Routine nasal packing versus no nasal packing following functional endoscopic sinus surgery

Abstract

This is the protocol for a review and there is no abstract. The objectives are as follows:

To assess the effects of nasal packing following functional endoscopic sinus surgery.

Background

Functional endoscopic sinus surgery (FESS) has been developed as a minimally invasive technique for managing the symptoms of chronic rhinosinusitis. Its principal aim is to restore ventilation of the paranasal sinuses and return them to their functioning pre‐disease state (Kennedy 1985). Additionally, endoscopic techniques (using specialised equipment used to look inside the nose) may be used in extended applications for the management of other pathological entities, including the excision of neoplastic (tumour) lesions and lacrimal system (relating to tear production) obstruction. These procedures are achieved through the use of rigid endoscopes and specialised endoscopic surgical instruments.

When performing endoscopic sinus surgery, adequate visualisation may be hampered by bleeding within the operative field (May 1994), which can occur as a consequence of mucosal trauma during dissection or direct vascular injury, and can be influenced by the underlying pathology (Ko 2008). Intraoperative bleeding may be reduced by preventative measures including administration of pre‐operative steroid medication (Wright 2007), specific anaesthetic techniques (Wormald 2005), intraoperative vasoconstrictors (Higgins 2011), and coagulation diathermy (sealing of bleeding vessels through the use of heat generated through specialised electrical equipment). However, bleeding may persist at the end of the procedure. Such an event, or suspicion by the surgeon that there may be an increased probability of postoperative bleeding, may prompt the insertion of nasal packing. 

Description of the condition

Postoperative bleeding after FESS occurs infrequently (Stankiewicz 2011). It can be minor and self resolving, without the need for intervention. However, the potential exists for continued bleeding that is not controlled through simple first aid measures. Persistent nasal bleeding may require nasal packing or alternative interventional procedures.

Description of the intervention

Although nasal packs may be placed as spacers to prevent lateralisation of the middle turbinate (movement of the internal nasal structure to the outer margins of the nasal cavity), they are more often used as an adjunct to reduce the incidence of postoperative bleeding. Variations in the type of nasal packing include the use of non‐absorbable packs, which are subsequently removed, absorbable nasal packing or no nasal packing. Each option has its individual merits and disadvantages. The use of immediate, non‐absorbable nasal packing may reduce the risk of postoperative bleeding but may be associated with discomfort both while the pack is in‐situ and during removal. Conversely, the use of absorbable nasal packing overcomes the potential discomfort during pack removal but may be associated with other disadvantages, such as the formation of synechiae (adhesions between the lining within the nose).

Why it is important to do this review

Nasal packing materials have been advocated for the control of postoperative bleeding (Jorissen 2004). Initially packing materials were non‐absorbable and hence required removal postoperatively. Pain arising from nasal packing removal was consequently an inherent issue (Chheda 2009; Mo 2008; von Schoenberg 1993). Attempts have been made to reduce this pain through means such as the adjunctive use of local anaesthesia (Karaaslan 2007), and through modifying packing materials, but levels of discomfort remain (Akbari 2012; Hesham 2011). Further, concerns regarding synechiae formation (Wang 2011), and more significant issues such as toxic shock syndrome, have been raised (Abram 1994).

Recently, a variety of absorbable materials have been presented, which overcome the issue of discomfort associated with pack removal (Lu 2005). Additionally, authors have described a lower incidence of postoperative scarring causing synechiae formation when these packs were used (Berlucchi 2009), but evidence contradictory to this has also been presented (Chandra 2004; Weitzel 2008). A number of randomised controlled trials have been published investigating the benefits of nasal packing. In most instances, within these studies the control group also received nasal packing but in a different form (Berlucchi 2009; Chang 2011; Cote 2010; Franklin 2007; Shoman 2009; Szczygielski 2007). Nevertheless, the question still remains as to whether nasal packs are required at all in order to reduce postoperative bleeding (Eliashar 2006; Suzuki 2010). To investigate this hypothesis, several authors have presented randomised controlled trials comparing the use of both absorbable and non‐absorbable packing against no packing (Wee 2012; Woodworth 2010; Wormald 2006).

This review will attempt to determine whether patients can be safely managed without nasal packing after functional endoscopic sinus surgery with respect to mitigating associated factors including discomfort due to pack removal.

Objectives

To assess the effects of nasal packing following functional endoscopic sinus surgery.

Methods

Criteria for considering studies for this review

Types of studies

Randomised controlled trials (RCTs).

Types of participants

We will only include trials with patients undergoing functional endoscopic sinus surgery for chronic rhinosinusitis with and without nasal polyps.

Types of interventions

We will include trials comparing nasal packing (intervention group) against no packing (control group).

We will include internal control studies where left and right sides are randomised.

Types of outcome measures

We will analyse the following outcomes in the review, but they will not be used as a basis for including or excluding studies.

Primary outcomes

• Postoperative bleeding rate requiring further intervention

Secondary outcomes

• Duration of postoperative stay

• Synechiae formation

• Reduction in postoperative middle turbinate lateralisation

• Re‐admission rate

• Pain or discomfort (at the time of pack removal and for the duration prior)

• Change in postoperative haemoglobin

• Number of occasions that the nasal bolster is changed postoperatively

• Infection

• Other adverse effects/complications

Search methods for identification of studies

We will conduct systematic searches for randomised controlled trials. There will be no language, publication year or publication status restrictions. We may contact original authors for clarification and further data if trial reports are unclear and we will arrange translations of papers where necessary.

Electronic searches

We will identify published, unpublished and ongoing studies by searching the following databases from their inception: the Cochrane Ear, Nose and Throat Disorders Group Trials Register; the Cochrane Central Register of Controlled Trials (CENTRAL, current issue); PubMed; EMBASE; CINAHL; LILACS; KoreaMed; IndMed; PakMediNet; CAB Abstracts; Web of Science; ISRCTN; ClinicalTrials.gov; ICTRP; Google Scholar and Google.

We will model subject strategies for databases on the search strategy designed for CENTRAL (Appendix 1). Where appropriate, we will combine subject strategies with adaptations of the highly sensitive search strategy designed by The Cochrane Collaboration for identifying randomised controlled trials and controlled clinical trials (as described in theCochrane Handbook for Systematic Reviews of Interventions Version 5.1.0, Box 6.4.b. (Handbook 2011)).

Searching other resources

We will scan the reference lists of identified publications for additional trials and contact trial authors if necessary. In addition, we will search PubMed, TRIPdatabase, The Cochrane Library and Google to retrieve existing systematic reviews relevant to this systematic review, so that we can scan their reference lists for additional trials. We will search for conference abstracts using the Cochrane Ear, Nose and Throat Disorders Group Trials Register and EMBASE. We will contact investigators and experts in the field, including members of the European Rhinologic Society, to obtain additional published or unpublished studies.

Data collection and analysis

Selection of studies

Two authors will independently screen all titles and abstracts to determine which studies fulfil the eligibility criteria. We will then assess full‐text copies of the selected studies and further assess those that continue to meet the eligibility criteria. We will place studies that are excluded in the 'Characteristics of excluded studies' table and record the reasons for exclusion. We will discuss any disagreements regarding identified work in an authors' meeting in order to decide whether trials should be included in or excluded from this review.

Data extraction and management

We will complete a data extraction form based on the Cochrane good practice data extraction template. We will extract the following information:

• Methods

  • Allocation

  • Design

  • 'Risk of bias' domains

• Participants

  • Number

  • Age

  • Gender

  • Setting

  • Eligibility criteria

  • Exclusion criteria

  • Baseline characteristics

• Interventions

  • Intervention group

  • Comparator group

  • Use of additional interventions

• Outcomes

  • Primary outcome

  • Secondary outcomes

  • Time points of assessment

  • Length of follow‐up

• Other

  • Participants lost to follow‐up

  • Funding sources

  • Declarations of interest

Two authors will review the data collected and discuss further analysis. Any potential disagreement will be resolved by referring to a third author for a final decision.

Assessment of risk of bias in included studies

MF and MMK will undertake assessment of the risk of bias of the included trials independently, with the following taken into consideration, as guided by theCochrane Handbook for Systematic Reviews of Interventions (Handbook 2011):

• sequence generation;

• allocation concealment;

• blinding;

• incomplete outcome data;

• selective outcome reporting; and

• other sources of bias.

We will use the Cochrane 'Risk of bias' tool in RevMan 5 (RevMan 2014), which involves describing each of these domains as reported in the trial and then assigning a judgement about the adequacy of each entry: 'low', 'high' or 'unclear' (or unknown) risk of bias.

Unit of analysis issues

We will assess studies utilising internal controls for inclusion in paired analysis. If no unit of analysis issues are noted in internal control studies, we will use the generic inverse variance function. If unit of analysis errors are noted, we will exclude these studies from the review.

Dealing with missing data

We will review the trials for missing information outlined in the primary or secondary parameters. We will make an attempt to contact the original investigators to identify potential missing data. To test whether some studies may have excluded individuals from the final results, we will conduct intention‐to‐treat analysis including all randomised participants.

Assessment of heterogeneity

We will assess the heterogeneity of the available results included in the meta‐analysis. Heterogeneity will be evident from the poor overlap of confidence intervals for individual studies. We will use the Chi² test to determine the statistical significance of the heterogeneity (P value < 0.05). We will interpret these values with caution for small studies with few participants. We will use the I² statistic to evaluate inconsistent data and evidence of heterogeneity. We will consider studies with I² values suggesting moderate (50% to 90%) to substantial (60% to 100%) heterogeneity in our review. Once heterogeneity is confirmed, various methods can be used to address it. We will recheck the data entry into RevMan to confirm method validation. We will examine methods of data analysis, as this is a frequent cause of heterogeneity. Heterogeneity can also be explored by conducting subgroup analysis where such variability exists.

We will conduct a fixed‐effect and a random‐effects meta‐analysis for selected trials. Fixed‐effect meta‐analysis will determine whether heterogeneity can be ignored. Random‐effects meta‐analysis will help clarify unexplained heterogeneity and enable the unifying of results from different studies.

Assessment of reporting biases

Bias may be identified at different stages of the review (data collection, extraction, analysis and discussion). We will evaluate publication bias with funnel plots for trials with sufficient numbers to include in the analysis. We will consider other forms of bias including language, location, time‐lag, citation and outcome‐related measures. We will evaluate the direction of the study results when examining potential sources of bias.

Data synthesis

We will calculate mean difference and standard deviation with 95% confidence interval for continuous data parameters (pain and length of hospital stay). We will analyse the risk of nasal bleeding as a primary parameter and synechiae formation (non‐continuous data) using risk ratio and odds ratio.

Subgroup analysis and investigation of heterogeneity

The subgroup analysis aims to categorise similar data for further evaluation and comparison of results. Subgroups for post‐FESS nasal bleeding that we will explore include:

• absorbable packing versus non‐absorbable packing;

• chronic sinusitis with nasal polyposis versus chronic sinusitis without nasal polyposis;

• extent of surgery ‐ limited FESS or full house FESS;

• surgical technique ‐ mucosal preservation versus snare polypectomy;

• postoperative maintenance ‐ manual debridement and systemic corticosteroids;

• indication for use of packing ‐ used to prevent adhesions or used for other purpose.

We will conduct meta‐regression if more than 10 studies are included in any subgroup. This will allow for the effect of multiple factors to be investigated simultaneously.  

Sensitivity analysis

In order to test the robustness of the results, we will repeat the pooled analyses after excluding studies of higher risk of bias. We will produce the reporting of sensitivity analysis in the form of a summary table in the review.

'Summary of findings' table

We will present a 'Summary of findings' table for the following outcome measures: postoperative bleeding, patient discomfort associated with nasal packing and nasal packing removal, duration of postoperative stay and postoperative synechiae formation. We will present this in the format suggested by the Cochrane Handbook for Systematic Reviews of Interventions 5.1.0, Figure 11.5.a (Handbook 2011).

Appendices

Appendix 1. CENTRAL search strategy

#1 MeSH descriptor: [Sinusitis] explode all trees #2 rhinosinusitis or nasosinusitis or sinusitis or pansinusitis or ethmoiditis or ethmoiditis or sphenoiditis         #3 kartagener* and syndrome* #4 inflamm* and sinus* #5 #1 or #2 or #3 or #4         #6 MeSH descriptor: [Chronic Disease] explode all trees #7 MeSH descriptor: [Recurrence] explode all trees      #8 chronic or persis*or recur*      #9 #6 or #7 or #8        #10 #5 and #9 #11 MeSH descriptor: [Endoscopy] explode all trees     #12 endoscop* or uncinectomy or antrostomy or antrotomy or ethmoidectomy or sphenoidotomy #13 fess   #14 MeSH descriptor: [Surgical Procedures, Operative] explode all trees #15 #11 or #12 or #13 or #14 #16 #10 and #15         #17 sinus:ti and surgery:ti       #18 MeSH descriptor: [Paranasal Sinus Diseases] explode all trees and with qualifiers: [Surgery ‐ SU] #19 #16 or #17 or #18 #20 MeSH descriptor: [Bandages] explode all trees       #21 MeSH descriptor: [Tampons, Surgical] explode all trees    #22 MeSH descriptor: [Surgical Sponges] explode all trees      #23 pack* or dressing* or bandag* or tampon*or meatal next spacer* or meatal next stent* or sponge* or gauze     #24 #20 or #21 or #22 or #23 #25 #19 and #24

What's new

Date	Event	Description
27 September 2016	Amended	Withdrawn from Issue 9, 2016. Authors unable to complete the review.

Contributions of authors

Link with editorial base and co‐ordinating contributions from co‐authors, updating the review (PM). Study selection, risk of bias (MK, MF). Statistical analysis (SOL). Drafting protocol (PM, MF, SOL). Running searches (Cochrane ENT Group Trials Search Co‐ordinator).

Sources of support

Internal sources

• University of Melbourne, Australia.

  Library resources

External sources

• National Institute for Health Research, UK.

  Infrastructure funding for the Cochrane Ear, Nose and Throat Disorders Group

Declarations of interest

Philip Michael: none known. Mohammed Farid: none known. Stephen O'Leary: none known. Matthew Kwok: none known.

Notes

Withdrawn from Issue 9, 2016. Authors unable to complete the review.

Withdrawn from publication for reasons stated in the review