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The Laryngoscope V C 2009 The American Laryngological, Rhinological and Otological Society, Inc. Long-Term Outcomes From the English National Comparative Audit of Surgery for Nasal Polyposis and Chronic Rhinosinusitis Claire Hopkins, DM(Oxon); Robert Slack, FRCS; Valerie Lund, FRCS; Peter Brown, FRCS; Lynn Copley, MSc; John Browne, PhD Objectives/Hypothesis: We present a large, prospective cohort study following patients who underwent surgery for chronic rhinosinusitis (CRS), with or without nasal polyps, in hospitals in England and Wales. Five-year outcomes will be reported, and we will revisit a previous analysis of the effectiveness of extensive surgery in the treatment of nasal polyposis. Methods: Baseline clinical data was collected for 3,128 patients undergoing surgery for CRS (with or without nasal polyps). Outcomes are described in terms of the proportion of patients undergoing revi- sion surgery and mean Sino-Nasal Outcome Test (SNOT-22) scores. Results: A total of 1,459 (52.2%) patients responded to 5-year follow-up. Revision surgery rates increased at each time point. Of the patients respond- ing, 279 patients (19.1%) had undergone further surgery during the 5 years since their original opera- tion. Of the patients with polyps, 20.6% had under- gone revision compared to 15.5% of patients with CRS alone. The mean SNOT-22 score for all patients was 28.2 (standard deviation [SD] ¼ 22.4) at 5 years after surgery. This is remarkably similar to the results observed at 3 months (25.5), 12 months (27.7), and 36 months (27.7), and represents a 14-point improvement over the baseline score. Polyp patients report better SNOT-22 scores at 5 years (mean ¼ 26.2; SD ¼ 21.6) than patients with CRS alone (mean ¼ 33.3; SD ¼ 23.7). Of the patients who had origi- nally received simple polypectomy, 21.2% had under- gone revision surgery compared to 20.0% of patients who had also received additional sinus surgery. The difference in unadjusted revision surgery rates is not statistically significant (v 2 ¼ 0.22; P ¼ .64). However, the difference becomes statistically significant when a multivariate logistic regression is used to adjust for baseline characteristics, with patients undergoing additional sinus surgery being less likely to undergo further surgery within the study period (adjusted odds ratio ¼ 0.66; P ¼ .04). Conclusions: We have shown sinonasal surgery to be safe and effective in reducing the symptoms associated with CRS over a 5-year period. The reduc- tion in symptoms is large, with no significant decline in symptomatic improvement from 12 to 60 months postsurgery. However, revision surgery rates approach 20% over this time, and patients should be counseled accordingly prior to surgery. Key Words: Outcome assessment, sinusitis, operative procedures. Laryngoscope, 119:2459–2465, 2009 INTRODUCTION Chronic rhinosinusitis (CRS), one of the most com- mon chronic diseases in Europe and the United States, is reported to be more prevalent than arthritis or hyper- tension, affecting between 5% and 15% of studied populations. 1 Symptoms include nasal obstruction, puru- lent nasal discharge, postnasal drip, anosmia, facial pain, and headaches. Studies have shown significant reduction in quality of life in patients with CRS. 2 Nasal polyposis is considered within the generality of CRS, 3 but why some, and not all patients with CRS develop polyps remains unknown. In the general population, the prevalence of polyposis is estimated to lie between 2% and 4%. 4 Treatment of CRS aims to reduce patients’ symptoms. This usually involves primary medical man- agement, with surgery reserved for cases unresponsive to conservative treatment, or where there are complica- tions of CRS. A wide range of surgical procedures are undertaken to treat CRS, the vast majority being undertaken endonasally. There are a large number of published studies, largely nonrandomized and From the Ear, Nose and Throat Department, Guys and St. Thomas’ Hospital (C.H.); the Ear, Nose and Throat Department, Royal United Hospital (R.S.), the Ear, Nose and Throat Department, Royal National Throat, Nose and Ear Hospital (V.L.), the Ear, Nose and Throat Department, Milton Keynes General Hospital (P .B.), and the Clinical Effectiveness Unit, Royal College of Surgeons of England (L.C., J.B.), London, United Kingdom. Editor’s Note: This Manuscript was accepted for publication June 25, 2009. Send correspondence to Claire Hopkins, Carmay, Chelsfield Lane, Orpington, UK BR6 7RR. E-mail: [email protected] DOI: 10.1002/lary.20653 Laryngoscope 119: December 2009 Hopkins et al.: Surgery Audit for Nasal Polyposis and CRS 2459

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Page 1: Long-term outcomes from the English national comparative audit of surgery for nasal polyposis and chronic rhinosinusitis

The LaryngoscopeVC 2009 The American Laryngological,Rhinological and Otological Society, Inc.

Long-Term Outcomes From the EnglishNational Comparative Audit of Surgery forNasal Polyposis and Chronic Rhinosinusitis

Claire Hopkins, DM(Oxon); Robert Slack, FRCS; Valerie Lund, FRCS; Peter Brown, FRCS;

Lynn Copley, MSc; John Browne, PhD

Objectives/Hypothesis: We present a large,prospective cohort study following patients whounderwent surgery for chronic rhinosinusitis (CRS),with or without nasal polyps, in hospitals in Englandand Wales. Five-year outcomes will be reported, andwe will revisit a previous analysis of the effectivenessof extensive surgery in the treatment of nasalpolyposis.

Methods: Baseline clinical data was collected for3,128 patients undergoing surgery for CRS (with orwithout nasal polyps). Outcomes are described interms of the proportion of patients undergoing revi-sion surgery and mean Sino-Nasal Outcome Test(SNOT-22) scores.

Results: A total of 1,459 (52.2%) patientsresponded to 5-year follow-up. Revision surgery ratesincreased at each time point. Of the patients respond-ing, 279 patients (19.1%) had undergone furthersurgery during the 5 years since their original opera-tion. Of the patients with polyps, 20.6% had under-gone revision compared to 15.5% of patients withCRS alone. The mean SNOT-22 score for all patientswas 28.2 (standard deviation [SD] ¼ 22.4) at 5 yearsafter surgery. This is remarkably similar to theresults observed at 3 months (25.5), 12 months (27.7),and 36 months (27.7), and represents a 14-pointimprovement over the baseline score. Polyp patientsreport better SNOT-22 scores at 5 years (mean ¼26.2; SD ¼ 21.6) than patients with CRS alone (mean¼ 33.3; SD ¼ 23.7). Of the patients who had origi-nally received simple polypectomy, 21.2% had under-gone revision surgery compared to 20.0% of patients

who had also received additional sinus surgery. Thedifference in unadjusted revision surgery rates is notstatistically significant (v2 ¼ 0.22; P ¼ .64). However,the difference becomes statistically significant when amultivariate logistic regression is used to adjust forbaseline characteristics, with patients undergoingadditional sinus surgery being less likely to undergofurther surgery within the study period (adjustedodds ratio ¼ 0.66; P ¼ .04).

Conclusions: We have shown sinonasal surgeryto be safe and effective in reducing the symptomsassociated with CRS over a 5-year period. The reduc-tion in symptoms is large, with no significant declinein symptomatic improvement from 12 to 60 monthspostsurgery. However, revision surgery ratesapproach 20% over this time, and patients should becounseled accordingly prior to surgery.

Key Words: Outcome assessment, sinusitis,operative procedures.

Laryngoscope, 119:2459–2465, 2009

INTRODUCTIONChronic rhinosinusitis (CRS), one of the most com-

mon chronic diseases in Europe and the United States,is reported to be more prevalent than arthritis or hyper-tension, affecting between 5% and 15% of studiedpopulations.1 Symptoms include nasal obstruction, puru-lent nasal discharge, postnasal drip, anosmia, facial pain,and headaches. Studies have shown significant reductionin quality of life in patients with CRS.2 Nasal polyposis isconsidered within the generality of CRS,3 but why some,and not all patients with CRS develop polyps remainsunknown. In the general population, the prevalence ofpolyposis is estimated to lie between 2% and 4%.4

Treatment of CRS aims to reduce patients’symptoms. This usually involves primary medical man-agement, with surgery reserved for cases unresponsiveto conservative treatment, or where there are complica-tions of CRS. A wide range of surgical proceduresare undertaken to treat CRS, the vast majority beingundertaken endonasally. There are a large numberof published studies, largely nonrandomized and

From the Ear, Nose and Throat Department, Guys and St. Thomas’Hospital (C.H.); the Ear, Nose and Throat Department, Royal UnitedHospital (R.S.), the Ear, Nose and Throat Department, Royal NationalThroat, Nose and Ear Hospital (V.L.), the Ear, Nose and ThroatDepartment, Milton Keynes General Hospital (P.B.), and the ClinicalEffectiveness Unit, Royal College of Surgeons of England (L.C., J.B.),London, United Kingdom.

Editor’s Note: This Manuscript was accepted for publication June25, 2009.

Send correspondence to Claire Hopkins, Carmay, Chelsfield Lane,Orpington, UK BR6 7RR. E-mail: [email protected]

DOI: 10.1002/lary.20653

Laryngoscope 119: December 2009 Hopkins et al.: Surgery Audit for Nasal Polyposis and CRS

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uncontrolled (level III), which document high levels ofsymptomatic improvement following endoscopic sinussurgery. Terris and Davidson5 performed a meta-analysisof 10 studies, with a total of 1,713 patients, and foundsubjective improvement in 73% to 97.5%. However, 12%of the patients required revision surgery. Revision ratesin some series of patients with CRS are as high as20%,6,7 and 75% when considering patients with nasalpolyposis treated with simple polypectomy alone.8 Moststudies of revision surgery after CRS surgery haveinvolved small sample sizes and short follow-up periods.There are no good comparative studies evaluating thebenefit of endoscopic sinus surgery over simple polypec-tomy in patients with nasal polyposis. A recentsystematic review on this topic highlighted the need forhigh-quality randomized trials.9

The National Comparative Audit of Surgery fornasal polyposis and chronic rhinosinusitis is a large, pro-spective cohort study following patients who underwentsurgery for these conditions in National Health Service(NHS) hospitals in England and Wales in 2000 and2001. The 12- and 36-month outcomes of this cohorthave been previously reported.10 Five-year outcomes arenow available and are presented here.

A further objective of this paper is to revisit a previousanalysis of the effectiveness of extensive surgery in thetreatment of nasal polyposis. Because a wide range of surgi-cal techniques were used in this audit, it is possible tocompare the effectiveness of different surgical methods. Inparticular the audit provides an opportunity to examine theeffectiveness of simple versus extensive surgical approachesto the treatment of polyposis. Using 36-month outcomesdata, we have previously shown no significant advantageto more extensive surgery in terms of improvement in the22-item Sino-Nasal Outcome Test (SNOT-22 scores),although there was a trend to reduced recurrence withmore extensive surgery.11 The effect of increasing extentof surgery has been re-examined in this group at 5 years.

MATERIALS AND METHODSBaseline clinical data was collected for 3,128 patients

undergoing surgery for CRS (with or without nasal polyps) in86 NHS Hospitals in England and Wales under the care of 270different consultant surgeons. The full methodology has beendescribed previously.9

Recruitment to the study occurred between April 2000 andMay 2001. All patients aged over 16 years of age undergoingsurgery for CRS, including nasal polyposis, were eligible forinclusion. The operating surgeon completed a standard form tocollect data on patient characteristics, surgical technique, andperioperative complications.

A total of 3,128 patients were identified, and were askedto complete a preoperative questionnaire about their demo-graphic status and disease history. They were sent outcomequestionnaires to complete at 3, 12, and 36 months postopera-tively. Patients who had consented to further follow-up werecontacted at 5 years and asked to complete the SNOT-22, and toreport on their need for further medical and surgical treatment.The SNOT-22 contains items on sinonasal symptoms, sleep,emotional and psychosocial functioning, where each item isscored on a range of 0 to 5 depending on severity, thus giving atotal score of 0 to 110. Higher scores represent higher severity.

Five-year outcomes are described in terms of the propor-tion of patients undergoing revision surgery and mean SNOT-22 scores. Revision surgery rates are calculated in a cumulativefashion based on patient responses from the 12-month, 36-month, and 5-year surveys.

To explore any potential bias introduced by loss to follow-up, the baseline characteristics and SNOT-22 scores at all previ-ous time points of responders and nonresponders werecompared.

In addition, to explore the extent to which prospectivelymeasured revision surgery rates were biased by loss to follow-up, an alternative dataset was interrogated. The Hospital Epi-sode Statistics (HES) database records operative data relatingto all patients admitted to the English NHS. The database cov-ers private patient admissions to NHS hospitals, but does notinclude patients treated in the private sector. All patients in the2000/2001 HES year (April 1, 2000–March 31, 2001) with anepisode containing an International Classification of Diseases(ICD-10) diagnosis code of J32 (chronic sinusitis) or J33 (nasalpolyps) in any of the diagnosis fields, or an Office for PopulationCensuses and Surveys (OPCS-4) operation code of E08.1 (nasalpolypectomy), or E12-E15 (sinus operations) in any of the proce-dure fields were identified. For these patients, all subsequentHES episodes in the 6-year period 2000/2001 to 2005/2006 wereextracted. Two patient groups (nasal polypectomy and sinussurgery) were defined according to the presence of an indexoperation. An index nasal polypectomy operation was defined asthe first occurrence of a nasal polypectomy together with a diag-nosis of chronic sinusitis or nasal polyps in the 2000/2001 HESyear. An index sinus operation was defined as the first occur-rence of a sinus operation together with a diagnosis of chronicsinusitis or nasal polyp in the 2000/2001 HES year. The samepatient could be included in both index groups. The index oper-ation was not necessarily the first operation of that type that apatient had ever undergone; rather, it was the first operation ofthat type that could be found in the 2000/2001 HES year. Forboth groups, a revision operation was defined as any polypec-tomy or sinus operation that occurred after the index operationup to March 31, 2006.

When considering the effect of increasing extent of surgeryin patients with polyposis, we compared patients who under-went only simple nasal polypectomy to those who hadadditional sinus surgery. The statistical approach to this com-parison replicated the methods used in a previously publishedanalysis, which used a subsample of 1,848 patients.10 Addi-tional surgery was defined as surgery to at least one of thefollowing; middle meatus/uncinate, anterior or posterior eth-moids, sphenoid or frontal sinuses. Patients were excluded fromthis analysis if they underwent an inferior meatal antrostomy,had not undergone a polypectomy, or had incomplete baselinedata. In our univariate analyses, we used a t test to compareSNOT-22 scores and a v2 test to compare revision surgery rates.In our multivariate analysis of outcome after different types ofsurgery, we used linear regression to adjust SNOT-22 scoresand logistic regression to adjust revision surgery rates forpotential confounding factors. To account for possible clusteringof patient outcomes within hospitals, we used robust standarderrors. All P values are 2-sided and P values < .05 were consid-ered a statistically significant result. Stata software version 8(StataCorp, College Station, TX) was used for all calculations.

RESULTSA total of 2,797 patients completed a baseline ques-

tionnaire and consented to further follow-up. Of these,1,952 had nasal polyps and 845 had CRS alone. A totalof 1,459 patients (52.2% response rate) responded to the

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5-year follow-up survey, of whom 1,045 had nasal polypsat baseline (53.5% response rate) and 414 had CRS alone(49.0% response rate).

Characteristics of both responders and nonrespond-ers are presented in Table I. It can be seen that bothgroups are similar in terms of the proportion of patientswho are male, have polyposis (including the extent ofpolyps in these patients), who have asthma and aller-gies, and those undergoing primary or revision surgery.

They differed in that the nonresponders at 5 yearsreported higher SNOT-22 scores at all earlier timepoints, including preoperatively, such that the postopera-tive change in SNOT-22 score was similar.

Revision surgery rates have increased at each timepoint after surgery (Fig. 1). A total of 279 patients(19.1%) had had at least one new sinonasal procedureduring the 5 years since their original operation. Thiscompares to 3.7% at 12 months and 13.1% at 36 monthsafter surgery. Of the patients with polyps, 215 (20.6%)had had revision surgery in the previous 5 years com-pared to 64 of the patients with CRS alone (15.5%).These figures are slightly higher than those derivedfrom the HES database. A total of 11,033 patients under-went an index nasal polypectomy in England during the2000/2001 HES year. Of these, 2,009 (18.2%) had had atleast one further sinonasal procedure by March 31,2006. A total of 11,333 patients underwent an indexchronic sinusitis procedure during the 2000/2001 HESyear. Of these, 1,557 (13.7%) had had at least one fur-ther sinonasal procedure by March 31, 2006.

Postoperative SNOT-22 scores at each follow-uppoint are shown in Figure 2. The mean SNOT-22 scorefor all patients was 28.2 (standard deviations [SD] ¼22.4) at 5 years after surgery. This is remarkably similarto the results observed at 3 months (25.5), 12 months(27.7), and 36 months (27.7), and represents a 14-pointimprovement over the baseline score. Polyp patientsreport better SNOT-22 scores in the 5-year follow-upsurvey (mean ¼ 26.2; SD ¼ 21.6) than patients withCRS alone (mean ¼ 33.3; SD ¼ 23.7). This tendency hasbeen present at all previous time points.

To explore the possible effect on these scores ofincluding the outcomes of patients who have alreadyundergone revision surgery, the results excluding theserevision patients were analyzed, but there was no signif-icant difference.

TABLE I.Characteristics of Responders and Nonresponders at 60 Months.

Responders,No. (%)

Nonresponders,No. (%)

No.Missing

Male 836 (58.9) 1,049 (61.4)

Previous surgery 669 (47.2) 639 (44.6) 276

No polyps 405 (29.0) 547 (32.5) 46

Grade 1 polyps 280 (20.0) 340 (20.2)

Grade 2 polyps 387 (27.7) 432 (25.7)

Grade 3 polyps 326 (23.3) 365 (21.7)

Smoker 200 (14.3) 369 (26.3) 324

Asthmatic 475 (33.8) 445 (31.3) 298

Patient-reported allergy 509 (36.9) 512 (36.8) 357

No. (SD) No. (SD)No.

Missing

Mean age, yr 52.9 (13.4) 46.6 (15.0) 6

Lund-Mackay score 10.8 (6.7) 10.4 (6.4) 1,288

Preoperative SNOT-22 40.9 (19.9) 43.0 (20.6) 325

3-month SNOT-22 24.0 (20.3) 27.6 (21.4) 844

12-month SNOT-22 26.1 (22.1) 30.4 (23.3) 872

36-month SNOT-22 27.1 (22.3) 29.8 (22.1) 13

SD ¼ standard deviation; SNOT-22 ¼ 22-item Sino-Nasal OutcomeTest.

Fig. 1. Revision surgery rates (%).

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HES Data InterrogationThe HES database identified 11,033 patients under-

going an index nasal polypectomy during the 2000/2001HES year. Of these, 2,009 (18.2%) had had at least onerevision sinonasal procedure by March 31, 2006, and 455(4.1%) had had more than one revision procedure. Atotal of 11,333 patients underwent an index chronic si-nusitis procedure during the 2000/2001 HES year. Ofthese 1,557 (13.7%) had had at least one revision sino-nasal procedure by March 31, 2006 and 331 (2.9%) hadhad more than one revision procedure. Where a revisionprocedure was recorded the median time to first revisionwas 2.4 years for patients who had had an index nasalpolypectomy and 2.1 years for patients who had had anindex chronic sinusitis procedure.

Effect of Increasing Extent of Surgeryin Polyp Patients

Five-year follow-up data were available for 463 ofthe 844 patients who had originally undergone simplepolypectomy (54.9% response rate) and 531 of the 1,004patients who had received a polypectomy with additionalsinus surgery (52.9% response rate). Unadjusted 5-yearSNOT-22 scores were significantly better in patientsundergoing simple polypectomy than those undergoingpolypectomy with additional surgery (difference in meanSNOT-22 scores 5.2; 95% confidence interval [CI] 2.5-7.9;P < .001), but this difference decreased to 2.8 (95% CI0.5-5.1; P ¼ .02) when adjustment was made for preoper-ative SNOT-22 scores. Further adjustment for sex, age,previous surgery, asthma status, aspirin sensitivity,polyp grade, and unilateral polyposis reduced the differ-ence even further to �0.3 (95% CI �2.6 to 2.1; P ¼ .83).

Of the simple polypectomy patients, 98 had under-gone a further sinonasal procedure at 5 years after theiroriginal operation (21.2%) compared to 106 of the patientswho had originally received a polypectomy with additionalsinus surgery (20.0%). The difference in unadjusted revi-sion surgery rates is not statistically significant (v2 ¼

0.22; P ¼ .64). However, the difference becomes statisti-cally significant when a multivariate logistic regression isused to adjust for the baseline characteristics describedabove, with patients undergoing additional sinus surgerybeing less likely to undergo further surgery within thestudy period (adjusted odds ratio ¼ 0.66; P ¼ .04).

DISCUSSION

Response RatesJust over one half of the patients who gave consent

to continued contact responded to the 60-month ques-tionnaires, compared with 65% at 36 months. Thiscontinued attrition is a common feature of such studies.Although it would be preferable to follow all patients, westill have data on a group of over 1,400 patients over a5-year time period, making this one of the largest andlongest running studies in this area to date.

We have considered whether patients’ outcomesmay be influencing their likelihood to respond, and wehave found that patients who did not respond at 60months had significantly poorer SNOT-22 scores at allearlier time points. If those with poorer outcomes wereless likely to return questionnaires at 5 years, thiswould bias the results presented. If all the nonrespond-ers had deteriorated to their preoperative SNOT-22scores, the mean score for the whole cohort at 60 monthswould have been 35.5 (95% CI 34.7-36.4), with an effectsize of 0.3, which is considered to be a medium-sizechange. However, if the SNOT-22 scores at 36 monthswere maintained in the nonresponders, the cohort meanat 60 months would have been 28.5 (95% CI 27.5-29.5),with an effect size of 0.67. The true mean is likely to liebetween these two values, showing sustained improve-ment following surgery.

OutcomesThe improvement in SNOT-22 scores demonstrated

at earlier time points has been maintained at 5 years,

Fig. 2. SNOT-22 at each follow-up point (95% confidence interval).

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with patients with polyps consistently achieving lowersymptom scores. Such prolonged benefit in terms ofsymptomatic benefit has not previously been docu-mented in other studies.

However, nearly one in five patients undergoingsurgery for sinonasal disease in this study had under-gone revision surgery within a 5-year period. There arefew other published long-term outcome studies to com-pare this study with. Kennedy6 has reported a revisionsurgery rate of 18% in a cohort of 72 patients, both withand without polyps, undergoing functional endoscopicsinus surgery with an average follow-up of 7.8 years.Pentilla7 reports 21% of patients with polyposis requiredrevision surgery following functional endoscopic sinussurgery (FESS), in a study with maximum follow-up of 9years. Our results compare favorably with both of thesesingle-surgeon long-term studies, despite the heteroge-nous nature of our patient group. These surgical failuresdemonstrate that adequate management of chronic rhi-nosinusitis is not only about appropriate surgicaldrainage, but show that we must continue to improveboth medical and surgical treatment modalities.

Interrogating the HES dataset, we have found simi-lar rates of revision surgery over a 5-year period. Wecan, therefore, be reassured we have not significantlyunderestimated the rates despite loss to follow-up. Therate found in the study cohort is slightly higher than inHES; patients may be reporting some revision proce-dures that were not captured by our search criteriausing the HES dataset (for example, division of adhe-sions). In addition, the HES data will fail to capturepatients undergoing revision surgery in the private sec-tor or outside of England. The high concordance ofresults suggests that HES data may be suitable for cap-turing long-term revision rates from surgical proceduresin future studies.

Other case series identified by a systematic reviewof FESS for polyposis report lower revision ratesbetween 3% and 9%, but the mean follow-up period inthese studies was 12 months, and the range 6 to 48months.11 The progressive increase in revision ratesshown in this study across the 5-year period highlightsthe need for long-term follow up when reporting outcomefrom sinonasal surgery. In particular, it will be impor-tant to compare new techniques, such as minimallyinvasive sinus techniques or balloon sinuplasty againstconventional procedures over a similar time course.

Despite the high revision surgery rate, we havedemonstrated sustained improvement in SNOT-22 scoresover a 5-year period. We have previously shown the sur-gery undertaken in this study to be safe, with a lowcomplication rate,12 and can now reassure our patientsthat results are likely to be maintained over time.

Extent of SurgerySimple polypectomy remains a common procedure

in the UK, with 7,915 procedures being reported in Eng-land in the 2005 to 2006 financial year.13 This practiceseems to be less common in other countries, particularlyin the United States. We believe that financial con-

straints in a publicly funded UK health service drivesurgeons to select management pathways associatedwith lowest cost to the healthcare provider, and there-fore some surgeons offer simple polypectomy instead ofFESS in cases of polyposis. Simple polypectomy is morecommon in patients with extensive polyps, as thesepatients have the most significant nasal obstruction.

At the time of the study, many of the patientsundergoing simple polypectomy did not have preopera-tive cross-sectional imaging, and the endoscope was usedin only 45% of cases. The reason for undertaking simplepolypectomy without computed tomography (CT) imag-ing is that there is no intention of entering the sinuses,merely to clear the airway and relieve obstructive symp-toms. As yet there is no evidence to suggest that CTimaging would prevent complications in this procedure,but routine imaging is simply the practice now adoptedby ear, nose, and throat surgeons. With more widespreadavailability of both endoscopes and microdebriders sincethe time of the study, many more simple polypectomiesare likely to be performed using these instruments, butagain there is no evidence to suggest that this results inimproved outcomes. Although the aim of the procedurein removing only the polyps is essentially the same, bet-ter visualization may facilitate better nasal clearance.

In the polyp patients, there is a significant reduc-tion in revision surgery rates when sinus surgery isperformed in addition to simple polypectomy. When thesinuses are mechanically obstructed by polyps, simpleclearance of polyps at the ostiomeatal complex may beinadequate to restore normal physiological function. Ifthe residual sinuses remain blocked by polypoidal tissue,it may not be possible to restore normal drainage with-out additional surgery. There are very few trialscomparing outcomes in patients undergoing surgery ofdiffering extent for nasal polyposis. Jankowski14 reportsthat only 6% of patients undergoing nasalization (radicalclearance of the sinuses including resection of the middleturbinate) required revision surgery, compared to 14% ofa group who received functional ethmoidectomy (averagefollow-up 34 months). As we did not find an increase incomplications in patients undergoing more extensivesurgery,12 it would seem to be good practice to clearobstructed sinuses where possible. However, clinicallythe actual difference in revision rates is small, and theseresults need to be replicated in a controlled trial.

Given that we have not demonstrated increasedsymptomatic benefit from increasing surgery, why mightfewer patients be requiring revision surgery? The lack ofcorrelation between subjective and objective findings insinonasal disease has been well documented. We also donot know if the patients who underwent revision hadhigher SNOT-22 scores prior to revision surgery,although it seems unlikely that patients would submitthemselves to treatment in the absence of symptomrecurrence.

Limitations of This StudyThis is a pragmatic study, the aim of which was to

capture real-life practice across the UK. The following

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definition was recently given for this type of studydesign15: ‘‘An explanatory approach recruits as homoge-neous a population as possible and aims primarily tofurther scientific knowledge. By contrast, the design of apragmatic trial reflects variations between patients thatoccur in real clinical practice and aims to inform choicesbetween treatments. To ensure generalisability prag-matic trials should, so far as possible, represent thepatients to whom the treatment will be applied. Theneed for purchasers and providers of healthcare to useevidence from trials in policy decisions has increased thefocus on pragmatic trials.’’ One result of the studydesign is that a large number of surgeons with differinglevels of technical ability and different surgical practicesare included. Although we feel that this is desirable, weaccept that as a result some individual surgeons mayfind it harder to compare their own practice with out-comes of this study.

This is an observational study, and despite adjust-ment for baseline characteristics, residual confoundingcannot be excluded. There are many differences inpatients undergoing simple polypectomy compared withthose undergoing additional sinus surgery that mayintroduce bias to this study. Comparing Lund-Mackay(LM) scores, patients with the most extensive disease oncross-sectional imaging underwent the most extensivesurgery. Sharp et al.16 have demonstrated that higherpreoperative CT scores predict failure from functionalendoscopic sinus surgery at 2 years. Even using multi-variable regression we are unlikely to have removed alleffects of such bias, and we may be underestimating theimpact of surgery as a result.

Nonrandomized allocation of treatment options mayintroduce bias in many further ways. We do not have ra-diological staging information on the majority of patientsundergoing simple polypectomy. Only 17% of thesepatients were subjected to preoperative CT, comparedwith 96% of cases where the posterior ethmoids wereentered. It is possible that this group differ in diseaseseverity; however, their baseline SNOT-22 scores werecomparable with other patients. Where LM scores areavailable, the patients have comparable disease extent(mean LM 11.7; 95% CI 10.2-13.2) to those undergoinganterior ethmoidectomy (mean LM 11.6; 95% CI 10.9-12.3), but less extensive disease extent to those under-going posterior ethmoidectomy (mean LM 14.8; 95% CI14.2-15.4).

Only 27% of simple polypectomies were performedby a consultant surgeon, compared with 65% of proce-dures involving the posterior ethmoids, and 78% ofradical operations entering all of the sinuses. Whenfaced with a poor outcome, a surgeon may be more likelyto undertake revision surgery if a nonconsultant surgeonhas performed the primary procedure. In addition, a sur-geon may be more likely to revise a simple procedure,feeling that there is more that can be done, than whensurgery has been more extensive in the first sitting.However, when polyps recur, they can be removed surgi-cally regardless of the extent of the primary procedure.

Only 77% of patients undergoing simple polypec-tomy had used topical steroids preoperatively, compared

with 94% patients undergoing surgery into the posteriorethmoids and/or sphenoid sinuses. A higher proportionof patients undergoing simple polypectomy had bilateralgrade III polyps than those undergoing more extensivesurgery. It is likely that when such polyps cause grossmechanical obstruction, the patient may be unwilling toconsider a trial of medical therapy, and opt to proceedstraight to surgery; equally the surgeon may considersuch treatment futile due to limited access to the nasalcavity. In the postoperative period the former group mayhave a better response rate to further medical therapy,whereas the latter group may contain more patients re-sistant to medical treatment. In addition, although wecollected data regarding postoperative steroid use ineach group, we do not know whether this was prescribedprophylactically or in response to observed polyp recur-rence, and this may add further bias.

The numbers of patients undergoing extensive sur-gery in this cohort are fairly small. The posteriorethmoids were the most distal sinuses entered in 16% ofpatients, the frontal sinuses were entered in only 6.6%,and the sphenoids were reported to have been entered inonly 6.0%. Sinonasal surgery is undertaken by manyconsultant surgeons in the UK. However, surgeonsundertaking these more extensive procedures are prob-ably more likely to have a specialist interest inrhinology, and may perform sinonasal surgery more fre-quently. Any difference in outcome may reflect thegreater surgical experience and expertise of those under-taking more extensive surgery, rather than the nature ofthe procedure itself.

Areas for Future ResearchWe have been unable to address any effects of use

of long-term medication on outcomes, as only limiteddata was collected on medication use. In particular, weare unable to ascertain whether topical steroids wereprescribed in response to a poor outcome, or in anattempt to prevent recurrence.

We have found results that suggest that the extentof surgery may influence the likelihood of undergoing re-vision surgery in polyp patients. However, given themany potential sources of bias, these results should beinterpreted with caution. They need to be replicated in amore controlled study before changes in current practicecan be advised. However, such a trial will be a consider-able challenge to undertake.

CONCLUSIONWe have shown sinonasal surgery to be safe and

effective in reducing the symptoms associated with CRSover a 5-year period. The reduction in symptoms islarge, with no significant decline in symptomaticimprovement from 12 to 60 months postsurgery. How-ever, revision surgery rates approach 20% over thistime, and patients should be counseled accordingly priorto surgery.

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BIBLIOGRAPHY

1. Melen I. Chronic sinusitis. J Allergy Clinic Immunol 2000;106:213–227.

2. Glicklich RE, Metson R. The health impact of chronic sinus-itis in patients seeking otolarygologic care. OtolarygolHead Neck Surg 1995;113:104–108.

3. Larsen K, Tos M. The estimated incidence of symptomaticnasal polyps. Acta Otolaryngol 2002;122:179–182.

4. Fokkens W, Lund VJ, Mullol J. European Position Paper onRhinosinusitis and Nasal Polyps group. European posi-tion paper on rhinosinusitis and nasal polyposis 2007.Rhinol Suppl 2007;(20):1–136.

5. Terris M. Davidson T. Review of published results forendoscopic sinus surgery. Ear Nose Throat J 1994;73:574–580.

6. Senior BA, Kennedy DW, Tanabodee J, Kroger H, HassabM, Lanza D. Long-term results of functional endoscopicsinus surgery. Laryngoscope 1998;108:151–157.

7. Pentilla M, Rautiainen M, Pukander J, Kataja M. Func-tional vs. radical maxillary surgery. Failures after func-tional endoscopic sinus surgery. Acta Otolaryngologica1997;117:173–176

8. Larsen K, Tos M. A long-term follow-up study of nasalpolyp patients after simple polypectomies. Eur Arch Oto-rhinolaryngol 1997;254(suppl 1):S85–S88.

9. Dalziel K, Stein K, Round A, Garside R, Royle P. Systematicreview of endoscopic sinus surgery for nasal polyps.Health Technol Assess 2003;7:iii,1–159.

10. Hopkins C, Browne J, Slack R, et al. The national compara-tive audit of surgery for nasal polyposis and chronic rhi-nosinusitis. Clin Otolaryngol 2006;31:390–398.

11. Browne J, Hopkins C, Slack R, et al. Health-related qualityof life after polypectomy with and without additional sur-gery. Laryngoscope 2006;116:297–302.

12. Hopkins C, Browne J, Slack R, et al. Complications of sino-nasal surgery. Laryngoscope 2006;116:1494–1499.

13. HES online. HES Service and the HES online website onbehalf of the NHS Information Centre for health andsocial care. Available at: http://www.hesonline.nhs.uk.Accessed February 17, 2009.

14. Jankowski R, Pigret D, Decroocq F, Blum A, Gillet P. Com-parison of radical (nasalisation) and functional ethmoi-dectomy in patients with severe sinonasal polyposis. Aretrospective study. Rev Laryngol Otol Rhinol (Bord)2006;127:131–140.

15. Roland M, Torgesen D. What are pragmatic trials? BMJ1998;316:285.

16. Sharp HR, Rowe-Jones JM, Mackay IM. The outcome of en-doscopic sinus surgery: correlation with computerized to-mography score and systemic disease. Clin Otolaryngol2001;24:39–42.

Laryngoscope 119: December 2009 Hopkins et al.: Surgery Audit for Nasal Polyposis and CRS

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