Introduction
Chronic rhinosinusitis is a common medical condition affecting up to 15 per cent of the Western population.Reference Fokkens, Lund, Mullol, Bachert, Alobid and Baroody1 Chronic rhinosinusitis has a profound influence on the quality of life (QoL) of affected people because of nasal obstruction, impaired olfaction, fatigue, social dysfunction and emotional manifestations. Medical treatment for chronic rhinosinusitis can greatly improve symptoms and QoL.Reference Low, Woods, Ullah and Carney2 However, in cases of medical treatment failure, functional endoscopic sinus surgery (FESS) represents a valuable alternative. The latter should not be considered as the only treatment, but rather as an adjuvant modality to remove the disease burden and increase the efficacy of post-operative medical therapy.Reference Fokkens, Lund, Mullol, Bachert, Alobid and Baroody1 In fact, FESS improves the drainage of the nasal sinuses and the delivery of topical medication after surgery.Reference Harvey, Goddard, Wise and Schlosser3
Given the above, it is not surprising that post-operative management plays a pivotal role in the treatment of chronic rhinosinusitis. In particular, nasal irrigation represents a key element in the post-operative period following FESS (grade of recommendation AReference Fokkens, Lund, Mullol, Bachert, Alobid and Baroody1). Specifically, nasal irrigation has been demonstrated to promote cleansing of the nasal cavities, enhance wound healing, and reduce oedema and nasal discharge after surgery.Reference Low, Woods, Ullah and Carney2, Reference Tomooka, Murphy and Davidson4 A variety of nasal irrigation solutions are available. These differ in terms of their composition (e.g. seawater, hypertonic, isotonic saline with or without additives), and the choice of solution will depend on the irrigation technique used (variations in pressure and/or volume).
As far as the irrigation technique is concerned, multiple studies have confirmed the benefit of high-volume, low-pressure douching over other methods of delivery.Reference Low, Woods, Ullah and Carney2, Reference Harvey, Goddard, Wise and Schlosser3, Reference Wormald, Cain, Oates, Hawke and Wong5 In addition, Harvey et al.Reference Harvey, Goddard, Wise and Schlosser3 investigated the paranasal sinus distribution of topical solutions following FESS in 10 cadavers. They reported that high-volume, low-pressure, gravity-dependent devices offer better delivery of solution in the paranasal sinuses than other methods.
However, information regarding the best solution composition for nasal irrigation after FESS is scarce and divergent,Reference Harvey, Hannan, Badia and Scadding6, Reference Chong, Head, Hopkins, Philpott, Glew and Scadding7 and only a few randomised controlled trials have been developed so far.Reference Freeman, Sivayoham, Jepson and de Carpentier8–Reference Fong, Garcia, Woods and Ooi11 Freeman et al.Reference Freeman, Sivayoham, Jepson and de Carpentier8 analysed the presence of adhesions, polyps, crusting, discharge and oedema post-operatively in a group of 22 patients who had only 1 nasal cavity irrigated with 2 ml of sterile saline via a mucosal atomisation device. The authors concluded that nasal saline douching improved the presence of discharge and oedema, but had no effect on adhesions or crusting. Low et al.Reference Low, Woods, Ullah and Carney2 compared the efficacy of normal saline, lactated Ringer's solution and hypertonic saline for nasal irrigation after FESS, administered via a squeeze bottle. They concluded that nasal irrigation with lactated Ringer's solution provides better results. Gelardi et al.Reference Gelardi, Guglielmi, De Candia, Maffezzoni, Berardi and Quaranta9 compared the effects of intranasal sodium hyaluronate and saline irrigation after FESS, and reported that sodium hyaluronate provided better results in terms of mucociliary clearance. Macchi et al.Reference Macchi, Terranova, Digilio and Castelnuovo10 reported that three-month intermittent treatment with nasal washes using 9 mg sodium hyaluronate plus saline solution after FESS was associated with significant improvements in nasal dyspnoea, nasal mucosa appearance on endoscopy and ciliary motility, compared to saline alone. Finally, Fong et al.Reference Fong, Garcia, Woods and Ooi11 concluded, in a recent systematic review, that sodium hyaluronate appears to be clinically safe and well tolerated, and may be useful in the early stages after sinus surgery to limit adhesion rate, even if provided in different preparations.
The growing interest for sodium hyaluronate in the clinical management of patients who have undergone FESS is related to the mucosal regenerative properties of this macromolecule. Sodium hyaluronate, in fact, improves mucosal stability, lubrication, water homeostasis and molecule filtering, and promotes modifications in cell behaviour (such as anti-inflammatory modulation), because of its binding mechanisms and architectural configuration within the connective tissue.Reference Fong, Garcia, Woods and Ooi11, Reference Fraser, Laurent and Laurent12
However, because of the variability in sodium hyaluronate preparations analysed so far (absorbable and non-absorbable dressings, and topical preparations such as cream, spray and nebulised ampules),Reference Fong, Garcia, Woods and Ooi11 the role of sodium hyaluronate in the post-operative care of patients who have undergone FESS for chronic rhinosinusitis is still a matter of debate. In particular, no information is available regarding the effect of sodium hyaluronate administered via nasal irrigation with saline, using a high-volume gravity-dependent device (which can be considered one of the best irrigation techniquesReference Harvey, Goddard, Wise and Schlosser3).
A multicentric, randomised controlled trial was developed to gather information regarding the effects of sodium hyaluronate provided via nasal irrigation with saline on chronic rhinosinusitis patients post-FESS. In particular, the project aimed to compare the clinical effects of nasal irrigation with isotonic saline (0.9 per cent) versus nasal irrigation with isotonic saline plus sodium hyaluronate (9 mg) in patients who had undergone FESS. The study hypothesis was that normal saline plus sodium hyaluronate would provide better results with respect to objective and subjective evaluations than normal saline alone following FESS. A deeper understanding of the effects of sodium hyaluronate after FESS would help clinicians in the post-operative care of patients who have undergone FESS for chronic rhinosinusitis.
Materials and methods
The study was carried out according to the declaration of Helsinki, and was previously approved by the Institutional Review Boards of the enrolled hospitals. The research entailed a multicentric, prospective, randomised, double-blind, parallel group study, in which normal saline (standard therapy) was compared with normal saline plus sodium hyaluronate. All patients gave their written informed consent to participate in the study.
Participants
Fifty-six consecutive patients (28 females and 28 males) who underwent FESS for chronic rhinosinusitis without polyps were enrolled in the study. The mean age of the cohort was 43.8 ± 17.7 years (range, 11–75 years).
Inclusion criteria were: age over 18 years; diagnosis of bilateral chronic rhinosinusitis without polyps, as confirmed by endoscopy and computed tomography (CT); patients undergoing bilateral FESS as primary procedure for chronic rhinosinusitis without polyps not respondent to medical therapy; and a good understanding of written and spoken Italian.
Exclusion criteria were: previous trauma; congenital abnormalities of facial growth; systemic granulomatous disease; known mucociliary clearance disorders; known head and neck malignancies or a history of previous radiotherapy to the head and neck; any other nasal surgery performed concomitantly; and an inability to give informed consent because of mental impairment. In addition, patients who underwent surgery for conditions other than chronic rhinosinusitis without polyps, or who underwent revision, unilateral or anterior (only middle meatal antrostomy and/or anterior ethmoidectomy) FESS, were also excluded.
All patients had undergone bilateral FESS, involving conservative mucosa-sparing antrostomy, and anteroposterior ethmoidectomy with preservation of the middle turbinate. Frontal and sphenoid sinuses were drained when needed. The patients underwent the sinus surgery in three different, high-volume rhinological centres, between December 2017 and March 2018. All surgical procedures were performed by three experienced surgeons (one for each centre, all with 10 years or more of FESS experience). These surgeons were blind to the douching solution used by the patients and were not involved in the post-operative evaluation of the patients.
Nasal douching
Douching was performed using a high-volume, 250 ml, low-pressure, gravity-dependent device. A member of the secretarial staff assigned 70 numbers to either a douching solution comprising normal saline alone (Nasir Isotonic; EP Medica, Fusignano, Italy) or a solution comprising normal saline plus 9 mg of high molecular weight sodium hyaluronate (Nasir Plus; EP Medica), using simple randomisation. Numbers from 1 to 70 were randomly assigned to the recruited patients using a randomised, computer-generated table held by secretarial staff. Similar to the study of Freeman et al.,Reference Freeman, Sivayoham, Jepson and de Carpentier8 ward staff telephoned the secretarial staff following surgery and allocated patients consecutively. Randomisation was performed independently for each centre.
At discharge, participants were given both written advice and a practical demonstration on how to carry out nasal douching. In particular, patients were advised to irrigate their nasal cavities twice a day for six weeks after surgery. Nasal irrigation solutions were provided by nursing staff on the day of surgery, using numbered boxes containing unmarked sacks of the same douching solution. Surgeons and patients were blind to the treatment allocation.
Compliance to the assigned treatment was evaluated by counting the amount of dispensed and returned sacks. The post-operative care of the patients was the same in the three centres. Nasal packing was maintained for 2 days; no oral antibiotics or oral steroids were prescribed. Post-operative follow up was performed at three and six weeks after surgery. During these visits, routine nasal toileting was kept to a bare minimum, so as not to influence the effectiveness of the nasal douching.
Nasal assessment
Each patient was evaluated before surgery, and at three and six weeks after surgery, using a set of objective and subjective (self-assessed) measurements. Pre-operative evaluation was performed the day before the surgical procedure, while post-operative assessments were carried out during the follow-up visits, before the application of any topical local anaesthetic.
For the objective evaluation, the Lund–Mackay radiological scoring system and Lund–Kennedy endoscopic scoring system were used.Reference Lund and Mackay13, Reference Lund and Kennedy14 The latter rates each sinonasal area on the basis of the degree of scarring, crusting, oedema, polyps and discharge. The total possible score is 20. The former consists of six items, with a total score ranging from 0 to 24, with higher scores representing worse radiological appearance of the sinonasal cavities. Both Lund–Mackay and Lund–Kennedy scores were assessed jointly by the two senior authors at the conclusion of the study, using digital videos recorded during the clinical evaluation (for the Lund–Kennedy scoring system) and the pre-operative CT scans of the paranasal sinuses (for the Lund–Mackay scoring system). All CT scans were performed on high-speed spiral CT scanners using non-contrast, axial, 1.5 mm sections. The morphological evaluation was performed on high-resolution coronal and sagittal sections, using a specialised computer software picture archiving and communication system (‘PACS’).Reference Gera, Mozzanica, Karligkiotis, Preti, Bandi and Gallo15 The investigators who performed the objective evaluation were blind to the douching solution used by the patients and were not involved in the surgical procedures.
For the subjective evaluation, the Italian versions of the Sino-Nasal Outcome Test 22 (SNOT-22)Reference Mozzanica, Preti, Gera, Gallo, Bulgheroni and Bandi16 and of the Nose Obstruction Symptom Evaluation (‘NOSE’) scaleReference Mozzanica, Urbani, Atac, Scottà, Luciano and Bulgheroni17 were used. The latter is a simple and fast questionnaire composed of five obstruction-related items which evaluate the severity of complaints that the patient has been experiencing over the past month as a result of nasal obstruction. The former is a questionnaire structurally composed of 22 chronic rhinosinusitis related items which evaluate the severity of complaints that the patient has been experiencing over the past weeks a result of chronic rhinosinusitis. In addition, similar to the study of Low et al.,Reference Low, Woods, Ullah and Carney2 six visual analogue scales (VASs) measuring the severity of symptoms (overall symptoms, nasal obstruction, headache, facial pain, smell alteration and nasal discharge) were used. These comprised 100 mm lines with the extremes ‘as bad as it can be’ (100 mm) and ‘no symptoms’ (0 mm).
Statistical analysis
Similar to the study of Salib et al.,Reference Salib, Talpallikar, Uppal and Nair18 the Lund–Kennedy post-operative score was considered the primary endpoint, and a difference of 1 point between the two groups was considered clinically significant. For the study to have a power of 80 per cent, 26 patients would need to be recruited to demonstrate a statistically significant difference between the 2 treatments (α = 0.05, two-sided), assuming a standard deviation of 1.5.
The results are given as arithmetic mean ± standard deviation. The Kolmogorov–Smirnoff test was used to test the normality of distribution in each group. As this test demonstrated a normal distribution of the variables, parametric tests were used to evaluate the differences between the two groups of patients. In particular, subjective and objective scores obtained before and after surgery were compared using a paired t-test. The t-test and the chi-square test were used when appropriate to compare the two groups. A significance level of 0.05 for all testing was used. Statistical analyses were performed using the SPSS® version 25.0 statistical software package.
Results
Of the 56 patients (28 males and 28 females), 30 (14 males and 16 females) were randomly allocated to the normal saline arm (group 1), and 26 (14 males and 12 females) were randomly allocated to the normal saline plus sodium hyaluronate arm (group 2) (Figure 1). No difference in sex distribution between the two groups was demonstrated with the chi-square test (p = 0.487). Allergy was reported by 15 patients (9 in group 1 and 6 in group 2), while asthma was reported by 6 patients (4 in group 1 and 2 in group 2). A total of 13 patients were active smokers (7 in group 1 and 6 in group 2). No differences between the two groups in the distribution of patients with allergy, asthma or smoking habit were demonstrated on chi-square tests (p = 0.449, p = 0.722 and p = 811, respectively).
Fig. 1. Flow diagram of the progress through the randomised trial phases of two groups.
Each patient underwent FESS for chronic rhinosinusitis without polyps. No complications were reported during surgery or the follow-up period. All patients attended the follow-up appointments; no patients were lost during the six-week follow-up period. All patients tolerated the nasal irrigation well and none of them discontinued the treatment.
Demographic data, and the distributions of objective and subjective scores pre-treatment, are depicted in Table 1. No significant differences were demonstrated in terms of age, or pre-operative Lund–Mackay, Lund–Kennedy, VAS, Nose Obstruction Symptom Evaluation and SNOT-22 scores, suggesting a similarity between the two study arms.
Table 1. Distribution of age, and pre-operative objective and subjective evaluation scores in the two study arms
Data represent means ± standard deviations, unless indicated otherwise. *Student's t-test. †Scores measured in centimetres. SNOT-22 = Sino-Nasal Outcome Test-22; NOSE = Nasal Obstruction Symptom Evaluation scale; VAS = visual analogue scale
Objective assessment
Objective assessment was performed using both the Lund–Mackay radiological scoring system and the Lund–Kennedy endoscopic scoring system in the pre-operative period, while only the Lund–Kennedy scoring system was utilised during follow up (at three and six weeks post-surgery). In group 1 and group 2, there was a significant deterioration in the Lund–Kennedy total score at three weeks. At six weeks, the Lund–Kennedy total score was significantly better than the scores obtained in the pre-operative period and at three weeks (see Table 2 for group 1 and Table 3 for group 2).
Table 2. Comparison of pre- and post-operative evaluation scores for group 1 (normal saline)
*Indicates a statistically significant difference. †Scores measured in centimetres. SD = standard deviation; pre-op = pre-operation; wk = weeks; post-op = post-operation; SNOT-22 = Sino-Nasal Outcome Test-22; NOSE = Nasal Obstruction Symptom Evaluation scale; VAS = visual analogue scale
Table 3. Comparison of pre- and post-operative evaluation scores for group 2 (normal saline plus sodium hyaluronate)
*Indicates a statistically significant difference. †Scores measured in centimetres. SD = standard deviation; pre-op = pre-operation; wk = weeks; post-op = post-operation; SNOT-22 = Sino-Nasal Outcome Test-22; NOSE = Nasal Obstruction Symptom Evaluation scale; VAS = visual analogue scale
When the two groups were compared, patients in group 2 scored significantly better in the crusting and scar subdomains of the Lund–Kennedy scoring system at three weeks, and in the secretion and scar subdomains at six weeks (see Table 4), on student's t-tests.
Table 4. Comparison of evaluation scores between groups at three and six weeks post-surgery
*Student's t-test. †Indicates a statistically significant difference. ‡Scores measured in centimetres. Group 1 = normal saline; group 2 = normal saline plus sodium hyaluronate; wk = weeks; post-op = post-operation; SD = standard deviation; SNOT-22 = Sino-Nasal Outcome Test-22; NOSE = Nasal Obstruction Symptom Evaluation scale; VAS = visual analogue scale
Subjective assessment
Regarding the subjective assessment, all patients autonomously completed the SNOT-22, the NOSE scale and the six VASs, at the three assessment times (pre-operatively, and at three and six weeks after surgery). The time required to complete the subjective self-assessment never exceeded 10 minutes.
Sino-Nasal Outcome Test-22
The paired t-test demonstrated a significant improvement in SNOT-22 scores after surgery (Figure 2), in both groups. The results are reported in Table 2 (for group 1) and Table 3 (for group 2). In particular, significant differences were found between the SNOT-22 scores obtained in the pre-operative evaluation and those obtained at three and six weeks, in both groups. In addition, a significant difference was also demonstrated between the SNOT-22 scores obtained at three weeks and those obtained at six weeks, in both groups. However, no significant differences were demonstrated between the two groups at three or six weeks after surgery with the student's t-test (Table 4).
Fig. 2. Changes in Sino-Nasal Outcome Test 22 (SNOT-22) scores in patients treated with normal saline (group 1) or normal saline plus sodium hyaluronate (group 2). Data are presented as mean and confidence intervals (95 per cent). Pre-op = pre-operation; wk = weeks; post-op = post-operation
Nose Obstruction Symptom Evaluation
The paired t-test demonstrated a significant improvement in NOSE scores after surgery (Figure 3), in both groups. The results are reported in Tables 2 and 3. In particular, significant differences were found between the NOSE scores obtained in the pre-operative evaluation and those at three and six weeks, in both groups. Only in group 1 was a significant difference demonstrated between the NOSE scores obtained at three weeks and those obtained at six weeks. Interestingly, at three weeks after surgery, the NOSE scores obtained in group 2 were significantly lower than those in group 1, while there were no differences between the two groups at six weeks (Table 4).
Fig. 3. Changes in Nasal Obstruction Symptom Evaluation scale (NOSE) scores in patients treated with normal saline (group 1) or normal saline plus sodium hyaluronate (group 2). Data are presented as mean and confidence intervals (95 per cent). Pre-op = pre-operation; wk = weeks; post-op = post-operation
Visual analogue scale
In group 1, significant improvements in VAS scores were demonstrated after three weeks for headache and facial pain only. However, six weeks after surgery, all the VAS scores improved significantly. Furthermore, significant improvements in VAS scores were demonstrated in the comparison between the third and sixth weeks, with the only exceptions being facial pain and nasal discharge (Table 2).
In group 2, improvements in VAS scores were demonstrated after three weeks for overall symptoms, nasal obstruction, headache and facial pain, while no significant improvements for smell alteration and nasal discharge were demonstrated. At six weeks after surgery, all the VAS scores improved significantly. No significant differences in headache, facial pain and smell alteration were found between VAS scores obtained at three and at six weeks (Table 3).
Significant differences were found between the two groups in the VAS scores for headache and smell alteration at three weeks (Figure 4). Specifically, patients in group 2 scored significantly better than patients in group 1. At six weeks, there were no differences between the two groups in the VAS scores (Table 4).
Fig. 4. Changes in visual analogue scale (VAS) scores in patients treated with normal saline (group 1) or normal saline plus sodium hyaluronate (group 2), for: (a) overall symptoms, (b) nasal obstruction, (c) facial pain, (d) headache, (e) smell alteration and (f) nasal discharge. Data are presented as mean and confidence intervals (95 per cent). Pre-op = pre-operation; wk = weeks; post-op = post-operation
Discussion
In the present study, the effect of nasal irrigation using either normal saline or normal saline plus sodium hyaluronate was analysed in a group of 56 patients who underwent FESS for chronic rhinosinusitis without polyps at 3 different centres. To our knowledge, this study is the first to investigate the clinical effect of high-volume, low-pressure, gravity-dependent nasal irrigation using saline plus sodium hyaluronate in patients who underwent FESS for chronic rhinosinusitis without polyps.
The results reported here are noteworthy. All patients tolerated the nasal irrigation well; none of the patients dropped out of the study. Furthermore, the subjective and objective scores improved during the six weeks of follow up in both treatment arms. These data further support the benefits of high-volume, low-pressure nasal saline irrigation post-FESS. Similar findings were reported by Salib et al.,Reference Salib, Talpallikar, Uppal and Nair18 who demonstrated the superiority of high-volume, low-pressure nasal saline irrigation over low-volume, high-pressure nasal saline irrigation following FESS. It is possible that the positive effect of nasal irrigation is related to an increase in mucociliary clearance and to the physical effects of hydrostatic pressure, which improves the removal of crusts and thick, tenacious secretions.Reference Tomooka, Murphy and Davidson4, Reference Salib, Talpallikar, Uppal and Nair18
Besides the positive effects of nasal irrigation post-FESS, specific findings related to the composition of the nasal irrigation solution are interesting. As far as the objective assessment is concerned, in the pre-operative condition no differences in the Lund–Mackay and Lund–Kennedy scores were demonstrated, suggesting a similarity between the two study arms. At three weeks after surgery, Lund–Kennedy scores were significantly increased in both groups. This finding is probably related to oedema, crust formation, mucosal alterations, secretions and impaired sinonasal ventilation, which frequently occur during the first month after FESS.Reference Cantone, Castagna, Sicignano, Ferranti, Rega and Di Rubbo19 Nonetheless, at three weeks after surgery, there were significant differences between the two groups for the Lund–Kennedy crusting and scar subdomain scores. Specifically, patients treated with normal saline plus sodium hyaluronate (group 2) scored significantly better than patients treated with normal saline alone (group 1). Similarly, at six weeks after surgery, patients in group 2 scored significantly better in the Lund–Kennedy scar and secretion subdomains than patients in group 1. These findings suggest a positive effect of sodium hyaluronate in reducing secretions, crusts and scar formation post-FESS.
Similar results were reported by Cantone et al.,Reference Cantone, Castagna, Sicignano, Ferranti, Rega and Di Rubbo19 who compared the effects of saline solution (2 ml) plus 9 mg of sodium hyaluronate (3 ml) versus saline solution alone (5 ml) on the improvement of post-operative discomfort and short-term QoL following FESS in a group of 124 patients. The authors found that Lund–Kennedy scores were better in patients treated with saline solution plus sodium hyaluronate than in those treated with saline solution alone 30 days after surgery. Gelardi et al.Reference Gelardi, Guglielmi, De Candia, Maffezzoni, Berardi and Quaranta9 compared saline irrigation versus intranasal sodium hyaluronate nebulised twice a day in a group of 36 patients. They found that patients receiving sodium hyaluronate had a significantly faster mucociliary clearance time, a lower incidence of rhinorrhoea, less nasal obstruction and a lower incidence of exudate on endoscopy than control subjects at one month. In addition, Macchi et al.Reference Macchi, Terranova, Digilio and Castelnuovo10 compared the effect of nebulised sodium hyaluronate plus saline solution versus saline solution alone, given for 15 days per month over 3 months, in a group of 46 patients. They found that significantly more patients in the saline group than the sodium hyaluronate group had catarrhal, purulent or haematic nasal secretions.
It is consequently possible to speculate that the application of sodium hyaluronate through nasal irrigation improved recovery of the nasal mucosa, as suggested by the better Lund–Kennedy scores of patients who used nasal saline plus sodium hyaluronate. This hypothesis is in agreement with the findings of Dal and BaharReference Dal and Bahar20 who reported faster wound healing and re-epithelisation in patients treated with a cross-linked hyaluronan gel post-FESS.
• Nasal irrigation is crucial for post-operative care after functional endoscopic sinus surgery (FESS)
• High-volume, low-pressure, gravity-dependent irrigation devices offer better solution delivery in paranasal sinuses
• Sodium hyaluronate may be useful in the early stages after sinus surgery, even if provided in different preparations
• Sodium hyaluronate improves mucosal stability, lubrication, water homeostasis and molecule filtering, and promotes cell behaviour modification
• The adjunct of sodium hyaluronate to high-volume, low-pressure, gravity-dependent saline irrigation in the early post-FESS period resulted in a better endoscopic appearance
• Furthermore, it increased patient-reported satisfaction for perceived nasal obstruction, headache and smell alteration
Regarding the subjective assessment, the SNOT-22 scores significantly improved after surgery in both groups, thus suggesting the efficacy of FESS in the treatment of chronic rhinosinusitis without polyps. The Nose Obstruction Symptom Evaluation scores also significantly improved post-operatively in both groups, but there was a significant difference between the groups in the scores at three weeks post-surgery. Specifically, patients in group 2 scored better than those in group 1, suggesting that the sensation of nasal patency was better in the patients treated with nasal saline plus sodium hyaluronate. Similarly, three weeks after surgery, patients in group 2 scored significantly better in VASs for headache and smell alteration than patients in group 1. No differences between groups were found in Nose Obstruction Symptom Evaluation and VAS scores at six weeks. Similar results were reported by Cantone et al.,Reference Cantone, Castagna, Sicignano, Ferranti, Rega and Di Rubbo19 who found that patients treated with saline solution plus sodium hyaluronate reported significantly higher scores in QoL at 30 days after surgery than patients treated with saline solution alone.
The presence of significant differences at three weeks post-surgery between the two groups of our sample suggests that sodium hyaluronate might provide a faster improvement of some nasal symptoms after FESS. It might be speculated that the application of sodium hyaluronate, by favouring nasal mucosa tissue repair, promotes wound healing and reduces crust formation. The reduced crusting could have played a role in improving the perception of nasal patency, and in reducing smell alteration and headache.
This study has several limitations. First of all, the number of enrolled patients is quite small, even if it is in line with previous reports. For this reason, caution should be used when interpreting the results. Moreover, similar to the study of Macchi et al.,Reference Macchi, Terranova, Digilio and Castelnuovo10 the control group of this study cannot be considered a placebo arm, as patients received the standard therapy of normal saline. For this reason, the possibility of detecting statistically significant differences between the groups might have been reduced. However, the inclusion of a control group of patients not undergoing nasal irrigation would be difficult to justify, as nasal irrigation has been found to be beneficial in the post-operative period.Reference Salib, Talpallikar, Uppal and Nair18 An additional potential criticism of the study concerns the choice of primary outcome instrument. We decided to use the Lund–Kennedy score for two reasons: first, it remains the most commonly used endoscopic scoring system; second, it contains items that specifically address the post-surgical status of patients.Reference Psaltis, Li, Vaezeafshar, Cho and Hwang21 Finally, the follow-up period was short (only six weeks); consequently, no information regarding the effect of nasal saline irrigation with or without sodium hyaluronate over a longer time period is available.
Conclusion
Sodium hyaluronate might be a useful adjunct to high-volume, low-pressure, gravity-dependent saline irrigation in the early post-operative period following FESS performed for chronic rhinosinusitis without polyps. Sodium hyaluronate seems to result in a better endoscopic appearance, and higher patient-reported satisfaction in terms of perceived nasal obstruction, headache and smell alteration. However, the clinical benefit appears limited, and further studies with a longer follow-up period are needed.
Acknowledgement
The nasal saline irrigations used in this study (Nasir Isotonic and Nasir Plus) were donated by EP Medica (Fusignano, Italy).
Competing interests
None declared
