patients with the chronic rhinosinusitis with and without nasal polyps. This confirms the significance of some minor symptoms of the clinical picture of chronic rhinosinusitis, what was also observed in our research of nP.

Although the criteria of assessment of therapeutic suc-cess and follow-up period are different, the majority of authors report symptomatic improvement after FESS-a in 73–98.4 % of patients with the chronic rhinosinusitis and nP [5–9, 20, 21].

In our study, after 6 and 12 months of FESS, statisti-cally significant improvement was achieved for all symp-toms except for dental pain after 6 months. As mentioned above, the intensity of dental pain was preoperatively very low and there was no particular clinical significance. The highest degree of improvement was achieved for nasal obstruction. One year after surgery, 76 patients (89.4 %) had an improvement in breathing through the nose (from severe to moderate 31.5 %, from severe to mild 64.8 % and from moderate to mild 80 %). In 58 patients (68.2 %), there was a significant decrease in nasal/postnasal secre-tion 12 months postoperatively (from severe to moderate 32.4 %, from severe to mild 51.4 % and from moderate to

Table 3 Dimension scales and summary scales of SF-36 before and after surgery (X ± SD)

Test time Test results

0 month 6 months 12 months 0–6 months 0–12 months 6–12 months

PF 76.9 ± 18.3 83.3 ± 17.6 81.9 ± 19.9 p < 0.001 p = 0.001 p = 0.388

RP 57.6 ± 41.2 77.1 ± 36.3 79.4 ± 34.1 p < 0.001 p < 0.001 p = 0.554

BP 70.7 ± 24.3 83.5 ± 23.8 81.1 ± 21.5 p < 0.001 p < 0.001 p = 0.291

gh 58.9 ± 18.7 66.6 ± 18.5 66.2 ± 18.5 p < 0.001 p < 0.001 p = 0.998

VT 59.5 ± 20.0 72.6 ± 17.5 72.0 ± 17.6 p < 0.001 p < 0.001 p = 0.924

SF 70.1 ± 21.9 84.4 ± 19.2 82.8 ± 20.2 p < 0.001 p < 0.001 p = 0.706

RE 65.9 ± 40.5 78.8 ± 36.3 81.6 ± 33.9 p = 0.006 p = 0.001 p = 0.397

Mh 66.7 ± 21.8 77.3 ± 19.2 77.3 ± 18.4 p < 0.001 p < 0.001 p = 0.900

PCS 64.6 ± 19.4 77.1 ± 18.2 75.9 ± 17.9 p < 0.001 p < 0.001 p = 0.261

MCS 64.2 ± 20.2 76.4 ± 18.2 75.9 ± 18.0 p < 0.001 p < 0.001 p = 0.698

0

2

4

6

8

10

12

14

16

18

20

0 month 6 month 12 month

8.4 ± 2.2

2.8 ± 2.7 3.7 ± 2.9

Fig. 1 Endoscopic score before and after operation (X ± SD)

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mild 75 %), while only 44 patients (51.8 %) had improve-ment in function of the sense of smell (from severe to mod-erate 25 %, from severe to mild 23.4 % and from moder-ate to mild 76.5 %). hyposmia is the only symptom whose mean value of the intensity after 6 and 12 months of sur-gical treatment was moderate (VAS ≥3–7). Reasons for poorer recovery of sense of smell may lie in the length of hyposmia (9.5 years on average) and a large number of previously operated patients (44.7 %), what all suggests a severe form of nP refractory to treatment. Federspil et al. [22] believed that there was certain kinetics of olfactory deficit recovery. Thus, FESS resulted immediately in the impairment of olfactory function and then led to gradual recovery and stabilization after 6 months of operation. nair et al. [17] pointed out that the patients with the chronic rhi-nosinusitis experienced, 1 year after FESS, a significant improvement regarding all symptoms but hyposmia in the nP subgroup. In study of Dufour et al. [18], postoperative improvement of the nasal breathing and the function of the smell was recorded in 61.7 and 32.1 % of patients with nP (VAS ≤3), while 44 % of patients still had anosmia (VAS ≥7). These results were worse in comparison with some earlier studies, probably due to longer period of follow-up (6.5 years), stricter selection of patients for surgical treat-ment (duration of symptoms––7 years on average) and VAS implementation for grading of symptom intensity. There-fore, the function of the smell in nP patients after FESS had the lowest degree of recovery, what was also confirmed by our study results.

In spite of the fact that all analyzed symptoms in our study had a tendency of maintenance after 6 months of surgical treatment, it should be pointed that mean inten-sity values of nasal obstruction, nasal/postnasal secretion, hyposmia, malaise and cough were slightly higher after 12 months of follow-up. Insignificant worsening of symp-toms in the postoperative period of 6–12 months has been recorded by some other authors as well. Alobid et al. [23] reported a significant improvement of symptoms after 12 months of FESS but also an insignificant worsening of nasal obstruction, rhinorrhea and hyposmia in comparison to values recorded 6 months after operation.

Earlier studies have shown that the Qol of nP patients was significantly lower in all domains of SF-36 question-naire in relation to control healthy individuals [3]. In rela-tion to patients with perennial allergic rhinitis, the patients with nP had significantly lower Qol in even 6 out of 8 domains of SF-36 survey what may be accounted for higher degree of nasal obstruction and hyposmia [3]. Our study demonstrated that the highest effect of nP on the Qol was in domains of RP, gh and VT, what is compatible with data reported by Radenne et al. [3]. In distinction from our research, where significant improvement of the Qol was achieved after FESS in all domains, Radenne et al. [3]

reported significant improvement of the Qol in Mh, VT, gh, SF, and BP domains. In PF domain, there was no sig-nificant difference in degree of the Qol what corresponds, to some extent, to our study results, because the lowest degree of improvement was recorded right in this domain. In our study, 1 year after the operation, the lowest degree of improvement of the Qol has been achieved for PF. This domain includes ten questions related to usual daily activities that generally not require more physical effort. Probably because of that the baseline Qol was the best in this domain. The Qol in a population of healthy subjects according to the values of SF-36 dimension scales ranging from 72 (VT) to 95 (PF) (3). In study of nP patients (4), the best baseline Qol was in PF domain (78), which is similar to our result (76.9). Furthermore, Alobid et al. [4] reported that the Qol of patients with nP is worse as compared to the general population for all SF-36 measuring scales, except for PF. For these reasons, the degree of improve-ment of the Qol in PF domain has not the same clinical significance in comparison to other domains. We expected a greater degree of improvement of the Qol in gh domain. however, just in this domain we have recorded the lowest value 1 year after the operation. A possible explanation is that a large number of patients on questions related to the opinion about their own health responded with an answer “I do not know”. This is certainly reflected in the score in this domain.

In our study, the highest degree of improvement of the Qol was achieved in RP, RE, VT, and SF domains. Slightly, lower degree of improvement we have noted in BP and Mh domains of SF-36 questionnaire. In clinical sense, this means a better functioning of the workplace, as well as regular living, social and family activities as a result of improved physical and emotional health.

It should be emphasized that study by Radenne et al. [3] also involved patients who were not surgically treated. In distinction from previous studies, which found higher impact of nP on mental vs. physical health, our results showed an equal effect of nP on these two aspects of health. Moreover, in our research, summary PCS and MCS scales had approximately higher values in relation to ref-erence data. In 6–12 months postoperative period, the ten-dency of maintenance of the Qol was recorded. In spite of numerous specific questionnaires for the assessment of Qol in patients with the chronic rhinosinusitis, it should be noted that there is no specific questionnaire for the assessment of Qol of patients with nP. Such questionnaire should be designed to illustrate more precisely the spec-trum and intensity of symptoms with their effect on daily activities, sleep disorders and other practical issues.

In our study, endoscopic score was significantly bet-ter after 6 and 12 months of operation for nP. neverthe-less, mean endoscopic score after 12 months of operation

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was significantly worse in relation to values recorded after 6 months of operation. Therefore, in distinction from the intensity symptoms and the Qol where the tendency of maintenance was recorded 6 months after FESS, endo-scopic score was featured by tendency of exacerbation. This confirms the results of many earlier studies reporting no correlation of subjective and objective tests used for the assessment of disease intensity and results of treatment of chronic rhinosinusitis and nP.

Regardless of excellent subjective results of treatment, Kennedy et al. [5] pointed that residual disease was recorded endoscopically in 44.9 % of patients after mean follow-up of 18 months. Robinson et al. [24] reported that 57–74 % of patients with the chronic rhinosinusitis after FESS mani-fested improvement of endoscopic score. nair et al. [17] emphasized a significant improvement of endoscopic score in patients with the chronic rhinosinusitis 1 year after opera-tion, but also a tendency of score increase in nP subgroup. In our research, significant improvement of endoscopic score was achieved after 12 months of FESS, but the recur-rence of nP was observed in 28 patients (32.9 %). Out of these, 5 patients (5.9 %) underwent, after 11 months follow-up, a revision surgery due to marked symptoms. According to literature data, recurrence rate of nP after surgical treat-ment is 11–60 %, depending upon the time of follow-up and study design [18, 25–28]. In our study, a recurrence rate of nP after a year of FESS was relatively high, but it has to be considered that almost a half of patients (44.7 %) had the history of at least one operation for nP. Accordingly, it was mostly about the patients having severe form of nP that was refractory to medicamentous and surgical treatment. This was supported by mean value of preoperative CT score (18.3) and a significant comorbidity percentage, before all, asthma (38.8 %) and aspirin intolerance (25.9 %).

During the 1 year follow-up, we have noticed that cer-tain factors (previous surgery, asthma and aspirin intoler-ance) may affect the results of surgical treatment of patients with nP and that will be the subject of our further research.

In conclusion, FESS performed in patients with nP achieves significant improvement of symptom intensity, Qol and endoscopic score. While the intensity of symp-toms and Qol showed a tendency to maintain between 6 and 12 months after surgery, endoscopic score showed a tendency of exacerbation in the same period.

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