Documente Academic
Documente Profesional
Documente Cultură
Background: Early postoperative care following endoscopic sinus surgery (ESS) has been suggested to minimize
avoidable complications and optimize long-term outcomes.
Several postoperative care strategies have been proposed
but a formal comprehensive evaluation of the evidence has
never been performed. The purpose of this article is to provide an evidence-based approach to early postoperative
care following ESS.
Methods: A systematic review of the literature was
performed and the Clinical Practice Guideline Manual,
Conference on Guideline Standardization (COGS), and the
Appraisal of Guidelines and Research Evaluation (AGREE)
instrument recommendations were followed. Study inclusion criteria were: adult population >18 years old; chronic
rhinosinusitis (CRS) based on published diagnostic criteria;
ESS following failed medical therapy; primary study objective was to evaluate an ESS early postoperative care strategy; and clearly dened primary clinical end-point.
Results: This review identied and evaluated the literature on 7 early postoperative care strategies following
ESS: saline irrigations, sinus cavity debridements, systemic
1
Division of Rhinology and Sinus Surgery, Department of
OtolaryngologyHead and Neck Surgery, Oregon Health and Science
University, Portland, OR; 2 Division of Rhinology and Sinus Surgery,
Department of OtolaryngologyHead and Neck Surgery, Medical
University of South Carolina, Charleston, SC; 3 Division of
OtolaryngologyHead and Neck Surgery, University of Utah, Salt Lake
City, UT; 4 Department of Otorhinolaryngology, Weill Medical College
of Cornell University, New York City, NY; 5 Division of Otolaryngology,
Brigham and Womens Hospital, Boston, MA; 6 Department of Otology
and Laryngology, Harvard Medical School, Boston, MA; 7 Department
of Otorhinolaryngology, University of Pennsylvania School of Medicine,
Philadelphia, PA
steroids, topical steroids, oral antibiotics, topical decongestants, and drug-eluting spacers/stents.
Conclusion: Based on the available evidence, use of nasal
saline irrigation, sinus cavity debridement, and standard
topical nasal steroid spray are recommended early postoperative care interventions. Postoperative antibiotic, systemic steroid, nonstandard topical nasal steroid solution,
and/or drug-eluting spacers/stents are options in postoperative management. These evidence-based recommendations should not necessarily be applied to all postoperative
patients and clinical judgment, in addition to evidence, is
C 2011
critical to determining the most appropriate care.
ARS-AAOA, LLC.
Key Words:
endoscopy; evidence-based medicine; postoperative care;
sinusitis; surgery
How to Cite this Article:
Rudmik L, Soler ZM, Orlandi RR, et al. Early postoperative care following endoscopic sinus surgery: an evidencebased review with recommendations. Int Forum Allergy
Rhinol, 2011; 1:417430
hronic rhinosinusitis (CRS) is a common disabling illness characterized by diffuse sinonasal inflammation,
resulting in symptoms of congestion, nasal drainage, facial pain, and olfactory dysfunction. Despite comprehensive medical therapy, a subgroup of patients with refractory disease often requires surgical treatment, usually in
the form of endoscopic sinus surgery (ESS). The surgical
treatment of CRS has been increasing steadily, with an
417
Rudmik et al.
estimated 250,000 paranasal sinus surgical procedures performed yearly in the United States.1
To optimize patient care and manage finite health care resources, strategies that optimize clinical outcomes and minimize subsequent revision surgery must be recognized and
implemented. Many experts have suggested that early postoperative care is a critical determinant of surgical success.
However, the definition of surgical success following ESS is
poorly defined. Most experts would agree that the ultimate
goal of early postoperative care is optimizing long-term
quality of life (QoL). However, postoperative care strategies which improve short-term clinical outcomes without
affecting the long-term QoL are still important for optimizing patient care. For example, postoperative antibiotics
may improve short-term symptoms; however, they may not
alter the long-term QoL outcomes following ESS. Improving short-term symptoms, even without long-term benefit,
is still an important aspect of patient care. Furthermore,
an early postoperative care intervention may compromise
short-term outcomes but improve long-term outcomes. For
example, postoperative sinus cavity debridement may result in temporary procedural-related pain while improving long-term healing outcomes. Since different postoperative care strategies often target different clinical goals, the
challenge is deciding which outcome is the most clinically
relevant. Therefore, we have not recommended a best
outcome assessment for each treatment. Instead, when reviewing the evidence, the reader should consider which specific outcome might be optimal for the case(s) under consideration and determine whether the studies addressed that
outcome.
Postoperative care is not standardized and a formal
evidence-based review of common clinical practices has
never been performed for ESS. The purpose of this review
is to identify early postoperative strategies commonly utilized after ESS and promote an evidence-based approach
418
care strategies
Potential strategies
Saline irrigations
Results
Topical steroids
Oral antibiotics
Topical decongestants
Drug-eluting spacers/stents
A total of 6 studies were identified where the primary objective was to evaluate the effects of nasal saline (NS) irrigation
on early ESS postoperative clinical outcomes (Table 4).1318
All study designs were randomized controlled trials and at
least single-blinded. When evaluating postoperative symptoms, 3 of the 4 studies demonstrated improved symptom
scores with saline irrigations.13,15,16 The highest quality article was a level 1b study by Liang et al.15 that compared
saline irrigations combined with postoperative debridement
to debridement alone. They demonstrated that NS irrigations combined with sinus debridement significantly improved both patient symptoms and endoscopic appearance
in the mild CRS patient cohort, while the addition of NS
irrigation to sinus debridement failed to demonstrate any
improvement in the moderate-severe CRS group.
When evaluating the impact of saline irrigations on
postoperative endoscopic appearance, a level 2b study by
Freeman et al.14 demonstrated that NS irrigations improved early (3 weeks) endoscopic appearance and mucociliary clearance; however, there was minimal difference
at 3 months after the ESS procedure. One disadvantage of
this study was the utilization of a low volume saline irrigation protocol (2 mL atomized). Conclusions from this
study cannot be directly applied to patients who utilize a
common high volume (240 mL) NS irrigation protocol. The
ideal volume and frequency of postoperative saline irrigation is poorly defined and future studies will be required to
evaluate this topic.
The only study evaluating hypertonic NS irrigations on
early postoperative care demonstrated that it increases
postoperative pain.17 Other general side-effects of saline
irrigations have been described including local irritation,
ear pain, nose bleeds, headache, nasal burning, and
nasal drainage.19 Recently, it has been shown that bacterial contamination of saline irrigation bottles is common. A
Research quality
Well-designed RCTs
Strong recommendation
Option
Strong recommendation/recommendation
Option
Recommendation
Option
Option
No recommendation
419
2008
Staffieri et al.18
Study
RCT
RCT
RCT
RCT
RCT
RCT
design
2b
1b
2b
1b
2b
2b
LOE
80
77
23
128
60
20
subjects
Number of
Began POD
#1; 20 mL;
4 daily
Began POD
#1; 240 mL;
1 daily
1) NS +
debridement;
2) Debridement
alone
1) NS;
2) SFT water
Began POD
#1; atomization
of 2 mL; 3
daily
Began POD
#1; 2
daily
Began POD
#1; 30 mL;
4 daily
Began POD
#2; 3 daily
protocol
Saline irrigation
1) NS;
2) No irrigations
1) NS;
2) Dexpanthenol
spray
1) NS;
2) HS;
3) No irrigations
1) Sea salt;
2) Sea salt +
mucolytic +
antiseptic
Study groups
1) Postoperative
mucosal
histomorphology
1) Symptoms;
2) Endoscopic
appearance
1) Endoscopic
appearance
1) Symptoms;
2) Mucociliary
clearance
1) Symptoms
1) Weight of
ethmoid crusts;
2) Symptoms
end-point
Primary ESS
Conclusion
CRS = chronic rhinosinusitis; ESS = endoscopic sinus surgery; HS = hypertonic saline; LOE = level of evidence; NS = normal saline; POD = postoperative day; RCT = randomized controlled trial; SFT = sulfurous
ferruginous-thermal.
2008
2008
Fooanant et al.13
Liang et al.15
2006
Pinto et al.17
2008
1996
Pigret and
Jankowski16
Freeman et al.14
Year
Study
Rudmik et al.
420
study by Lewenza et al.20 demonstrated 32 different bacterial species colonizing sinus rinse bottles with no correlation
between the duration of bottle use and degree of colonization. Although bacterial colonization is prevalent, the role it
plays on ESS outcomes is unclear as multiple studies including Lee et al.21 have failed to demonstrate that colonization
leads to increased post-ESS infection rates.
Summary:
1.
2.
3.
4.
5.
6.
7.
8.
Postoperative debridement
Postoperative sinonasal cavity debridement has been advocated to prevent potential synechiae and sinus ostial
stenosis, and to improve patient symptoms. Removal of old
blood, nasal secretions, unresorbed packing, and exposed
bony lamellae are thought to reduce the inflammatory load
and remove potential framework for scarring.22,23
This review identified 4 randomized controlled studies evaluating ESS postoperative debridement on clinical
outcomes (Table 5).2427 Three trials were level 1b studies and demonstrated significant symptom and endoscopic
improvement with postoperative debridement. The study
by Bugten et al.24 (level 1b) demonstrated that postoperative sinus cavity debridement resulted in reduced crust
and middle meatal adhesion rates at 3 months follow-up.
In 2008, Bugten et al.28 reported the long-term results of
their debridement group and demonstrated that the initial short-term improvements were stable after 56 weeks.
The remaining 2 level 1b studies identified in this review
attempted to elucidate the ideal timing of postoperative debridement. The study by Lee and Byun26 demonstrated that
patients who received multiple debridements within the first
week received similar short-term (4 weeks) and long-term
(6 months) symptom outcomes compared to patients with
debridement(s) at 1-week intervals. However, the patients
who received multiple debridements within in the first week
after ESS reported the greatest disturbances in socioeconomic activities and had the highest rate of omitting postoperative clinic visits. As a result, Lee and Byun26 concluded
that the optimal frequency of post-ESS sinus cavity debridements was at 1-week intervals. The study by Kemppainen
421
3.
4.
5.
6.
7.
8.
2002
2006
2008
2008
Nilssen et al.27
Bugten et al.24
Kemppainen et al.25
Study
RCT
RCT
RCT
RCT
design
1b
1b
1b
2b
LOE
30
90
60
17
subjects
Number of
1) Frequent
debridement;
2) Standard
debridement;
3) Delayed
debridement
1) Frequent
debridement +
saline irrigations;
2) Standard
debridement +
saline
irrigation
1) Debridement alone;
2) Saline irrigation
alone
1) Debridement;
2) No debridement
Study groups
1) Endoscopic
appearance
1) Symptoms;
2) Endoscopic
appearance
end-point
Primary ESS
Frequent debridement
1) Early symptoms;
2) Late HRQoL;
= 2 per week;
Standard debridement 3) Late endoscopic
appearance
= 1 per week;
Delayed debridement =
1 every 2
weeks
Frequent debridement
1) Symptoms
= 3 within
first week post-ESS;
Standard debridement
= 1 at
week 1 post-ESS
Debridement on
POD# 6 and 12
Single-side debridement
on: POD# 3, weeks
1, 2, 4, and month 3
protocol
Debridement
2007
Study
RCT; doubleblind;
placebocontrolled
design
1b
LOE
24
subjects
Number of
Study
1) Perioperative
systemic steroids;
2) Placebo
groups
PO prednisone 30 mg:
Beginning 5 days
preoperatively and
continuing for 9 days
post-ESS; placebo:
same schedule
as above
protocol
Systemic steroid
ESS = endoscopic sinus surgery; LOE = level of evidence; PO = per os (oral medication); RCT = randomized controlled trial.
Year
Study
1) Technical ease of
surgery;
2) Symptoms;
3) Endoscopic
appearance
end-point
Primary ESS
ESS = endoscopic sinus surgery; HRQoL = health-related quality of life; LOE = level of evidence; POD = postoperative day; RCT = randomized controlled trial.
Year
Study
Conclusion
Conclusion
Rudmik et al.
422
4.
5.
6.
7.
423
34
2009
2009
2006
Jorissen et al.32
Stjarne et al.33
RCT doubleblind
placebo
controlled
multicenter
RCT doubleblind
placebocontrolled
RCT doubleblind
placebocontrolled
RCT doubleblind
placebocontrolled
Study design
3b
1b
1b
1b
1b
LOE
36
104
99
109
162
subjects
Number of
Steroid nasal
drops:
1) Dexamethasone
ophthalmic;
2) Prednisolone
ophthalmic;
3) Ciprofloxacin/
dexamethasone
1) Mometasone
nasal spray;
2) Placebo
1) Mometasone
nasal spray;
2) Placebo
spray
1) Fluticasone
nasal spray;
2) Placebo
spray
1) Fluticasone
nasal spray;
2) Placebo
spray
Study groups
Started steroid
nasal drops
within 3 months
of ESS
Started QD nasal
spray 2 weeks
after ESS
Started nasal
sprays 6 weeks
post-ESS
Protocol
Topical Steroid
BID = twice a day; ESS = endoscopic sinus surgery; LOE = level of evidence; QD = once daily; RCT = randomized controlled trial.
2005
2004
Year
Rowe-Jones et al.31
Dijkstra et al.
Study
1) Ostial patency;
2) Oral steroid
rescue
episodes;
3) Revision
sinus surgery
1) Days to polyp
recurrence
1) Endoscopic
appearance;
2) Number of
oral steroid
rescue
episodes
1) Symptoms;
2) Endoscopic
appearance;
3) Number of
oral steroid
rescue episodes
1) Patients
withdrawn from
study because
of recurrent
disease
end-point
Primary ESS
Conclusion
Rudmik et al.
424
3.
4.
5.
6.
7.
Postoperative antibiotics
Bacterial infection following ESS is thought to contribute to prolonged healing time, worse patient symptoms,
and potential local complications. Traditionally, a shortcourse of postoperative antibiotic (710 days) has been
recommended22,39 ; however, the literature regarding their
use is conflicting.
This review identified 3 randomized trials evaluating the role of postoperative antibiotics following ESS
(Table 8).4042 The earliest study, a randomized doubleblind, placebo controlled trial (level 1b) by Annys and
Jorissen,40 evaluated a short-course of postoperative antibiotics (2 days) and demonstrated it had no benefit on ESS
clinical outcomes. This provides convincing evidence that
a short-course of antibiotics after ESS has minimal value.
However, conclusions regarding the benefit of longer, more
traditional, postoperative antibiotic courses (ie, 714 days)
cannot be made from this study. A level 2b study by
Jiang et al.41 utilized a randomized methodology to assign
patients to a longer course of antibiotic group (Amoxicillin/Clavulante 375 mg 3 times a day [TID] 3 weeks)
425
3.
6.
7.
Topical decongestant
BID = twice a day; ESS = endoscopic sinus surgery; LOE = level of evidence; QD = once daily; RCT = randomized controlled trial; TID = 3 times a day.
Jiang et al.41
4.
5.
75
1) Oral antibiotic;
2) Placebo
1) Symptoms
2) Endoscopic
appearance
3) Crust formation
71
1) Oral antibiotic;
2) No antibiotic
1) Symptoms
2) Endoscopic
appearance
3) Culture rates
40
2000
202
end-point
protocol
Primary ESS
Oral antibiotic
subjects
Study groups
Number of
LOE
Study design
Year
Study
Conclusion
Rudmik et al.
7.
426
427
ESS = endoscopic sinus surgery; LOE = level of evidence; RCT = randomized controlled trial.
Xylometazoline 0.1%
2 puffs 4 per
day; saline spray
6 per day
Humphreys et al.45
2009
120
2b
RCT
1) Topical
decongestant;
2) Normal saline
spray
Primary ESS
end-point
protocol
Study groups
subjects
LOE
design
Study
Year
Topical
decongestant
Number of
Study
Conclusion
2008
2008
2010
Huvenne et al.48
Kang et al.49
Cote et al.50
RCT doubleblind
placebocontrolled
RCT
Prospective
cohort
Study design
1b
2b
3b
LOE
19
32
10
subjects
Number of
1) Ethmoid cavity
steroid-soaked
dressing;
2) Placebo
1) Ethmoid cavity
steroid-soaked
dressing;
2) Steroid nasal
spray
1) Drug eluting
frontal sinus
stent;
2) Placebo frontal
sinus stent
Study groups
Nasopore soaked in
Triamcinolone
packing;
Nasopore
soaked in saline
Triamcinalone
(40 mg)-soaked
gauze packing
qWeekly
2 months
DC-releasing stent
Drug-eluting device
1) Endoscopic
appearance
1) Nasal polyp
recurrence
1) Frontal sinus
symptoms;
2) Local MMP-9
levels
end-point
Primary ESS
Conclusion
B
N/A
A
D
B
N/A
B
Debridement
Systemic steroids
Postoperative antibiotics
Topical decongestants
Grade of
evidence
Equal
Harm
Equal
Equal
Benefit
Equal
Benefit
Benefit
Balance of benefit
to harm
Recommendation
N/A
Single level 1b study protocol: Nasopore packing soaked with triamcinolone steroid
placed with ethmoid cavity after ESS. Removed at the 1 week postoperative
debridement
Recommendation against
Option
Single level 1b study protocol was: Prednisone (30 mg) started 5 days preoperatively
and continued for up to 9 days after ESS (no taper) in CRS patients with nasal polyps
Option
Option
Recommendation
Option
Recommendation
Recommendation
BID = twice a day; CRS = chronic rhinosinusitis; ESS = endoscopic sinus surgery; N/A = not applicable.
Saline irrigation
Postoperative treatment
strategy
ESS = endoscopic sinus surgery; DC = doxycycline; LOE = level of evidence; MMP = matrix metalloproteinase; POD = postoperative day; qWeekly = every week; RCT = randomized controlled trial.
Year
Study
Rudmik et al.
428
7.
Overall summary
Based on the best available evidence, an evidenced-based
early postoperative care protocol after ESS would include
nasal saline irrigation, sinus cavity debridement, and initiation of a standard topical nasal steroid spray (Table 11).
Postoperative antibiotics are an option, which reflects the
tradeoff between short-term clinical benefit and the downside of medication side-effects and costs. There is 1 highlevel evidence study to support the use of postoperative
systemic steroids to improve both early and long-term endoscopic appearance; however, given the potential adverse
effects, the use of systemic steroids remains an option
until further evidence is available. In such instances, the
option level assignment for this intervention would typically require shared decision-making and discussion with
the patient prior to prescribing.
Off-label topical steroid therapy and ethmoid cavity
steroid eluting spacers/stents are both options that may
be considered in special cases, such as sinus ostial stenosis,
severe inflammatory disease, and/or rapid polyp recurrence.
The literature recommends against the routine use of early
topical decongestants. This review is not intended to supersede clinical judgment, but rather to assist clinicians
with understanding the available evidence and develop
an evidence-based approach to early postoperative care
after ESS.
Conclusion
10.
11.
Evaluation of small and large volume saline irrigations on ESS postoperative outcomes.
Evaluation of the frequency of saline irrigations on
ESS postoperative outcomes.
Evaluation of adverse effects of postoperative systemic steroid use.
Evaluation of postoperative systemic steroids in patients with CRS without nasal polyps.
Evaluation of the systemic and ocular effects of
long-term off-label topical nasal steroid drops.
Evaluation of the ideal duration of prophylactic
antibiotics.
Evaluation of the ideal antimicrobial agent used for
postoperative antibiotics.
Evaluation of the safety and systemic effects of
drug-eluting middle meatal spacers.
Evaluation of multiple early sinus cavity debridements and their timing.
Evaluation of long-term clinical outcomes of
early postoperative care strategies.
Evaluation of the wound healing effects of higherdose topical steroid concentration irrigations and
drug-eluting middle meatal spacers.
References
1.
2.
3.
4.
5.
6.
429
7.
Rudmik et al.
the novel Perioperative Sinus Endoscopy (POSE) scoring system. Laryngoscope. 2007;117:128.
30. Poetker DM, Reh DD. A comprehensive review of the
adverse effects of systemic corticosteroids. Otolaryngol Clin North Am. 2010;43:753768.
31. 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;43:210.
32. Jorissen M, Bachert C. Effect of corticosteroids on
wound healing after endoscopic sinus surgery. Rhinology. 2009;47:280286.
33. Stjarne P, Olsson P, Alenius M. Use of mometasone furoate to prevent polyp relapse after endoscopic
sinus surgery. Arch Otolaryngol Head Neck Surg.
2009;135:296302.
34. Dijkstra MD, Ebbens FA, Poublon RM, et al. Fluticasone propionate aqueous nasal spray does not influence the recurrence rate of chronic rhinosinusitis and
nasal polyps 1 year after functional endoscopic sinus
surgery. Clin Exp Allergy. 2004;34:13951400.
35. Nasonex (mometasone furoate monohydrate) product
information. Available at: http://www.nasonex.com.
Accessed March 2nd, 2011.
36. DelGaudio JM, Wise SK. Topical steroid drops for the
treatment of sinus ostia stenosis in the postoperative
period. Am J Rhinol. 2006;20:563567.
37. Bhalla RK, Payton K, Wright ED. Safety of budesonide
in saline sinonasal irrigations in the management of
chronic rhinosinusitis with polyposis: lack of significant adrenal suppression. J Otolaryngol Head Neck
Surg. 2008;37:821825.
38. Welch KC, Thaler ER, Doghramji LL, et al. The effects of serum and urinary cortisol levels of topical
intranasal irrigations with budesonide added to saline
in patients with recurrent polyposis after endoscopic
sinus surgery. Am J Rhinol Allergy. 2010;24:26
28.
39. Stammberger H, Posawetz W. Functional endoscopic
sinus surgery. Concept, indications and results of the
430