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Article Type : Review

Postoperative nasal debridement following functional endoscopic sinus surgery, a systematic review of the literature. R.Green (MBBS, DOHNS) A.Banigo(MBBS, DOHNS) I.Hathorn (FRCSEd, ORLHNS)

ENT Department Edinburgh, Lauriston Building

Correspondance address Richard Green ENT department Lauriston Building Lauriston Place Edinburgh EH3 9HA [email protected] Telephone: 0131 536 1000

Abstract Background; Chronic rhinosinusitis (CRS) is a significant health problem, the optimal postoperative treatment regime for patients post functional endoscopic sinus surgery (FESS) has been a topic debated for years.

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Objective of review; To systematically review and critically evaluate the evidence relating to postoperative debridement of the nasal cavity following FESS to guide best practice.

Search strategy; A search of the following databases was performed: Cochrane Database of Systematic Reviews (DSR), Database of Abstracts of Reviews of Effectiveness (DARE), Cochrane Central Register of Control Trials (CCTR). Ovid Medline, EMBASE, Pubmed. The following key words were used: Postoperative, FESS, sinus surgery, debridement, follow up, from 1970 to 2013

Evaluation method; Two independent reviewers assessed the relevant articles using the consort guidance on systematic reviews (1).

Results; The best evidence available was 1B, with six RCTs identified. Four studies compared debridement against no debridement and two looked at the frequency of the debridement. Cumulatively results for 337 patients were included. Visual analogue scales (VAS) were used in all studies. None of the results at the long term follow up showed any difference in SNOT scores or objective endoscopic scores. Four of the six studies demonstrated some benefit in symptom scores but only one in the long term. Two papers demonstrated the debridement group suffered more pain in the postoperative period

Conclusions Currently there is no clear evidence for frequent post-operative debridement. Further welldesigned RCTs are required to establish clear benefit, optimal frequency, extent and timing of debridement.

5 Key points •

Limited evidence showing benefit in symptom scores with debridement following FESS.



One study found a reduction in adhesions with postoperative debridement.

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Patients report increased pain and inconvenience with postoperative debridement.



More frequent debridement may give a small short term benefit in symptom score but not long term.



No clear evidence to justify using frequent postoperative nasal debridement as routine care following FESS.

Introduction: Chronic rhinosinusitis (CRS) is a significant health problem with an overall prevalence of 10.9% in Europe (2). The updated European position paper on rhinosinusitis and nasal polyps (EPOS) 2012 guidelines provide a detailed review on the aetiology, diagnosis and step-wise approach to management of rhinosinusitis in different settings (2). The guidance does not include best evidence based practice for follow up of Functional Endoscopic Sinus Surgery (FESS) patients post-operatively. The optimal postoperative treatment regime for patients post FESS has been a topic debated for years. In the early 1980’s and 1990’s Stammberger, Kennedy, and Lund and McKay described extensive aggressive postoperative debridements and cleaning of the sinuses (3,4,5). These broadly suggested performing debridement days after surgery followed by weekly or bi-weekly.

In the latter part of the 90’s two studies looked at minimal follow up and intervention in postoperative FESS patients (6,7). Although the studies had relatively small numbers, they did show comparable postoperative success rates comparing symptom scores such as nasal obstruction and discharge. However, none of the above studies were randomised controlled trials.

The advocates of debridement suggest that it will help with remucosalisation and improve overall surgical success. This has to be weighed up against the cost and potential for patient discomfort during the debridement. The variety of treatment methods indicates the lack of evidence and guidance in this area. Studies looking at postoperative regimes with saline irrigation have demonstrated a benefit in irrigating especially in short-term symptom control (8,9). Topical corticosteroids have strong supporting evidence with three RCTs demonstrating a benefit for their use post operatively. Patients with nasal polyps appear to receive the most benefit as polyp recurrence rate was reduced and time to polyp recurrence was lengthened (10-12). A RCT by Wright et al demonstrated the benefits of peri and This article is protected by copyright. All rights reserved.

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postoperative systemic steroids in improving ease of surgery and post-operative appearance (13). Post-operative antibiotics has conflicting evidence with two RCTs demonstrating no benefit but a recent paper by Albu et al showed improvement in patient symptoms and reduced crust formation in the antibiotic group (14-16). A recent review by Rudmik et al into general postoperative care summarized that the evidence suggests that a strong postoperative care protocol would involve using nasal saline irrigations beginning 24 to 48 hours after ESS and starting a topical nasal steroid spray in the first 1 to 2 weeks after ESS (17).

There is a wide range of practice in surgical debridement and follow-up amongst rhinologists post FESS. We wanted to establish what the evidence suggests is best practice.

Objective of review: To systematically review and critically evaluate the evidence relating to postoperative debridement of the nasal cavity following FESS to guide best practice.

Methods: As part of a systematic review of postoperative surgical debridement a search of the following Evidence based medicine databases was performed: Cochrane Database of Systematic Reviews (DSR), Database of Abstracts of Reviews of Effectiveness (DARE), Cochrane Central Register of Control Trials (CCTR). Ovid Medline, EMBASE, Pubmed. The search was limited to the English Language and the following key words were used: Postoperative, FESS, sinus surgery, debridement, follow up, from 1970 to 2013. The titles and abstracts of the searches were screened and then all RCTs that compared debridement versus no debridement or that looked at the frequency of debridement were included.

Two independent reviewers assessed the relevant articles using the consort guidance on systematic reviews (1).

Illustration 1.

Results: The best evidence available was 1B, there were six RCTs identified, two of the studies were from the same author but it was unclear if the same patient data was used in both studies (19,20). Four studies compared debridement against no debridement and two This article is protected by copyright. All rights reserved.

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looked at the frequency of the debridement (18-23). Cumulatively results for 337 patients were included.

The six studies included with the outcome measures and debridement regimes are listed in table 1 and 2.

Table 1. Subjective and Objective measures in studies comparing debridement against no debridement

Table 2. Subjective and Objective measures in studies comparing the frequency of sinus debridement.

Visual Analogue Scores Visual analogue scores (VAS) for the patient’s symptoms were recorded in all 6 studies (1823). Most of the VAS included nasal discharge, blockage, headaches, sneezing and facial pain. Two used the VAS to assess postoperative pain (18,20).

Of the 4 studies that compared debridement with no debridement two showed a statistical benefit in VAS, these were the two studies by Bugten et al (19-20). They demonstrated on short term follow up a benefit in nasal congestion at 12 days and in their second study on long-term follow up with an average 56 weeks (range 33-77), that nasal blockage, congestion and sneezing were significantly reduced (19,20). In the sub group analysis they found that this was only the case in patients with chronic rhinosinusitis with nasal polyps. The two other studies showed no significant benefit in any symptom scores however the Nillsen et al paper was under powered (18,21). There were two studies showing patients experienced significantly more pain in the debridement group resulting in higher doses of analgesia being required (18,20).

The 2 studies that compared frequency of debridement both demonstrated that more frequent debridement improved certain patient symptoms such as nasal discharge in the short term, however both studies showed that at 6 month up there was no difference in VAS (22,23). This article is protected by copyright. All rights reserved.

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Sino-nasal outcome test There were two studies that used SNOT as an outcome measure (17,22). Neither showed that at 3 and 6 months follow up either debridement or frequency of debridement had any effect on the SNOT score.

Objective Endoscopic Sinus Scores All except the Bugten et al 2008 and Bugten et al 2006 used a validated form of endoscopic scoring (19,20). This included the Lund-MacKay and Lund Kennedy systems. The two studies that compared debridement against no debridement showed no difference in the Lund Kennedy Endoscopic Score (LKES) at 3 or 6 months respectively (18,21). The two studies that compared the frequency of debridement showed no improvement on the Lund MacKay scores from more frequent debridement (22,23). The assessment in Bugten et al 2006 used a non validated scoring system but seemed very similar to the Lund Kennedy with adhesion rate added (20). They found fewer significant crusts in the debridement group at 12 days and at 12 weeks significantly fewer adhesions in the debridement group (20). In the Bugten et al 2006 paper even the group with more nasal crusting and adhesions had the same overall satisfaction scores at 6 months as the debridement group. The smaller study of Nillsen et al using the patients as there own control demonstrated no difference in adhesion rates (21).

Other outcome measures Other outcome measures included recording the number of acute rhinosinusitus (ARS) episodes in the Bugten et al 2008 paper (19). This demonstrated no difference in the number of episodes of ARS between debridement and no debridement.

A validated postoperative inconvenience score (POIS) was used in the Asaffar et al study (18). This consisted of an 11 part questionnaire asking the patient to grade from 1 to 5 their postoperative experience and the satisfaction at the outpatient regime and the impact on their social and work life. Alsaffar et al described debridement having a negative impact on patient satisfaction and more inconvenience and Lee et al that more frequent debridement was more disruptive to working patients and students in active education and resulted in patients failing to attend appointments (18,23). This article is protected by copyright. All rights reserved.

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We were unable to perform a meta-analysis for a number of reasons. The inclusion / exclusion criteria were often different, only two of the studies separated the groups into CRS with or without polyps (19,20). Although all of the studies used VAS in some form they often had different questions and the other outcome measures differed enough that we were unable to correlate the data into a meta-analysis.

Discussion Current postoperative management of FESS patients varies greatly between individual surgeons. This variation in current practice indicates the lack of consensus on this topic. The above results demonstrate conflicting evidence with some showing limited benefit and others no benefit. The main studies showing symptom score improvement and reduction in adhesions were the Bugten papers 2006 and 2008. These studies appeared to have recruited patients at the same time and had the same debridement regime, suggesting that this may be the same patient group, although this is not clear. They have assessed the short term results in symptom scores and endoscopic sinus appearance in the 2006 paper and longer term (56 week) symptom score and frequency or ARS in the 2008 paper (19,20).

Overall completeness and applicability of evidence; The studies reviewed were all relevant to the question we posed. The overall completeness of the studies varied with not one being sufficiently blinded or with large enough numbers for us to take their results as being more significance than the others. It is difficult to draw firm conclusions regarding the best post-operative regimes given the conflicting results from the above studies. Two of four studies showed symptom score benefit of debridement and two did not (18-21). The two studies looking at frequency of debridement showed more frequent debridement was beneficial in the short term but neither of these studies had a no debridement group to compare (22,23). Only one study demonstrated any long term benefit, and other than one study showing more adhesions in the non-debridement group there was no validated objective benefit from debridement (19,20).

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Trail Limitations Quality of evidence. There were multiple issues with all the studies when assessing them using the consort guidance for review of RCTs. There was variability in the pre and post-operative medical treatment. All studies used saline douching, however one used pre-operative steroids either topical or systemic depending on the presence of nasal polyps (19,20). One used systemic steroids, systemic antibiotics and anti-mucolytics (23). We know from previous studies that systemic steroids improve post-operative sinus appearance therefore it could be argued that the systemic steroids used improved the control groups so that it was more difficult to show a benefit from debridement.

Length of follow up was limited in half of the studies, only one with long term follow up at a year and two having follow-up at 6 months.

The extent of the FESS performed varied between the papers. Most of them indicated the extent of surgery depended on the involved sinuses including frontal and sphenoid. Some performed more limited FESS (uncinectomy and middle meatal antrostomies) (18,22). Although extent of surgery was variable between trials, within each one the authors tried to show that both intervention arms had similar baseline characteristics such as gender, age and extent of surgery. Two of the papers didn’t mention if there had been single or multiple surgeons performing the operations (18,21 ). It is likely that more extensive surgery would result in an increase in mucosal trauma which in turn would likely increase adhesions and middle turbinate lateralisation which may benefit more from debridement.

Potential biases in review; There was a significant potential for bias in the papers. The main issue is that of blinding or lack of it. Two of the studies attempted to partially blind the patients or the consultants. However, due to the nature of the intervention it is always going to be an issue and given that none of the studies were adequately blinded conclusions drawn from the results have to be made carefully (18,20).

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Interpretation of the symptom scores also needs to be performed with caution. Although VAS scores are well accepted, their subjective nature means several factors can play into the symptom improvement perceived by the patient. There is a recognised ”therapeutic effect” from a consultation alone and given that the debridement group met more frequently with their clinician than the non-debridement group this may have contributed to their improved VAS scores. It is also not stated if during these extra consultations for debridement, discussions may have arisen between the clinician and the patient checking their compliance with saline douching. It is possible that patients seen more often would be more compliant with their nasal douching regime. In addition, patients seen more often may feel obliged to report better symptom scores to avoid disappointing their surgeon

Comparison with other reviews; The only other review in the literature was part of a general post-operative review of management follow FESS surgery. The section on debridement was brief and included four of the six papers in our review (19,21-23). Their conclusions were that the most accepted practice would include a sinus cavity debridement at 1 week after FESS, while subsequent debridements are often surgeon dependent and based on the degree of crusting and inflammation (17). This review was done in North America where the system is very different to the United Kingdom and performing nasal debridement three times a week for each patient as in some of the studies that have been reviewed would be unrealistic. Due to the review being performed prior to the Alsaffar et al paper, the Bugten et al 2008 paper that demonstrated some benefit in VAS is likely to hold more significant weight when they were drawing their conclusions. They also concluded that repeated early debridement seemed to offer no benefit.

Implications for clinical practice; Implications for research There is some supporting evidence for post-operative nasal debridement following FESS surgery in the form of improved symptom scores, but certainly not all of the studies demonstrated this. The study with the most significant positive findings only found that this was the case with patients with CRSwNP. The more frequent debridement regimes offer little improvement when compared to debriding once or twice post-operatively. The negative aspect of debridement is that of potential discomfort as well as the socioeconomic This article is protected by copyright. All rights reserved.

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implications. These implications are not just for the patient but also for the NHS with an ever-increasing demand for outpatient appointments and efficiency. Due to the lack of clear evidence for or against nasal debridement the follow up protocol for FESS patients is still very much a surgeon’s preference. We currently do not believe there is clear evidence for frequent post-operative debridement. Further well designed RCTs using clealy defined inclusion/exclusion criteria are required to demonstrate any possible benefit, as well as to determine optimal frequency, and timing of post operative debridement.

No conflict of interest.

References: 1. CONSORT 2010 Explanation and Elaboration: updated guidelines for reporting parallel group randomised trials. Moher D, Hopewell S, Schulz K, Montori V, Gøtzsche P, Devereaux P et al. BMJ 2010;340:c869 doi: 10.1136/bmj.c869 2. Fokkens WJ, Lund VJ, Mullol J, Bachert C, Alobid I, Baroody F. EPOS 2012: European position paper on rhinosinusitis and nasal polyps 2012. A summary for otorhinolaryngologists. Rhinology. 2012 Mar;50(1):1-12. doi: 10.4193/Rhino50E2 3. Stammberger H. Endoscopic endonasal surgery:concets in treatment of recurring rhinosinusitis, I: Anatomic and pathophysiologic considerations. Otolaryngol Head Neck Surg 1986;94:143-145 4. Kennedy DW. Prognostic factors, outcomes and staging in ethmoids sinus surgery. Laryngoscope 1992;102 (suppl 57) 1-18 5. Lund VJ, McKay IS. Outcome based assessment of endoscopic sinus surgery. J R Soc Med 1994:87:70-72 6. Fernandes SV. Postoperative care in functional endoscopic sinus surgery. Laryngoscope 109, June 1999 7. Ryan R. Wittet H. Norval C. Marks N. Minimal foolow-up after functional endoscopic sinus surgery. Does it affect outcome. Rhinology, 34 44-45, 1996 8. Pinto JM, Elwany S, Baroody FM, et al. Effects of saline sprays on symptoms after endoscopic sinus surgery. Am J Rhinol 2006;20:191–6

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9. Freeman SR, Sivayoham ES, Jepson K, et al. A preliminary randomised controlled trial evaluating the efficacy of saline douching following endoscopic sinus surgery. Clin Otolaryngol 2008;33:462–5 10. Rowe-Jones JM, Medcalf M, Durham SR, et al. Functional endoscopic sinus surgery: 5 year follow up and results of a prospective, randomised, stratified, double-blind, placebo controlled study of postoperative fluticasone propionate aqueous nasal spray. Rhinology 2005;43:2–10. 11. Jorissen M, Bachert C. Effect of corticosteroids on wound healing after endoscopic sinus surgery. Rhinology 2009;47:280–6. 12. Stjarne P, Olsson P, Alenius M. Use of mometasone furoate to prevent polyp relapse after endoscopic sinus surgery. Arch Otolaryngol Head Neck Surg 2009;135:296–302 13. Wright ED, Agrawal S. Impact of perioperative systemic steroids on surgical outcomes in patients with chronic rhinosinusitis with polyposis: evaluation with the novel Perioperative Sinus Endoscopy (POSE) scoring system. Laryngoscope 2007;117:1–28 14. Annys E, Jorissen M. Short term effects of antibiotics (Zinnat) after endoscopic sinus surgery. Acta Otorhinolaryngol Belg 2000;54:23–8. 15. Jiang RS, Liang KL, Yang KY, et al. Postoperative antibiotic care after functional endoscopic sinus surgery. Am J Rhinol 2008;22:608–12. 16. Albu S, Lucaciu R. Prophylactic antibiotics in endoscopic sinus surgery: A short follow-up study. Am J Rhinol Allergy 2010;24:306–9 17. Rudmik L, Smith T. Postoperative care in endoscopic sinus surgery. Otolaryngol Clin N Am 45 (2012, 1019-1032 18. Alsaffar H, Sowerby L, Rotenberg BW. Postoperative nasal debridement after endoscopic sinus surgery: a randomized controlled trial. Ann Otol Rhinol Laryngol. 2013 Oct;122(10):642-7 19. Bugten V, Nordgård S, Steinsvåg S. Long-term effects of postoperative measures after sinus surgery. Eur Arch Otorhinolaryngol. 2008 May;265(5):531-7. Epub 2007 Oct 25. 20. Bugten V, Nordgård S, Steinsvåg S. The effects of debridement after endoscopic sinus surgery. Laryngoscope. 2006 Nov;116(11):2037-43.

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21. Nilssen E, Wardrop P, El-Hakim H, White PS, Gardiner Q, Ogston S. A randomized control trial of post-operative care following endoscopic sinus surgery: debridement versus no debridement The Journal of Laryngology & Otology February 2002, Vol. 116, pp. 108–111 22. Kemppainen T, Sepp J, Tuomilehto H, Kokki H, Nuutinen J. Repeated early debridement does not provide significant symptomatic benefit after ESS. Rhinology, 46, 238-242, 2008. 23. Lee JY, Byun JY, Relationship Between the Frequency of Postoperative Debridement and Patient Discomfort, Healing Period, Surgical Outcomes, and Compliance After Endoscopic Sinus Surgery Laryngoscope 118: October 2008.

Author

Numbers in the study

Debridement regime

Blinded

Follow up interval

Outcome measures

Success (statistically significant)

Nilssen et al 2001

Total 16, patients were there own controls N=16 control N=16 debridement Total 58 N=30 control N= 28 debridement

Randomised which side was debrided on the first visit.

No

3 days, 1 week, 2 weeks, 1 month and 3 months.

VAS, LKES. Both only performed at 3 months.

No difference in adhesion rate. No difference in mean symptom score or LKES.

Debridement group at 6 and 12 days

Partially (Consultants commenting on adhesions were blinded)

12 days then 10-14 weeks

VAS. None validated scoring system 2 consultants looking for adhesions and assessment of sinuses

Fewer severe crusts at 12 days in the debridement group. Nasal congestion decreased more rapidly in the debridement group from day 7 to day 12. More adhesions in the control group other sinuses assessment no difference. More pain in debridement. No difference in patient satisfaction.

Bugten et al 2006

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Bugten et al 2008

Total 60 N=31 Saline N=29 debridement

Debridement group at 6 and 12 days.

No

12 weeks and 56 weeks (range 32-77)

VAS. Episodes of ARS between week 1256.

Alsaffar et al 2013

Total 58 N=30 control N=28 debridement

Debridement at 2 then 4 weeks.

Partially (Patients were quasi blinded by deception)

4 weeks and 6 months

POIS. SNOT 21. LKES

Benefit at 56 weeks for nasal blockage/congestion and sneezing. Only in CRSwNP. No difference in frequency of ARS. Higher pain at 4 weeks with the debridement and POIS showed worse in the debridement group. No difference with SNOT 21 and LKES

LKES (Lund-Kennedy endoscopic scoring system) POIS (Post operative inconvenience score) VAS (visual analogue scale) SNOT 21 (Sino-nasal outcome test -21) CRSwNP (Chronic rhinosinusitis with nasal polyps) ARS (Acute rhinosinusisits)

Table 1. Subjective and Objective measures in studies comparing debridement against no

debridement

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Author

Numbers in the study

Debridement regime

Blinded

Follow up interval

Outcome measures

Success

Kemppainen et al 2008

Total 90 N=43 N=47

43 patients day 1 then day 3-5 then day 7. 47 patients just day 7

No

1 week and 4 weeks

Lee et al 2008

Total 30 N=10 in each arm

Group 1 (twice a week, Group 2 (once a week), Group 3 (once every 2 weeks. (All for 4 weeks total)

No

2 week intervals for 1 month then 1 month intervals for 6 months

Lund MacKay symptom score and LundMacKay endoscopic score VAS symptom, Lund MacKay, SNOT 20.

Only difference was at 1 week with the repeated debridement less nasal discharge. No benefit at 4 weeks for either outcome measure No difference in SNOT 20 or Lund MacKay at 6 months. No difference in adhesions. VAS at 4 weeks suggested that nasal discharge and headache were worse in group 3. In group 1 bigger impact on socioeconomic impact and patients omitted to come only in group 1

VAS (visual analogue scale) SNOT 20 (Sino-nasal outcome test – 20) Table 2. Subjective and Objective measures in studies comparing the frequency of sinus

debridement

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Accepted Article This article is protected by copyright. All rights reserved.

Postoperative nasal debridement following functional endoscopic sinus surgery, a systematic review of the literature.

Chronic rhinosinusitis is a significant health problem, and the optimal postoperative treatment regime for patients post functional endoscopic sinus s...
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