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A comparison of two myringoplasty techniques in Nepalese children: A prospective randomized trial
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 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 b
A R T I C L E I N F O
A B S T R A C T
Article history: Received 4 April 2015 Received in revised form 13 June 2015 Accepted 10 July 2015 Available online 20 July 2015
Background: In children, the success of myringoplastywith temporalis fascia is lower compared to adults and cartilage as an alternative graft material has shown higher success rate. Objective: To compare results of myringoplasty using tragal cartilage palisades with the use of temporalis fascia in children with large tympanic membrane perforations. 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 around 6 weeks after surgery was used as morphological outcome measure. Pre- and postoperative audiograms were compared to evaluate audiological outcome in two groups. Results: Forty seven out of 55 patients completed follow-up. The graft uptake rate in the cartilage palisades and temporalis fascia myringoplasty group was 91.3% (21/23) and 83.33% (20/24), respectively; the difference was not statistically significant (P = 0.666). The mean preoperative airbone 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. ß 2015 Elsevier Ireland Ltd. All rights reserved.
Keywords: Chronic otitis media Myringoplasty Cartilage palisades Temporalis fascia Children Large perforation
1. Introduction Chronic otitis media (COM) is any structural change in middle ear system associated with a permanent defect in tympanic membrane (TM) [1]. TM perforation with no associated middle ear inflammation and discharge is classified as COM mucosal inactive [2]. The usual causes are infection, atelectasis, ventilation tube insertion, and trauma [3]. COM is more prevalent in low socioeconomic groups and overcrowded homes with significant smoke exposure and substandard sanitation [1]. The overall
§ The abstract of ongoing research was presented at the 6th National Conference of Society of Otolaryngologists of Nepal on February 23rd, 2013. * Corresponding author at: Children’s Hospital for Eye, ENT and Rehabilitation Services (CHEERS), BP Eye Foundation, Manohara, Madhyapur thimi 16, Bhaktapur, Nepal. Tel.: +977 9841372760. E-mail address: [email protected] (P. Tripathi).
http://dx.doi.org/10.1016/j.ijporl.2015.07.014 0165-5876/ß 2015 Elsevier Ireland Ltd. All rights reserved.
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 estimated to be 9.28% [4]. COM mucosal disease usually presents with intermittent ear discharge of variable duration and hearing loss dependent on the size of the perforation [5]. The treatment is aimed at controlling active infection with the use of systemic and/or topical antibiotics, followed by surgical repair of the TM defect. A wide variety of grafting materials, such as fascia, perichondrium, periostium, vein, (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] but there is no consensus on the age limit below which results are generally poor [8–10]. Reasons for early closure of TM defect in children are to prevent frequent infections to avoid effect of hearing loss on speech and language development [11] and to allow unrestricted water-related activities [12]. Various factors
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contributing to low success rate of myringoplasty in children are high frequency of otitis media and URTIs, immature immune system, and unpredictable eustachian tube function [13–15]. Presently, temporalis muscle fascia is the most frequently used grafting material for the repair of tympanic membrane perforation in children and recent studies have reported graft success rate of 70–91% [8,9,11,12,16,30], which is comparable to success rate of 60–99% [17,18] in adults. The problems with the use of fascia as a graft material are due to atrophy or shrinkage of graft or its nonvascularization leading to failure [19]. TF can undergo atrophy in atelectatic ear, cholesteatoma, and revision tympanoplasty [20]. Due to these reasons, surgeons have advocated the use of more stable, less compliant materials like cartilage for the reconstruction of the TM perforation. Currently, cartilage tympanoplasty is variously recommended in high-risk perforations like subtotal or bilateral perforations, revision tympanoplasty, anterior perforation, coexisting craniofacial abnormalities, atelectatic ears, and cholesteatoma [21]. Cartilage palisades technique was first described by Heermann in 1962 [22]. Currently, it is the commonest technique used in cartilage tympanoplasty [23]. The reported graft uptake rate with cartilage palisades myringoplasty is higher than fascia and reported to have successful outcome in 82–100% of cases [22,24–26]. Results have also shown that there is no significant interference with hearing by use of cartilage for myringoplasty [26–28]. However, there is no previous prospective study comparing the results of fascia myringoplasty with the cartilage palisades myringoplasty in children. The aim of the study is to compare the results of myringoplasty with cartilage palisades and temporalis muscle fascia in large TM perforations in children.
2. Materials and methods This is a prospective, randomized, interventional, and comparative study carried out over a period of 18 months from December 2011 to June 2013. The study was carried out at Ganesh Man Singh Memorial Academy (GMSMA) of ENT-Head and Neck Studies, TU Teaching Hospital, Institute of Medicine (IOM), Kathmandu, Nepal. Inclusion criteria for the surgery were children of 6–14 years with COM mucosal inactive (dry for at least 4 weeks) and large perforation in tympanic membrane (>2 quadrants perforation). The exclusion criteria were congenital craniofacial abnormalities, for example, cleft palate and frank otorrhea and for hearing evaluation residual perforation or total failure, restricted or fixed ossicles, and patients with preoperative sensorineural hearing loss (BC > 25 dB) were excluded. Convenient sampling method was used for sample size calculation after reviewing the number of surgeries carried out in previous years. Detail history was obtained, ear otoscopy was done, and pure tone audiometry was performed 1 week prior to surgery. Average hearing threshold was calculated from 0.5, 1, 2, 3, and 4 KHz frequencies. Air–bone gap (ABG) was measured by the difference between average of air conduction and bone conduction thresholds done at the same time. Children meeting the inclusion criteria were randomly divided into two groups by simple random sampling method. The numbers of possible myringoplasty were estimated by reviewing the record of surgeries done in previous years as we have limited availability of operation theater. After exclusion criteria, it was estimated that about 50–55 cases were done in 18-months period in children. For random selection, lottery method was used. Folded paper were marked with group A and B and placed in a container. There were 30 marked as group A and 30 marked as group B, which were prepared by first author (PT). After patient met inclusion criteria and consented for participation, lottery was done by pulling out one of the folded paper from the container just before surgery by
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the surgeon. The paper was then discarded. Then the surgery was proceeded as cartilage palisade or temporalis fascia myringoplasty. Group A: tragal cartilage palisades (TCP) Group B: temporalis fascia (TF) Ethical committee approval was obtained before starting the study from Ethical Committee of Institutional Review Board (IRB) of Institute of Medicine, Nepal. Surgical procedure: In both groups, the surgery was carried via either of permeatal, endaural, or postaural approach depending on the necessity to approach tympanic membrane and middle ear. Freshening of the perforation margin was done to remove the epithelized tissue. A standard tympanomeatal flap was then raised and folded anteriorly along with annulus. Middle ear was assessed for ossicular status and other pathologies. Then the middle ear space was filled with gel foam up to the level of handle of malleus and annulus. After placing the graft material (cartilage palisade or fascia as described later), the tympanomeatal flap was then repositioned over the graft and gelfoam soaked in ciprofloxacin (0.3%), ear drops was placed over the flap and graft. Then ribbon gauze impregnated with bismuth iodoform paraffin paste (BIPP) was packed into the external auditory canal above the gelfoam. Endaural and postaural skin incisions were sutured in layers with 4-0 Vicryl and skin with 4-0 Ethilon, and a mastoid bandage was applied. For group A (tragal cartilage palisades): An incision was made on medial aspect of tragus and tragal cartilage along with perichondrium was then harvested and the incision site was closed with 4-0 Vicryl if required. Perichondrium from convex 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 facing laterally toward the external auditory canal and then appropriate-sized pieces of cartilage were placed in posterior quadrant and any gap remaining between palisades was filled with smaller cartilage pieces. In most cases about 3–4 tragal cartilage palisades were used. For group B (temporalis fascia): Temporalis muscle fascia graft was harvested by a horizontal incision about 2 cm above the upper attachment of pinna for permeatal approach. In postaural and endaural approach, same skin incision was used for harvesting the graft. Standard underlay temporalis fascia grafting was done [29]. Postoperative care: Both groups A and B received similar care with oral amoxicillin 25–50 mg/kg/day for 7 days. Ibuprofen (5–10 mg/kg/dose) + paracetamol (15 mg/kg/dose) as tablet or syrup was given three times daily after surgery for 3 days. The mastoid dressing was changed on the first postoperative day and thereafter on alternate days. Nonabsorbable sutures, if applied, were removed on sixth postoperative day and the BIPP pack was removed on 10th postoperative day. Antibiotic–steroid ear drops Ocupol-D1 (chloramphenicol + dexamethasone + polymyxin-B sulfate) were prescribed for 2 weeks after removal of pack. Follow-up evaluation of the patients was done at or around 6 weeks after surgery. The follow-up evaluation of the patient was done by first author (PT) who was not involved in the surgery of the patient. For morphological outcome, intact graft was taken as success and perforation of any size was taken as failure. For functional outcome evaluation, the postoperative hearing was compared with the preoperative hearing status. Preoperative and postoperative air–bone gap was calculated and compared. Results analyzed were graft uptake rate and change in postoperative hearing thresholds. SPSS 18 software was used for analysis of results. The statistical tests used for analysis were fisher’s exact test, dependent and independent t-test. The level of statistical significance was set at the P < 0.05.
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3. Observations and results A total of 55 patients meeting the inclusion criteria were included in the study. These patients were randomly selected for either cartilage palisades or temporalis fascia myringoplasty. There were 27 patients in group A (cartilage palisades group) and 28 in group B (temporalis fascia group). Eight patients were excluded from the study as they did not return for follow-up, four in each group. After exclusion, there were 23 patients in group A and 24 in group B (shown in flowchart). There were total of 25 boys and 22 girls included in the study and the distribution in two groups was not statistically significant.
Total cases (n=55)
Randomization
Group B (n=28)
Group A (n=27)
N=4
N=23
Lost to follow
N=4
N= 24
Follow up completed
The age of the children included in our study ranged from 6 to 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 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 group B. The follow-up period between two groups was not statistically significant (P = 0.184). Graft uptake: In group A, there were total of 23 children who had completed at least 6 weeks’ follow-up and 21(91.3%) had graft uptake. Similarly, in group B there were 24 cases, of which 20 (83.33%) had graft uptake (Table 1). The graft take was higher in group A compared to group B but the difference was not statistically significant (P = 0.666). 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 between the two calculated as ABG was measured preoperatively
and postoperatively in both groups. Preoperative hearing status (BCT, ACT, and ABG) of the children in both groups was comparable (Table 2). The hearing was improved postoperatively in both groups and air conduction threshold of two groups was comparable and was not statistically significant. The postoperative ABG between two groups was statistically significant (P = 0.040). It was less than 20 dB in group B but more than 20 dB in group A. The ABG closure was 11.06 dB in group A and 16.76 dB in group B. There was better ABG closure in group B but the difference observed in ABG closure was not statistically significant (P = 0.133) (Table 2). Hearing results in group A (cartilage palisades group): The 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 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 improvement 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 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. 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 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 (fascia group, improved).
4. Discussion The study we conducted was prospective and randomized. So, this was stronger study associated with less chance of selection bias. In literature review, we found only one prospective and randomized study, which was done in adults, while the remaining studies were retrospective chart reviews and were not randomized. Although we have used different approaches for myringoplasty, the study done comparing outcome of myringoplasty with different surgical approaches has shown no difference in graft uptake rate [8]. Age range in our study did not differ from majority
Table 2 Comparison of hearing results between Group A (cartilage palisades group) and Group B (temporalis fascia group) (n = 34). Group A (cartilage palisades) (n = 17)
Group B (temporalis fascia) (n = 17)
P value
BCT (dB) ACT (dB) ABG (dB) BCT (dB)
8.0 44.2 36.2 7.8
7.8 41.5 33.8 9.2
0.871 0.441 0.412 0.301
ACT (dB) ABG (dB) ABG closure (dB)
32.9 25.1 11.0
26.4 17.2 16.8
0.107 0.040 0.133
Table 1 Graft status (n = 47). Group B (temporalis fascia)
Group A (cartilage palisades) n
%
n
Preoperative P value
%
Success
21
91.30
20
83.33
Failure
2 23
8.70 100
4 24
16.67 100
Postoperative 0.666
Graft Total (Fisher’s exact test).
(Independent t-test).
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of recent studies, which also included children of up to age 14 years [11,12,16,30]. The results of myringoplasty we obtained were comparable to similar studies carried out elsewhere [11,12,16,30]. But, there were only limited studies done with palisades technique in children and there was only one study comparable to our study. In 2008, Ozbek et al. [24] retrospectively reviewed chart of 45 children who had undergone myringoplasty with cartilage palisades or temporalis fascia at a tertiary referral center in Turkey. In their study, the graft uptake rate in palisade group was 100% while in the temporalis fascia group it was 70.2% and it was calculated to be statistically significant (P = 0.008); while in our study the difference was not significant. The number and age of children in their study was similar to our study. Our study was a prospective study as opposed to their retrospective chart review and our patients were randomly selected for the two treatment options. Our study had shorter follow-up period compared to their mean follow-up of 19 months. The short-term follow-up might be responsible for the better outcome in temporalis fascia group as it has been observed that the fascia may undergo atrophy and shrinkage on long term [19]. A randomized controlled trial by Cabra and Monux [22] comparing the results of cartilage palisades and temporalis fascia in adult and pediatric patients had graft uptake of 82.26% in palisades group and 64.4% in temporalis fascia group at 24 months. The difference was statistically significant (P = 0.03) and differed from our results. The study by Kazikdas et al. [26] done in adult patients had graft uptake rate of 95.7% (22/23) in the cartilage palisades group and 75% (21/28) in the fascia group. The difference was not statistically significant (P = 0.059), which was similar to our results. The mean follow-up period was 18.7 months, which was longer than our follow-up period. The technique followed was also comparable to our study but it was a retrospective chart review. 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 literature have shown improvement in acoustic properties with thinner cartilages of about 0.5 mm [31], we did not attempt at thinning the cartilage. The hearing improvement in both our groups was statistically significant. There was better ABG closure in fascia group but it was not statistically significant. The hearing results we obtained were comparable to similar studies done. Ozbek et al. [24] used pre- and postoperative ABG and gap closure for functional evaluation. In both their cartilage palisades and fascia groups, the gap closure was statistically significant (P < 0.001). When two groups were compared for their pre- and postoperative ABG and gap closure, there was no significant difference. Their sample size, age group, and techniques were similar to our study, but they had a longer follow-up period. As in our study, they used full-thickness cartilage pieces with no attempt at thinning of the cartilage. In a study by Kazikdas et al. [26], the mean ABG changes between cartilage palisades and temporalis fascia group were not statistically significant (P > 0.05), which is again comparable to our study. In their study, the cartilage was thinned after removal to the approximate size of 0.5 mm but it did not change the outcome as the results were similar in both the groups. There was no significant difference in hearing improvement between cartilage palisades and temporalis fascia group in randomized controlled trial by Cabra et al. [22]. They also used the full-thickness cartilage for the reconstruction of defect. Other studies done by Dornhoffer, Neumann et al, Amedee et al. using cartilage palisades without comparison to the temporalis fascia also showed significant hearing improvement postoperatively [32–34]. All these studies have shown that the repair of a tympanic membrane perforation using either cartilage palisades or temporalis fascia significantly improved hearing. The improvement of
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hearing in two groups was comparable and not statistically significant. Although cartilage is thicker and stiffer, it did not seriously hamper postoperative hearing status. Our study has limitations of having small sample size and shortterm follow-up period. The long-term outcome of the study may show some changes from the present results. Since, there were no significant differences between the groups we would recommend the use of temporalis fascia for pediatric myringoplasty, as it is a simpler technique. Cartilage palisades in the tympanic membrane will partially obscure the view of the middle ear. Furthermore, in the pediatric age group recurrent otitis media may require insertion of ventilation tubes that is more difficult or even impossible in the palisades group. The palisade technique may be reserved for recurrent perforations or severe atelectasis. 5. Conclusion The graft uptake rate in cartilage palisades and temporalis fascia myringoplasty group on short-term follow-up was similar. There was significant hearing improvement postoperatively in ACT and ABG closure in both cartilage palisades and temporalis fascia groups. When the hearing improvements in two groups were compared, there was no statistical significant difference (P = 0.133). Hence, there is no significant difference in morphological and functional outcome in pediatric myringoplasty using either cartilage palisades or temporalis fascia evaluated on shortterm basis. Further, conclusion could be drawn only when a larger sample is evaluated on long-term basis. In view of the similar results, we would recommend the use of temporalis fascia for simple perforations with palisades reserved for recurrent perforations and severe atelectasis. Conflict of interest No conflict of interest. References [1] S.A. Telian, C.E. Schmalbach, Chronic otitis media, in: J.B. Snow, J.J. Ballenger (Eds.), Ballenger’s Otorhinolaryngology: Head and Neck Surgery, 16th ed., BC Decker Inc., Spain, 2003, pp. 261–293. [2] G.G. Browning, S.N. Merchant, G. Kelly, L.R. Swan, R. Canter, W.S. McKerrow, Chronic otitis media, in: M. Gleeson, G.G. Browning, M.J. Burton, R. Clarke, J. Hibbert, N.S. Jones, et al. (Eds.), Scott-Brown’s Otorhinolaryngology: Head and Neck Surgery, 7th ed, Edward Arnold (publishers) Ltd, London, 2008, pp. 3395–3446. [3] M. Knapik, I. Saliba, Pediatric myringoplasty: a study of factors affecting outcome, Int. J. Ped. Otorhinolaryngol. 75 (2011) 818–823. [4] P. Little, A. Bridges, R. Guragain, D. Friedman, R. Prasad, N. Weir, Hearing impairment and ear pathology in Nepal, J. Laryngol. Otol. 107 (1993) 395–400. [5] R.P. Mehta, J.J. Rosowski, S.E. Voss, E. O’Neil, S.N. Merchant, Determinants of hearing loss in perforations of the tympanic membrane, Otol. Neurotol. 27 (2) (2006) 136–143. [6] M.T. Kalcioglu, Y. Firat, E. Selimoglu, Cartilage tympanoplasty with Island technique: a comparison with the temporalis muscle fascia technique, J. Int. Adv. Otol. 5 (1) (2009) 45–50. [7] J.T. Vrabec, R.W. Deskin, J.J. Grady, Meta-analysis of pediatric tympanoplasty, Arch. Otolaryngol. Head Neck Surg. 125 (1999) 530–534. [8] A. Halim, J. Borgstein, Pediatric myringoplasty: postaural versus transmeatal approach, Int. J. Ped. Otorhinolaryngol. 73 (2009) 1580–1583. [9] S. Kumar, A. Acharya, E. Hadjihannas, C. Panagamuwa, A.L. McDermott, Pediatric myringoplasty: definition of ‘‘success’’ and factors affecting outcome, Otol. Neurotol. 31 (2010) 1417–1420. [10] B. Skotnicka, E. Hassmann-Poznan´ska, Myringoplasty in children–success factors, Otolaryngol. Pol. 62 (1) (2008) 65–70. [11] N. Umapathy, P.J. Dekker, Myringoplasty is it worth performing in children, Arch. Otolaryngol. Head Neck Surg. 129 (2003) 1053–1055. [12] G.B. Singh, T.S. Sidhu, A. Sharma, N. Singh, Tympanoplasty type I in children—an evaluative study, Int. J. Ped. Otorhinolaryngol. 69 (2005) 1071–1076. [13] C.W. Gross, M. Bassila, R.H. Lazar, T.E. Long, S. Stagner, Adipose plug myringoplasty: an alternative to formal myringoplasty techniques in children, Otolaryngol. Head Neck Surg. 101 (6) (1989) 617–620.
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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 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 b
A R T I C L E I N F O
A B S T R A C T
Article history: Received 4 April 2015 Received in revised form 13 June 2015 Accepted 10 July 2015 Available online 20 July 2015
Background: In children, the success of myringoplastywith temporalis fascia is lower compared to adults and cartilage as an alternative graft material has shown higher success rate. Objective: To compare results of myringoplasty using tragal cartilage palisades with the use of temporalis fascia in children with large tympanic membrane perforations. 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 around 6 weeks after surgery was used as morphological outcome measure. Pre- and postoperative audiograms were compared to evaluate audiological outcome in two groups. Results: Forty seven out of 55 patients completed follow-up. The graft uptake rate in the cartilage palisades and temporalis fascia myringoplasty group was 91.3% (21/23) and 83.33% (20/24), respectively; the difference was not statistically significant (P = 0.666). The mean preoperative airbone 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. ß 2015 Elsevier Ireland Ltd. All rights reserved.
Keywords: Chronic otitis media Myringoplasty Cartilage palisades Temporalis fascia Children Large perforation
1. Introduction Chronic otitis media (COM) is any structural change in middle ear system associated with a permanent defect in tympanic membrane (TM) [1]. TM perforation with no associated middle ear inflammation and discharge is classified as COM mucosal inactive [2]. The usual causes are infection, atelectasis, ventilation tube insertion, and trauma [3]. COM is more prevalent in low socioeconomic groups and overcrowded homes with significant smoke exposure and substandard sanitation [1]. The overall
§ The abstract of ongoing research was presented at the 6th National Conference of Society of Otolaryngologists of Nepal on February 23rd, 2013. * Corresponding author at: Children’s Hospital for Eye, ENT and Rehabilitation Services (CHEERS), BP Eye Foundation, Manohara, Madhyapur thimi 16, Bhaktapur, Nepal. Tel.: +977 9841372760. E-mail address: [email protected] (P. Tripathi).
http://dx.doi.org/10.1016/j.ijporl.2015.07.014 0165-5876/ß 2015 Elsevier Ireland Ltd. All rights reserved.
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 estimated to be 9.28% [4]. COM mucosal disease usually presents with intermittent ear discharge of variable duration and hearing loss dependent on the size of the perforation [5]. The treatment is aimed at controlling active infection with the use of systemic and/or topical antibiotics, followed by surgical repair of the TM defect. A wide variety of grafting materials, such as fascia, perichondrium, periostium, vein, (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] but there is no consensus on the age limit below which results are generally poor [8–10]. Reasons for early closure of TM defect in children are to prevent frequent infections to avoid effect of hearing loss on speech and language development [11] and to allow unrestricted water-related activities [12]. Various factors
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contributing to low success rate of myringoplasty in children are high frequency of otitis media and URTIs, immature immune system, and unpredictable eustachian tube function [13–15]. Presently, temporalis muscle fascia is the most frequently used grafting material for the repair of tympanic membrane perforation in children and recent studies have reported graft success rate of 70–91% [8,9,11,12,16,30], which is comparable to success rate of 60–99% [17,18] in adults. The problems with the use of fascia as a graft material are due to atrophy or shrinkage of graft or its nonvascularization leading to failure [19]. TF can undergo atrophy in atelectatic ear, cholesteatoma, and revision tympanoplasty [20]. Due to these reasons, surgeons have advocated the use of more stable, less compliant materials like cartilage for the reconstruction of the TM perforation. Currently, cartilage tympanoplasty is variously recommended in high-risk perforations like subtotal or bilateral perforations, revision tympanoplasty, anterior perforation, coexisting craniofacial abnormalities, atelectatic ears, and cholesteatoma [21]. Cartilage palisades technique was first described by Heermann in 1962 [22]. Currently, it is the commonest technique used in cartilage tympanoplasty [23]. The reported graft uptake rate with cartilage palisades myringoplasty is higher than fascia and reported to have successful outcome in 82–100% of cases [22,24–26]. Results have also shown that there is no significant interference with hearing by use of cartilage for myringoplasty [26–28]. However, there is no previous prospective study comparing the results of fascia myringoplasty with the cartilage palisades myringoplasty in children. The aim of the study is to compare the results of myringoplasty with cartilage palisades and temporalis muscle fascia in large TM perforations in children.
2. Materials and methods This is a prospective, randomized, interventional, and comparative study carried out over a period of 18 months from December 2011 to June 2013. The study was carried out at Ganesh Man Singh Memorial Academy (GMSMA) of ENT-Head and Neck Studies, TU Teaching Hospital, Institute of Medicine (IOM), Kathmandu, Nepal. Inclusion criteria for the surgery were children of 6–14 years with COM mucosal inactive (dry for at least 4 weeks) and large perforation in tympanic membrane (>2 quadrants perforation). The exclusion criteria were congenital craniofacial abnormalities, for example, cleft palate and frank otorrhea and for hearing evaluation residual perforation or total failure, restricted or fixed ossicles, and patients with preoperative sensorineural hearing loss (BC > 25 dB) were excluded. Convenient sampling method was used for sample size calculation after reviewing the number of surgeries carried out in previous years. Detail history was obtained, ear otoscopy was done, and pure tone audiometry was performed 1 week prior to surgery. Average hearing threshold was calculated from 0.5, 1, 2, 3, and 4 KHz frequencies. Air–bone gap (ABG) was measured by the difference between average of air conduction and bone conduction thresholds done at the same time. Children meeting the inclusion criteria were randomly divided into two groups by simple random sampling method. The numbers of possible myringoplasty were estimated by reviewing the record of surgeries done in previous years as we have limited availability of operation theater. After exclusion criteria, it was estimated that about 50–55 cases were done in 18-months period in children. For random selection, lottery method was used. Folded paper were marked with group A and B and placed in a container. There were 30 marked as group A and 30 marked as group B, which were prepared by first author (PT). After patient met inclusion criteria and consented for participation, lottery was done by pulling out one of the folded paper from the container just before surgery by
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the surgeon. The paper was then discarded. Then the surgery was proceeded as cartilage palisade or temporalis fascia myringoplasty. Group A: tragal cartilage palisades (TCP) Group B: temporalis fascia (TF) Ethical committee approval was obtained before starting the study from Ethical Committee of Institutional Review Board (IRB) of Institute of Medicine, Nepal. Surgical procedure: In both groups, the surgery was carried via either of permeatal, endaural, or postaural approach depending on the necessity to approach tympanic membrane and middle ear. Freshening of the perforation margin was done to remove the epithelized tissue. A standard tympanomeatal flap was then raised and folded anteriorly along with annulus. Middle ear was assessed for ossicular status and other pathologies. Then the middle ear space was filled with gel foam up to the level of handle of malleus and annulus. After placing the graft material (cartilage palisade or fascia as described later), the tympanomeatal flap was then repositioned over the graft and gelfoam soaked in ciprofloxacin (0.3%), ear drops was placed over the flap and graft. Then ribbon gauze impregnated with bismuth iodoform paraffin paste (BIPP) was packed into the external auditory canal above the gelfoam. Endaural and postaural skin incisions were sutured in layers with 4-0 Vicryl and skin with 4-0 Ethilon, and a mastoid bandage was applied. For group A (tragal cartilage palisades): An incision was made on medial aspect of tragus and tragal cartilage along with perichondrium was then harvested and the incision site was closed with 4-0 Vicryl if required. Perichondrium from convex 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 facing laterally toward the external auditory canal and then appropriate-sized pieces of cartilage were placed in posterior quadrant and any gap remaining between palisades was filled with smaller cartilage pieces. In most cases about 3–4 tragal cartilage palisades were used. For group B (temporalis fascia): Temporalis muscle fascia graft was harvested by a horizontal incision about 2 cm above the upper attachment of pinna for permeatal approach. In postaural and endaural approach, same skin incision was used for harvesting the graft. Standard underlay temporalis fascia grafting was done [29]. Postoperative care: Both groups A and B received similar care with oral amoxicillin 25–50 mg/kg/day for 7 days. Ibuprofen (5–10 mg/kg/dose) + paracetamol (15 mg/kg/dose) as tablet or syrup was given three times daily after surgery for 3 days. The mastoid dressing was changed on the first postoperative day and thereafter on alternate days. Nonabsorbable sutures, if applied, were removed on sixth postoperative day and the BIPP pack was removed on 10th postoperative day. Antibiotic–steroid ear drops Ocupol-D1 (chloramphenicol + dexamethasone + polymyxin-B sulfate) were prescribed for 2 weeks after removal of pack. Follow-up evaluation of the patients was done at or around 6 weeks after surgery. The follow-up evaluation of the patient was done by first author (PT) who was not involved in the surgery of the patient. For morphological outcome, intact graft was taken as success and perforation of any size was taken as failure. For functional outcome evaluation, the postoperative hearing was compared with the preoperative hearing status. Preoperative and postoperative air–bone gap was calculated and compared. Results analyzed were graft uptake rate and change in postoperative hearing thresholds. SPSS 18 software was used for analysis of results. The statistical tests used for analysis were fisher’s exact test, dependent and independent t-test. The level of statistical significance was set at the P < 0.05.
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3. Observations and results A total of 55 patients meeting the inclusion criteria were included in the study. These patients were randomly selected for either cartilage palisades or temporalis fascia myringoplasty. There were 27 patients in group A (cartilage palisades group) and 28 in group B (temporalis fascia group). Eight patients were excluded from the study as they did not return for follow-up, four in each group. After exclusion, there were 23 patients in group A and 24 in group B (shown in flowchart). There were total of 25 boys and 22 girls included in the study and the distribution in two groups was not statistically significant.
Total cases (n=55)
Randomization
Group B (n=28)
Group A (n=27)
N=4
N=23
Lost to follow
N=4
N= 24
Follow up completed
The age of the children included in our study ranged from 6 to 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 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 group B. The follow-up period between two groups was not statistically significant (P = 0.184). Graft uptake: In group A, there were total of 23 children who had completed at least 6 weeks’ follow-up and 21(91.3%) had graft uptake. Similarly, in group B there were 24 cases, of which 20 (83.33%) had graft uptake (Table 1). The graft take was higher in group A compared to group B but the difference was not statistically significant (P = 0.666). 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 between the two calculated as ABG was measured preoperatively
and postoperatively in both groups. Preoperative hearing status (BCT, ACT, and ABG) of the children in both groups was comparable (Table 2). The hearing was improved postoperatively in both groups and air conduction threshold of two groups was comparable and was not statistically significant. The postoperative ABG between two groups was statistically significant (P = 0.040). It was less than 20 dB in group B but more than 20 dB in group A. The ABG closure was 11.06 dB in group A and 16.76 dB in group B. There was better ABG closure in group B but the difference observed in ABG closure was not statistically significant (P = 0.133) (Table 2). Hearing results in group A (cartilage palisades group): The 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 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 improvement 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 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. 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 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 (fascia group, improved).
4. Discussion The study we conducted was prospective and randomized. So, this was stronger study associated with less chance of selection bias. In literature review, we found only one prospective and randomized study, which was done in adults, while the remaining studies were retrospective chart reviews and were not randomized. Although we have used different approaches for myringoplasty, the study done comparing outcome of myringoplasty with different surgical approaches has shown no difference in graft uptake rate [8]. Age range in our study did not differ from majority
Table 2 Comparison of hearing results between Group A (cartilage palisades group) and Group B (temporalis fascia group) (n = 34). Group A (cartilage palisades) (n = 17)
Group B (temporalis fascia) (n = 17)
P value
BCT (dB) ACT (dB) ABG (dB) BCT (dB)
8.0 44.2 36.2 7.8
7.8 41.5 33.8 9.2
0.871 0.441 0.412 0.301
ACT (dB) ABG (dB) ABG closure (dB)
32.9 25.1 11.0
26.4 17.2 16.8
0.107 0.040 0.133
Table 1 Graft status (n = 47). Group B (temporalis fascia)
Group A (cartilage palisades) n
%
n
Preoperative P value
%
Success
21
91.30
20
83.33
Failure
2 23
8.70 100
4 24
16.67 100
Postoperative 0.666
Graft Total (Fisher’s exact test).
(Independent t-test).
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of recent studies, which also included children of up to age 14 years [11,12,16,30]. The results of myringoplasty we obtained were comparable to similar studies carried out elsewhere [11,12,16,30]. But, there were only limited studies done with palisades technique in children and there was only one study comparable to our study. In 2008, Ozbek et al. [24] retrospectively reviewed chart of 45 children who had undergone myringoplasty with cartilage palisades or temporalis fascia at a tertiary referral center in Turkey. In their study, the graft uptake rate in palisade group was 100% while in the temporalis fascia group it was 70.2% and it was calculated to be statistically significant (P = 0.008); while in our study the difference was not significant. The number and age of children in their study was similar to our study. Our study was a prospective study as opposed to their retrospective chart review and our patients were randomly selected for the two treatment options. Our study had shorter follow-up period compared to their mean follow-up of 19 months. The short-term follow-up might be responsible for the better outcome in temporalis fascia group as it has been observed that the fascia may undergo atrophy and shrinkage on long term [19]. A randomized controlled trial by Cabra and Monux [22] comparing the results of cartilage palisades and temporalis fascia in adult and pediatric patients had graft uptake of 82.26% in palisades group and 64.4% in temporalis fascia group at 24 months. The difference was statistically significant (P = 0.03) and differed from our results. The study by Kazikdas et al. [26] done in adult patients had graft uptake rate of 95.7% (22/23) in the cartilage palisades group and 75% (21/28) in the fascia group. The difference was not statistically significant (P = 0.059), which was similar to our results. The mean follow-up period was 18.7 months, which was longer than our follow-up period. The technique followed was also comparable to our study but it was a retrospective chart review. 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 literature have shown improvement in acoustic properties with thinner cartilages of about 0.5 mm [31], we did not attempt at thinning the cartilage. The hearing improvement in both our groups was statistically significant. There was better ABG closure in fascia group but it was not statistically significant. The hearing results we obtained were comparable to similar studies done. Ozbek et al. [24] used pre- and postoperative ABG and gap closure for functional evaluation. In both their cartilage palisades and fascia groups, the gap closure was statistically significant (P < 0.001). When two groups were compared for their pre- and postoperative ABG and gap closure, there was no significant difference. Their sample size, age group, and techniques were similar to our study, but they had a longer follow-up period. As in our study, they used full-thickness cartilage pieces with no attempt at thinning of the cartilage. In a study by Kazikdas et al. [26], the mean ABG changes between cartilage palisades and temporalis fascia group were not statistically significant (P > 0.05), which is again comparable to our study. In their study, the cartilage was thinned after removal to the approximate size of 0.5 mm but it did not change the outcome as the results were similar in both the groups. There was no significant difference in hearing improvement between cartilage palisades and temporalis fascia group in randomized controlled trial by Cabra et al. [22]. They also used the full-thickness cartilage for the reconstruction of defect. Other studies done by Dornhoffer, Neumann et al, Amedee et al. using cartilage palisades without comparison to the temporalis fascia also showed significant hearing improvement postoperatively [32–34]. All these studies have shown that the repair of a tympanic membrane perforation using either cartilage palisades or temporalis fascia significantly improved hearing. The improvement of
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hearing in two groups was comparable and not statistically significant. Although cartilage is thicker and stiffer, it did not seriously hamper postoperative hearing status. Our study has limitations of having small sample size and shortterm follow-up period. The long-term outcome of the study may show some changes from the present results. Since, there were no significant differences between the groups we would recommend the use of temporalis fascia for pediatric myringoplasty, as it is a simpler technique. Cartilage palisades in the tympanic membrane will partially obscure the view of the middle ear. Furthermore, in the pediatric age group recurrent otitis media may require insertion of ventilation tubes that is more difficult or even impossible in the palisades group. The palisade technique may be reserved for recurrent perforations or severe atelectasis. 5. Conclusion The graft uptake rate in cartilage palisades and temporalis fascia myringoplasty group on short-term follow-up was similar. There was significant hearing improvement postoperatively in ACT and ABG closure in both cartilage palisades and temporalis fascia groups. When the hearing improvements in two groups were compared, there was no statistical significant difference (P = 0.133). Hence, there is no significant difference in morphological and functional outcome in pediatric myringoplasty using either cartilage palisades or temporalis fascia evaluated on shortterm basis. Further, conclusion could be drawn only when a larger sample is evaluated on long-term basis. In view of the similar results, we would recommend the use of temporalis fascia for simple perforations with palisades reserved for recurrent perforations and severe atelectasis. Conflict of interest No conflict of interest. References [1] S.A. Telian, C.E. Schmalbach, Chronic otitis media, in: J.B. Snow, J.J. Ballenger (Eds.), Ballenger’s Otorhinolaryngology: Head and Neck Surgery, 16th ed., BC Decker Inc., Spain, 2003, pp. 261–293. [2] G.G. Browning, S.N. Merchant, G. Kelly, L.R. Swan, R. Canter, W.S. McKerrow, Chronic otitis media, in: M. Gleeson, G.G. Browning, M.J. Burton, R. Clarke, J. Hibbert, N.S. Jones, et al. (Eds.), Scott-Brown’s Otorhinolaryngology: Head and Neck Surgery, 7th ed, Edward Arnold (publishers) Ltd, London, 2008, pp. 3395–3446. [3] M. Knapik, I. Saliba, Pediatric myringoplasty: a study of factors affecting outcome, Int. J. Ped. Otorhinolaryngol. 75 (2011) 818–823. [4] P. Little, A. Bridges, R. Guragain, D. Friedman, R. Prasad, N. Weir, Hearing impairment and ear pathology in Nepal, J. Laryngol. Otol. 107 (1993) 395–400. [5] R.P. Mehta, J.J. Rosowski, S.E. Voss, E. O’Neil, S.N. Merchant, Determinants of hearing loss in perforations of the tympanic membrane, Otol. Neurotol. 27 (2) (2006) 136–143. [6] M.T. Kalcioglu, Y. Firat, E. Selimoglu, Cartilage tympanoplasty with Island technique: a comparison with the temporalis muscle fascia technique, J. Int. Adv. Otol. 5 (1) (2009) 45–50. [7] J.T. Vrabec, R.W. Deskin, J.J. Grady, Meta-analysis of pediatric tympanoplasty, Arch. Otolaryngol. Head Neck Surg. 125 (1999) 530–534. [8] A. Halim, J. Borgstein, Pediatric myringoplasty: postaural versus transmeatal approach, Int. J. Ped. Otorhinolaryngol. 73 (2009) 1580–1583. [9] S. Kumar, A. Acharya, E. Hadjihannas, C. Panagamuwa, A.L. McDermott, Pediatric myringoplasty: definition of ‘‘success’’ and factors affecting outcome, Otol. Neurotol. 31 (2010) 1417–1420. [10] B. Skotnicka, E. Hassmann-Poznan´ska, Myringoplasty in children–success factors, Otolaryngol. Pol. 62 (1) (2008) 65–70. [11] N. Umapathy, P.J. Dekker, Myringoplasty is it worth performing in children, Arch. Otolaryngol. Head Neck Surg. 129 (2003) 1053–1055. [12] G.B. Singh, T.S. Sidhu, A. Sharma, N. Singh, Tympanoplasty type I in children—an evaluative study, Int. J. Ped. Otorhinolaryngol. 69 (2005) 1071–1076. [13] C.W. Gross, M. Bassila, R.H. Lazar, T.E. Long, S. Stagner, Adipose plug myringoplasty: an alternative to formal myringoplasty techniques in children, Otolaryngol. Head Neck Surg. 101 (6) (1989) 617–620.
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