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Efficacy of nasal septal splints for preventing complications after septoplasty: A meta-analysis
Journal Pre-proof Efficacy of nasal septal splints for preventing complications after septoplasty: A meta-analysis
Su Jin Kim, Dong Sik Chang, Myoung Su Choi, Ho Yun Lee, Jung-Soo Pyo PII:
S0196-0709(19)30928-7
DOI:
https://doi.org/10.1016/j.amjoto.2020.102389
Reference:
YAJOT 102389
To appear in:
American Journal of Otolaryngology--Head and Neck Medicine and Surgery
Received date:
4 October 2019
Please cite this article as: S.J. Kim, D.S. Chang, M.S. Choi, et al., Efficacy of nasal septal splints for preventing complications after septoplasty: A meta-analysis, American Journal of Otolaryngology--Head and Neck Medicine and Surgery(2020), https://doi.org/10.1016/ j.amjoto.2020.102389
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© 2020 Published by Elsevier.
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Efficacy of nasal septal splints for preventing complications after septoplasty: a meta-analysis
Running title: Septal Splints After Septoplasty
Su Jin Kima, Dong Sik Changa, Myoung Su Choia, Ho Yun Leea,*, Jung-Soo Pyob,* Department of Otorhinolaryngology, Eulji University Hospital, Eulji University School of
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a
Department of Pathology, Eulji University Hospital, Eulji University School of Medicine,
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Medicine, Republic of Korea
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Republic of Korea
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Corresponding author: Department of Otorhinolaryngology (H.Y. Lee) and Department of
Republic of Korea
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Pathology (J.S. Pyo), Eulji University Hospital, 95 Dunsanseo-ro, Seo-gu, Daejeon 35233,
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E-mail address: [email protected] (H.Y. Lee); [email protected] (J.S. Pyo)
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ABSTRACT Background: The efficacy of nasal septal splints, which are used as alternatives to nasal packs for preventing complications such as synechia and maintaining septal stability after septoplasty, remains controversial. The present meta-analysis assessed the efficacy and safety of nasal septal splints used after septoplasty. Methods: PubMed and Google Scholar databases were systematically searched until June 20,
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2019. Randomized controlled trials or cohort or case–control studies comparing patients who
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received nasal septal splints with those who did not receive splints after septoplasty were included. Primary outcomes included postoperative pain, infection, bleeding, hematoma
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formation, synechia, and perforation. Random effects models were used to calculate risk
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differences and risk ratios with 95% confidence intervals (CIs).
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Results: Thirty-three eligible studies were included. The estimated rate of synechia was significantly lower in the splint group (0.037, 95% CI 0.024–0.056) than in the no splint
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group (0.087, 95% CI 0.055–0.135; P=0.003), while visual analog scale scores for pain and
between groups.
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the estimated rates of infection, bleeding, hematoma, and perforation were comparable
Conclusions: These findings suggest that the use of nasal septal splints as alternatives or in addition to nasal packing prevent synechia after septoplasty without increasing other complications, including pain, thus adding to evidence supporting the use of septal splints, particularly in cases where postoperative synechia is expected.
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1. Introduction Nasal packing after septoplasty has been considered an essential procedure for the prevention of postoperative bleeding and hematoma. In addition, it provides an additional benefit of supporting the mucosal flap and maintaining the stability of the remaining structures. Currently, several types of packing methods are available. Typical nonabsorbable, completely occlusive packs such as Merocel® or gauze are widely used because of their
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simplicity. However, these packs frequently cause increased discomfort and pain and lower
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the quality of life [1]. Therefore, some clinicians prefer to place Merocel® or gauze in glove fingers before insertion or use absorbable packing in order to prevent mucosal injury and pain
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during removal [2,3]. An alternative to nasal packing is the use of silicone septal splints with
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or without airway for the prevention of postoperative synechia and maintenance of septal
postoperative pain [5].
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stability [4]. The transseptal suture technique is also used and has been reported to reduce
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Although various meta-analyses have assessed the efficacy and complications of various
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packing methods, the results remain debatable, particularly with regard to the use of septal splints [6-8]. Some studies considered septal splinting as a packing method and reported that transseptal sutures are less painful than nasal packing [6,7], whereas others classified septal splinting as a nonpacking method and reported that all nonpacking methods, including transseptal sutures, are less painful than packing methods and lower the risk of postoperative synechia [8]. Previous studies evaluating the necessity of nasal packing after septoplasty found that septal splints did not decrease the postoperative complications and caused increased pain [9]. To our knowledge, no meta-analysis has focused on the efficacy of septal splinting as an individual method. Accordingly, we performed a meta-analysis to evaluate evidence regarding the efficacy and safety of nasal septal splints used as alternatives or in addition to
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nasal packing after septoplasty.
2. Material and Methods 2.1. Published study search and selection criteria For this systematic review and meta-analysis, relevant articles were obtained via a search of the PubMed and Google Scholar databases from inception through June 20, 2019. The
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databases were searched using terms related to “septoplasty” and “septal splints.” The titles
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and abstracts of all retrieved articles were screened for exclusion. Review articles were also screened for the retrieval of additional eligible studies. The inclusion criteria were as follows:
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inclusion of human patients subjected to septoplasty; use of packing methods including septal
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splints; and evaluation of postoperative pain/discomfort using a grading scale and/or
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evaluation of postoperative complications, including infection, hematoma, bleeding, septal perforation, and/or synechia. Case reports, studies that were not original researches, and
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studies published in languages other than English were excluded.
2.2 Data extraction
The following data were extracted from each eligible study by two independent authors (S.J.K., J.S.P.): first author’s name, year of publication, study method, number of patients, intervention, and outcome measures. The rates of postoperative complications, including infection, bleeding, hematoma, synechia, and septal perforation, were the primary outcome measures, while patient-reported postoperative pain, assessed using the visual analog scale (VAS), was the secondary outcome measure.
2.3. Statistical analyses All data were analyzed using the Comprehensive Meta-Analysis software package
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(Biostat, Englewood, NJ). We investigated the rates of complications according to the use of septal splints (septal splints [splint group] vs. no septal splints [no splint group]) after septoplasty and performed a meta-analysis for the pooled rates. Because the eligible studies included heterogenous populations, a random effects model was chosen over a fixed effects model. Heterogeneity between studies was checked using Q and I2 statistics and presented using P-values. Sensitivity analysis was conducted to assess the heterogeneity of eligible
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studies and the impact of each study on the combined effect. In addition, the meta-regression
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test was performed to elucidate the heterogeneity between subgroups. Publication bias was assessed using Begg’s funnel plot and Egger’s test. A P-value of <0.05 was considered
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statistically significant.
3.1. Selection and characteristics
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3. Results
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Altogether 1321 reports were identified during the database search. From these, 1261
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irrelevant articles were excluded after title and abstract screening. The full-text of the remaining 65 articles was assessed for eligibility, and 32 were excluded for the following reasons: different intervention (n = 11), irrelevant outcome (n = 8), insufficient information (n = 7), and nonoriginal articles (n = 6). Eventually, 33 articles [3,10-41] were included in the meta-analysis (Fig. 1. and Table 1).
3.2. Complications in the splint and no splint groups The overall estimated rates of infection, bleeding, hematoma, synechia, and perforation after septoplasty were 0.038 (95% CI 0.026–0.054), 0.048 (95% CI 0.030–0.078), 0.021 (95% CI 0.014–0.031), 0.056 (95% CI 0.039–0.079), and 0.043 (95% CI 0.032–0.057), respectively (Table 2). There were no significant differences in the estimated rates of infection (0.042, 95%
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CI 0.023–0.076 vs. 0.029, 95% CI 0.017–0.049, respectively), bleeding (0.040, 95% CI 0.020–0.079 vs. 0.058, 95% CI 0.026–0.123, respectively), hematoma (0.019, 95% CI 0.010– 0.033 vs. 0.023, 95% CI 0.014–0.040, respectively), synechia (0.037, 95% CI 0.024–0.056 vs. 0.087, 95% CI 0.055–0.135, respectively), and perforation (0.039, 95% CI 0.025–0.061 vs. 0.046, 95% CI 0.031–0.067, respectively) between the splint and no splint groups. According to the meta-regression test, the estimated rate of synechia was significantly lower in the splint
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group (0.037, 95% CI 0.024-0.056) than in the no splint group (0.087, 95% CI 0.055–0.135;
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P = 0.003), regardless of the use of additional procedures. However, there were no significant intergroup differences in the estimated rates of infection, bleeding, hematoma, and
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perforation.
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The overall estimated VAS score for postoperative pain was 4.391 (95% CI 3.332–5.450),
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and there was no difference between the splint (4.344, 95% CI 3.198–5.489) and no splint
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4. Discussion
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(4.612, 95% CI 2.930–6.294) groups (Table 3).
In the present study, we found that the incidence of synechia after septoplasty was significantly lower in patients who received nasal septal splints than in those who did not receive splints. In addition, the application of septal splints did not lead to a significant increase in pain. Nasal packing after septoplasty has been used for minimizing the risk of hematoma and provides an additional benefit of supporting the mucosal flap and maintaining the stability of the remaining structures. An ideal nasal pack should provide sufficient support and minimize pain and complications. Therefore, transseptal suturing can be used as an effective alternative to conventional occlusive packing [5], although it is not in widespread use because of the increased procedural duration and technical difficulties. To overcome these shortcomings,
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some researchers suggested the use of suturing devices [42]. Septal splinting has also been widely used in place of or in addition to nasal packing, with the primary aims being the prevention of synechia and promotion of healing. However, the effectiveness and safety of these splints remain controversial [9]. Previous meta-analyses have evaluated septal splinting by including it as a nasal packing [6,7] or nonpacking method [8]; therefore, clear conclusions regarding its superiority over other methods could not be drawn. The findings of
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the present study are novel because, to the best of our knowledge, this is the first meta-
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analysis focusing on the efficacy of septal splinting as an individual method. We found that septal splints only resulted in a significant decrease in synechia formation
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in the meta-regression analysis. That is, the use of septal splints could prevent synechia after
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septoplasty, regardless of the use of an additional packing material. This finding is consistent
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with previous assumptions regarding the efficacy of septal splints. The incidence of synechia after septoplasty has been reported to be as high as 31% when septal surgery is combined
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with inferior turbinate surgery [9,43]. Because synechia can cause patient discomfort or
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functional limitations, revision surgery or additional synechiolysis may be unavoidable. A septal splint acts as a mechanical barrier between the septal mucosa and lateral nasal wall, thus preventing the formation of synechia in an effective manner. For this reason, splints have been used after not only septoplasty but also other intranasal surgeries associated with a risk of postoperative synechia, such as endoscopic sinus surgery [44]. Despite the routine use of splints in clinical practice, evidence supporting their routine use has been limited [9]. Our findings add to evidence supporting the use of septal splints after septoplasty. We also found that the use of septal splints did not affect the rates of other complications, including infection, bleeding, hematoma, and perforation. Moreover, subgroup analysis did not find differences in pain scores between septal splints and transseptal sutures (P = 0.059) and packing (P = 0.189; not shown in the Results section). We assume that the pain score
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with septal splints was exaggerated because several types of septal splints, including the paininducing rigid type, were included in our analysis. Currently, however, thin silastic septal splints made of silicone are used, and they generally do not induce pain. In addition, appropriate positioning of the splint without touching the roof and floor of the nasal cavity is crucial [45]. Interestingly, a randomized study using the contralateral nasal cavity for comparisons found that none of the patients were even aware of their septal splints until they
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were removed. Moreover, contrary to expectations, less discomfort and a better mucosal
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status were observed on the splinted side than on the contralateral side [4]. In addition to the prevention of postoperative synechia, septal splints may have the
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following advantages. First, they promote the healing process by moisturizing and
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humidifying the mucosa, particularly when the septal mucosa is injured [4,44]. Second, they
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mechanically protect the mucosa and prevent unexpected trauma during postoperative care. For these reasons, the use of septal splints is recommended in cases of septal mucosal injury
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or septal perforation repair. Third, these splints stabilize the remaining cartilages and support
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the stretched mucosa on the convex side, eventually contributing to better correction. However, septal splints also have some disadvantages. They are relatively more expensive than suture material or gauze packs. Although the properties of splints have been improved over time, they may still cause patient discomfort because of their structure or the surrounding crust formation. Although extremely rare, toxic shock syndrome has been reported to occur in a patient who received plastic septal splints without other additional packing material after septoplasty [46]. Finally, the operating time may increase because of additional procedures involving placement and fixation of the splints in the appropriate location. Taken together, surgeons need to make patient-specific decisions regarding the packing method during surgery. In this study, we adopted a random effects model because the eligible studies included
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heterogenous populations. Heterogeneity refers to variability in the data of merged individual studies that exceeds the sampling error. To estimate the extent of heterogeneity, forest plots, Q statistics, and I2 statistics are frequently used. In Q statistics, a small P-value of <0.1 is considered a sign of heterogeneity; in this case, random effects models are adopted because they are more conservative than fixed effects models. In addition, meta-regression analysis can be used to confirm whether the particular covariates explain the heterogeneity. Finally,
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publication bias or reporting bias that could have affected the results of the meta-analysis was
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assessed using a funnel plot and Egger’s test, as described earlier.
This study has several limitations. First, each of the included studies differed in terms of
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their design. We enrolled not only randomized controlled trials but also retrospective studies,
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and this may have affected the outcome. Second, some outcomes were not included in the
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analysis because of different measurement methods. For example, pain assessed as a binary variable (instead of using VAS) was excluded. Finally, nonstandardized factors such as the
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surgical technique, splint material and design, fixation method, timing of splint removal,
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follow-up period, and timing of follow-up assessments, may have influenced the results of the meta-analysis. 5. Conclusion
The findings of this study suggest that nasal septal splints prevent synechia after septoplasty without increasing other complications, including pain, thus adding to evidence supporting the use of septal splints, particularly in cases where postoperative synechia is expected. Declarations of interest: None Funding: This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors.
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Figure captions Fig. 1. Flow chart of study search and selection methods
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Author statement Su Jin Kim: Conceptualization, Data Curation, Writing - Original Draft, Review & Editing Dong Sik Chang: Validation, Resources Myoung Su Choi: Validation, Methodology Ho Yun Lee: Validation, Writing - Original Draft, Review & Editing, Supervision, Project administration Jung-Soo Pyo: Methodology, Software, Formal analysis, Investigation, Data Curation,
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Validation, Supervision
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Table 1 Main characteristics of studies eligible for a meta-analysis on the efficacy of septal splinting after septoplasty. Study
Year
Design
Sampl Intervention
Outcome measures
e size 2018 RCT
23
splint vs.
pain, infection, bleeding,
suture
hematoma, crust, synechia,
2018 Prospective
169
Bingöl F [12]
2017 Prospective randomized
60
Kayahan B [13]
2017 Prospective randomized
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2016 Prospective
pain, hematoma
splinta vs. pack
pain
splinta vs.
pain
109
suture vs. pack splinta
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infection, bleeding, hematoma, synechia,
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Ozdogan F [14]
61
perforation
splinta vs. pack
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Ersözlü T [11]
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Kuboki A [10]
perforation
Karatas A [15]
2016 Prospective randomized
95
splinta
pain, crust, synechia
Nandyal CB
2016 Prospective randomized
50
splint vs. pack
hematoma, synechia,
[16] Mahmood K [17]
2016 Prospective quasi-
perforation 260
splintb vs. pack
synechia
randomized
Naik K [18]
2015 RCT
184
splint vs. pack
synechia
Amin AK [19]
2015 Prospective randomized
59
splinta vs.
pain, crust, synechia
suture Wadhera R [20]
2014 Prospective randomized
60
splint vs. pack
pain, bleeding, hematoma,
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synechia, perforation Deniz M [21]
2014 Retrospective
130
splint vs. pack
infection, bleeding, synechia, perforation
Karataş D [22]
228
2014 Prospective randomized
150
splint vs.
pain, infection, hematoma,
suture vs. pack
synechia, perforation
splinta vs.
pain, infection, bleeding,
suture vs. pack
hematoma, synechia,
96
Yu SS [25]
80
[26]
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2013 Prospective randomized
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Özkırış M [27]
synechia, perforation
splinta vs. pack
73
splint
pain, bleeding
splint vs.
pain, infection, hematoma,
suture vs. pack
synechia, perforation
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2013 Prospective randomized
splinta vs. pack
pain, infection, bleeding,
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Bernardo MT
2013 RCT
perforation
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Ertugay ÇK [24] 2014 Prospective randomized
ro
of
Cayonu M [23]
2014 -
150
hematoma, perforation
Yilmaz MS [3]
2013 Prospective randomized
75
splinta vs. pack
pain, bleeding, synechia
Veluswamy A
2012 Prospective randomized
80
splint vs. pack
pain, synechia
Acıoğlu E [29]
2012 RCT
119
splinta vs. pack
pain, bleeding
Asaka D [30]
2012 Prospective randomized
35
splint vs. pack
pain, crust, synechia,
[28]
perforation Jawaid A [31]
2012 RCT
160
splint vs. pack
bleeding, hematoma, synechia
Yaseen A [32]
2012 Prospective randomized
60
splintb vs. pack
synechia
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Aksoy E [33]
2011 Retrospective
splinta
96
17
bleeding, hematoma, synechia
Kula M [34]
Ardehali MM
2010 Prospective randomized
2009 Prospective randomized
48
105
[35]
splint vs.
infection, synechia,
suture vs. pack
perforation
splintb vs.
pain, hematoma, synechia,
suture
perforation synechia
82
splintb vs. pack
Malki D [37]
107
splintb vs.
ro
1999 Prospective randomized
of
Júnior RGC [36] 2008 Retrospective
pain, synechia
control
von Schoenberg
1993 Prospective randomized
71
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M [39] 1992 RCT
splinta vs. pack
synechia, perforation
splintb vs. pack
pain
89
splintb vs. pack
infection, bleeding, hematoma, synechia,
Campbell JB [41]
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Cook JA [40]
43
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1995 Prospective cohort
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Guyuron B [38]
1987 -
a
Splint with airway
b
Splint with additional packing
RCT: randomized controlled trial.
perforation 68
splintb vs. pack
synechia
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Table 2 Estimated rates of complications according to the packing method after septoplasty. Egger’s
Number Fixed effect
Heterogeneity test
Random effect
[95% CI]
[Q-value, I2, P-value]
[95% CI]
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Test
subsets
[P-value]
26
0.039 [0.027, 0.055]
25.740, 2.875, 0.422
Splint group
12
0.049 [0.030, 0.079] 14.514, 24.210, 0.206 0.042 [0.023, 0.076] 0.002
14
0.029 [0.017, 0.049]
Bleeding, overall
13
0.066 [0.047, 0.091] 18.723, 35.908, 0.095 0.048 [0.030, 0.078] <0.001
Splint group
9
0.066 [0.043, 0.099] 14.272, 43.945, 0.075 0.040 [0.020, 0.079] <0.001
4
0.065 [0.036, 0.115]
4.448, 32.558, 0.217
0.058 [0.026, 0.123] 0.092
27
0.021 [0.014, 0.031]
0.021 [0.014, 0.031] <0.001
0.019 [0.010, 0.033]
3.988, 0.000, 0.996
0.019 [0.010, 0.033] 0.001
0.023 [0.014, 0.040] <0.001
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Infection, overall
No splint
Hematoma, overall
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group
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No splint
0.029 [0.017, 0.049] 0.006
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group
9.122, 0.000, 0.764
0.038 [0.026, 0.054] <0.001
10.687, 0.000, 0.999
14
0.023 [0.014, 0.040]
6.378, 0.000, 0.931
52
0.118 [0.101, 0.138] 190.187, 73.184, < 0.001 0.056 [0.039, 0.079] <0.001
27
0.053 [0.038, 0.072] 39.854, 34.761, 0.040 0.037 [0.024, 0.056] <0.001
26
0.158 [0.133, 0.187] 112.630, 78.691, < 0.001 0.087 [0.055, 0.135] <0.001
34
0.043 [0.032, 0.057]
26.704, 0.000, 0.772
0.043 [0.032, 0.057] <0.001
Splint group
16
0.039 [0.025, 0.061]
10.790, 0.000, 0.767
0.039 [0.025, 0.061] <0.001
No splint
18
0.046 [0.031, 0.067]
15.676, 0.000, 0.547
0.046 [0.031, 0.067] <0.001
No splint group Synechia, overall
15
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Splint group
Splint group No splint group Perforation, overall
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CI: confidence interval.
19
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Table 3 Estimated visual analog scale scores for postoperative pain according to the packing method after septoplasty. Number Fixed effect
Heterogeneity test
[95% CI]
[Q-value, I2, P-value]
of
p e
subsets Pain VAS score, overall
f o
ro
Random effect
Egger’s Test
[95% CI]
[P-value]
r P
17
4.455 [3.760, 5.151] 34.501, 53.625, 0.005 4.391 [3.332, 5.450] 0.623
Splint group
8
4.344 [3.198, 5.489] 6.775, 0.000, 0.453 4.344 [3.198, 5.489] 0.063
No splint group
9
4.520 [3.645, 5.395] 27.669, 71.087, 0.001 4.612 [2.930, 6.294] 0.751
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CI: confidence interval; VAS: visual analog scale.
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Highlights This meta-analysis assessed the efficacy of septal splints after septoplasty.
The rate of synechia was significantly lower in patients who received splints.
Pain scores and infection, bleeding, hematoma, and perforation rates were unaffected.
Nasal septal splints can prevent synechia after septoplasty.
Nasal septal splints do no increase other complications after septoplasty.
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Figure 1
Su Jin Kim, Dong Sik Chang, Myoung Su Choi, Ho Yun Lee, Jung-Soo Pyo PII:
S0196-0709(19)30928-7
DOI:
https://doi.org/10.1016/j.amjoto.2020.102389
Reference:
YAJOT 102389
To appear in:
American Journal of Otolaryngology--Head and Neck Medicine and Surgery
Received date:
4 October 2019
Please cite this article as: S.J. Kim, D.S. Chang, M.S. Choi, et al., Efficacy of nasal septal splints for preventing complications after septoplasty: A meta-analysis, American Journal of Otolaryngology--Head and Neck Medicine and Surgery(2020), https://doi.org/10.1016/ j.amjoto.2020.102389
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© 2020 Published by Elsevier.
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Efficacy of nasal septal splints for preventing complications after septoplasty: a meta-analysis
Running title: Septal Splints After Septoplasty
Su Jin Kima, Dong Sik Changa, Myoung Su Choia, Ho Yun Leea,*, Jung-Soo Pyob,* Department of Otorhinolaryngology, Eulji University Hospital, Eulji University School of
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a
Department of Pathology, Eulji University Hospital, Eulji University School of Medicine,
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b
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Medicine, Republic of Korea
re
Republic of Korea
*
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Corresponding author: Department of Otorhinolaryngology (H.Y. Lee) and Department of
Republic of Korea
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Pathology (J.S. Pyo), Eulji University Hospital, 95 Dunsanseo-ro, Seo-gu, Daejeon 35233,
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E-mail address: [email protected] (H.Y. Lee); [email protected] (J.S. Pyo)
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ABSTRACT Background: The efficacy of nasal septal splints, which are used as alternatives to nasal packs for preventing complications such as synechia and maintaining septal stability after septoplasty, remains controversial. The present meta-analysis assessed the efficacy and safety of nasal septal splints used after septoplasty. Methods: PubMed and Google Scholar databases were systematically searched until June 20,
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2019. Randomized controlled trials or cohort or case–control studies comparing patients who
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received nasal septal splints with those who did not receive splints after septoplasty were included. Primary outcomes included postoperative pain, infection, bleeding, hematoma
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formation, synechia, and perforation. Random effects models were used to calculate risk
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differences and risk ratios with 95% confidence intervals (CIs).
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Results: Thirty-three eligible studies were included. The estimated rate of synechia was significantly lower in the splint group (0.037, 95% CI 0.024–0.056) than in the no splint
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group (0.087, 95% CI 0.055–0.135; P=0.003), while visual analog scale scores for pain and
between groups.
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the estimated rates of infection, bleeding, hematoma, and perforation were comparable
Conclusions: These findings suggest that the use of nasal septal splints as alternatives or in addition to nasal packing prevent synechia after septoplasty without increasing other complications, including pain, thus adding to evidence supporting the use of septal splints, particularly in cases where postoperative synechia is expected.
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1. Introduction Nasal packing after septoplasty has been considered an essential procedure for the prevention of postoperative bleeding and hematoma. In addition, it provides an additional benefit of supporting the mucosal flap and maintaining the stability of the remaining structures. Currently, several types of packing methods are available. Typical nonabsorbable, completely occlusive packs such as Merocel® or gauze are widely used because of their
of
simplicity. However, these packs frequently cause increased discomfort and pain and lower
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the quality of life [1]. Therefore, some clinicians prefer to place Merocel® or gauze in glove fingers before insertion or use absorbable packing in order to prevent mucosal injury and pain
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during removal [2,3]. An alternative to nasal packing is the use of silicone septal splints with
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or without airway for the prevention of postoperative synechia and maintenance of septal
postoperative pain [5].
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stability [4]. The transseptal suture technique is also used and has been reported to reduce
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Although various meta-analyses have assessed the efficacy and complications of various
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packing methods, the results remain debatable, particularly with regard to the use of septal splints [6-8]. Some studies considered septal splinting as a packing method and reported that transseptal sutures are less painful than nasal packing [6,7], whereas others classified septal splinting as a nonpacking method and reported that all nonpacking methods, including transseptal sutures, are less painful than packing methods and lower the risk of postoperative synechia [8]. Previous studies evaluating the necessity of nasal packing after septoplasty found that septal splints did not decrease the postoperative complications and caused increased pain [9]. To our knowledge, no meta-analysis has focused on the efficacy of septal splinting as an individual method. Accordingly, we performed a meta-analysis to evaluate evidence regarding the efficacy and safety of nasal septal splints used as alternatives or in addition to
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nasal packing after septoplasty.
2. Material and Methods 2.1. Published study search and selection criteria For this systematic review and meta-analysis, relevant articles were obtained via a search of the PubMed and Google Scholar databases from inception through June 20, 2019. The
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databases were searched using terms related to “septoplasty” and “septal splints.” The titles
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and abstracts of all retrieved articles were screened for exclusion. Review articles were also screened for the retrieval of additional eligible studies. The inclusion criteria were as follows:
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inclusion of human patients subjected to septoplasty; use of packing methods including septal
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splints; and evaluation of postoperative pain/discomfort using a grading scale and/or
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evaluation of postoperative complications, including infection, hematoma, bleeding, septal perforation, and/or synechia. Case reports, studies that were not original researches, and
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studies published in languages other than English were excluded.
2.2 Data extraction
The following data were extracted from each eligible study by two independent authors (S.J.K., J.S.P.): first author’s name, year of publication, study method, number of patients, intervention, and outcome measures. The rates of postoperative complications, including infection, bleeding, hematoma, synechia, and septal perforation, were the primary outcome measures, while patient-reported postoperative pain, assessed using the visual analog scale (VAS), was the secondary outcome measure.
2.3. Statistical analyses All data were analyzed using the Comprehensive Meta-Analysis software package
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(Biostat, Englewood, NJ). We investigated the rates of complications according to the use of septal splints (septal splints [splint group] vs. no septal splints [no splint group]) after septoplasty and performed a meta-analysis for the pooled rates. Because the eligible studies included heterogenous populations, a random effects model was chosen over a fixed effects model. Heterogeneity between studies was checked using Q and I2 statistics and presented using P-values. Sensitivity analysis was conducted to assess the heterogeneity of eligible
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studies and the impact of each study on the combined effect. In addition, the meta-regression
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test was performed to elucidate the heterogeneity between subgroups. Publication bias was assessed using Begg’s funnel plot and Egger’s test. A P-value of <0.05 was considered
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statistically significant.
3.1. Selection and characteristics
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3. Results
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Altogether 1321 reports were identified during the database search. From these, 1261
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irrelevant articles were excluded after title and abstract screening. The full-text of the remaining 65 articles was assessed for eligibility, and 32 were excluded for the following reasons: different intervention (n = 11), irrelevant outcome (n = 8), insufficient information (n = 7), and nonoriginal articles (n = 6). Eventually, 33 articles [3,10-41] were included in the meta-analysis (Fig. 1. and Table 1).
3.2. Complications in the splint and no splint groups The overall estimated rates of infection, bleeding, hematoma, synechia, and perforation after septoplasty were 0.038 (95% CI 0.026–0.054), 0.048 (95% CI 0.030–0.078), 0.021 (95% CI 0.014–0.031), 0.056 (95% CI 0.039–0.079), and 0.043 (95% CI 0.032–0.057), respectively (Table 2). There were no significant differences in the estimated rates of infection (0.042, 95%
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CI 0.023–0.076 vs. 0.029, 95% CI 0.017–0.049, respectively), bleeding (0.040, 95% CI 0.020–0.079 vs. 0.058, 95% CI 0.026–0.123, respectively), hematoma (0.019, 95% CI 0.010– 0.033 vs. 0.023, 95% CI 0.014–0.040, respectively), synechia (0.037, 95% CI 0.024–0.056 vs. 0.087, 95% CI 0.055–0.135, respectively), and perforation (0.039, 95% CI 0.025–0.061 vs. 0.046, 95% CI 0.031–0.067, respectively) between the splint and no splint groups. According to the meta-regression test, the estimated rate of synechia was significantly lower in the splint
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group (0.037, 95% CI 0.024-0.056) than in the no splint group (0.087, 95% CI 0.055–0.135;
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P = 0.003), regardless of the use of additional procedures. However, there were no significant intergroup differences in the estimated rates of infection, bleeding, hematoma, and
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perforation.
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The overall estimated VAS score for postoperative pain was 4.391 (95% CI 3.332–5.450),
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and there was no difference between the splint (4.344, 95% CI 3.198–5.489) and no splint
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4. Discussion
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(4.612, 95% CI 2.930–6.294) groups (Table 3).
In the present study, we found that the incidence of synechia after septoplasty was significantly lower in patients who received nasal septal splints than in those who did not receive splints. In addition, the application of septal splints did not lead to a significant increase in pain. Nasal packing after septoplasty has been used for minimizing the risk of hematoma and provides an additional benefit of supporting the mucosal flap and maintaining the stability of the remaining structures. An ideal nasal pack should provide sufficient support and minimize pain and complications. Therefore, transseptal suturing can be used as an effective alternative to conventional occlusive packing [5], although it is not in widespread use because of the increased procedural duration and technical difficulties. To overcome these shortcomings,
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some researchers suggested the use of suturing devices [42]. Septal splinting has also been widely used in place of or in addition to nasal packing, with the primary aims being the prevention of synechia and promotion of healing. However, the effectiveness and safety of these splints remain controversial [9]. Previous meta-analyses have evaluated septal splinting by including it as a nasal packing [6,7] or nonpacking method [8]; therefore, clear conclusions regarding its superiority over other methods could not be drawn. The findings of
of
the present study are novel because, to the best of our knowledge, this is the first meta-
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analysis focusing on the efficacy of septal splinting as an individual method. We found that septal splints only resulted in a significant decrease in synechia formation
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in the meta-regression analysis. That is, the use of septal splints could prevent synechia after
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septoplasty, regardless of the use of an additional packing material. This finding is consistent
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with previous assumptions regarding the efficacy of septal splints. The incidence of synechia after septoplasty has been reported to be as high as 31% when septal surgery is combined
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with inferior turbinate surgery [9,43]. Because synechia can cause patient discomfort or
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functional limitations, revision surgery or additional synechiolysis may be unavoidable. A septal splint acts as a mechanical barrier between the septal mucosa and lateral nasal wall, thus preventing the formation of synechia in an effective manner. For this reason, splints have been used after not only septoplasty but also other intranasal surgeries associated with a risk of postoperative synechia, such as endoscopic sinus surgery [44]. Despite the routine use of splints in clinical practice, evidence supporting their routine use has been limited [9]. Our findings add to evidence supporting the use of septal splints after septoplasty. We also found that the use of septal splints did not affect the rates of other complications, including infection, bleeding, hematoma, and perforation. Moreover, subgroup analysis did not find differences in pain scores between septal splints and transseptal sutures (P = 0.059) and packing (P = 0.189; not shown in the Results section). We assume that the pain score
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with septal splints was exaggerated because several types of septal splints, including the paininducing rigid type, were included in our analysis. Currently, however, thin silastic septal splints made of silicone are used, and they generally do not induce pain. In addition, appropriate positioning of the splint without touching the roof and floor of the nasal cavity is crucial [45]. Interestingly, a randomized study using the contralateral nasal cavity for comparisons found that none of the patients were even aware of their septal splints until they
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were removed. Moreover, contrary to expectations, less discomfort and a better mucosal
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status were observed on the splinted side than on the contralateral side [4]. In addition to the prevention of postoperative synechia, septal splints may have the
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following advantages. First, they promote the healing process by moisturizing and
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humidifying the mucosa, particularly when the septal mucosa is injured [4,44]. Second, they
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mechanically protect the mucosa and prevent unexpected trauma during postoperative care. For these reasons, the use of septal splints is recommended in cases of septal mucosal injury
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or septal perforation repair. Third, these splints stabilize the remaining cartilages and support
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the stretched mucosa on the convex side, eventually contributing to better correction. However, septal splints also have some disadvantages. They are relatively more expensive than suture material or gauze packs. Although the properties of splints have been improved over time, they may still cause patient discomfort because of their structure or the surrounding crust formation. Although extremely rare, toxic shock syndrome has been reported to occur in a patient who received plastic septal splints without other additional packing material after septoplasty [46]. Finally, the operating time may increase because of additional procedures involving placement and fixation of the splints in the appropriate location. Taken together, surgeons need to make patient-specific decisions regarding the packing method during surgery. In this study, we adopted a random effects model because the eligible studies included
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heterogenous populations. Heterogeneity refers to variability in the data of merged individual studies that exceeds the sampling error. To estimate the extent of heterogeneity, forest plots, Q statistics, and I2 statistics are frequently used. In Q statistics, a small P-value of <0.1 is considered a sign of heterogeneity; in this case, random effects models are adopted because they are more conservative than fixed effects models. In addition, meta-regression analysis can be used to confirm whether the particular covariates explain the heterogeneity. Finally,
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publication bias or reporting bias that could have affected the results of the meta-analysis was
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assessed using a funnel plot and Egger’s test, as described earlier.
This study has several limitations. First, each of the included studies differed in terms of
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their design. We enrolled not only randomized controlled trials but also retrospective studies,
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and this may have affected the outcome. Second, some outcomes were not included in the
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analysis because of different measurement methods. For example, pain assessed as a binary variable (instead of using VAS) was excluded. Finally, nonstandardized factors such as the
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surgical technique, splint material and design, fixation method, timing of splint removal,
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follow-up period, and timing of follow-up assessments, may have influenced the results of the meta-analysis. 5. Conclusion
The findings of this study suggest that nasal septal splints prevent synechia after septoplasty without increasing other complications, including pain, thus adding to evidence supporting the use of septal splints, particularly in cases where postoperative synechia is expected. Declarations of interest: None Funding: This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors.
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with inferior turbinate surgery. Auris Nasus Larynx 2012;39(1):53-8. Jawaid A, Tahir M, Abdullah A, Akbar F, Jamalullah M. Intranasal pressure splints-a
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surgery. J Craniofac Surg 2011;22(3):1008-9. Kula M, Yuce I, Unlu Y, Tutus A, Caglı S, Ketencı I. Effect of nasal packing and haemostatic septal suture on mucociliary activity after septoplasty: an assessment by rhinoscintigraphy. Eur Arch Otorhinolaryngol 2010;267(4):541-6 35.
Ardehali M, Bastaninejad S. Use of nasal packs and intranasal septal splints following septoplasty. Int J Oral Maxillofac Surg 2009;38(10):1022-4.
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Júnior RGC, Brandão FH, de Sousa Carvalho MRM, de Aquino JEP, de Paula SHP, Fabi RP, et al. Frequency of Nasal Synechia after Septoplasty with Turbinectomy with or without the Use of Nasal Splints. Intl Arch Otorhinolaryngol 2008;12(1):24-7.
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Cook JA, Murrant NJ, Evans KL, Lavelle RJ. Intranasal splints and their effects on intranasal adhesions and septal stability. Clin Otolaryngol Allied Sci 1992;17(1):24-7. Campbell J, Watson M, Shenoi P. The role of intranasal splints in the prevention of
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post-operation nasal adhesions. J Laryngol Otol 1987;101(11):1140-3. Korkut AY, Teker AM, Eren SB, Gedikli O, Askiner O. A randomised prospective
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Mlynski G. Surgery of the nasal septum. Facial Plast Surg 2006;22(4):223-9.
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Figure captions Fig. 1. Flow chart of study search and selection methods
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Author statement Su Jin Kim: Conceptualization, Data Curation, Writing - Original Draft, Review & Editing Dong Sik Chang: Validation, Resources Myoung Su Choi: Validation, Methodology Ho Yun Lee: Validation, Writing - Original Draft, Review & Editing, Supervision, Project administration Jung-Soo Pyo: Methodology, Software, Formal analysis, Investigation, Data Curation,
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Validation, Supervision
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Table 1 Main characteristics of studies eligible for a meta-analysis on the efficacy of septal splinting after septoplasty. Study
Year
Design
Sampl Intervention
Outcome measures
e size 2018 RCT
23
splint vs.
pain, infection, bleeding,
suture
hematoma, crust, synechia,
2018 Prospective
169
Bingöl F [12]
2017 Prospective randomized
60
Kayahan B [13]
2017 Prospective randomized
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2016 Prospective
pain, hematoma
splinta vs. pack
pain
splinta vs.
pain
109
suture vs. pack splinta
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infection, bleeding, hematoma, synechia,
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Ozdogan F [14]
61
perforation
splinta vs. pack
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Ersözlü T [11]
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Kuboki A [10]
perforation
Karatas A [15]
2016 Prospective randomized
95
splinta
pain, crust, synechia
Nandyal CB
2016 Prospective randomized
50
splint vs. pack
hematoma, synechia,
[16] Mahmood K [17]
2016 Prospective quasi-
perforation 260
splintb vs. pack
synechia
randomized
Naik K [18]
2015 RCT
184
splint vs. pack
synechia
Amin AK [19]
2015 Prospective randomized
59
splinta vs.
pain, crust, synechia
suture Wadhera R [20]
2014 Prospective randomized
60
splint vs. pack
pain, bleeding, hematoma,
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synechia, perforation Deniz M [21]
2014 Retrospective
130
splint vs. pack
infection, bleeding, synechia, perforation
Karataş D [22]
228
2014 Prospective randomized
150
splint vs.
pain, infection, hematoma,
suture vs. pack
synechia, perforation
splinta vs.
pain, infection, bleeding,
suture vs. pack
hematoma, synechia,
96
Yu SS [25]
80
[26]
na
2013 Prospective randomized
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Özkırış M [27]
synechia, perforation
splinta vs. pack
73
splint
pain, bleeding
splint vs.
pain, infection, hematoma,
suture vs. pack
synechia, perforation
re
2013 Prospective randomized
splinta vs. pack
pain, infection, bleeding,
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Bernardo MT
2013 RCT
perforation
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Ertugay ÇK [24] 2014 Prospective randomized
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Cayonu M [23]
2014 -
150
hematoma, perforation
Yilmaz MS [3]
2013 Prospective randomized
75
splinta vs. pack
pain, bleeding, synechia
Veluswamy A
2012 Prospective randomized
80
splint vs. pack
pain, synechia
Acıoğlu E [29]
2012 RCT
119
splinta vs. pack
pain, bleeding
Asaka D [30]
2012 Prospective randomized
35
splint vs. pack
pain, crust, synechia,
[28]
perforation Jawaid A [31]
2012 RCT
160
splint vs. pack
bleeding, hematoma, synechia
Yaseen A [32]
2012 Prospective randomized
60
splintb vs. pack
synechia
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Aksoy E [33]
2011 Retrospective
splinta
96
17
bleeding, hematoma, synechia
Kula M [34]
Ardehali MM
2010 Prospective randomized
2009 Prospective randomized
48
105
[35]
splint vs.
infection, synechia,
suture vs. pack
perforation
splintb vs.
pain, hematoma, synechia,
suture
perforation synechia
82
splintb vs. pack
Malki D [37]
107
splintb vs.
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1999 Prospective randomized
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Júnior RGC [36] 2008 Retrospective
pain, synechia
control
von Schoenberg
1993 Prospective randomized
71
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M [39] 1992 RCT
splinta vs. pack
synechia, perforation
splintb vs. pack
pain
89
splintb vs. pack
infection, bleeding, hematoma, synechia,
Campbell JB [41]
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Cook JA [40]
43
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1995 Prospective cohort
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Guyuron B [38]
1987 -
a
Splint with airway
b
Splint with additional packing
RCT: randomized controlled trial.
perforation 68
splintb vs. pack
synechia
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Table 2 Estimated rates of complications according to the packing method after septoplasty. Egger’s
Number Fixed effect
Heterogeneity test
Random effect
[95% CI]
[Q-value, I2, P-value]
[95% CI]
of
Test
subsets
[P-value]
26
0.039 [0.027, 0.055]
25.740, 2.875, 0.422
Splint group
12
0.049 [0.030, 0.079] 14.514, 24.210, 0.206 0.042 [0.023, 0.076] 0.002
14
0.029 [0.017, 0.049]
Bleeding, overall
13
0.066 [0.047, 0.091] 18.723, 35.908, 0.095 0.048 [0.030, 0.078] <0.001
Splint group
9
0.066 [0.043, 0.099] 14.272, 43.945, 0.075 0.040 [0.020, 0.079] <0.001
4
0.065 [0.036, 0.115]
4.448, 32.558, 0.217
0.058 [0.026, 0.123] 0.092
27
0.021 [0.014, 0.031]
0.021 [0.014, 0.031] <0.001
0.019 [0.010, 0.033]
3.988, 0.000, 0.996
0.019 [0.010, 0.033] 0.001
0.023 [0.014, 0.040] <0.001
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Infection, overall
No splint
Hematoma, overall
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group
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No splint
0.029 [0.017, 0.049] 0.006
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group
9.122, 0.000, 0.764
0.038 [0.026, 0.054] <0.001
10.687, 0.000, 0.999
14
0.023 [0.014, 0.040]
6.378, 0.000, 0.931
52
0.118 [0.101, 0.138] 190.187, 73.184, < 0.001 0.056 [0.039, 0.079] <0.001
27
0.053 [0.038, 0.072] 39.854, 34.761, 0.040 0.037 [0.024, 0.056] <0.001
26
0.158 [0.133, 0.187] 112.630, 78.691, < 0.001 0.087 [0.055, 0.135] <0.001
34
0.043 [0.032, 0.057]
26.704, 0.000, 0.772
0.043 [0.032, 0.057] <0.001
Splint group
16
0.039 [0.025, 0.061]
10.790, 0.000, 0.767
0.039 [0.025, 0.061] <0.001
No splint
18
0.046 [0.031, 0.067]
15.676, 0.000, 0.547
0.046 [0.031, 0.067] <0.001
No splint group Synechia, overall
15
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Splint group
Splint group No splint group Perforation, overall
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CI: confidence interval.
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Table 3 Estimated visual analog scale scores for postoperative pain according to the packing method after septoplasty. Number Fixed effect
Heterogeneity test
[95% CI]
[Q-value, I2, P-value]
of
p e
subsets Pain VAS score, overall
f o
ro
Random effect
Egger’s Test
[95% CI]
[P-value]
r P
17
4.455 [3.760, 5.151] 34.501, 53.625, 0.005 4.391 [3.332, 5.450] 0.623
Splint group
8
4.344 [3.198, 5.489] 6.775, 0.000, 0.453 4.344 [3.198, 5.489] 0.063
No splint group
9
4.520 [3.645, 5.395] 27.669, 71.087, 0.001 4.612 [2.930, 6.294] 0.751
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CI: confidence interval; VAS: visual analog scale.
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Highlights This meta-analysis assessed the efficacy of septal splints after septoplasty.
The rate of synechia was significantly lower in patients who received splints.
Pain scores and infection, bleeding, hematoma, and perforation rates were unaffected.
Nasal septal splints can prevent synechia after septoplasty.
Nasal septal splints do no increase other complications after septoplasty.
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Figure 1