Comparative Study on Temporalis Fascia Graft Versus Tragal Cartilage in Type-1 Tympanoplasty in Paediatric Patients

Abstract

The aim of the study was to compare anatomical and functional outcomes of temporalis fascia graft versus tragal cartilage graft in type 1 tympanoplasty in paediatric patients. A prospective, comparative and randomised study. A detailed history was taken from all the patients visiting the ENT OP dept after fulfilling the inclusion and exclusion criterion patients were enrolled for the study. Written and informed consent was taken for all the patients from legally acceptable guardians. Preoperative assessment was done and the patients were subjected to type1 tympanoplasty with Temporalis fascia graft or tragal cartilage graft. All the patients were followed up on the third, sixth postoperative months to assess hearing improvement. All the patients were followed up on the first and third,sixth postoperative months for graft status with otoscopic examination. In the present study out of 80 patients, 40 patients underwent type 1 tympanoplasty with temporalis fascia and the remaining 40 patients with tragal cartilage. Both groups were assessed postoperatively for anatomical and functional success with maximum follow up of six months. There was no statistical significance between the outcome and the age or site and size of tympanic membrane perforation. Both groups had comparable graft success rate and hearing improvement. The cartilage group had a higher anatomical success rate. The functional outcome was similar. However, there was no statistically significant difference found in the outcome of two groups. Tympanoplasty can be performed in a paediatric age group with a good success rate in suitable patients. It can be done at an early age,safely with good anatomical and functional outcomes. The age group, site or size of perforation, the type of graft used for tympanoplasty does not alter the anatomical or functional outcome significantly.

Supplementary Information

The online version contains supplementary material available at 10.1007/s12070-023-03490-1.

Introduction

Chronic otitis media is chronic inflammation of the mucoperiosteal lining of the middle ear cleft characterised by ear discharge, permanent perforation of the tympanic membrane and impairment of hearing. It is one of the most common ear diseases encountered in developing countries due to poor socioeconomic standards, poor nutrition, lack of health, education and unhygienic habits [1–3].

A study, conducted by Kumari et al. [4], of prevalence and associated risk of factors of otitis media and its subtypes in the South Indian population in 2016, 2602 subjects were included, reported the prevalence of mucosal-chronic suppurative otitis media (18.5%). In a systematic review of epidemiology of otitis media in children from developing countries, children < 6 years were studied within 90 developing and newly industrialised countries. Based on literature searches from 1992 to 2011 in this study, prevalence of Otitis media was found to be 9.2% in India [5].

Types of Chronic Suppurative Otitis Media:

1. Mucosal disease (Tubotympanic) also known as safe disease. It is characterised by profuse, mucoid, odourless discharge and central perforation.

2. Squamosal disease (Atticoantral) also known as unsafe disease,associated with formation of cholesteatoma leading to bony erosion. It is characterised by scanty, foul smelling discharge and marginal perforation.

The term Tympanoplasty was first used in 1953 by Wullstein [6] to describe surgical techniques for reconstruction of the middle ear hearing mechanism that had been impaired or destroyed by chronic ear disease. Tympanoplasty implies surgical reconstruction of tympanic membrane with eradication of middle ear disease and restoration of hearing mechanism [7]. The main goal of tympanoplasty is “sound protection for round window and sound pressure transformation for oval window” [8]. In the past, traditional otologic practice advocated avoidance of tympanoplasty in paediatric age groups less than 7 years. The reason being that anatomical modulation of Eustachian tube in younger age groups could cause recurrent otitis media [9]. Literature states that maturation of eustachian tubes is complete by approximately 6 years of age [10, 11]. Therefore tympanoplasty can theoretically be safely performed after the age of 6 years in suitable patients. The youngest child to undergo tympanoplasty is 2 years 10 months child with successful bilateral cartilage tympanoplasty as per case report by Ashish et al. [12]. For tympanoplasty, various graft materials are used since decades viz: “Autogenous grafts namely Temporalis fascia, perichondrium from tragus, cartilage from tragus or concha, areolar tissue from ear lobule, fascia lata, vein, ear canal skin, heterotopic skin’’ [13].

In paediatric age groups, perforated tympanic membrane results in impairment of hearing with ear discharge and pain, thus affecting day to day activities. Impaired hearing impacts not only speech and development but also academic performance and the child’s ability to integrate himself in the society at large. Early tympanoplasty in children is thus advisable to prevent the possibility of chronic ear disease and its complications, to improve hearing without use of hearing aids, improve the academic performance and the overall development of the child.

Aim and Objectives

Aim

To compare anatomical and functional outcomes of temporalis fascia graft versus tragal cartilage graft in type 1 tympanoplasty in paediatric patients.

Objectives

1. To compare postop graft status of type 1 tympanoplasty using temporalis fascia versus tragal cartilage graft in paediatric patients.

2. To compare air bone gap improvement after type 1 tympanoplasty using temporalis fascia versus tragal cartilage graft in paediatric patients.

Material and Methods

This study was conducted over a period of 1 year, and a total of 80 patients fulfilling the desired inclusion criteria were evaluated on the basis of detailed history and exhaustive ENT examination. The parents of the patients were explained in detail about the procedures and a written consent was obtained. Ear otoscopic examination was done to see the site and size of perforation. Size of the perforation was recorded in terms of percentage of the part of tympanic membrane involved. Necessary pre-operative investigations were done. Diagnostic Nasal Endoscopy, Pure Tone Audiometry, Examination Under Microscope (whenever required), Pre anaesthetic check up was done for all patients. Pre operative hearing was documented in audiometry. Patients were alternatively divided into two groups preoperatively based on the type of graft to be used.

Inclusion Criteria

Age group 7–13yrs, with Mucosal inactive chronic otitis media, Conductive type of hearing loss and dry ear for at least 6 weeks.

Exclusion Criteria

Chronic otitis externa, Squamous chronic otitis media, Sensorineural hearing loss, Ossicular chain defect, Sinonasal polyposis, Rhinosinusitis, Adenoid hypertrophy, Bleeding disorders, Congenital defects.

The standard steps of Type I Tympanoplasty via Postauricular approach and underlay technique were followed in all the patients.

Outcome Measures

Anatomical success of graft was compared by otoscopic examination post operatively at first, third, sixth months.

Functional success was recorded postoperatively at third and sixth month audiometry, and compared with the preoperative audiometry in terms of gain in Air Bone Gap (ABG).

Statistical Analysis

Statistical testing has been conducted with the statistical package for the social science system version SPSS 20.0. Continuous variables were presented as mean & SD for normally distributed data and Median (IQR) for non normal data.The data was presented in terms of frequencies and percentages for categorical variables. The statistical analysis of nominal categorical data was carried out using Chi-square test or Fisher’s exact test as appropriate. The comparison of normally distributed continuous variables was performed using Student’s t test, Pre and Post comparison by Paired t-test and Non-normal distribution continuous variables were compared using Mann Whitney U test. For all statistical tests, p value less than 0.05 was taken to indicate a significant difference.

Results

The mean age of the study population was 9.7 years. The mean age of the temporalis fascia group was 9.8 years and that in the cartilage graft group was 9.6 years.

Anatomical success was documented in 29 patients of fascia group and 35 patients of cartilage group. Among the 29 patients with successful surgery, 21 patients were in the 7–10 years age group and 8 patients in the 11–13 years age group. In the cartilage graft group, among the 35 patients with successful outcome, 26 patients were 7–10 years of age and 9 of 11–13 years age group. Graft success and failure rate was compared between the two groups.The graft success rate was higher in the cartilage graft group. Though the failure rate was higher with temporalis fascia graft, statistical significance could not be established in either age groups. Thus, both temporalis fascia or cartilage graft can be used in paediatric tympanoplasty with similar surgical outcomes Tables 1 and Table 2 & Fig. 1 and Fig. 2.

Table 1.

Showing graft success rate in the two groups (fascia and cartilage) according to age groups

Age	Graft Success		Chi square value	P value
	Fascia (n = 40)	Cartilage (n = 40)
7–10	21(52.5%)	26 (65%)	1.28	0.256
11–13	8 (20%)	9 (22.5%)	0.075	0.785
Total	29 (72.5%)	35 (87.5%)

Table 2.

Showing graft failure rate in the two groups (fascia and cartilage) according to age groups

Age	Graft failure		Chi square value	P value
	Fascia (n = 40)	Cartilage (n = 40)
7–10	6(15%)	4(10%)	0.457	0.499
11–13	5(12.5%)	1(2.5%)	2.88	0.09
Total	11(27.5%)	5(12.5%)

Fig. 1.

Showing age wise graft successful uptake in the two graft groups

Fig. 2.

Showing age wise result graft failure in the two graft groups. Graft failure rate was compared between the two groups. Though the failure rate was higher with temporalis fascia graft vs cartilage graft, statistical significance could not be established in either age groups. Chi square test was applied. P value was found to be 0.49 for 7–10 yrs age and 0.09 for 11–13 years age group

Functional success of Tympanoplasty is defined as ABG ≤ 20db postoperatively. In the present study, patients who underwent temporalis fascia graft tympanoplasty had pre-operative mean ABG of 29.4 and postoperative 3rd month mean ABG 19.45 and 6th month mean ABG 18.90. There was statistically significant improvement in mean ABG postoperatively in the fascia graft tympanoplasty group. In patients who underwent cartilage graft tympanoplasty pre-operative mean ABG was 28.67 and postoperative 3rd month mean ABG 18.90 and 6th month mean ABG 18.05. There was statistically significant improvement in mean ABG postoperatively in the cartilage tympanoplasty group Figs. 3 and 4.

Fig. 3.

Showing group wise pre op ABG distribution. In the present study, of the 40 patients of temporalis fascia graft group, when assessed preoperatively, 3 (7.5%) patients had preoperative ABG ≤ 20 dB, 24 (60%) had ABG of 21–30 dB, 13(32.5%) patients ABG of 31–40 dB. Whereas, among 40 patients of tragal cartilage graft group, one (2.5%) patient had preoperative ABG ≤ 20 dB, 25 (62.5%) patients had preoperative ABG of 21–30 dB, 14 (35%) patients had preoperative ABG of 31–40 dB

Fig. 4.

Showing age wise distribution of postop_6th month ABG. Functional success is defined as ABG ≤ 20 dB postoperatively. In the present study, of the 80 patients who underwent type 1 tympanoplasty, 63 (78.75%) patients had postoperative 6th month ABG of ≤ 20 dB, whereas 17 (21.25%) patients had postoperative 6th month ABG of 21-30 dB. 45 patients (71.4%) of the 63 patients with ABG ≤ 20 dB, were of 7–10 years age and 18 (28.6%) patients were of 11–13 years age. Total of 17 patients whose 6th month postoperative ABG was 21–30 dB, included 12 patients (70.6%) of 7–10 years of age and 5 patients (29.4%) of 11–13 years of age. Chi square test was applied. The P value calculated was 0.447, thus no statistical significance could be established between the postoperative ABG and age groups

Functional outcome of both grafts in terms of mean ABG was significant on comparing pre op mean ABG with post op 6th month mean ABG in either groups. The mean ABG of fascia graft group postoperatively at 6 months was 18.90 and that of cartilage graft group was 18.05. The postoperative median ABG gain in the fascia group was 10 and 10.5 in the cartilage group. The p value is 0.832. Hence, no statistically significant difference was found when postoperative functional outcome was compared in between the two groups. Thus both grafts result in similar outcomes Figs. 5 and 6.

Fig. 5.

Showing group wise distribution of postop_6th month ABG. In the present study, 40 patients underwent temporalis fascia tympanoplasty, and 30 (75%) patients achieved 6th month post-operative ABG of ≤ 20 dB, 10 (25%) patients ABG of 21–30 dB. Other group of 40 patients who underwent tragal cartilage tympanoplasty, 33 patients (82.5%) of them had 6th month post-operative ABG of ≤ 20 dB and 7 patients (17.5%) achieved ABG of 21–30 dB. Chi square test was applied. P value was 0.412. Hence no statistically significant difference could be established between the two groups in terms of functional outcome i.e. ABG gain at 6 months postoperatively

Fig. 6.

Showing comparison of mean ABG of preop and postop_6th month in two graft groups. The mean ABG of fascia graft group postoperatively at 6 months was 18.90 and that of cartilage graft group was 18.05. Unpaired student t-test was applied and p value was found to be 0.391. Overall postoperative ABG gain was comparable in both groups but no statistically significant difference was found. Thus both grafts result in similar outcome

Discussion

Under this study, overall 80 patients were included between 7 and 13 years of age and were divided into two groups alternatively with 40 in each group as per inclusion criteria. Out of 80, there were 54 children of age group 7–10 years and 23 children in the age group of 11–13 years. Overall the mean age of the study population was 9.7 years.Temporalis fascia group included 27 patients of 7–10 years and 13 patients of 11–13 years, with the mean age of 9.8 years and that of cartilage graft group included 30 patients of 7–10 years and 10 patients of 11–13 years, with the mean age of 9.6 years. In a study by Yegin et al. [17], of 78 children to study comparison of temporalis fascia graft with cartilage graft in type 1 tympanoplasty, the children were of age group 7–18 years. There were 40 patients in the temporalis fascia graft group and 38 patients in the tragal cartilage graft group. Another study by Shyamakant Prasad et al. [16], in 2010–2013 included children of the age group 9–13yrs. Overall 80 patients were divided randomly into two groups with equal subject count. In the age group of 9–11 years, 19 were in cartilage group and 14 in temporalis fascia group whereas in the age group of 11–13 years, 21 were in cartilage group and 26 were in temporalis fascia group. However, they did not report any statistical difference in graft uptake among younger and older.

In the present study out of 80 patients, 40 in each group, anatomical success was documented in 29 patients of the fascia group and 35 patients of the cartilage group. Among the 29 patients with successful surgery, 21 patients were 7–10 years old and 8 patients of 11–13 years age group. In the cartilage graft group, among the 35 patients with successful outcome, 26 patients were 7–10 years of age and 9 of 11–13 years age group. Graft success and failure rate was compared between the two groups. The graft success rate was higher in the cartilage graft group, however statistical significance could not be established. Thus, either of temporalis fascia or cartilage graft can be used in paediatric tympanoplasty with similar anatomical outcome. Prasad et al. [16] in 2010–2013 in their study reported 95% success in the cartilage group and 82.5% in the temporalis fascia group. Children in the age group of 9–11 yrs had statistically significant better outcomes with cartilage graft than temporalis fascia graft. However in the overall study no statistical correlation was found between the type of graft and graft uptake. Yegin et al. [17] in 2013–2014 in their study, reported that graft success rate was significantly higher in the cartilage group (92.1%) than in the fascia group(65%), with high rate of reperforations in the fascia graft group. They also quoted a study by couloigner et al.[14], in which no significant difference was found between the type of graft and graft uptake in paediatric tympanoplasty. In a study by Demirci et al. [18] in 2014 they reported that the graft success rate was 82.9% in the fascia group while it was 92% in the cartilage group. However, the differences between the fascia and the cartilage groups were not statistically significant with respect to anatomical or functional outcome. They concluded that cartilage and fascia grafts yield similar results for hearing gain and graft success rate in paediatric tympanoplasty. Albirmawy [19], in their study of comparison between cartilage perichondrium composite ring graft and temporalis fascia in type one tympanoplasty in children, reported significantly higher success rate in the cartilage perichondrium group than in fascia group. Another study by Ozbek et al. [15] in 2008, compares cartilage palisades and fascia as graft in type 1 tympanoplasty in children. They reported a statistically significant higher success rate in the cartilage group (100%) than in the fascia group (72%).

Functional success of the tympanoplasty is considered as ABG ≤ 20 dB postoperatively. In the present study, of the 80 patients who underwent type 1 tympanoplasty, 63 (78.75%) patients had postoperative 6th month ABG of ≤ 20 dB. 45 patients of these were of 7–10 years age and 18 patients were of 11–13 years age. A total of 17 patients whose 6th month postoperative ABG was 21-30 dB, included 12 patients (70.6%) of 7–10 years of age and 5 patients (29.4%) of 11–13 years of age. Also, of the 40 patients of temporalis fascia tympanoplasty, 30 (75%) patients achieved 6th month postoperative ABG of ≤ 20 dB, 10 (25%) patients ABG of 21-30 dB. In the other group of 40 patients who underwent tragal cartilage tympanoplasty, 33 patients (82.5%) of them had 6th month postoperative ABG of ≤ 20 dB and 7 patients (17.5%) achieved ABG of 21-30 dB. No statistically significant difference could be established between the two groups of fascia or cartilage graft, nor in the age groups, in terms of functional outcome i.e. ABG gain at 6 months postoperatively. The patients who underwent temporalis fascia graft tympanoplasty had preoperative mean ABG of 29.4 dB and postop 6th month mean ABG 18.90 dB. Unpaired student t test was applied, P value was 0.001.This shows that there was statistically significant improvement in mean ABG postoperatively in the fascia graft tympanoplasty group. In patients who underwent cartilage graft tympanoplasty pre-operative mean ABG was 28.67 dB and 6th month mean ABG 18.05 dB. Unpaired student t test was applied, P value was 0.001. This shows that there was statistically significant improvement in mean ABG postoperatively in the cartilage tympanoplasty group. The functional outcome of both grafts in terms of mean ABG was significant on comparing pre op mean ABG with post op 6th month mean ABG in either groups. The mean ABG of fascia graft group postoperatively at 6 months was 18.90 dB and that of cartilage graft group was 18.05. Unpaired student t-test was applied and p value was found to be 0.391. Thus, no statistically significant difference was found when postoperative functional outcome was compared in between the two groups. Thus both grafts result in similar outcomes. A study by Yegin et al. [17] in 2013–2014 reports that the functional success rate in the cartilage group was higher than in the fascia group but statistical significance could not be observed. A study by Demirci et al. [18] in 2014 and Ozbek et al. [15] in 2008 regarding paediatric tympanoplasty and another study by Prasad et al. [16] in 2010–2013 also reported no significant difference in functional (audiological) success between the two groups. Couloigner et al. [14] in their study, noted no significant differences in outcome between two techniques.

Conclusion

Tympanoplasty thus can be performed in paediatric age groups with a good outcome. There is no statistically significant association between tympanoplasty outcome and age,the type of graft used. Various graft materials can be used for tympanoplasty. The temporalis fascia, most commonly used graft material for tympanic membrane reconstruction, has a high success rate. The tragal cartilage graft holds few significant advantages over the fascia graft as it is more resistant to pressure changes and infection in the middle ear. It can be thus concluded that temporalis fascia or tragal cartilage grafts can be used with similar functional outcome of tympanoplasty, irrespective of the age group. Though studies report higher success rate with the cartilage graft than the temporalis fascia, a statistically significant difference could not be established in most of the studies. Thus both the grafts have equal efficacy in paediatric tympanoplasty.

Supplementary Information

Below is the link to the electronic supplementary material.

Abbreviations

TM

Tympanic membrane

Pre-op

Preoperative

Post-op

Postoperative

ABG

Air bone gap

ABG_6th

Air bone gap post operative 6th month

WHO

World Health Organisation

CSOM

Chronic suppurative otitis media

dB

Decibel

EAC

External auditory canal

HIV

Human immunodeficiency virus

HCV

Hepatitis C virus

HbsAg

Hepatitis b surface Antigen

ENT

Ear nose throat

DM

Diabetes mellitus

INR

International normalised ratio

ECG

Electro Cardio Gram

SD

Standard deviation

GA

General anaesthesia

WI

Wound infection

FP

Facial palsy

Dg

Dysguesia

AS

Anterior superior quadrant

AI

Anterior inferior quadrant

PS

Posterior superior quadrant

PI

Posterior inferior quadrant

S

Small

M

Medium

ST

SubTotal

T

Total

Funding

No funding has been received for the study.

Declarations

Conflict of interest

No conflict of interest.

Ethical Approval

All the ethical standards advised by the ethical committee were followed strictly and approved by the ethical committee of the hospital where the study has been conducted.

Informed Consent

Informed consent has been taken from the legally acceptable guardians of all the participants.