AMERI CA N JOURNAL OF OT OLAR YNGOLOGY–H E AD AN D N E CK M EDI CI N E AN D S U RGE RY 3 6 ( 2 0 15 ) 47–5 1
Available online at www.sciencedirect.com
ScienceDirect www.elsevier.com/locate/amjoto
Quality of life outcomes after functional endoscopic sinus surgery for nasal polyposis C. Adnane⁎, T. Adouly, A. Zouak, M. Mahtar Department of ENT, 20 août hospital, Ibn Rochd University Hospital, Casablanca, Morocco
ARTI CLE I NFO
A BS TRACT
Article history:
Purpose: The objective of this study is to determine the results of functional endoscopic
Received 15 July 2014
sinus surgeries (FESS) for chronic rhinosinusitis with polyps and assess the association between surgery and specific quality of life outcomes. Materials and methods: A prospective study was performed in a tertiary referral center. Fifty-eight patients affected by chronic rhinosinusitis with nasal polyposis underwent endoscopic sinus surgery from January 2011 to April 2013 and followed for 1 year. The rhinosinustis disability index (RSDI), a validated disease-specific instrument, was used to quantify the patient's symptoms before and 12 months after surgery. Results: A strongly statistically significant reduction was seen between the mean scores on RSDI before and after FESS [86.43 (IQR = 16.10) versus 51.16 (IQR = 18.95), Wilcoxon signedrank test, p < 0.0001]. In multiple regression model, only four preoperative characteristics predicted the outcomes. The high mucosal eosinophilia density was the most important preoperative predictor. Conclusions: There is evidence which supports the efficacy of FESS to improve long-term QOL outcomes in patients with CRS. The mucosal eosinophilia density and prior sinus surgery appeared to be the most predictive factors of surgical outcomes. © 2015 Elsevier Inc. All rights reserved.
1.
Introduction
Nasal polyposis is a chronic inflammatory disease which originates in the upper part of the nose around the openings to the ethmoidal sinuses [1,2]. It is a subgroup of chronic rhinosinusitis that affected around 4% of the general population [3]. The diagnosis of nasal polyposis is clinical and based on the nasal endoscopy. Since Kennedy et al. introduced functional endoscopic sinus surgery; it has become largely used for treating nasal polyposis resistant to medical treatment [4–6]. There are very little published studies on functional endoscopic sinus surgery (FESS) results in chronic rhinosinusitis (CRS) with polyps that exclude other CRS categories.
The purpose of this study is to report outcomes of 58 patients with nasal polyposis undergoing FESS and assess the association between surgery and specific quality of life outcomes. In addition, preoperative patient factors are evaluated to predict clinically significant outcomes which can help for surgical case selection.
2.
Materials and methods
2.1.
Study design
A prospective study was carried out between January of 2011 and April of 2013 at a university hospital, tertiary referral center, after approval of the ethics committee.
⁎ Corresponding author at: Hopital 20, aout ORL Chu Ibn Rochd, Casablanca 20000 Morocco. Tel.: +212 066 1377 305. E-mail address: [email protected] (C. Adnane). http://dx.doi.org/10.1016/j.amjoto.2014.09.003 0196-0709/© 2015 Elsevier Inc. All rights reserved.
48
AMERI CAN JOURNAL OF OTOLAR YNGOLOGY–H E AD AN D N E CK M EDI CI N E AN D S U RGE RY 3 6 ( 2 0 15 ) 47–5 1
2.2.
Patient sample
A total of 58 patients who underwent FESS from January 2011 to April 2013 were evaluated and followed for 1 year. Inclusion criteria were: - Chronic rhinosinusitis (CRS) patients with bilateral nasal polyps (NP) who had not improved after at least 6 months of drug therapy; - Patients undergoing functional endoscopic sinus surgery (FESS); - Age above 18 years. Exclusion criteria were: -
Other subgroups of CRS; Secondary CRS; No preoperative CT scan; Age under 18 years; Pregnancy; Immunodeficiency; Patients who underwent revision endoscopic sinus surgery during the study for other complications.
2.3.
topical nasal steroid on each nostril every 12 hours for 1 year; saline irrigation and endoscopic dressing were performed for 6 weeks.
2.5.
The rhinosinustis disability index (RSDI), a validated diseasespecific instrument, was used to quantify the patient's symptoms before and 12 months after surgery [10]. Thirty questions were asked and each was scored on 0 to 4 scale (0 = never, 1 = almost never, 2 = sometimes, 3 = almost always, 4 = always). The RSDI was calculated for a total score and for functional, emotional and physical fields (Table 2). The endoscopic examination was scored by the physician using the Lund–Kennedy scoring system before and 12 months after surgery [11]. It includes three parameters: nasal polyps (0 = absent, 1 = polyps within the middle meatus, 2 = beyond the middle meatus, 3 = reaching to or below the lower border of the inferior turbinate or medial to the middle turbinate); edema and crusting (0 = absent, 1 = mild, 2 = severe) and discharge (0 = absent, 1 = clear and thin discharge, 2 = thick and purulent discharge).
Diagnosis of CRS with nasal polyposis 2.6.
The diagnosis of nasal polyposis was based on the definition of the European academy of allergology and clinical immunology (EAACI) [7]. Preoperative CT scans of the sinuses were classified using the Lund–Mackay scoring system [8].
2.4.
Quality of life assessment and endoscopy scores
Treatment and follow-up
Medical treatment was the first therapy introduced at least for 6 months. It was based on topical nasal steroid (budenoside spray) on each nostril every 12 hours and short cures of oral steroid (prednisolone) for 7 days (maximum 3 cures per year). FESS was performed under general anesthesia, the surgical technique was as described by Messerklinger and the extent of surgery was at least a bilateral unciformectomy with functional anterior ethmoidectomy [9]. Septoplasty and/or inferior turbinoplasty were performed when indicated (Table 1). Postoperative care was as follows: the nasal packing was removed 2 days post operatively; all patients received amoxicillin and clavulanic acid (1 g/125 mg) twice a day for 10 days and
Statistical analysis
The data sets were analyzed using SPSS 20.0. The normal distribution was assessed by using Shapiro–Wilk test and skewness kurtosis z-values. Clinically significant improvement was defined as a change of ≥½ standard deviation (SD) of the baseline RSDI score [12]. So the improvement was defined as a decrease of ≥ 8.0515 points. The Wilcoxon signed-rank test was used to compare RSDI scores before and after FESS. Correlation and multiple regression analysis were used to assess the relationship between preoperative characteristics and significant improvement after surgery. Multiple regression models were chosen using forced entry method and stepwise method selection. A p value under 0.05 (5%) was considered statistically significant for all analyses.
3.
Results
There were 58 patients who met the inclusion criteria for this study. The sex-ratio was 1 (29 male and 29 female). The average
Table 1 – Repartition of surgical procedures performed.
Maxillary antrostomy Ethmoïdectomy Partial Total Sphenoidotomy Frontal sinusotomy Septoplasty Inferior turbinectomy
Right side number Left side number (%) (%)
Table 2 – Mean change in QOL after endoscopic sinus surgery.
58 (100)
58 (100)
RSDI
Preoperative (mean ± SD)
Postoperative (mean ± SD)
Absolute Δ (mean ± SD)
13 45 8 2
13 (22.4) 45 (77.6) 4 (6.9) 0
Total Physical Functional Emotional
86.43 28.60 27.64 30.19
51.16 15.50 16.64 19.02
35.28 13.10 11.00 11.17
(22.4) (77.6) (13.8) (3.4)
4 (6.9) 3 (5.2)
3 (5.2)
± ± ± ±
16.103 6.644 5.139 5.841
± ± ± ±
18.950 6.642 6.558 6.653
Δ: absolute change value of RSDI score. QOL: quality of life. RSDI: Rhinosinusitis Disability Index. SD: standard deviation.
± ± ± ±
17.390 6.415 5.660 6.481
49
AMERI CA N JOURNAL OF OT OLAR YNGOLOGY–H E AD AN D N E CK M EDI CI N E AN D S U RGE RY 3 6 ( 2 0 15 ) 47–5 1
Table 3 – Characteristics of patients with nasal polyposis. Mean ± SD Age (years) Gender: Male Female Clinical characteristics: Asthma Aspirin intolerance Prior sinus surgery Preoperative diagnostic testing: Lund–Kennedy endoscopy score Lund–Mackay CT score
Number (%)
39.22 ± 11.54 29 (50) 29 (50) 27 (46.6) 3 (5.2) 8 (13.8) 9.62 ± 2.15 21.12 ± 3.39
CT: computed tomography. SD: standard deviation.
age was 39.22 years and the median was 40.00 years (IQR = 19 and SD = 11.544). Characteristics of patients in the study are described in Table 3. Asthma was more prevalent (46.6%). Epithelial hyperplasia was observed in all the patients and 44.8% of patients were with high mucosal eosinophilia (Table 4). A strongly statistically significant reduction was seen between the scores attained pre and postoperatively on RSDI [86.43 (IQR = 16.10) versus 51.16 (IQR = 18.95), Wilcoxon signed-rank test, p < 0.0001] (Fig. 1). According to clinical significant improvement based on a decrease of 8.0515 points or superior on the RSDI, only one patient had not improved. On univariate analysis, the Spearman's rank correlation coefficient and the Mann–Whitney U test were used to choose predictor factors that significantly affected QOL improvement at the p ≤ 0.5. Twelve predictors were retained for multiple regression model: age, gender, prior sinus surgery, asthma, ASA intolerance, Lund–Kennedy endoscopy score, Lund–Mackay CT score, high mucosal eosinophilia density, squamous metaplasia, glandular hypertrophy, total ethmoidectomy and preoperative RSDI score. The first multiple regression model used forced entry method. Only four preoperative characteristics predicted the outcomes (Table 5). This model was able to explain 45.1% of the change in QOL (R2 = 0.451 and adjusted R2 = 0.305). There was no collinearity within our data (VIF
Available online at www.sciencedirect.com
ScienceDirect www.elsevier.com/locate/amjoto
Quality of life outcomes after functional endoscopic sinus surgery for nasal polyposis C. Adnane⁎, T. Adouly, A. Zouak, M. Mahtar Department of ENT, 20 août hospital, Ibn Rochd University Hospital, Casablanca, Morocco
ARTI CLE I NFO
A BS TRACT
Article history:
Purpose: The objective of this study is to determine the results of functional endoscopic
Received 15 July 2014
sinus surgeries (FESS) for chronic rhinosinusitis with polyps and assess the association between surgery and specific quality of life outcomes. Materials and methods: A prospective study was performed in a tertiary referral center. Fifty-eight patients affected by chronic rhinosinusitis with nasal polyposis underwent endoscopic sinus surgery from January 2011 to April 2013 and followed for 1 year. The rhinosinustis disability index (RSDI), a validated disease-specific instrument, was used to quantify the patient's symptoms before and 12 months after surgery. Results: A strongly statistically significant reduction was seen between the mean scores on RSDI before and after FESS [86.43 (IQR = 16.10) versus 51.16 (IQR = 18.95), Wilcoxon signedrank test, p < 0.0001]. In multiple regression model, only four preoperative characteristics predicted the outcomes. The high mucosal eosinophilia density was the most important preoperative predictor. Conclusions: There is evidence which supports the efficacy of FESS to improve long-term QOL outcomes in patients with CRS. The mucosal eosinophilia density and prior sinus surgery appeared to be the most predictive factors of surgical outcomes. © 2015 Elsevier Inc. All rights reserved.
1.
Introduction
Nasal polyposis is a chronic inflammatory disease which originates in the upper part of the nose around the openings to the ethmoidal sinuses [1,2]. It is a subgroup of chronic rhinosinusitis that affected around 4% of the general population [3]. The diagnosis of nasal polyposis is clinical and based on the nasal endoscopy. Since Kennedy et al. introduced functional endoscopic sinus surgery; it has become largely used for treating nasal polyposis resistant to medical treatment [4–6]. There are very little published studies on functional endoscopic sinus surgery (FESS) results in chronic rhinosinusitis (CRS) with polyps that exclude other CRS categories.
The purpose of this study is to report outcomes of 58 patients with nasal polyposis undergoing FESS and assess the association between surgery and specific quality of life outcomes. In addition, preoperative patient factors are evaluated to predict clinically significant outcomes which can help for surgical case selection.
2.
Materials and methods
2.1.
Study design
A prospective study was carried out between January of 2011 and April of 2013 at a university hospital, tertiary referral center, after approval of the ethics committee.
⁎ Corresponding author at: Hopital 20, aout ORL Chu Ibn Rochd, Casablanca 20000 Morocco. Tel.: +212 066 1377 305. E-mail address: [email protected] (C. Adnane). http://dx.doi.org/10.1016/j.amjoto.2014.09.003 0196-0709/© 2015 Elsevier Inc. All rights reserved.
48
AMERI CAN JOURNAL OF OTOLAR YNGOLOGY–H E AD AN D N E CK M EDI CI N E AN D S U RGE RY 3 6 ( 2 0 15 ) 47–5 1
2.2.
Patient sample
A total of 58 patients who underwent FESS from January 2011 to April 2013 were evaluated and followed for 1 year. Inclusion criteria were: - Chronic rhinosinusitis (CRS) patients with bilateral nasal polyps (NP) who had not improved after at least 6 months of drug therapy; - Patients undergoing functional endoscopic sinus surgery (FESS); - Age above 18 years. Exclusion criteria were: -
Other subgroups of CRS; Secondary CRS; No preoperative CT scan; Age under 18 years; Pregnancy; Immunodeficiency; Patients who underwent revision endoscopic sinus surgery during the study for other complications.
2.3.
topical nasal steroid on each nostril every 12 hours for 1 year; saline irrigation and endoscopic dressing were performed for 6 weeks.
2.5.
The rhinosinustis disability index (RSDI), a validated diseasespecific instrument, was used to quantify the patient's symptoms before and 12 months after surgery [10]. Thirty questions were asked and each was scored on 0 to 4 scale (0 = never, 1 = almost never, 2 = sometimes, 3 = almost always, 4 = always). The RSDI was calculated for a total score and for functional, emotional and physical fields (Table 2). The endoscopic examination was scored by the physician using the Lund–Kennedy scoring system before and 12 months after surgery [11]. It includes three parameters: nasal polyps (0 = absent, 1 = polyps within the middle meatus, 2 = beyond the middle meatus, 3 = reaching to or below the lower border of the inferior turbinate or medial to the middle turbinate); edema and crusting (0 = absent, 1 = mild, 2 = severe) and discharge (0 = absent, 1 = clear and thin discharge, 2 = thick and purulent discharge).
Diagnosis of CRS with nasal polyposis 2.6.
The diagnosis of nasal polyposis was based on the definition of the European academy of allergology and clinical immunology (EAACI) [7]. Preoperative CT scans of the sinuses were classified using the Lund–Mackay scoring system [8].
2.4.
Quality of life assessment and endoscopy scores
Treatment and follow-up
Medical treatment was the first therapy introduced at least for 6 months. It was based on topical nasal steroid (budenoside spray) on each nostril every 12 hours and short cures of oral steroid (prednisolone) for 7 days (maximum 3 cures per year). FESS was performed under general anesthesia, the surgical technique was as described by Messerklinger and the extent of surgery was at least a bilateral unciformectomy with functional anterior ethmoidectomy [9]. Septoplasty and/or inferior turbinoplasty were performed when indicated (Table 1). Postoperative care was as follows: the nasal packing was removed 2 days post operatively; all patients received amoxicillin and clavulanic acid (1 g/125 mg) twice a day for 10 days and
Statistical analysis
The data sets were analyzed using SPSS 20.0. The normal distribution was assessed by using Shapiro–Wilk test and skewness kurtosis z-values. Clinically significant improvement was defined as a change of ≥½ standard deviation (SD) of the baseline RSDI score [12]. So the improvement was defined as a decrease of ≥ 8.0515 points. The Wilcoxon signed-rank test was used to compare RSDI scores before and after FESS. Correlation and multiple regression analysis were used to assess the relationship between preoperative characteristics and significant improvement after surgery. Multiple regression models were chosen using forced entry method and stepwise method selection. A p value under 0.05 (5%) was considered statistically significant for all analyses.
3.
Results
There were 58 patients who met the inclusion criteria for this study. The sex-ratio was 1 (29 male and 29 female). The average
Table 1 – Repartition of surgical procedures performed.
Maxillary antrostomy Ethmoïdectomy Partial Total Sphenoidotomy Frontal sinusotomy Septoplasty Inferior turbinectomy
Right side number Left side number (%) (%)
Table 2 – Mean change in QOL after endoscopic sinus surgery.
58 (100)
58 (100)
RSDI
Preoperative (mean ± SD)
Postoperative (mean ± SD)
Absolute Δ (mean ± SD)
13 45 8 2
13 (22.4) 45 (77.6) 4 (6.9) 0
Total Physical Functional Emotional
86.43 28.60 27.64 30.19
51.16 15.50 16.64 19.02
35.28 13.10 11.00 11.17
(22.4) (77.6) (13.8) (3.4)
4 (6.9) 3 (5.2)
3 (5.2)
± ± ± ±
16.103 6.644 5.139 5.841
± ± ± ±
18.950 6.642 6.558 6.653
Δ: absolute change value of RSDI score. QOL: quality of life. RSDI: Rhinosinusitis Disability Index. SD: standard deviation.
± ± ± ±
17.390 6.415 5.660 6.481
49
AMERI CA N JOURNAL OF OT OLAR YNGOLOGY–H E AD AN D N E CK M EDI CI N E AN D S U RGE RY 3 6 ( 2 0 15 ) 47–5 1
Table 3 – Characteristics of patients with nasal polyposis. Mean ± SD Age (years) Gender: Male Female Clinical characteristics: Asthma Aspirin intolerance Prior sinus surgery Preoperative diagnostic testing: Lund–Kennedy endoscopy score Lund–Mackay CT score
Number (%)
39.22 ± 11.54 29 (50) 29 (50) 27 (46.6) 3 (5.2) 8 (13.8) 9.62 ± 2.15 21.12 ± 3.39
CT: computed tomography. SD: standard deviation.
age was 39.22 years and the median was 40.00 years (IQR = 19 and SD = 11.544). Characteristics of patients in the study are described in Table 3. Asthma was more prevalent (46.6%). Epithelial hyperplasia was observed in all the patients and 44.8% of patients were with high mucosal eosinophilia (Table 4). A strongly statistically significant reduction was seen between the scores attained pre and postoperatively on RSDI [86.43 (IQR = 16.10) versus 51.16 (IQR = 18.95), Wilcoxon signed-rank test, p < 0.0001] (Fig. 1). According to clinical significant improvement based on a decrease of 8.0515 points or superior on the RSDI, only one patient had not improved. On univariate analysis, the Spearman's rank correlation coefficient and the Mann–Whitney U test were used to choose predictor factors that significantly affected QOL improvement at the p ≤ 0.5. Twelve predictors were retained for multiple regression model: age, gender, prior sinus surgery, asthma, ASA intolerance, Lund–Kennedy endoscopy score, Lund–Mackay CT score, high mucosal eosinophilia density, squamous metaplasia, glandular hypertrophy, total ethmoidectomy and preoperative RSDI score. The first multiple regression model used forced entry method. Only four preoperative characteristics predicted the outcomes (Table 5). This model was able to explain 45.1% of the change in QOL (R2 = 0.451 and adjusted R2 = 0.305). There was no collinearity within our data (VIF
