International Journal of Pediatric Otorhinolaryngology 79 (2015) 1556–1560

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International Journal of Pediatric Otorhinolaryngology

journal homepage: www.elsevier.com/locate/ijporl

A comparison of two myringoplasty techniques in Nepalese children:

A prospective randomized trial§
Prashant Tripathi a,*, Rajendra Prasad Guragain b, Chop Lal Bhusal b, Sureshwar Lal Karna b,
Johannes Borgstein c
a
Children’s Hospital for Eye, ENT and Rehabilitation Services (CHEERS), BP Eye Foundation, Manohara, Bhaktapur, Nepal
b
Ganesh Man Singh Memorial Academy of ENT-Head and Neck Studies, TUTH, Kathmandu, Nepal
c
Department of Otolaryngology, Tergooi Hospital, Rijksstraatweg 1, 1261AN, Blaricum, Netherlands

A R T I C L E I N F O A B S T R A C T

Article history: Background: In children, the success of myringoplastywith temporalis fascia is lower compared to adults
Received 4 April 2015 and cartilage as an alternative graft material has shown higher success rate.
Received in revised form 13 June 2015 Objective: To compare results of myringoplasty using tragal cartilage palisades with the use of
Accepted 10 July 2015
temporalis fascia in children with large tympanic membrane perforations.
Available online 20 July 2015
Materials and methods: This is a prospective and randomized study conducted in children of age 6–14
years with large tympanic membrane perforation of more than two quadrants. Status of graft at or
Keywords:
around 6 weeks after surgery was used as morphological outcome measure. Pre- and postoperative
Chronic otitis media
audiograms were compared to evaluate audiological outcome in two groups.
Myringoplasty
Cartilage palisades Results: Forty seven out of 55 patients completed follow-up. The graft uptake rate in the cartilage
Temporalis fascia palisades and temporalis fascia myringoplasty group was 91.3% (21/23) and 83.33% (20/24),
Children respectively; the difference was not statistically significant (P = 0.666). The mean preoperative air-
Large perforation bone gaps (ABG) in cartilage palisades and temporalis fascia group were 36.2 ! 8.9 dB and 33.8 ! 7.5 dB,
the difference was not statistically significant (P = 0.412). Similarly, the postoperative ABG in cartilage
palisades and temporalis fascia group were 25.1 ! 12.2 dB and 17.2 ! 9.2 dB, respectively, the difference was
statistically significant (P = 0.040). The gap closure was 11.0 dB in palisades group and 16.8 dB in fascia
group, but it was not significant (P = 0.133).
Conclusion: In our study of pediatric myringoplasty, the morphological and functional outcomes in both
cartilage palisades and temporalis fascia groups were comparable.
! 2015 Elsevier Ireland Ltd. All rights reserved.

1. Introduction prevalence of COM in Nepal is estimated to be 7.4% and is more

prevalent in children of age between 0 and 15 years where it is
Chronic otitis media (COM) is any structural change in middle estimated to be 9.28% [4].
ear system associated with a permanent defect in tympanic COM mucosal disease usually presents with intermittent ear
membrane (TM) [1]. TM perforation with no associated middle ear discharge of variable duration and hearing loss dependent on the
inflammation and discharge is classified as COM mucosal inactive size of the perforation [5]. The treatment is aimed at controlling
[2]. The usual causes are infection, atelectasis, ventilation tube active infection with the use of systemic and/or topical antibiotics,
insertion, and trauma [3]. COM is more prevalent in low followed by surgical repair of the TM defect. A wide variety of
socioeconomic groups and overcrowded homes with significant grafting materials, such as fascia, perichondrium, periostium, vein,
smoke exposure and substandard sanitation [1]. The overall (allograft) dura mater, and cartilage have been used for the closure
of TM perforations [6].
The success of myringoplasty in children increases with age [7]
§
The abstract of ongoing research was presented at the 6th National Conference but there is no consensus on the age limit below which results are
of Society of Otolaryngologists of Nepal on February 23rd, 2013.
generally poor [8–10]. Reasons for early closure of TM defect in
* Corresponding author at: Children’s Hospital for Eye, ENT and Rehabilitation
children are to prevent frequent infections to avoid effect of
Services (CHEERS), BP Eye Foundation, Manohara, Madhyapur thimi 16, Bhaktapur,
Nepal. Tel.: +977 9841372760. hearing loss on speech and language development [11] and to
E-mail address: prashantiom@gmail.com (P. Tripathi). allow unrestricted water-related activities [12]. Various factors

http://dx.doi.org/10.1016/j.ijporl.2015.07.014
0165-5876/! 2015 Elsevier Ireland Ltd. All rights reserved.
 P. Tripathi et al. / International Journal of Pediatric Otorhinolaryngology 79 (2015) 1556–1560 1557

contributing to low success rate of myringoplasty in children are the surgeon. The paper was then discarded. Then the surgery was
high frequency of otitis media and URTIs, immature immune proceeded as cartilage palisade or temporalis fascia myringoplasty.
system, and unpredictable eustachian tube function [13–15]. Group A: tragal cartilage palisades (TCP)
Presently, temporalis muscle fascia is the most frequently used Group B: temporalis fascia (TF)
grafting material for the repair of tympanic membrane perforation Ethical committee approval was obtained before starting the
in children and recent studies have reported graft success rate of study from Ethical Committee of Institutional Review Board (IRB)
70–91% [8,9,11,12,16,30], which is comparable to success rate of of Institute of Medicine, Nepal.
60–99% [17,18] in adults. The problems with the use of fascia as Surgical procedure: In both groups, the surgery was carried via
a graft material are due to atrophy or shrinkage of graft or its either of permeatal, endaural, or postaural approach depending on
nonvascularization leading to failure [19]. TF can undergo atrophy in the necessity to approach tympanic membrane and middle ear.
atelectatic ear, cholesteatoma, and revision tympanoplasty [20]. Due Freshening of the perforation margin was done to remove the
to these reasons, surgeons have advocated the use of more stable, epithelized tissue. A standard tympanomeatal flap was then raised
less compliant materials like cartilage for the reconstruction of the and folded anteriorly along with annulus. Middle ear was assessed
TM perforation. Currently, cartilage tympanoplasty is variously for ossicular status and other pathologies. Then the middle ear
recommended in high-risk perforations like subtotal or bilateral space was filled with gel foam up to the level of handle of malleus
perforations, revision tympanoplasty, anterior perforation, coexist- and annulus. After placing the graft material (cartilage palisade or
ing craniofacial abnormalities, atelectatic ears, and cholesteatoma fascia as described later), the tympanomeatal flap was then
[21]. Cartilage palisades technique was first described by Heermann repositioned over the graft and gelfoam soaked in ciprofloxacin
in 1962 [22]. Currently, it is the commonest technique used in (0.3%), ear drops was placed over the flap and graft. Then ribbon
cartilage tympanoplasty [23]. The reported graft uptake rate with gauze impregnated with bismuth iodoform paraffin paste (BIPP)
cartilage palisades myringoplasty is higher than fascia and reported was packed into the external auditory canal above the gelfoam.
to have successful outcome in 82–100% of cases [22,24–26]. Results Endaural and postaural skin incisions were sutured in layers with
have also shown that there is no significant interference with 4-0 Vicryl and skin with 4-0 Ethilon, and a mastoid bandage was
hearing by use of cartilage for myringoplasty [26–28]. However, applied.
there is no previous prospective study comparing the results of For group A (tragal cartilage palisades): An incision was made
fascia myringoplasty with the cartilage palisades myringoplasty in on medial aspect of tragus and tragal cartilage along with
children. The aim of the study is to compare the results of perichondrium was then harvested and the incision site was
myringoplasty with cartilage palisades and temporalis muscle closed with 4-0 Vicryl if required. Perichondrium from convex
fascia in large TM perforations in children. surface was removed and cartilage palisades of different sizes were
prepared. The first cartilage piece was kept anterior to handle of
malleus and parallel to its long axis with the perichondrium side
2. Materials and methods facing laterally toward the external auditory canal and then
appropriate-sized pieces of cartilage were placed in posterior
This is a prospective, randomized, interventional, and compar- quadrant and any gap remaining between palisades was filled with
ative study carried out over a period of 18 months from December smaller cartilage pieces. In most cases about 3–4 tragal cartilage
2011 to June 2013. The study was carried out at Ganesh Man Singh palisades were used.
Memorial Academy (GMSMA) of ENT-Head and Neck Studies, TU For group B (temporalis fascia): Temporalis muscle fascia
Teaching Hospital, Institute of Medicine (IOM), Kathmandu, Nepal. graft was harvested by a horizontal incision about 2 cm above the
Inclusion criteria for the surgery were children of 6–14 years upper attachment of pinna for permeatal approach. In postaural
with COM mucosal inactive (dry for at least 4 weeks) and large and endaural approach, same skin incision was used for harvest-
perforation in tympanic membrane (>2 quadrants perforation). ing the graft. Standard underlay temporalis fascia grafting was
The exclusion criteria were congenital craniofacial abnormalities, done [29].
for example, cleft palate and frank otorrhea and for hearing Postoperative care: Both groups A and B received similar
evaluation residual perforation or total failure, restricted or fixed care with oral amoxicillin 25–50 mg/kg/day for 7 days. Ibuprofen
ossicles, and patients with preoperative sensorineural hearing loss (5–10 mg/kg/dose) + paracetamol (15 mg/kg/dose) as tablet or
(BC > 25 dB) were excluded. Convenient sampling method was syrup was given three times daily after surgery for 3 days.
used for sample size calculation after reviewing the number of The mastoid dressing was changed on the first postoperative day
surgeries carried out in previous years. and thereafter on alternate days. Nonabsorbable sutures, if
Detail history was obtained, ear otoscopy was done, and pure applied, were removed on sixth postoperative day and the BIPP
tone audiometry was performed 1 week prior to surgery. Average pack was removed on 10th postoperative day. Antibiotic–steroid
hearing threshold was calculated from 0.5, 1, 2, 3, and 4 KHz ear drops Ocupol-D1 (chloramphenicol + dexamethasone +
frequencies. Air–bone gap (ABG) was measured by the difference polymyxin-B sulfate) were prescribed for 2 weeks after removal
between average of air conduction and bone conduction thresh- of pack.
olds done at the same time. Follow-up evaluation of the patients was done at or around
Children meeting the inclusion criteria were randomly divided 6 weeks after surgery. The follow-up evaluation of the patient was
into two groups by simple random sampling method. The numbers done by first author (PT) who was not involved in the surgery of the
of possible myringoplasty were estimated by reviewing the record patient. For morphological outcome, intact graft was taken as
of surgeries done in previous years as we have limited availability success and perforation of any size was taken as failure. For
of operation theater. After exclusion criteria, it was estimated that functional outcome evaluation, the postoperative hearing was
about 50–55 cases were done in 18-months period in children. compared with the preoperative hearing status. Preoperative and
For random selection, lottery method was used. Folded paper postoperative air–bone gap was calculated and compared.
were marked with group A and B and placed in a container. There Results analyzed were graft uptake rate and change in
were 30 marked as group A and 30 marked as group B, which were postoperative hearing thresholds. SPSS 18 software was used for
prepared by first author (PT). After patient met inclusion criteria analysis of results. The statistical tests used for analysis were
and consented for participation, lottery was done by pulling out fisher’s exact test, dependent and independent t-test. The level of
one of the folded paper from the container just before surgery by statistical significance was set at the P < 0.05.
1558 P. Tripathi et al. / International Journal of Pediatric Otorhinolaryngology 79 (2015) 1556–1560

3. Observations and results and postoperatively in both groups. Preoperative hearing status
(BCT, ACT, and ABG) of the children in both groups was comparable
A total of 55 patients meeting the inclusion criteria were (Table 2). The hearing was improved postoperatively in both
included in the study. These patients were randomly selected for groups and air conduction threshold of two groups was compara-
either cartilage palisades or temporalis fascia myringoplasty. There ble and was not statistically significant. The postoperative ABG
were 27 patients in group A (cartilage palisades group) and 28 in between two groups was statistically significant (P = 0.040). It was
group B (temporalis fascia group). Eight patients were excluded less than 20 dB in group B but more than 20 dB in group A. The ABG
from the study as they did not return for follow-up, four in each closure was 11.06 dB in group A and 16.76 dB in group B. There
group. After exclusion, there were 23 patients in group A and 24 in was better ABG closure in group B but the difference observed in
group B (shown in flowchart). There were total of 25 boys and ABG closure was not statistically significant (P = 0.133) (Table 2).
22 girls included in the study and the distribution in two groups Hearing results in group A (cartilage palisades group): The
was not statistically significant. ACT was 44.17 ! 10.97 dB preoperatively and 32.94 ! 13.13 dB
postoperatively. There was improvement of 11.23 dB in ACT and it
was statistically significant (P = 0.005). Similarly, the preoperative
Total cases (n=55) ABG was 36.17! 8.93 dB and postoperatively it was 25.11 ! 12.16 dB.
The gap closure was 11.06 dB and it was statistically significant
(P = 0.001). Hence, there was statistically significant hearing im-
Randomization provement postoperatively in group A.
Hearing results in group B (temporalis fascia group): The
mean ACT was 41.58 ! 8.18 dB preoperatively and 26.41! 9.58 dB
postoperatively. There was mean improvement of 15.17 dB and the
Group A (n=27) Group B (n=28)
change was statistically significant (P = 0.000). The ABG was
33.82 ! 7.5 dB preoperatively and 17.17 ! 9.25 dB postoperatively.
The gap closure was 16.65 dB and this difference was also statistically
significant (P = 0.000). Hence, there was statistically significant
hearing improvement in group B as well.
N=4 Lost to follow N=4 So, there was significant hearing improvement in both groups
postoperatively but the difference between two groups was not
statistically significant.
The complications noted on the follow-up after the surgery
were residual perforation (six patients), graft infection (in three
N=23 Follow up completed N= 24 patients, all in the cartilage group; improved after treatment),
hypertrophied (keloid) scar at postaural incision site (one case in the
cartilage palisade group), and otomycosis with pinna dermatitis
The age of the children included in our study ranged from 6 to (fascia group, improved).
14 years. In group A, the mean age was 9.78 years ranging from 6 to
12 years. In group B, the mean age was 10.42 years ranging from
6 to 14 years. The age distribution in two groups was similar with 4. Discussion
no significant difference (P = 0.28). The average follow-up period
for group A was 3.13 ! 1.91 months and was 4.2 ! 3.16 months for The study we conducted was prospective and randomized. So,
group B. The follow-up period between two groups was not this was stronger study associated with less chance of selection
statistically significant (P = 0.184). bias. In literature review, we found only one prospective and
Graft uptake: In group A, there were total of 23 children who randomized study, which was done in adults, while the remaining
had completed at least 6 weeks’ follow-up and 21(91.3%) had graft studies were retrospective chart reviews and were not random-
uptake. Similarly, in group B there were 24 cases, of which 20 ized. Although we have used different approaches for myringo-
(83.33%) had graft uptake (Table 1). The graft take was higher in plasty, the study done comparing outcome of myringoplasty with
group A compared to group B but the difference was not different surgical approaches has shown no difference in graft
statistically significant (P = 0.666). uptake rate [8]. Age range in our study did not differ from majority
Comparison of hearing results in two groups: After an
exclusion criterion was applied, there were 17 patients in each
group eligible for hearing evaluation. The bone conduction
threshold (BCT), air conduction threshold (ACT), and the difference Table 2
Comparison of hearing results between Group A (cartilage palisades group) and
between the two calculated as ABG was measured preoperatively
Group B (temporalis fascia group) (n = 34).

Group A Group B P value

(cartilage (temporalis
Table 1 palisades) fascia)
Graft status (n = 47). (n = 17) (n = 17)
Group A Group B Preoperative BCT (dB) 8.0 7.8 0.871
(cartilage (temporalis P value ACT (dB) 44.2 41.5 0.441
palisades) fascia) ABG (dB) 36.2 33.8 0.412
BCT (dB) 7.8 9.2 0.301
n % n %
Postoperative
Success 21 91.30 20 83.33 0.666 ACT (dB) 32.9 26.4 0.107
Graft ABG (dB) 25.1 17.2 0.040
Failure 2 8.70 4 16.67 ABG closure 11.0 16.8 0.133
Total 23 100 24 100 (dB)

(Fisher’s exact test). (Independent t-test).

 P. Tripathi et al. / International Journal of Pediatric Otorhinolaryngology 79 (2015) 1556–1560 1559

of recent studies, which also included children of up to age 14 years hearing in two groups was comparable and not statistically
[11,12,16,30]. significant. Although cartilage is thicker and stiffer, it did not
The results of myringoplasty we obtained were comparable to seriously hamper postoperative hearing status.
similar studies carried out elsewhere [11,12,16,30]. But, there were Our study has limitations of having small sample size and short-
only limited studies done with palisades technique in children and term follow-up period. The long-term outcome of the study may
there was only one study comparable to our study. In 2008, Ozbek show some changes from the present results.
et al. [24] retrospectively reviewed chart of 45 children who had Since, there were no significant differences between the groups
undergone myringoplasty with cartilage palisades or temporalis we would recommend the use of temporalis fascia for pediatric
fascia at a tertiary referral center in Turkey. In their study, the graft myringoplasty, as it is a simpler technique. Cartilage palisades
uptake rate in palisade group was 100% while in the temporalis in the tympanic membrane will partially obscure the view of the
fascia group it was 70.2% and it was calculated to be statistically middle ear. Furthermore, in the pediatric age group recurrent otitis
significant (P = 0.008); while in our study the difference was not media may require insertion of ventilation tubes that is more
significant. The number and age of children in their study was difficult or even impossible in the palisades group.
similar to our study. Our study was a prospective study as opposed The palisade technique may be reserved for recurrent perfora-
to their retrospective chart review and our patients were randomly tions or severe atelectasis.
selected for the two treatment options. Our study had shorter
follow-up period compared to their mean follow-up of 19 months.
5. Conclusion
The short-term follow-up might be responsible for the better
outcome in temporalis fascia group as it has been observed that
The graft uptake rate in cartilage palisades and temporalis
the fascia may undergo atrophy and shrinkage on long term [19].
fascia myringoplasty group on short-term follow-up was similar.
A randomized controlled trial by Cabra and Monux [22]
There was significant hearing improvement postoperatively in
comparing the results of cartilage palisades and temporalis fascia
ACT and ABG closure in both cartilage palisades and temporalis
in adult and pediatric patients had graft uptake of 82.26% in
fascia groups. When the hearing improvements in two groups
palisades group and 64.4% in temporalis fascia group at 24 months.
were compared, there was no statistical significant difference
The difference was statistically significant (P = 0.03) and differed
(P = 0.133). Hence, there is no significant difference in morpholog-
from our results. The study by Kazikdas et al. [26] done in adult
ical and functional outcome in pediatric myringoplasty using
patients had graft uptake rate of 95.7% (22/23) in the cartilage
either cartilage palisades or temporalis fascia evaluated on short-
palisades group and 75% (21/28) in the fascia group. The difference
term basis. Further, conclusion could be drawn only when a larger
was not statistically significant (P = 0.059), which was similar to our
sample is evaluated on long-term basis.
results. The mean follow-up period was 18.7 months, which was
In view of the similar results, we would recommend the use of
longer than our follow-up period. The technique followed was also
temporalis fascia for simple perforations with palisades reserved
comparable to our study but it was a retrospective chart review.
for recurrent perforations and severe atelectasis.
The hearing thresholds were separately calculated for both
cartilage palisades and fascia groups and were compared for the
functional outcome evaluation. Although some studies in the Conflict of interest
literature have shown improvement in acoustic properties with
thinner cartilages of about 0.5 mm [31], we did not attempt at No conflict of interest.
thinning the cartilage. The hearing improvement in both our
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