artykuł oryginalny / original article

Is ventilation tube insertion necessary in

children with otitis media with effusion?
Czy zakładanie drenu wentylacyjnego u dzieci chorych
na wysiękowe zapalenie ucha środkowego jest konieczne?

Authors’ Contribution:
A – Study Design
Yakup YeginCBADF, Mustafa ÇelikA, Burak OlgunBC, Hasan Emre KoçakBCE,
B – Data Collection
C – Statistical Analysis Fatma Tülin KayhanBCEF
D – Data Interpretation
E – Manuscript Preparation Bakırköy Dr.Sadi Konuk Training and Research Hospital, Department of Otorhinolaryngology - Head and Neck Surgery, Istanbul,
F – Literature Search
G – Funds Collection Turkey

Article history: Received: 09.10.2015  Accepted: 22.11.2015  Published: 15.12.2015

ABSTRACT:  bjectives: To compare audiological outcomes of ventilation tube insertion (VTI) and myringotomy alone in associa-
O
tion with adenoidectomy in patients with otitis media with effusion (OME). Study Design: Retrospective clinical chart
review.
Materials and Methods: In total, 148 patients (78 male, 70 female; mean age of 6.02±1.98 years, range 4 to 7 years) who
underwent adenoidectomy in association with VTI or myringotomy alone in our clinic were included in this study. De-
mographics and audiological outcomes were collected. The patients were divided randomly into two groups, group A
(72) subjected to adenoidectomy with VTI, and group B (76) subjected to adenoidectomy with myringotomy. Audio-
logical studies comparing both groups at six months were also continued to follow up patients for one year after sur-
gery. Results with a p-value of <0.05 were considered statistically significant.
Results: The mean pure-tone hearing threshold preoperatively in group A was 28.68±11.72 dB, while it was 24.25±12.68
dB in group B. At postoperative six months, that mean value in group A was 8.4±2.32 dB, while it was 10.4±3.36dB
in group B. Statistical analysis showed statistically significant difference between the means of pure-tone hearing
thresholds in both groups during the whole follow-up period (p<0.05).
Conclusion: According to our data, audiological outcomes of VTI were higher as compared with myringotomy alone

in association with adenoidectomy. However, further studies with a higher number of patients are needed to compare
the audiological outcomes of various ventilation tube types.
KEYWORDS: Otitis media, audiometry, child, adenoidectomy, ventilation tube.

STRESZCZENIE: 
Cel: Porównanie wyników badań audiologicznych u chorych na wysiękowe zapalenie ucha środkowego (WZUŚ) po
-

adenoidektomii z założeniem drenu wentylacyjnego (ang. ventilation tube insertion, VTI) oraz po adenoidektomii z
samą myringotomią.
Projekt badania: Retrospektywny przegląd kart pacjentów.
-

Materiał i metody: Do badania włączono w sumie 148 pacjentów (78 mężczyzn, 70 kobiet; średnia wieku 6,02±1,98 lat,

zakres od 4 do 7 lat), którzy zostali poddani w naszej klinice zabiegowi adenoidektomii w połączeniu z VTI lub z samą
-

myringotomią. Zebrano dane demograficzne oraz wyniki badań audiologicznych. Pacjentów podzielono losowo na
dwie grupy: grupę A (72), którą poddano adenoidektomii z VTI, oraz grupę B (76), którą poddano adenoidektomii
z myringotomią. Wyniki audiologiczne porównujące obie grupy po upływie 6 miesięcy kontynuowano również u
-

pacjentów pozostających w obserwacji w okresie do jednego roku po operacji. Wyniki istotne statystycznie przyjęto
dla poziomu istotności p < 0,05.
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OTOLARYNGOL POL 2015; 69 (6): 39-44 DOI: 10.5604/00306657.1184542 39

 artykuł oryginalny / original article

Wyniki: Średnia wartość progu słyszalności czystego tonu przed operacją wynosiła 28,68±11,72 dB w grupie A oraz
24,25±12,68 dB w grupie B. W okresie 6 miesięcy po operacji średnie wartości wynosiły 8,4±2,32 dB w grupie A oraz
10,4±3,36 dB w grupie B. Analiza porównawcza wykazała istotną statystycznie różnicę między średnimi wartościami
progów słyszalności czystego tonu w obu grupach podczas całego okresu obserwacji (p < 0,05).
Wnioski: Nasze dane sugerują, że wyniki audiologiczne po VTI i adenoidektomii były lepsze w porównaniu z samą
myringotomią w połączeniu z adenoidektomią. Potrzebne są jednak dalsze badania, prowadzone z udziałem większej
grupy pacjentów, aby porównać wyniki audiologiczne po zastosowaniu różnego rodzaju drenów wentylacyjnych.
SŁOWA KLUCZOWE: zapalenie ucha środkowego, audiometria, dziecko, adenoidektomia, dren wentylacyjny

INTRODUCTION MATERIALS AND METHODS

Otitis media with effusion (OME) is characterized by an accu- A retrospective review of data collected from January 2012 to
mulation of fluid in the middle ear behind an intact tympan- December 2014 was performed at Bakırköy Dr. Sadi Konuk
ic membrane, without the symptoms or signs of acute infec- Training and Research Hospital - Department of Otolaryngol-
tion.(1) OME is especially often at childhood.(2) OME is most ogy - Head and Neck Surgery. In total, 148 patients (78 male,
appropriately diagnosed by careful otoscopy with an under- 70 female; average age of 6.02±1.98 years, range 4 to 7 years)
standing of clinical signs and symptoms. Between three and
ten years of age , the incidence rate of OME is approximately
Tab. 1. Patient demographics
20% and 50%.(3) However, OME can affect hearing, education,
CHARACTERISTICS GROUP A GROUP B P*
language or behavior of children (4). Therefore, OME can be a (N:72) (N:76)
serious problem for children.
Age, yr±SD 5.8±1.4 6.1±0.9 0.09

OME is classified as acute effusion which is defined as last- Male, no.(%) 32 (%44.4) 46 (%60.5) 0.612
ing up to 3 weeks, subacute which is defined as lasting up to Female, no.(%) 40 (%55.6) 30 (%39.5) 0.118
3 months, or chronic which is defined as lasting up to more Major complaints
than 3 months.(5,6) -OSAS, no.(%) 24 (%33.3) 28 (%36.9) 0.122
-Hearing impairment, no.(%) 48 (%66.7) 48 (%63.1) 0.416

A variety of causative factors have been proposed as contrib- Mean follow-up period, 14.6±2.8 14.2±4.2 0.208
months± SD
uting to OME including eustachian tube dysfunction, adenoid
hypertrophy, immunodeficiency, hereditary-genetic factors, Passive smokers, no.(%) 68 (%94.4) 73 (%96.05) 0.232
viral or bacterial infection, allergy and local manifestation of Allergic rhinitis, no.(%) 23 (%31.95) 25 (%32.9) 0.423
an autoimmune disease(7-9). However, the present consensus Duration of OME, range 8.8 (4-13) 7.2 (3.5-15) 0.388
favors a multifactorial approach. (months)
* Paired Samples test
Variable treatment options are recommended such as antibiot- *p<0.05
ics, local and systemic decongestant, adenoidectomy, ventilation
tube insertion(VTI)(10,11).  Medical treatment has good outcomes
but unfortunately, recurrence occurs commonly(11). Ventilation who underwent adenoidectomy with myringotomy and ad-
tube insertion (VTI) which is usually performed under general enoidectomy with VTI were included in the study. Inclusion
-

anesthesia, continues to be one of the most commonly performed criteria of this study were bilateral otitis media with effusion
surgical procedures in children worldwide(12). There is strong (OME), cases who gave their informed consent, both ears
support that VTI improves hearing and quality of life at least in with air-bone gap of more than 20 dB in pure-tone frequen-
-

short term but long-term outcomes are controversial(13,14). Ad- cy mean, and variable degrees of adenoid hypertrophy with
ditionally, VTI has some possible complications such as infection, at least 3 months of medical treatment. All of the patients
-

otorrhoea, myringosclerosis and residual perforation. were followed up for at least six months prior to surgery in
our clinic. All the patients had endoscopic examination of
In the present study, we compare the audiological outcomes the nose and postnasal space, pneumatic otoscopy, pure-tone
-

of VTI and myringotomy in association with adenoidectomy audiometry (PTA) and tympanometry preoperatively. Retrac-
in patients with OME. tion in pars flaccida and pars tensa was evaluated according
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40 WWW.OTOLARYNGOLOGYPL.COM

Tab. 2. Comparison of preoperative and postoperative six-month PTA between group A and B.
MEAN PTA PREOPERATIVE (DB) POSTOPERATIVE (DB)
Group A 28.68±11.72 8.4±2.32
Group B 24.25±12.68 10.4±3.36
a
PairedSamples test, bMannWhitney U test, **p<0.01, *p<0.05
a: Comparison PTA between group A and B pre- and postoperatively, b: Comparison between two groups in terms of gain
to Tos et al.(15) and Sade et al.(16) respectively, if any retrac-
tion was found. Patients with a history of previous adenoid-
ectomy, tonsillectomy or ear surgery, genetic syndromes and
congenital malformations, cleft palate, tympanic membrane
perforation or chronic suppurative otitis media, sensorineu-
ral hearing loss, irregular follow-up and no written informed
consent were excluded from the study. All operation risks and
complications were explained to children’s parents and some
parents did not accept VTI considering complications and
sequelae such as myringosclerosis, otorrhoea and especially
residual perforations. The patients included in the study were
divided randomly into two groups according to the operation
type. Group A consisted of 72 patients who were assigned to
adenoidectomy and myringotomy with VTI, while group B
consisted of 76 patients assigned to adenoidectomy with my-
ringotomy without VTI. Children from group B were treat-
ed with myringotomy only, despite indications to the drain,
due to the lack of parents’ consent because of complications
of VTI such as infection, otorrhoea, myringosclerosis and es-
pecially residual perforation. Adenoidectomy was performed
by using St.Clair-Thomsen® curate under general anesthesia
in supine position and heamostasis was secured by packing.
Myringotomy was performed by using Agnes Myringotom®,
radial incision was performed in the anteroinferior part of
the tympanic membrane, suction of the middle ear fluid was
done and shepard tympanostomy tube was inserted in group
A patients only. All the operations were performed by one
of the surgeons in our department, according to well estab-
lished principles of ear surgery. All of the patients received
prophylactic antibiotherapy (amoxicillin-clavulanate 40 mg/
kg/day) after surgery lasting up to seven days. All of the pa-
tients were invited for control examinations at post-opera-
tive first, second and third weeks. Then, the patients were
-
invited for control examinations on monthly periods during
the first postoperative years. The status of tympanic mem-
brane was recorded in the first, third and sixth postoperative
-
month and the audiological evaluations were recorded at six
month after procedure. Audiometry was made in a sound-
-
proof booth with the use of a standard headset. Calibration
was performed before the study started. Air Conduction
(AC) and bone conduction (BC) levels were calculated at
-
four frequencies (0.5,1,2 and 4 kHz), all registered in 5 dB
HL (decibel hearing level). Measurements were performed
-
OTOLARYNGOL POL 2015; 69 (6): 39-44
artykuł oryginalny / original article
PA GAIN PB
<0.001** 20.2±10.52 0.038*
<0.001** 13.8±9.83
by an audiometrician. All patients were informed about this
study and written informed consent was obtained from the
patients who participated in this study. The study protocol
was approved by the same hospital’s local ethics committee
(eth.committe no. 2015/176).
STATISTICAL ANALYSIS
The Number Cruncher Statistical System (NCSS) 2007 Sta-
tistical Software (UT, USA) was used for statistical analysis.
The median values of total power were calculated from the fil-
tered raw data for each of the two groups at each benchmark.
Data were evaluated using descriptive statistical methods
(mean, standard deviation, median, and interquartile range).
In addition to the significance of intergroup differences ana-
lyzed using Student’s t-test, the significance of the medians
was analyzed with Mann-Whitney U test. A paired t-test was
performed to test the differences between preoperative and
postoperative audiological outcomes. The qualitative compar-
isons of data were performed using the chi-square test and
Fisher Freeman Halton test. Results with a p-value of <0.05
were considered statistically significant.
RESULTS
In total, 148 patients were included in this study, 70 female
(54.0%) and 78 male (38.5%), with a mean age of 6.02±1.98
years, range 4 to 7 years. There were 72 patients in group A
and 76 patients in group B. The mean follow-up period was
14.4± 3.4 months (range 6 to 32 months). The characteris-
tics of the groups are summarized in Table 1 ( Table 1). The
preoperative tympanograms were flat (type B) in all patients
in both groups. The tympanic membranes were immobile in
all patients in both groups; pneumatic otoscopy was used.
The age, gender and appearance of the tympanic membrane
were not statistically significantly different between the two
groups (p>0.05). In group A, pre- and post-operative mean
PTA was 28.68±11.72 dB and 8.4±2.32 dB, respectively. Post-
operative gain was 20.2±10.52 dB in group A. In group B,
pre- and post-operative mean PTA was 24.25±12.68 dB and
10.4±3.36 dB, respectively. Postoperative gain was 13.8±9.83
41
 artykuł oryginalny / original article

Tab. 3. Preoperative otoscopic findings.

dB in group B (Table 2). The audiological outcomes of group A
OTOSCOPIC FINDINGS GROUP A (N:72) GROUP B (N:76)
were significantly higher than of group B, statistically at sixth
month postoperatively (p<0.05). Table 3 shows preoperative Air bubbles 28 (%38.9) 17 (%22.6)
otoscopic findings of the tympanic membrane. Retracted degree, pars tensa, no. (%)
-stage 1 34 (%47.2) 29 (%38.2)
-stage 2 21 (%29.2) 17 (%22.35)
-stage 3 13 (%18.0) 17 (%22.35)
DISCUSSION -stage 4 4 (%5.6) 13 (%17.1)
Retracted degree, pars flaxida, no.
In literature, there is no consensus on the treatment of OME (%) 56 (%77.8) 49 (%64.5)
although OME is a common and serious disease in children. -type 0, 9 (%12.5) 17 (%22.3)
-type 1, 3 (%4.2) 8 (%10.5)
However, progressive spontaneous resolution may also play -type 2, 4 (%5.5) 2 (%2.7)
a role in variable treatment methods of OME (5). Approxi- -type 3
mately 25% of newly detected OME cases of unknown prior
duration in children resolve by 3 months, with resolution
being defined as a change in tympanogram from type B to improvement in the duration of middle ear effusion, time to
type A/C1 (10-13). A variety of treatment options have been recurrence, and need for repeated procedures (21). Perhaps
proposed, including medical and surgical treatments (10,11). this result could be explained with the fact that tympanos-
However, management of OME in children remains con- tomy tube maintains ventilation and drainage of the middle
troversial. Moreover, indications concerning management ear cleft for long duration when compared to myringotomy
of OME differ depending on the author. Some authors rec- alone which heals in the first few days after surgery. Mandel
ommend long-term follow-up of OME, in contrast to oth- et al. showed that myringotomy alone was ineffective for the
er authors who recommend earlier surgery in prevention of treatment of chronic OME, because the incision closes with-
long-term sequelae of OME (5,10,14). In the study of Brook in several days; in contrast, ventilation tubes ventilate the
et al. the bacterial colonization was higher in the adenoids of middle ear for an average of 12 to 14 months (12,13). Vlastos
children with OME and according to them the mechanical et al. reported that VTI confers a short-term improvement,
debridement of the nasopharynx may reduce the bacterial as compared to simple myringotomy in children older than
colonization (17). Adenoidectomy reduces distortion of the 3 years with OME (14). Rovers et al. reported that VTI im-
mucosal lining of the nasopharynx, making it a less hospi- proved the hearing level by a mean of 12 dB (22). In a pro-
table environment for bacterial colonization (18). However, spective study of Hakansson et al. the ears treated with VTI
adenoidectomy improved nasopharyngeal airways and re- had a significantly higher hearing level, observed mainly in
moved the overall pressure on nasopharyngeal orifices of the the high frequency spectrum of audiometry, and more fre-
Eustachian tube allowing improved aeration of the middle quently presented with a middle ear pathology than control
ear cleft. Therefore, adenoidectomy was suggested for treat- groups (23). However, VTI indications remain controver-
ment of OME. However, adenoidectomy increased the risk of sial and VTI candidancy is not clear in literature. In clinical
postsurgical hemorrhage (4). It was demonstrated that chil- practice the guideline of Rosenfeld et al. assessing VTI can-
dren with OME planned for adenoidectomy and myringot- didacy was based on: number of episodes of OME, hearing
omy with or without VTI experienced significantly shorter difficulties, other symptoms attributable to OME, structural
duration of middle ear effusion postoperatively than those abnormalities of the tympanic membrane or middle ear, re-
who were treated with myringotomy or VTI alone without current episodes of AOM with middle ear effusion (MEE).
adenoidectomy (18,19). In a retrospective study of Yousaf et Rosenfeld et al. recommended VTI for children with chron-
al., the ears with OME that fails to resolve or recur should be ic bilateral OME with hearing difficulty, chronic OME with
-

managed with myringotomy and VTI or adenoidectomy (20). symptoms, recurrent AOM with MEE;  child with recurrent
In the study by Gleinser et al. adenoidectomy with the first AOM or with OME of any duration is at increased risk for
tympanostomy tube for the treatment of otitis media may speech, language, or learning problems from otitis media
-

decrease the risk of repeat tube placement, especially in chil- because of baseline sensory, physical, cognitive, or behav-
dren aged >4-10 years (19). However, adenoidectomy and ioral factors (24). Additionally, in the study of Djurhuus et
-

VTI may decrease the risk of repeat surgery in children older al. the ventilation tubes reduced the risk of cholesteatoma
than 4 years (5). Myringotomy with aspiration alone with- in Danish population (25). However, VTI has some possi-
out placement of a ventilation tube has proved disappointing ble complications and sequelae including otorrhoea, infec-
-

in long-term follow-up in children. Improved hearing is an tion, residual perforation and myringosclerosis. Zielnik-Ju-
absolute benefit of myringotomy with VTI; there was also rkiewicz et al. reported that in children with OME treated
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42 WWW.OTOLARYNGOLOGYPL.COM
 artykuł oryginalny / original article

with VTI the amount of sequlae increased with time and she
recommended the follow-up time to be at least 8 years after
the treatment (26). In a randomized controlled clinical trial
study of Ingels et al. young children treated with VTI due to
persistent OME had a higher risk of developing otorrhoea
because of the tubes, and they had a higher risk of treatment
with antibiotics (27).
In the present study, adenoidectomy was performed on all pa-
tients in both groups and two surgical approaches to treatment
of children with adenoiditis with bilateral otitis media with ef-
fusion were compared. Our data suggested that there is a sta-
tistically significant difference in term of hearing improvement
between children treated with adenoidectomy and myringoto-
my with VTI and children who were treated by adenoidectomy
with myringotomy.
The limitations of this study were as follows: small sample size
and inability to assess the cases after 1 year with the use of au-
diological outcomes of two approaches.
CONCLUSION
In conclusion, we observed statistically significantly better au-
diological outcomes in VTI with adenoidectomy as compared
with adenoidectomy with myringotomy alone in a short-term
follow-up. We suggest that VTI has good audiological outcomes
for treatment of OME in children. We also recommend VTI for
all potential children with OME that fails to resolve or recur and
long-term follow-up after treatment of OME. However, further
studies with a higher number of patients are needed to com-
pare the audilogical outcomes of various ventilation tube types.

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Word count: 2660  Tables: 3  Figures: –  References: 27

Access the article online:  DOI: 10.5604/00306657.1184542  Full-text PDF: www.otolaryngologypl.com/fulltxt.php?ICID=1184542

Corresponding author: Mustafa Çelik; Bakırköy Dr.Sadi Konuk Training and Research Hospital, Department of Otorhinolaryngology - Head and
Neck Surgery, Istanbul, Turkey; e-mail: dr.mcelik@yahoo.com

Copyright © 2015 Polish Society of Otorhinolaryngologists Head and Neck Surgeons. Published by Index Copernicus Sp. z o.o. All rights reserved. 

Competing interests: The authors declare that they have no competing interests.

Cite this article as: Yegin Y., Çelik M., Olgun B., Koçak H.e., Kayhan F. : Is ventilation tube insertion necessary in children with otitis media with effusion? Otolaryngol Pol 2015; 69 (6): 39-44
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