Study on temporalis fascia graft versus temporalis fascia with cartilage graft

Background: The aim of this analytical study is to compare the hearing improvement in type I Tympanoplasty between Temporalis Fascia used alone and temporalis Fascia with cartilage as graft material. Material and Methods: The study was done in ENT department at PSGIMSR, from October 2016 to July 2018. A total of 21,453 cases attended the ENT Outpatient department during the study period. Out of these, 75 cases with dry perforation of the tympanic membrane were chosen for the study. Patients were selected in random, excluding ear discharge, Attico-antral disease, and complications of chronic otitis media. Results: In the study population, disease afflicting the nose and throat were also ruled out. Detailed evaluation of each case was done comprising of history taking, clinical examination, investigations including pure tone audiometry. Patients were divided into 2 groups. Group A consist of 50 patients underwent type I Tympanoplasty with temporalis fascia alone. Group B consist of 25 patients underwent type I Tympanoplasty with combined Temporalis Fascia & Conchal Cartilage. Post-operative hearing improvement measured by Audiometry is compared among the two groups and found that small perforations had best improvement with Temporalis Fascia graft, large and subtotal perforation had good improvement in postoperative hearing with combined Temporalis Fascia and Conchal Cartilage graft. Conclusion: Mean hearing improvement in Group A with temporalis graft was 12.98 dB (better) than Group B, with Temporalis Fascia & Cochal Cartilage graft mean hearing improvement was 8.96 dB.


Introduction
Tympanoplasty is done primarily to achieve a dry ear by eradicating middle ear disease and hearing improvement by closure of any Tympanic Membrane perforation by grafting with/without Ossicular reconstruction. The result of Tympanoplasty is measured by the success or failure of the graft uptake and hearing improvement. Various graft materials had been used by trial and error. These materials ranged from skin grafted from other areas of the body such as Thiersch graft, Split-skin graft, Pedicle graft from canal skin, Vein graft, Temporalis fascia graft, Scleral and Corneal graft, Perichondrial tissue, Cartilage [1][2][3][4][5].. Cartilage graft also provides firm support to prevent retraction formation. The greatest advantage of the Cartilage graft is its very low metabolic rate. Perichondrium and Cartilage [2] share with fascia the quality of being mesenchymal tissue. Cartilage are inherently thicker and stiffer compared to temporalis fascia. They mechanically reduce the vibratory pattern of the tympanic membrane in response to sound waves, contributing to some impairment in functional results.
This phenomenon is seen more in relation to higher tones. The mass effect of the cartilage over the prosthesis is always a concern. Cartilage has comparatively lower compliance than fascia. Cartilage is preferred in case of large or anteriorly placed perforations or associated eustachian tube dysfunction but at the cost of delayed hearing restoration for six months. As soon as the patient presents to the hospital, detailed clinical history and examination will be carried out as per the proforma prepared. Laboratory investigations will be done. All patients will be subjected to preoperative Audiometric evaluation (PTA).

Original Research Article
Type 1 Tympanoplasty will be done using different graft materials once the pre-operative investigations are noted and extent of disease established.
Follow up with audiometric evaluations will be conducted at the end of 3 rd month following surgery and results will be compared with pre-operative Audiogram results

Potential benefits
1. Improvement in hearing outcome of patients, will be helpful in proper diagnosis and better treatment of patients having conductive hearing loss. 2. Knowledge of the level of improvement of hearing and the rate of healing using different graft materials will be known.  Retroauricular approach was used in 24 cases (92.3%) with medium perforation of the tympanic membrane, which was the most. Endaural approach for surgery was used in 12 patients (41.4%) with small perforations of the tympanic membrane, which was the most ( Table 2). In a total of 75 cases, small perforation of the tympanic membrane was present in 29 individuals (38.7%) which was the highest. Subtotal perforation was present in 4 individuals (5.3%) which was the low (Table 3).  Out of the total 75 cases, both endaural and retroauricular approach for surgery was used. Temporalis fascia was used in 50 cases (66.7%), out of which endaural approach and retroauricular approach was used in 14 cases and 36 cases respectively (Table 4).
Temporalis fascia with cartilage graft was used in 25 cases (33.3%) in which all cases were operated using retroauricular approach. Post-operative hearing when temporalis fascia was used as graft material was 11-20 dB in 28 individuals which was the highest and was lowest in 1 individual (7.1%) with post-operative hearing of 31-40 dB (Table 5).
In the group in which cartilage with fascia was used, highest individuals was 13 (92.9%), where the post-operative hearing was 31-40 dB. The post-operative hearing was 41-50 dB in 3 individuals which was the lowest.

Original Research Article
Tropical Journal of Ophthalmology and Otolaryngology Available online at: www.medresearch.in 384|P a g e When temporalis fascia alone was used as graft, Post-operative hearing improvement was observed in 26 individuals (74.3%) with an improvement of 11-15 dB. In the group with fascia and cartilage graft, the highest individuals was 11 (61.1%) with an improvement of 6-10 dB ( Table 6).
The most improvement in hearing when temporalis fascia is used, was observed in 2 cases (100%) with 21-25 dB of hearing improvement. 11-15 dB was the maximum improvement observed when fascia with cartilage was used in 9 cases (25.7%).

Discussion
A total of 21,453 cases attended the ENT Outpatient department during the study period. Out of these, 75 cases with dry perforation of the tympanic membrane were chosen for the study. Patients were selected in random, excluding patients with active ear discharge, attico-antral disease, and complications of chronic otitis media. In the study population, disease afflicting the nose and throat were also ruled out.
Detailed evaluation of each case was done comprising of history taking, clinical examination, investigations.
Pre-operative as well as hearing assessment after the patients underwent type-1 tympanoplasty was performed using underlay technique.

Tympanic membrane perforation:
Tympanic membrane perforation was present in all 75 patients in the study. Ear discharge was not seen in any of the patients. Based on the quadrant of tympanic membrane involved, perforation was graded into small, medium, large and subtotal perforation. Perforation of the Pars Flaccida was ruled out in all 75 of the participants in this study [6][7][8][9][10].
In the present study of 75 participants, small perforation was seen in 29 cases (38.6%), medium perforation was present in 26 cases (34.6%), large perforation was present in 16 cases (21.3%) and subtotal perforation was present in 4 cases (5.3%).

Tropical Journal of Ophthalmology and Otolaryngology
Available online at: www.medresearch.in 385|P a g e In a study done by Kshitij Patil [1], maximum number of cases had subtotal perforation, i.e., 59 cases (49.17%), followed by large central perforation in 51 cases (42.5%), while 10 cases (8.33%) had total perforation.

Surgical approach:
In the present study, both endaural and retroauricular approach were used for different patients. 61 patients (81.3%) underwent surgery through retroauricular approach and 14 patients (18.7%) underwent surgery by endaural approach.
In the study done by Ramagiri Vijay Kumar [11], in patients of group A 14 (70%) were operated by postaural route, 5 patients (25%) by permeatal route and 1 patient (5%) by endaural route. 13 patients (65%) of group B were operated using endaural route and 7 patients (35%) by using postaural route. All the patients of group C were taken by permeatal route. So permeatal route was used in 63.3% of all cases.

Graft Material:
The study participants of the present study were divided into two groups based on usage of graft material namely temporalis fascia alone and temporalis fascia used along with conchal cartilage. In the present study, 50 individuals (60.66%) underwent type-1 tympanoplasty using temporalis fascia alone as graft material. 25 individuals (39.44%) underwent surgery by using temporalis fascia along with conchal cartilage.
The usage of graft material and size of perforation had a correlation in the present study [12]. Temporalis fascia was used to close small and medium sized perforations. Small perforations of the tympanic membrane was present in 29 cases (100%), temporalis fascia alone was used in all of those cases.
In patients with medium perforation of the tympanic membrane, out of a total 26 cases 19 individuals (73.1%) underwent closure of perforation using temporalis fascia alone and in 7 individuals (26.9%) temporalis fascia with conchal cartilage was used as graft material.
In a study done by Ramagiri Vijay Kumar [11] participants were split into 3 groups of 20 patients in each group. Grouping of patients were based on graft material used, i.e. temporalis fascia, tragal perichondrium and ear lobule fat graft into group A, B and C respectively Pre-operative hearing: In a total study population of 75 individuals, the participants were divided into group A and group B based on usage of graft material to repair the tympanic membrane perforation. Patients in Group A underwent type-I tympanoplasty with temporalis fascia used as graft material, in Group B patients were operated with conchal cartilage and fascia used as graft.
The pre-operative hearing in dB was noted for all participants before surgery. The maximum number of participants i.e. 27 patients (36%) had a pre-operative hearing loss of 21-30 dB. The least number was 5 patients (6.66%), who had a pre-operative hearing loss of 51-60 dB.
In group A, the total number of participants were 50 individuals (66.7%) who underwent surgery using temporalis fascia as graft. In that group, the mean preoperative hearing was 26.9 dB. In group B, where conchal cartilage with fascia was used as graft material, the mean pre-operative hearing was 42.7 dB.
In a study done by Kshitij Patil [1], the mean preoperative hearing loss was found to be maximum for cases with total perforations which were 49.15±7.34 dB, followed by subtotal perforations of 35.38±10.10 dB and for large perforations it was 31.73±9.84 dB. The overall mean pre-operative hearing loss was 34.72±10.4 dB.

Post-operative hearing:
In the present study, group A participants who underwent type-1 tympanoplasty using temporalis fascia as graft, the highest improvement in post-operative hearing was 21-25 dB observed in 2 patients. In the same group, the greatest number of participants with hearing improvement was 26 patients (74.3%), with a hearing improvement of 11-15 dB.
In group B conchal cartilage with fascia was used as graft material. Here, the highest improvement in postoperative hearing was observed in 9 patients (25.7%) with hearing improvement of 11-15 dB. The most number of participants with hearing improvement was 11 patients (61.1%) with a hearing improvement of 6-10 dB.
In a study done by Gaurav Batni [9], in which type-1 tympanoplasty was performed on 100 patients. The mean pre-operative air conduction was 38.47±11.25 dB. The mean post-operative air conduction was 23.92±13.80 dB. Mean air bone gap pre-operatively was 23.55±7.56 dB and post operatively was 11.60±7.70 dB.
In a study done by Sharan kumar Shetty [10], 50 cases ofchronic suppurative otitis media with tubotympanic disease were used as participants.