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This is a reprint of a Cochrane protocol, prepared and maintained by The Cochrane Collaboration and published in The Cochrane
Library 2016, Issue 1
http://www.thecochranelibrary.com
Sinonasal debridement versus no debridement for the postoperative care of patients undergoing endoscopic sinus surgery (Protocol)
Copyright 2016 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
TABLE OF CONTENTS
HEADER . . . . . . . . . .
ABSTRACT . . . . . . . . .
BACKGROUND . . . . . . .
OBJECTIVES . . . . . . . .
METHODS . . . . . . . . .
ACKNOWLEDGEMENTS
. . .
REFERENCES . . . . . . . .
APPENDICES . . . . . . . .
CONTRIBUTIONS OF AUTHORS
DECLARATIONS OF INTEREST .
SOURCES OF SUPPORT . . . .
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Sinonasal debridement versus no debridement for the postoperative care of patients undergoing endoscopic sinus surgery (Protocol)
Copyright 2016 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
1
1
1
3
3
6
6
7
8
8
9
[Intervention Protocol]
Department of Otolaryngology - Head and Neck Surgery, Rabin Medical Center, Petah Tikva, Israel. 2 Tel Aviv Universitys Faculty
of Management and Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel. 3 Division of Rhinology, Department of Otolaryngology, Stanford University School of Medicine, Stanford, California, USA. 4 Sackler Faculty of Medicine, Tel Aviv University, Tel
Aviv, Israel
Contact address: Ethan Soudry, Department of Otolaryngology - Head and Neck Surgery, Rabin Medical Center, Petah Tikva, Israel.
ethanso@clalit.org.il.
Editorial group: Cochrane ENT Group.
Publication status and date: New, published in Issue 1, 2016.
Citation: Tzelnick S, Alkan U, Leshno M, Hwang P, Soudry E. Sinonasal debridement versus no debridement for the postoperative
care of patients undergoing endoscopic sinus surgery. Cochrane Database of Systematic Reviews 2016, Issue 1. Art. No.: CD011988.
DOI: 10.1002/14651858.CD011988.
Copyright 2016 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
ABSTRACT
This is the protocol for a review and there is no abstract. The objectives are as follows:
To assess the effects (benefits and harms) of postoperative sinonasal debridement versus no debridement following endoscopic sinus
surgery.
BACKGROUND
or symptoms of rhinosinusitis between episodes. Chronic rhinosinusitis (CRS) is defined by symptoms of nasal congestion, facial
pain/pressure, anterior or posterior nasal drainage and reduced or
absent sense of smell, lasting more than 12 weeks and associated
with objective findings on nasal endoscopy or imaging (Fokkens
2012; Rosenfeld 2007). CRS is further subtyped as CRS with nasal
polyps (CRSwNP) and CRS without nasal polyps (CRSsNP). CRSwNP and CRSsNP are now considered unique disease subsets
that share some common clinical features but often differ on a
molecular level, and they can differ with regard to treatment outcomes. Whereas the etiology and pathogenesis of acute rhinosinusitis are typically linked to an infectious process, CRS comprises
a group of disorders that arise from complex inflammatory processes triggered by an array of exogenous agents. At present, fac-
Sinonasal debridement versus no debridement for the postoperative care of patients undergoing endoscopic sinus surgery (Protocol)
Copyright 2016 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
tors that have been associated with the etiology and pathogenesis
of CRS include fungi, resistant bacteria, superantigens, biofilms,
atopy, mucociliary dysfunction, environmental irritants, acquired
sinonasal obstruction (especially of the ostiomeatal complex), osteitis, and genetic or epigenetic variation of the host.
Treatment of CRS most commonly involves pharmacological therapy, with surgery generally reserved for those patients whose symptoms persist after appropriate medical therapy. Guidelines for the
conservative treatment of CRS lack consensus. Treatment alternatives commonly include nasal saline lavages, intranasal glucocorticoids, systemic glucocorticoids and oral or topical antibiotics
(Hamilos 2011). For those patients refractory to comprehensive
medical management, the current literature provides compelling
evidence that those patients who undergo endoscopic sinus surgery
(ESS) for CRS will on average have improved quality of life outcomes after surgery (Rudmik 2014).
First reports of ESS came out in the 1970s but it was only in
1985 that the principles of ESS were published in the English
literature (Kennedy 1985). Since then ESS has become one of the
most common procedures performed by ENT physicians, with
an estimated 250,000 ESS procedures performed yearly in the
United States alone (Bhattacharyya 2010), for the indication of
chronic sinusitis as well as other indications (Luong 2006). The
aim of ESS in CRS is to clear inflammation and infection, to
restore mucociliary function by re-establishing physiological sinus
ventilation and drainage, and to allow improved topical delivery
of medications.
Short- and long-term (eight years of follow-up) results of ESS
have shown excellent subjective improvement and stability over the
years with respect to symptoms such as headache, nasal discharge,
congestion, change in sense of smell and recurrent infections (
Senior 1998). An improvement in quality of life was reported in
85% of patients (Damm 2002).
Recent literature demonstrates that patients who elect for surgical
management report more improvement than medically managed
patients on quality of life instruments. In addition, they report
less use of oral antibiotics and oral steroids and fewer missed days
of work or school. Followed up to one year, the surgical cohort
still reported improved quality of life outcomes compared with
the medical cohort (Smith 2005; Smith 2013).
Intranasal synechiae, the most common complication of ESS, can
occur in up to 20% of operated patients (Henriquez 2013). These
can lead to impaired nasal airflow, contribute to ostial blockage and
impair delivery of topical medications. The presence of synechiae
has been shown to be associated with significantly decreased postoperative disease-specific quality of life scores, such as the physical
and emotional Rhinosinusitis Disability Index (RSDI) score and
Chronic Sinusitis Survey (CSS) score compared with patients who
did not develop synechiae (Henriquez 2013). Lateralization of the
middle turbinate and synechiae to the lateral nasal wall, another
very common postoperative complication, may impair adequate
postoperative endoscopic follow-up and delivery of topical medi-
cations. One study has shown that patients who developed middle turbinate lateralization may have had higher revision surgery
rates compared to patients who did not develop middle turbinate
lateralization (Bassiouni 2015).
Several postoperative measures have been suggested to reduce postoperative infection, inflammation and synechiae and ultimately
to improve patient outcome. Most commonly these include saline
irrigations, topical and systemic steroids, oral antibiotics, middle
meatal spacers and intranasal debridement (Dautremont 2014;
Low 2014; Rudmik 2011).
It is suggested that nasal saline irrigations assist in softening and
removing postoperative nasal crusting and thus improve mucociliary clearance (Jorissen 2004). Topical nasal steroids have been
shown to reduce mucosal edema and decrease the risk of disease
recurrence, with the advantage of reducing the use of systemic
steroids (DelGaudio 2006). Although used commonly, there is
controversy in the literature regarding the efficacy of antibiotics in
the postoperative period (Albu 2010; Annys 2000; Jiang 2008).
Absorbable and non-absorbable nasal packing, specifically in the
middle meatus, is also often used to control immediate postoperative bleeding and as spacers to prevent lateralization of the middle
turbinate. Recently, the use of drug-eluting stents has been introduced, as temporary spacers offering slow-release steroid therapy
to the middle meatus (Huang 2015; Rudmik 2011).
A recent survey of the members of the American Academy of Otolaryngology - Head and Neck Surgery showed that the majority
of surgeons recommend saline irrigations and antibiotics in the
immediate postoperative period, and conduct postoperative nasal
debridement (Portela 2012).
Sinonasal debridement versus no debridement for the postoperative care of patients undergoing endoscopic sinus surgery (Protocol)
Copyright 2016 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Types of participants
Inclusion criteria
Exclusion criteria
OBJECTIVES
To assess the effects (benefits and harms) of postoperative sinonasal
debridement versus no debridement following endoscopic sinus
surgery.
METHODS
Types of studies
Randomized controlled trials. We will exclude any study in which
patients had less than three months follow-up. We will consider
studies in which the patients acted as self controls, i.e. one side of
the nose underwent debridement and the other side did not (splitnose studies), only for the secondary endoscopy outcomes. This
study design, although important in terms of objective outcomes,
can introduce a high risk of bias, as patient-reported outcome
Revision cases.
Concomitant septoplasty.
Types of interventions
Postoperative nasal debridement versus no debridement.
Primary outcomes
Health-related quality of life, using disease-specific healthrelated quality of life scores, such as the Sino-Nasal Outcome
Test-22 (SNOT-22), Rhinosinusitis Outcome Measures-31
(RSOM-31) and SNOT-20.
Disease severity, as measured by patient-reported symptom
score (such as the Chronic Sinusitis Survey (CSS) questionnaire
and visual analogue scales).
Significant adverse effect(s): significant bleeding requiring
intervention, severe pain, iatrogenic injury.
Secondary outcomes
Sinonasal debridement versus no debridement for the postoperative care of patients undergoing endoscopic sinus surgery (Protocol)
Copyright 2016 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Selection of studies
Two authors (TS and AU) will independently assess the titles and
abstracts retrieved by the search strategy, blinded to decisions made
by each other. We will obtain in full text any studies that could
potentially meet the inclusion criteria and review these independently. We will settle any differences in opinion by discussion with
the senior authors ES and PHH.
Electronic searches
Published, unpublished and ongoing studies will be identified by
searching the following databases from their inception:
the Cochrane Register of Studies ENT Disorders Group
Trials Register (search to date);
the Cochrane Central Register of Controlled Trials
(CENTRAL, current issue);
PubMed (1946 to date);
Ovid EMBASE (1974 to date);
EBSCO CINAHL (1982 to date);
LILACS (search to date);
KoreaMed (search to date);
IndMed (search to date);
PakMediNet (search to date);
Web of Knowledge, Web of Science (1945 to date);
CNKI (searched via Google Scholar to date);
ClinicalTrials.gov, www.clinicaltrials.gov (search via the
Cochrane Register of Studies to date);
ICTRP (search to date);
ISRCTN, www.isrctn.com (search to date);
Google Scholar (search to date);
Google (search to date).
The subject strategies for databases will be modeled on the search
strategy designed for CENTRAL (Appendix 1). Where appropriate, these will be combined with subject strategy adaptations of
the highly sensitive search strategy designed by Cochrane for identifying randomized controlled trials and controlled clinical trials
(as described in the Cochrane Handbook for Systematic Reviews of
Interventions Version 5.1.0, Box 6.4.b. (Handbook 2011)).
Sinonasal debridement versus no debridement for the postoperative care of patients undergoing endoscopic sinus surgery (Protocol)
Copyright 2016 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
We will use RevMan 5.3 for data analysis. We will assess dichotomous data by calculating the risk ratio (RR) and continuous data
by calculating the mean difference (MD) for outcomes measured
on the same scale and/or the standardized mean difference (SMD)
for outcomes measured on different scales, with 95% confidence
intervals (CI).
Data synthesis
We will only include randomized controlled trials, as recommended by the Cochrane Handbook for Systematic Reviews of Interventions (Handbook 2011). In the included studies the unit of
randomization will be the individual participant. We will consider
studies in which the patients acted as self controls, i.e. one side
of the nose underwent debridement and the other side did not
(split-nose studies), only for the secondary endoscopy outcomes.
Where studies present results at multiple time points during follow-up (repeated observations such as one month, three months,
six months), we will analyze the longest follow-up from each study
in order to avoid a unit of analysis error.
Sinonasal debridement versus no debridement for the postoperative care of patients undergoing endoscopic sinus surgery (Protocol)
Copyright 2016 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
ACKNOWLEDGEMENTS
This project was supported by the National Institute for Health
Research, via Cochrane Infrastructure, Cochrane Programme
Grant or Cochrane Incentive funding to Cochrane ENT. The
views and opinions expressed therein are those of the authors and
do not necessarily reflect those of the Systematic Reviews Programme, NIHR, NHS or the Department of Health.
REFERENCES
Additional references
Albu 2010
Albu S, Lucaciu R. Prophylactic antibiotics in endoscopic
sinus surgery: a short follow-up study. American Journal of
Rhinology & Allergy 2010;24(4):3069.
Alsaffar 2013
Alsaffar H, Sowerby L, Rotenberg BW. Postoperative nasal
debridement after endoscopic sinus surgery: a randomized
controlled trial. Annals of Otology, Rhinology and Laryngology
2013;122(10):6427.
Bugten 2006
Bugten V, Nordgrd S, Steinsvg S. The effects of
debridement after endoscopic sinus surgery. Laryngoscope
2006;116(11):203743.
Damm 2002
Damm M, Quante G, Jungehuelsing M, Stennert E. Impact
of functional endoscopic sinus surgery on symptoms and
quality of life in chronic rhinosinusitis. Laryngoscope 2002;
112(2):3105.
Annys 2000
Annys E, Jorissen M. Short term effects of antibiotics
(Zinnat) after endoscopic sinus surgery. Acta Oto-RhinoLaryngologica Belgica 2000;54:238.
Dautremont 2014
Dautremont JF, Mechor B, Rudmik L. The role of
immediate postoperative systemic corticosteroids when
utilizing a steroid-eluting spacer following sinus surgery.
Otolaryngology - Head and Neck Surgery 2014;150(4):
68995.
Bassiouni 2015
Bassiouni A, Chen PG, Naidoo Y, Wormald PJ. Clinical
significance of middle turbinate lateralization after
endoscopic sinus surgery. Laryngoscope 2015;125(1):3641.
DelGaudio 2006
DelGaudio JM, Wise SK. Topical steroid drops for the
treatment of sinus ostia stenosis in the postoperative period.
American Journal of Rhinology 2006;50:5637.
Bhattacharyya 2009
Bhattacharyya N. Contemporary assessment of the disease
burden of sinusitis. American Journal of Rhinology & Allergy
2009;23:3925.
Fokkens 2012
Fokkens WJ, Lund VJ, Mullol J, Bachert C, Alobid I,
Baroody F, et al. European Position Paper on Rhinosinusitis
and Nasal Polyps 2012. Rhinology. Supplement 2012;3:
1298.
Bhattacharyya 2010
Bhattacharyya N. Ambulatory sinus and nasal surgery in the
United States: demographics and perioperative outcomes.
Laryngoscope 2010;120(3):6358.
Blackwell 2014
Blackwell DL, Lucas JW, Clarke TC. Summary health
statistics for U.S. adults: national health interview survey,
2012. Vital Health Statistics 10 2014;260:1161.
Hamilos 2011
Hamilos DL. Chronic rhinosinusitis: epidemiology and
medical management. Journal of Allergy and Clinical
Immunology 2011;128(4):693707.
Handbook 2011
Higgins JPT, Green S (editors). Cochrane Handbook
for Systematic Reviews of Interventions Version 5.1.0
Sinonasal debridement versus no debridement for the postoperative care of patients undergoing endoscopic sinus surgery (Protocol)
Copyright 2016 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Henriquez 2013
Henriquez OA, Schlosser RJ, Mace JC, Smith TL, Soler
ZM. Impact of synechiae after endoscopic sinus surgery on
long-term outcomes in chronic rhinosinusitis. Laryngoscope
2013;123(11):26159.
Huang 2015
Huang Z, Hwang P, Sun Y, Zhou B. Steroid-eluting sinus
stents for improving symptoms in chronic rhinosinusitis
patients undergoing functional endoscopic sinus surgery.
Cochrane Database of Systematic Reviews 2015, Issue 6.
[DOI: 10.1002/14651858.CD010436.pub2]
Jiang 2008
Jiang RS, Liang KL, Yang KY. Postoperative antibiotic care
after functional endoscopic sinus surgery. American Journal
of Rhinology 2008;22:60812.
Jorissen 2004
Jorissen M. Postoperative care following endoscopic sinus
surgery. Rhinology 2004;42(3):11420.
Kennedy 1985
Kennedy DW. Endoscopic sinus surgery: evolution and
technical innovations. Archives of Otolaryngology 1985;111:
6439.
Low 2014
Low TH, Woods CM, Ullah S, Carney AS. A doubleblind randomized controlled trial of normal saline, lactated
Ringers, and hypertonic saline nasal irrigation solution after
endoscopic sinus surgery. American Journal of Rhinology &
Allergy 2014;28(3):22531.
Luong 2006
Luong A, Marple BF. Sinus surgery: indications and
techniques. Clinical Reviews in Allergy and Immunology
2006;30(3):21722.
Portela 2012
Portela RA, Hootnick J, McGinn J. Perioperative care
in functional endoscopic sinus surgery: a survey study.
Rudmik 2011
Rudmik L, Soler ZM, Orlandi RR, Stewart MG,
Bhattacharyya N, Kennedy DW, et al. Early postoperative
care following endoscopic sinus surgery: an evidence-based
review with recommendations. International Forum of
Allergy & Rhinology 2011;1(6):41730.
Rudmik 2014
Rudmik L, Mace J, Soler ZM, Smith TL. Long-term utility
outcomes in patients undergoing endoscopic sinus surgery.
Laryngoscope 2014;124(1):1923.
Senior 1998
Senior BA, Kennedy DW, Tanabodee J, Kroger H, Hassab
M, Lanza D. Long-term results of functional endoscopic
sinus surgery. Laryngoscope 1998;108(2):1517.
Smith 2005
Smith TL, Batra PS, Seiden AM, Hannley M. Evidence
supporting endoscopic sinus surgery in the management of
adult chronic rhinosinusitis: a systematic review. Journal of
Rhinology 2005;19:53743.
Smith 2013
Smith TL, Kern R, Palmer JN, Schlosser R, Chandra RK,
Chiu AG, et al. Medical therapy vs surgery for chronic
rhinosinusitis: a prospective, multi-institutional study with
1-year follow-up. International Forum of Allergy & Rhinology
2013;3(1):49.
Sinonasal debridement versus no debridement for the postoperative care of patients undergoing endoscopic sinus surgery (Protocol)
Copyright 2016 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
APPENDICES
CONTRIBUTIONS OF AUTHORS
Ethan Soudry initiated the review and will select eligible studies, analyze and interpret the data, assess trial quality, revise the review
and approve the final content.
Tzelnick Sharon will select eligible studies, assess trial quality, perform data extraction, analyze and interpret the data, draft and revise
the review.
Alkan Uri will select eligible studies, assess trial quality, perform data extraction, draft and revise the review.
Peter Hwang will analyze and interpret the data, revise the review and approve the final content.
Moshe Leshno will analyze and interpret the data, revise the review and approve the final content.
Sinonasal debridement versus no debridement for the postoperative care of patients undergoing endoscopic sinus surgery (Protocol)
Copyright 2016 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
DECLARATIONS OF INTEREST
Ethan Soudry: none known.
Tzelnick Sharon: none known.
Alkan Uri: none known.
Peter Hwang: consultancy for Intersect ENT, Medtronic and Sinuwave. Consultancies are unrelated to the subject matter of the
manuscript.
Moshe Leshno: none known.
SOURCES OF SUPPORT
Internal sources
No sources of support supplied
External sources
National Institute for Health Research, UK.
Infrastructure funding for Cochrane ENT
Sinonasal debridement versus no debridement for the postoperative care of patients undergoing endoscopic sinus surgery (Protocol)
Copyright 2016 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.