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Indian Journal of Otolaryngology and Head & Neck Surgery logoLink to Indian Journal of Otolaryngology and Head & Neck Surgery
. 2020 Sep 12;74(1):23–31. doi: 10.1007/s12070-020-02133-z

Impact of Patient Guidance Handouts on Outcomes of FESS

Bhanu Bhardwaj 1,3, Jaskaran Singh 1,4,✉, Tanya Singh 2,5
PMCID: PMC8743313  PMID: 35070922

Abstract

Post-operative care in FESS is an important aspect. Nasal saline irrigation and Nasal steroid spray are highly recommended worldwide in post-operative protocol after endoscopic sinus surgery. Hence patients compliance for both these procedures becomes a deciding factor for outcomes following FESS and there is not much evidence in literature regarding the same. The present study was conducted to evaluate the role of giving patients pictorial handouts regarding nasal saline irrigations and various positions of using nasal steroid spray in improving outcomes of FESS. It was a randomised control study.46post operative patients of FESS were randomised into two groups. Group A patients were verbally explained and practically demonstrated the technique of nasal saline irrigation and nasal steroid spray in the language best understood and by showing them the relevant images. Group B patients were also verbally explained as well as practically demonstrated the above mentioned procedure but were also given pictorial handouts (depicting in detail the positions of nasal saline irrigation and steroid spray} which were explained and handed over to them at the time of discharge. The patients were evaluated a 1st, 2nd 3rd and 4th post-operative week for compliance of both the procedures and its effect on post-operative cavity. In the present study there were 21 females versus 25 males. The average male: female ratio in group A was 1.3 versus 1 in group B. The mean age was 35.5652 ± 4.595 in group B versus 33.1739 ± 4.438 in group A. The average compliance over three weeks was 2.5765 ± 0.207 in Group B as compared to 1.4935 ± 0.27 in Group A. The t score for the difference in compliance between two groups was 15.2691. The two-tailed P value was less than 0.0001. The average Lund and Kennedy endoscopic appearance score for crusting was 1.75 ± 0.532, 1.217 ± 0.6, 0.696 ± 0.703 for Group A in post-operative follow up during week 1, 2 and 3 respectively as compared to 1.45 ± 0.59, 0.304 ± 0.47, 0.826 ± 0.49 for Group B. The P value was < 0.05 for the difference in both groups for all three weeks. The average Lund and Kennedy score for edema and other parameters has been enumerated in Table 1. 11/23 followed correct method for nasal saline irrigation in Group A as compared to 20/23 in Group B. 18/23 used nasal steroidal spray in all positions compared to only 9/23 in Group A. 3/23 in group B had polypoidal mucosa at frontal recess area at 1 month post-operative as compared to 16/23. Overall their was a negative correlation between the compliance of nasal saline irrigation with edema, crusting and discharge. The respective R score was −0.5311, −0.25296 and −0.19889 respectively. The pictorial handouts definitely improved compliance and hence outcomes in our study. We recommend this practice in routine to all our fellow rhinologists.

Keywords: Outcomes, ESS, Compliance, Crusting, Post-operative, Lund kennedy endoscopic appearance score, Positions, Nasal saline irrigation, Nasal steroid spray, Edema, Correlation

Introduction

Chronic rhinosinusitis with and without nasal polyps is a common disease affecting millions of patients all over the world. It is characterized by inflammation of the lining of the nose and para-nasal sinuses leading to nasal blockage, rhinorrhoea, facial pressure/pain and loss of sense of smell. Functional endoscopic sinus surgery (FESS) has become the gold standard treatment for medically refractive disease. The objective of endonasal sinus surgery is to restore and improve osteo-meatal ventilation or drainage, the removal of polyps, the removal of presumably irreversible pathological hyperplastic mucosal foci. Since it has the role of an adjuvant modality good post-operative care is highly recommended by international leaders as an important part of the patient’s management and is considered critical for the long-term success of endoscopic sinus surgery [1–3].

In particular, nasal irrigation represents a key element in the post-operative period following FESS (grade of recommendation A1). Specifically, nasal irrigation has been demonstrated to promote cleansing of the nasal cavities, enhance wound healing, and reduce oedema and nasal discharge after surgery. Saline douching reduces nasal discharge and may improve oedema during the healing phase following ESS which may represent a possible anti-inflammatory role [3, 4].

Although importance of post-operative cleaning and care have been emphasised in majority of available literature but still there is no standardised management protocol following functional endoscopic sinus surgery (FESS). There is a wide variation between surgeons, and also within the same surgeon’s practice at different times. Wigand has advised intense post-operative cleaning up to one week, Lund and MacKay have described cavity cleaning 5–10 days after surgery and then weekly thereafter until adequate healing occurs [1, 5–7]. Three most recent level 1b trials evaluating postoperative topical steroid sprays demonstrated a significant clinical improvement following ESS. There is significant evidence to support the clinical benefits of topical nasal steroids following ESS for refractory chronic rhinosinusitis [1].

Though the significance of both the procedures has been highlighted enough in the literature as important part of post-operative care protocol after FESS but the due importance has not been given to evaluate the compliance of patients regarding both the procedures and its effect on outcomes. We planned the present study to evaluate the role of giving pictorial handouts depicting the methods and steps of nasal saline irrigation as well as the exact position for topical drug application at time of discharge in patients undergoing FESS and see its impact on outcomes.

Methods and Materials

Present study titled, “IMPACT OF PATIENT GUIDANCE HANDOUTS ON OUTCOMES OF FESS” was a randomised control trial conducted in department of Otorhinolaryngology of Sri Guru Ram Das University of health sciences from January 2019 to May 2020. All necessary clearance was taken from research committee of the institute before initiation of recruitment of patients and study compiled with ethical principles of declaration of Helsinki which are important for involving human subjects in study. Detailed consent were obtained from patient in the language best understood by them regarding pros and cons of procedures depicted pictorally and their participation in present study.

It was ensured that patient confidentiality was maintained at all points in the study. CONSORT guidelines were followed to report the study. It was a non-funded study.

Participant Selection

Total of 46 Post-operative patients who underwent Functional endoscopic sinus surgery for CRS with/without polyposis from January 2019 to May 2020 were recruited in the study for evaluation of results for Post-operative recovery.

Inclusion Criteria

All adult patient who underwent surgery for chronic rhinosinusitis with polyps or without polyps included in the study.

Exclusion Criteria

  1. Age < 18 years

  2. FESS for CSF Rhinnorhea/skull base tumors/Angiofibroma

The patients were randomly divided into two groups. Group A patients were given pictorial handouts regarding the position of nasal saline irrigation and positions for instilling sinus medication (Figs. 1, 2). [https://www.uptodate.com/contents/images/PI/60094/Medication_positions_PI.jpg].

Fig. 1.

Fig. 1

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Pictorial handout showing the methods of saline irrigation

Fig. 2.

Fig. 2

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Pictorial handouts showing the method for administration of nasal steroidal spray

Methodology

All patients who underwent functional endoscopic sinus surgery on were advised to start nasal saline washes (with a nasowash starter kit readily available at the pharmacy of the hospital containing 200 ml squeeze bottle with 7.86 gm of premix satchet which contains 4 gm of salt. This on mixing produces a 200 ml of hypertonic saline solution) on third post-operative day along with topical Azelastine & Fluticasone spray.

Group A

Patients were verbally explained and practically demonstrated the technique of nasal saline irrigation in the language best understood and by showing them the relevant images. After their confirmation about understanding the process they were advised to repeat this three times a day in both nostrils using atleast 100 ml of saline in each nostril per wash. The nasal steroid spray was advised to be put in latera, supine and kneel down positions one puff in each nostril in each position at least 2 times a day. The positioning was again explained and demonstrated in detail.

Group B

Patients were also verbally explained as well as practically demonstrated the above mentioned procedure but were also given pictorial handouts which were explained and handed over to them at the time of discharge. The handouts depicted the exact positions of both the procedures (Figs. 1, 2).

Each patient was followed for three postoperative clinic visits during the study period, and the typical follow-up schedule was at approximately 1 week, 2 weeks, and 3 weeks after surgery. Endoscopy was performed at each visit and no questions were asked about frequency and technique of saline irrigation and steroid spray. Surgical debridement was done. Lund and Kennedy Endoscopic appearance score was noted in both groups on diagnostic nasal endoscopy before postoperative debridement. Patients were advised to do saline washes and use spray as in routine practice. In 4th post-operative (4th week) visit patients were interviewed regarding their compliance and methods of nasal saline irrigation and nasal spray. A diagnostic nasal endoscopy was done at 1 month (4 weeks) Post-operative by a trained ent specialist not involved in study. He was advised to inspect frontal recess and maxillary regions for any polypoidal mucosa and report the same in Yes/No format. The data was tabulated and analysed.

Outcomes Studied

  1. Lund and Kennedy endoscopic appearance scores [8] were noted and compared in both groups week-wise. Unpaired t test was applied and p values were calculated.

  2. A two by two contingency table was formulated for parameters enumerated below and fisher test was applied to calculate p value.
    • Compliance Of nasal Saline wash was taken as more than 2 times of cleaning everyday with atleast 100 ml of saline in each nostril everytime.
    • Compliance of steroidal spray was taken as 2 puffs in each nostril at least twice a day in atleast one position
    • Correct method of nasal saline wash as explained (Yes/No)
    • Use Nasal steroid spray in at least 3 positions as explained (Yes/No)
  3. Pearson Coefficient was calculated for the correlation between compliance of nasal saline wash in the study and the parameters enumerated below.
    • Crusting
    • Edema
    • Discharge
    • Polyps
    • Scarring

The study was observer blind as the proformas for Lund and Kennedy endoscopic scores at each were filled by the trained ENT specialist not involved in the study. The patients were interviewed regarding their compliance as well as other parametersat the end of 1 month by an observer who was not involved in the trial. The results were statistically analysed by an assessor who was blinded to the details of the study.

Results

In the present study there were 21 females versus 25 males. The average male: female ratio in group A was 1.3 versus 1 in group B. The mean age was 35.5652 ± 4.595 in group B versus 33.1739 ± 4.438 in group A. The average compliance over three weeks was 2.5765 ± 0.207 in Group B as compared to 1.4935 ± 0.27 in Group A. the t score for the difference in compliance between two groups was 15.2691. The two-tailed P value was less than 0.0001. The average Lund and Kennedy endoscopic appearance score for crusting was 1.75 ± 0.532, 1.217 ± 0.6, 0.696 ± 0.703 for Group A in post-operative follow up during week1, 2 and 3 respectively as compared to 1.45 ± 0.59, 0.304 ± 0.47, 0.826 ± 0.49for Group B. The P value was < 0.05 for the difference in both groups for all three weeks. The average Lund and Kennedy score for edema and other parameters has been enumerated in Table 1. 11/23 followed correct method for nasal saline irrigation in Group A as compared to 20/23 in Group B (Table 2). The mean compliance in Group B over three weeks was 2.5765 ± 0.207 and group A was 1.4935 ± 0.27 respectively. 18/23 used nasal steroidal spray in all positions compared to only 9/23 in Group A (Table 2). 3/23 in group B had polypoidal mucosa at frontal recess area at 1 month post-operative as compared to 16/23 (Table 2). Overall their was a negative correlation between the compliance of nasal saline irrigation with edema, crusting and discharge. The respective R score was −0.5311, −0.25296 and −0.19889 respectively (Figs. 3, 4, 5).

Table 2.

Stastiscal analysis of various parameters between two groups

s.no Parameter evaluated Group A (n = 23) Group B (n = 23) Fisher exact score P value
1. Compliance for saline irrigation 8 20 0 P value < 0.05
2. Correct method followed for saline irrigation 11 21 0.0031 P value < 0.05
3. Compliance for nasal steroidal spray 21 23 0.4889 Not significant P > 0.05
4. Practised the nasal steroidal spray in all positions explained 9 18 0.0156 Pvalue < 0.05
5. Any polypoidal mucosa seen in frontal recess At 4th week 16 03 0.0002 P value < 0.05
6. Any polypoidal mucosa in maxillary sinus at 4th week 5 1 0.1868 Not significant P > 0.05
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Table 1.

Week-wise comparison of Lund and Kennedy endoscopic scores in both the groups during follow up

Variable 1st week t-Score P value 2nd week t-Score P value 3rd week t-Score P value
Crusting
 Group A 1.75 ± 0.532 3.18 P < 0.05 1.45 ± .59 3.9020 P < 0.05 0.696 ± 0.703 2.2231 P < 0.05
 Group B 1.217 ± 0.6 0.826 ± 0.49 0.304 ± 0.47
Edema
 Group A 1.364 ± 0.492 2.0610 P < 0.05 1.174 ± 0.576 3.5526 PP < 0.05 0.78 ± 0.624 4.8359 P < 0.05
 Group B 1.043 ± 0.562 0.62 ± 0.477 0.087 ± 0.288
Discharge
 Group A 1.409 ± 0.503 1.1916 P > 0.05 0.913 ± 0.596 1.876 P > 0.05 0.478 ± 0.665 2.2291 P < 0.05
 Group B 1.174 ± 0.576 0.609 ± 0.499 0.13 ± 0.344
Polyp
 Group A 0.292 ± 0.046 3.3702 P 0.05 0.13 ± 0.344 0.3457 P > 0.05 0.043 ± 0.209 0.3168 P > 0.05
 Group B 0.087 ± 0.288
Scarring 0.167 ± 0.381 0.091 ± 0.137
 Group A 0.261 ± 0.449 0.7031 P > 0.05 0.304 ± 0.47 0.6605 P > 0.05 0.319 ± 0.422 0.0144 P> 0.05
 Group B 0.174 ± 0.388 0.217 ± 0.422 0.317 ± 0.518
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Fig. 3.

Fig. 3

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The scatter diagram with trendline showing a negative correlation between mean compliance of Nasal Saline irrigation with average of scores of crusting over first three post-operative weeks after endoscopic sinus surgery. This correlation is between the compliance and scores pertaining to crusting (Lund and Kennedy endoscopic appearance score)of the sample as a whole. Increase in compliance shows decrease in crusting

Fig. 4.

Fig. 4

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The scatter diagram with trendline showing a negative correlation between mean compliance of Nasal Saline irrigation with average scores of edema over first three post-operative weeks after endoscopic sinus surgery. This correlation is between compliance and scores of edema (Lund and Kennedy endoscopic appearance score) of the sample as a whole. Increase in compliance shows decrease in Post-operative edema

Fig. 5.

Fig. 5

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The scatter diagram with trendline showing a negative correlation between mean compliance of Nasal Saline irrigation with average of scores of Post-operative discharge over first three post-operative weeks after endoscopic sinus surgery. This correlation is between the compliance and scores pertaining to post-operative discharge (Lund and Kennedy endoscopic appearance score)of the sample as a whole. Increase in compliance shows decrease in Post-operative discharge

Discussion

Present study, “IMPACT OF PATIENT GUIDANCE HANDOUTS ON OUTCOMES OF FESS” was conducted at a tertiary care hospital from January 2019 to May 2020. 46 post-operative patients of FESS were randomly recruited into two groups where Group B participiants were handed over pictorial handouts depicting the technique and positioning of nasal saline irrigation and nasal steroid spray along with verbal instructions as well as demonstration at time of discharge as compared to Group A where no pictorial handouts were given but only verbal instructions and demonstration of the techniques required in above mentioned procedure. It was found that giving pictorial handouts regarding nasal irrigation and various positions of using nasal steroid spray at time of discharge improved the compliance of nasal saline irrigation and methodology of nasal steroid spray which leads to better post-operative cavities after functional endoscopic sinus surgery.

Although there were many strengths of present study like homogenous population, well designed post-operative scores for evaluation of surgical field, extensive review of literature,careful selection of patients fitting into inclusion criteria, stringent follow up,the main limitation of present study was small cohort hence concerns about generalizability and internal as well as external validity of trial but despite of these limitations present study has tried best in its capacity contributing to an important aspect of FESS which its post-operative care protocols for nasal cleaning and topical drug application along with opening the gates for further research on this topic.

The overall compliance of nasal saline irrigation in our study was60.8% as compared to a study by Yoo et al. which showed a compliance as high as 82%. They mentioned that younger people had better compliance than elderly [9]. Though the mean age of the population in our group was 34.3696 ± 3.779 we feel that in our region it was more about the attitude of the population towards a non-drug based regimen.

The compliance of nasal saline irrigation in our study correlated inversely with three parameters of Lund &Kennedy endoscopic appearance scores mainly crusting, edema and nasal discharge during post-operative follow up in first 3 weeks. Better compliance was associated with decrease in these parameters leading to better post-operative healing and results (Figs. 3, 4, 5). The correlation between better compliance and decrease post-operative edema was found to be statistically significant (Fig. 4). Proper post-operative nasal cleaning and topical application of intra-nasal steroids is considered as an important means of facilitating the healing of nasal mucosa and has been shown to prevent the development of crusting and adhesions in the middle meatus [10].. During the healing process of mucosa after FESS, large crusting and clot may trap mucosa, which can re-infect the sinuses [11]. The old blood itself may be a good culture medium for bacteria. The crusts may act as bridges across which scar formation may occur, leading to an obstructed postoperative cavity Severe crusting may also cause nasal blockage. Bugten et al. in their, partly blinded, controlled clinical trial, discovered that crusts in the middle meatus after sinus surgery is associated with postoperative adhesions [10]..

In our trial mean compliance in Group B (2.5765 ± 0.207) over three weeks was better as compared to group A (1.4935 ± 0.27) for nasal saline irrigation. The two-tailed P value was less than 0.0001. By conventional criteria, this difference is considered to be extremely statistically significant. Saline irrigation has been shown to be effective in improving sinonasal disease, both subjectively and objectively and is also a cornerstone in the postoperative care of patients after functional endoscopic sinus surgery [12, 13]. This is also reflected in our study where there are decreased Lund & Kennedy endoscopic appearance scores of crusting in group B compared to group A in post-operative week 1, 2 and 3. The difference was statistically significant (Table 2).

Freeman et al. in their study found Saline douching reduces nasal discharge and may improve oedema during the healing phase following ESS which may represent a possible anti-inflammatory role. No long-term effect was however found [4]. As discussed by Rudmik et al. this is because he used low volume saline washes [1]. Also in our study the group B (better compliance) had less post-operative edema as compared to group A on weekly basis and the difference was statistically significant. The nasal discharge in post-operative cavity was also less in group B as compared to group A and difference was statistically significant at third postoperative week (Table 1). Though we didn’t evaluate the patient symptom relief according to any particular score or VAS because we felt a time period of 3 weeks post-operative was too biased in favour of symptom improvement but we would still like to emphasize that the cavities of patients who were more compliant with nasal saline irrigation in both frequency and technique were more clean and crusts if present were much loose as compared to non-compliant patients. The routine post operative endoscopic debridement in compliant patients was much less painful.

Multiple studies have confirmed the benefit of high-volume, low-pressure douching over other methods of delivery. In addition, Harvey et al. 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 [13–15].

In studies conducted by Lin Shi et al., Bugten et al., Fishman et al., Nilssen et al., Kemppainen et al. and data from 6 RCT emphasised that proper method of Nasal rinsing with saline solution with the use of high volumes (about 250 ml) and compressible nasal douching devices is recommended in post-operative period for early recovery [9, 16–24]. Findings of above mentioned studies are in accordance with our present study where every parameter in Lund and Kennedy endoscopic appearance score, improved along better post-operative cavities over period of time from first postoperative week to third postoperative week if patient followed proper pictorial handout depicting exact position and method for sinus cleaning and topical drug application given to them at time of discharge (Tables 1, 2).

The impact of handouts in terms of better methodology as well as frequency for nasal saline irrigation was significant. Only 8 out of 23 showed compliance to nasal saline irrigation in terms of frequency in group A compared to 20/23 in group B; while only 11 patients in group A followed correct instructions for nasal saline washes as compared to 21 patients in group B. This difference was statistically significant (Table 2).

Intranasal application techniques can deliver topical steroid medication without the systemic side effects of oral steroid therapy. Due to their localized anti-inflammatory effects and excellent safety profile, standard topical nasal steroid sprays have become a common treatment modality for Chronic rhinosinusitis [1]. Though there was no significant difference in both groups regarding the compliance of steroid spray but 18 patients in group B used nasal spray in all positions explained as compared to 9 patients in group A leading to less polypoidal mucosa in group B patients especially in frontal recess region as compared to Group A This difference was also statistically significant (Table 2). The patients in group A were less confident regarding the technique and positions of nasal steroid spray as compared to Group B.

On questioning the patients we found that patients who were not given handouts felt a less scientific basis a towards a non-drug based regimen than a drug based regimen leading to a substantial difference in compliance of nasal saline irrigation in both groups but little or practically no difference in compliance regarding frequency of use of nasal steroid spray but definitely the group with handouts followed better technique of nasal steroid spray. The Group B patients also commented that a printed documentation and pictorial representation of nasal saline irrigation emphasised its relevance much more to them than it would have done otherwise while group A patients commented that they would have appreciated if they were provided a pictorial representation of various positions in which they had to use steroid spray.

Moreover some authors state that though there are no major drawbacks associated with earlier topical steroid spray therapy (before 2 weeks after ESS), the limited accessibility as a result of old blood and crusts would often negate any clinical benefit [21]. If this is to be considered then our results strongly point that a good compliance for nasal irrigation can ensure a better topical drug delivery for nasal steroid spray due to decrease crusting.

We want to emphasize that giving pictorial handouts depicting nasal saline irrigation and positions of using nasal steroid spray is not a huge investment on the part of the surgeon but it can yield to better post-operative healing after FESS by improving patient compliance and methodology of both the procedures.

Conclusion

Giving pictorial handouts depicting nasal saline irrigation methods and positions of using nasal steroid spray at time of discharge after FESS is a highly beneficial practice leading to better post-operative cavities. We highly recommend this practice among fellow rhinologists to improve patient compliance as well as technique of nasal irrigation and instillation of nasal steroidal spray leading to better outcomes. We also suggest further research to evaluate the long term symptom control (> 6 months) in patients undergoing saline wash after FESS and the effect of nasal saline irrigation on efficacy of nasal steroid spray in early post-operative period.

Compliance with Ethical Standards

Conflict of Interest

All authors declare that they have no conflict of interest.

Ethical Approval

Before starting the study ethical clearance was taken from institutional ethical committee as per Declaration of Helsinki.

Consent

Informed consent was taken by all the patients before surgery and enrolment into the study.

Footnotes

Publisher's Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Change history

3/15/2021

A Correction to this paper has been published: 10.1007/s12070-020-02195-z

Contributor Information

Bhanu Bhardwaj, Email: entwithdrbhanu@gmail.com.

Jaskaran Singh, Email: jassigill001@gmail.com.

Tanya Singh, Email: drtanyasingh13@gmail.com.

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