Our Experience of Comparison of Hearing Outcomes in Patients Undergoing Type-1 Tympanoplasty with Different Graft Materials

Abstract

The present study was undertaken to compare the results of various autogenous tissues: temporalis fascia, sliced tragal cartilage and fascia lata as graft materials for type I tympanoplasty in terms of hearing improvement in safe type of chronic suppurative otitis media. A total of 75 cases with central perforation were considered in the study. Of the 75 cases, temporalis fascia graft was used in 25 cases (Group-A), fascia lata graft in 25 cases (Group-B), and sliced tragal cartilage graft in 25 cases (Group-C). The results were evaluated in the form of hearing improvement with respect to the graft materials. A significant association was observed between the groups, that is, temporalis fascia (Group-A), fascia lata (Group-B), and sliced tragal cartilage (Group-C) in terms of improvement in AB gap (P = 0.047). Improvement in AB gap was statistically significant between groups B and A, but not between the other groups. In the present study, fascia lata showed better graft uptake as compared to temporalis fascia and sliced tragal cartilage. The hearing assessment at post-operative 3rd month showed statistically significant hearing improvement with fascia lata when compared to temporalis fascia.

Introduction

A condition known as mucosal chronic otitis media is one in which the tympanic membrane has a central perforation, either with or without involvement of the ossicular chain. The majority of the perforation, which is located in the pars tensa, is the result of an earlier episode of acute otitis media. The tympanic membrane perforation might be brought about by chronic otitis media (COM) or following injury (traumatic), generally bringing about hearing loss.

Due to low socioeconomic standards, poor nutrition, a lack of health information, and unsanitary behaviours, it is one of the most frequent ear disorders in impoverished nations [1–3]. Hearing loss after COM is debilitating, has a significant negative impact on a person's social life, and is a major cause of deafness in India [4]^.

When the perforation doesn't heal naturally or with conservative care, surgery is needed to close it. The tympanic membrane's region of vibration is restored by the healed hole, which enhances hearing. Surgery is therefore the core of the therapy. Myringoplasty or type 1 tympanoplasty are two well established procedures [5] performed frequently for treating mucosal chronic otitis media by Otorhinolaryngologists [6]. Some often utilized autologous transplant materials are cartilage, fat, perichondrium, fascia lata, and vein [7, 8]. Time-tested autologous graft materials for healing holes in the tympanic membrane include the temporalis fascia, tragal perichondrium, cartilage, fat, and fascia lata. Given the variety of materials available, it is likely that there is no obvious favourite and that each surgeon will choose a different type of graft material [9, 10]. However, the temporalis fascia is the most popular grafting material among otologists because to its anatomic closeness, translucency, and flexibility, and a successful closure is predicted in around 90% of primary tympanoplasties [11].

With the use of temporalis fascia as a graft material, failure rates are greater in larger perforations [12, 13], and the likelihood of recurrent perforation rises in conditions such retracted pockets and atelectatic ears [14]. The failure of perforation closure has been linked to graft displacement [15], poor implantation, autolysis, infection, bleeding, and malfunction of the Eustachian tube [4].

With the introduction of numerous novel tympanoplasty methods and increased awareness of cosmetic issues, fascia lata, an autologous free fascia graft obtained from the thigh, has lately become more well-known as a graft in tympanoplasty [16]. The first surgeon to do a tympanoplasty using fascia lata was Fritz Zoellner in 1956 [6]. The fascia lata tightens the thigh muscles, encircles them generally, and has higher three-dimensional stability [17]. Consequently, by supporting the face muscles, has been utilized as grafts for individuals with facial paralysis [18].

Tragal cartilage is a somewhat avascular kind of fibroelastic cartilage [5]. Tympanic membrane holes can be repaired using cartilage, which has proven to be a good graft material. The likelihood of reperforation and retraction is lower since it is more stiff. But the tragal cartilage's ability to carry sound is debatable because of its rigidity and thickness. The latest innovation in the approach involves harvesting the graft from the same endaural incision and slicing it to gain acoustic advantages [19]. Tragal cartilage provides a number of benefits, including being a mesodermal graft, being easily accessible, having a conical shape, being a conical graft, and being big enough for myringoplasty of a whole perforation. Concerns have been raised over cartilage tympanoplasty because of its thickness.

Thus, maintaining good hearing is still tough to do and is among otology surgery's most challenging duties. Our comparative study of three distinct graft materials—temporalis fascia, fascia lata and sliced tragal cartilage—used in type 1 tympanoplasty was carried out to assess the improvement in postoperative hearing while taking into consideration all of these parameters and the positive outcomes.

Materials and Methods

Patients with mucosal chronic otitis media (COM) had been selected from the OPD or outpatient branch of otorhinolaryngology at Sri Aurobindo Institute of Medical Sciences, Indore from the period July 2021 to July 2022.

Inclusion Criteria

1. Chronic otitis media, inactive, mucosal and with perforation

2. Patients, both male and woman among the age ranging from 18 to 60 years

3. Pure tone Audiogram showing conductive type of hearing loss.

4. Ear must be dry and discharge free for at the very least 2 weeks earlier than the procedure

5. Ossicular chain continuity ought to be intact (intraoperatively)

Exclusion Criteria

1. Patients less than 18 years of age and more than 60 years of age

2. Sensorineural type of hearing loss

3. Squamosal type of chronic otitis media.

4. Associated elements like chronic kidney disease or immunocompromised state.

5. Severe anaemia

6. Re-perforation

Comparative research was carried out primarily based on graft uptake and audiological outcome i.e. the closure of the Air Bone Gap.

In our study, 75 Patients had been selected, randomized and subjected to type 1 tympanoplasty by the use of temporalis fascia, fascia lata or sliced tragal cartilage. 25 patients were selected for for type 1 tympanoplasty with temporalis fascia, other 25 for type 1 tympanoplasty with fascia lata graft while the final 25 for type 1 tympanoplasty with sliced tragal cartilage graft. On a specially prepared proforma, every detail of the history examination, investigations, surgery, and follow-up findings was recorded. Pre-operative PTA was performed and average of 3 frequencies (500 Hz, 1000 Hz and 2000 Hz) were calculated. After pre anesthetic checkup and medical fitness for surgery, Type 1 Tympanoplasty was performed on patients under local anesthesia and if necessary, general anesthesia by the same surgeon. Postaural approach of surgery was used in all cases, and an underlay technique was used to keep the graft in place. The standard procedure was used to collect the sliced tragal cartilage and temporal fascia. A very small, aesthetically acceptable incision was used to extract the fascia lata.

Mastoid dressing was removed on POD7 and daily dressings were done at the surgical wound. All the patients had been given a course of antibiotics, analgesics, and decongestants for a week. The sutures were removed on POD10 and antibiotic ear drops were started. PTA was performed at 3rd month follow-up post operatively to assess hearing outcome. Pre-operative and post-operative (3rd month) PTA were compared to assess improvement in hearing. An average of 500 Hz, 1000 Hz and 2000 Hz frequency was calculated in pre-operative and post-operative PTA which was then compared statistically. Graft uptake was assessed at 3rd month post-operative period for complete closure, reperforation, residual or medialization if any.

Observation and Results

Our Study was a prospective study which involved 75 patients. They were included in the study after obtaining informed consent after explaining them the procedure in their native language. Patients who did not fit the inclusion criteria or who were unwilling to give consent were not included in our study. These patients were further divided into 3 groups. Group A underwent type-1 Tympanoplasty using Temporalis Fascia, Group B were subjected to type-1 Tympanoplasty using Fascia Lata while Group C underwent type-1 Tympanoplasty using sliced Tragal Cartilage. Our study compared the baseline characteristics along with the hearing outcomes & graft uptake in these 3 groups. The results and findings have been mentioned below (Tables 1, 2 and 3).

Table 1.

Baseline characteristics and hearing outcomes between the three groups

	Temporalis fascia (TF)	Fascia Lata (FL)	Sliced tragal cartilage (TC)	P value	Significance
Mean age	34.92 ± 10.29	36.88 ± 9.23	36.68 ± 9.38	0.732	Non-Significant
Male	13	13	12	0.948	Non-Significant
Female	12	12	13	0.948	Non-Significant
Mean duration of symptoms in months	12.2 ± 7.11	11.32 ± 6.05	11.32 ± 6.05	0.855	Non-Significant
Pre-operative AB gap	32 ± 5.77	32.8 ± 5.22	33 ± 5.2	0.787	Non-Significant
Post-operative AB gap	18.6 ± 6.04	15.8 ± 7.02	17.8 ± 6.62	0.306	Non-Significant
Improvement in AB gap	13 ± 4.78	17 ± 5.77	15.2 ± 6.2	0.047	Significant

Table 2.

Improvement in AB Gap between individual groups

		P-Value	Significance
TF	FL	0.042	Significant
FL	TC	0.784	Not Significant
TF	TC	0.512	Not Significant

Table 3.

Graft assessment (3rd month post operatively)

		Reperforation/Recurrence	Medialization
Group A	TF	1/25	2/25
Group B	FL	0/25	1/25
Group C	TC	2/25	0/25

Pre-operative and post-operative which was then compared statistically. Graft uptake was assessed 3rd month post operatively for complete closure, reperforation or residual perforation if any.

Graph 1 showed pre-operative AB gap which was 32 dB, 32.8 dB and 33 dB in temporalis fascia, fascia lata and sliced tragal cartilage groups respectively. Graph 2 showed post-operative AB gap at 3rd month which was 18.6 dB, 15.8 dB and 17.8 dB in temporalis fascia, fascia lata and sliced tragal cartilage groups respectively. Graph 3 showed improvement in the pre-operative and 3rd month post-operative AB gap which was 13 dB, 17 dB and 15.8 dB in temporalis fascia, fascia lata and sliced tragal cartilage groups respectively. It can be seen very evidently that all the 3 groups showed improvement in hearing (Figs. 1, 2, 3).

Graph 1.

Pre-operative AB Gap of the three groups

Graph 2.

Post-operative AB Gap of the three groups (3rd month post-operative)

Graph 3.

Improvement in AB Gap of the three groups (3rd month post-operative)

Fig. 1.

Pre-operative and Post-operative right ear using temporalis fascia graft in type 1 tympanoplasty

Fig. 2.

Pre-operative and Post-operative left ear using fascia lata graft in type 1 tympanoplasty

Fig. 3.

Pre-operative and Post-operative left ear using sliced tragal cartilage graft in type 1 tympanoplasty

Table 2 showed statistical comparison of Improvement in AB Gap of 2 individual groups with each other. So, when we compared temporalis fascia with fascia lata, there was a statistically significant difference in the improvement in AB gap but no statistically significant difference could be seen in improvement in AB gap when we compared fascia lata with sliced tragal cartilage or on comparison of temporalis fascia with sliced tragal cartilage.

Graft assessment was performed on post post-operative 3rd month which showed 1/25 patients in group 1 and 2/25 in group 3 had reperforation/ recurrence while in group 2 graft uptake was seen in all cases. In group A and B, 2/25 and 1/25 cases respectively had graft medialization on 3rd month post operatively.

Discussion

After the first reports of tympanic membrane grafting in the 1950s, surgical repair of tympanic membrane and grafting have come a long way. Numerous technical developments throughout the years have increased the precision of tympanic membrane restoration surgery to a high extent. Finding an appropriate material for tympanic membrane grafting was a major issue in the early stages of tympanoplasty development. Tympanic membrane grafting has evolved based on biological tissues with collagen matrices that are of mesodermal origin [12]. The most commonly used materials in use are still the temporalis fascia and perichondrium.

With a p value of 0.732, the difference in age groups between the three groups was not statistically significant. The mean age of all the cases together was 36.16 (range 18–60 years) (Table 1). Similarly, in the study conducted by Rohan Vijay Gupta et al [20], the authors evaluated the outcomes of type I tympanoplasty. Out of the total 42 patients evaluated in the study, the mean age was 38.11 years and the range was from 18 to 70 years.

In our study, out of 75 patients, 38 were males (50.7%), while 37 were females (49.5%). With a p value of 0.948, the gender difference was not statistically significant (Table 1). Similarly, the mean duration of symptoms was also found to be non-significant with a p value of 0.855 (Table 1).

The mean preoperative AB gap in the groups corresponding to the Temporalis Fascia, Fascia Lata, and Sliced tragal cartilage, respectively, was 32 dB, 32.8 dB, and 33 dB (Table 1, Graph 1). With a P-value of 0.787, the result was not significant (Table 1). The mean post-operative AB gap in the groups of Temporalis Fascia, Fascia Lata, and Sliced tragal cartilage was 18.6 dB, 15.8 dB, and 17.8 dB, respectively (Table 1, Graph 2). The statistical significance was found to be non-significant due to the p-value being 0.306 (Table 1). Finally, with a p-value of 0.047, the mean improvement in the AB gap in the groups of Temporalis Fascia, Fascia Lata, and Sliced tragal cartilage, which was 13 dB, 17 dB, and 15.2 dB respectively, was found to be statistically significant (Table 1, Graph 3).

As observed in our study, the improvement in hearing was better and statistically significant when Fascia Lata was compared to Temporalis Fascia (p value—0.042). No statistically significant difference was seen while comparing Fascia Lata with Sliced tragal cartilage (p value—0.784) or while comparing Sliced tragal cartilage with Temporalis Fascia (p value—0.512) (Table 2).

Similarly, in study done by Patil et al [11], the various graft materials used did not significantly differ in terms of mean gain of Air Bone gap. The tragal perichondrium gained 10.92 dB, the temporalis fascia gained 9.36 dB, and the fascia lata gained 12.10 dB.

While in another study done by Landge et al [21], the mean gain in hearing of with temporalis fascia was 13.56 ± 5.79, with tragal cartilage was 11.58 ± 2.57 while with fascia lata was 12.19 ± 4.75 dB. Findings that were noted by Dornhoffer [22] showed improvement in AB gap of 10.2 dB for tragal perichondrium. While, a study conducted by Indorewala [17] noted a gain of 15 dB for fascia lata and 17 dB for temporalis fascia.

Because of its anatomic proximity, flexibility and translucency, the temporalis fascia is the most preferred grafting material among ENT surgeons and a successful closure is anticipated in approximately 90% of primary tympanoplasties [11]. It is also frequently employed for its special properties such as its low metabolic rate, which results in a lower oxygen requirement, resistance to infection, and the ability to get a large quantity of graft from a single incision with good anatomical and functional outcomes and few problems [21].

Poor hearing outcomes can result from post-operative atrophy of temporalis fascia grafts in cases of middle-ear pathologies, retraction pockets, or atelectatic ears [14, 23]. Compared to temporalis fascia, cartilage grafts are more resistant to infections, resorption, and retraction. As a result, cartilage grafts were considered better than temporalis fascia grafts [24–26].

Fascia Lata showed better hearing outcomes than Sliced tragal cartilage and Temporalis Fascia and a similar finding was seen in study done by Patil et al [11]. This can probably be due to its higher three-dimensional stability [17]. This second incision and taking the graft from a totally different site consumed more time, manpower, money and was also cosmetically not easily accepted by patients. Additionally, the tragal cartilage and fascia lata were found to be thicker and more rigid than the temporalis fascia [11].

Conclusion

In present study, group B (Fascia Lata) showed better graft uptake as compared to group A (Temporalis Fascia) & group C (Sliced Tragal Cartilage) at 3rd month post operatively. Sliced tragal cartilage did not show graft displacement while in temporalis fascia and fascia lata cases, graft medialization was noted.

The hearing assessment at post-operative 3rd month showed statistically significant hearing improvement results when fascia lata was compared with temporalis fascia. However, there was no statistically significant difference in the outcome of hearing improvement when we compared fascia lata with sliced tragal cartilage or on comparison of temporalis fascia with sliced tragal cartilage.

Abbreviations

TM

Tympanic membrane

COM

Chronic otitis media

ABgap

Air bone gap

dB

Decibels

OPD

Outpatient department

POD

Post-operative day

PTA

Pure tone audiometry

TF

Temporalis fascia

TC

Tragal cartilage

FL

Fascia lata

Funding

No funding sources.

Declarations

Conflict of interest

None declared by any of the authors of this study.

Ethical approval

The study was approved by the Institutional Ethics Committee.