INTRODUCTION

Hearing is a sense that enables man to establish contact with his fellows via speech to experience life more fully. Deafness in varying degrees of severity is a big impediment to the integration of a person into the social structure. The otologist in the past had not much to offer to hearing handicapped people with chronic middle ear disease. With recent times the advent of the antibiotic era, the operating microscope and modern anesthetics techniques aimed at producing a dry, magnified operating field, have radically altered the outlook. Permanent perforation of the tympanic membrane resulting as sequelae of chronic suppurative otitis media is a major cause of deafness. Stalwarts from past as far back as Hippocrates have asserted the same. Controversies range about every step of the operation from the incision to the material used for packing. A great deal of experimental work is being done often with contradictory results. The first known attempt to close a perforation of tympanic membrane to improve hearing was made by Marcus Banzer in 1640 using prosthesis made of pigs bladder. Since then various graft materials like pigs bladder, Thiersch skin graft, Split-skin graft, Pedicled graft from ear canal skin, temporalis fascia graft, Vein graft, Sclera, Corneal graft, tympanic membrane homograft and perichondrium have been used for closure of the perforated tympanic membrane. Various autografts have been used for repair of the tympanic membrane perforation like full thickness skin graft (House 1953), Pedicled skin grafts (Frenckner 1955), split skin graft (Wullestein 1952 and Zollner 1953), vein graft (Shea 1960), Fascia grafts (Heermann 1960) and Perichondrium (Jansen1963 and Goodhill 1967). Each of these grafts material has its advantages and disadvantages over each other. The healing of tympanic membrane perforation is preceded by ingrowths of connective tissue edges over which the epithelium migrates to close the perforation, keeping this physiological principle in consideration it follows that connective tissue grafts, that is grafts of mesodermal origin like vein, perichondrium or fascia, prove superior to all other graft materials. Clinical investigations and animal experiments have shown that these connective tissues replace the missing fibrous element of the tympanic membrane and
1

allow squamous epithelium and mucosal tissue to cover is medial and lateral surface (Wolferman 1970). Taking the above mentioned facts in consideration, this study was taken up to compare the results of the two connective tissue graft materials. viz temporalis fascia and the tragal perichondrium. The study includes the advantages and disadvantages of these graft materials vis--vis to each other.

AIMS AND OBJECTIVES

This is a comparative study of tympanoplasty operation using the temporalis fascia and tragal perichondrium as a graft material. This study is carried out to compare the: 1. Selection of grafting materials depending on type of defects in tympanic membrane.

2. Graft uptake rate of temporalis fascia and tragal perichondrium in Myringoplasty and Type-I Tympanoplasty. 3. Hearing improvement post operatively by using these materials.

REVIEW OF LITERATURE
It was Marcus Banzer in 1640 who in a treatise described a method for covering drum perforation with a piece of pigs bladder. Autenrieth (1815) used the wall of fishs air bladder impregnated with varnish as prosthetic material to close tympanic perforation. Yearsley (1848) replaced the prosthetic materials with a membrane of cotton soaked in heavy oil. Toynbee (1852) used a more advanced technique with this rubber membrane which could be applied and removed by the patients by means of a thin silver thread attached to its centre. Politzer (1885) published a method for closing the perforation by means of scars obtained by cautery of the edges and growing inwards from rims. Katz (1889) used a thin membrane of colloidin as cover. Lucae and Politzer (1908) described modification of the method used by Toynbee. Wullestein H1 (1952) published a method for split-skin covering of perforation of the drum by tympanoplasty operations in cases of chronic otitis. Zollner F
2

(1953) also described split-skin transplantation for covering of drum

perforation. Zollner introduced tympanoplasties intended to replace large drum defects combined with defects of ossicles. He pointed out the importance of the split-skin graft of German method, was changed to full thickness skin grafts. Zollner F 3 (1953) said that he abandoned split-skin graft because of its low resistance, preferring full thickness retro-auricular skin grafts since the skin of this site is thin and hairless. Frenckner P4(1955) gave a method for myringoplasties covering the perforation with pedicle graft from the ear canal skin. Of the cases opened upon,15 were re-examined postoperatively with only 1 failure. Zollner F5 (1955) described 21 myringoplasties performed with split-skin graft, there were 6 failures. Wullestein H gave a systematization of the tymapnoplasty operation which has ever since been followed all over the world. He also gave an account of 89

cases of

myringoplasty. It was stated that 32% reached the 15 db-line while 52% more

reached the db-line. Full thickness skin graft was used. Wright WK 6 (1956) gave the results of myringoplasties performed with different types of skin grafts. The necessity of traumatic surgery by grafting was pointed out and the importance of keeping infection away was emphasized. In 34 cases grafted with splitskin from brachium there were 25 takes and 9 failure and 23 cases with skin from the mastoid area showed 22 take and in 4 cases grafted with pedicle flaps from the ear canal, 4 failure . Wright WK accounts for causes of failure, postoperative reinfection is the commonest inspite of treatment with antibiotics, even locally applied but there are cases with no apparent cause of perforation and late failures. Wullestein H
[7]

(1956) in a paper dealing with 400 tympanoplasties discussed the

inspection of the middle ear during operation. The following steps ought to be (1) Control of antrum, (2) Upper control of middle ear and (3) Lower control of middle ear. In one, it is necessary to enlarge the bony auditory meatus a little bit backward and then open antrum thourgh a drill hole only closed behind a broad bridge which gives protection to the whole epitympanum and the ossicles. Control of upper middle ear is done mobilization of the drum of limbos, whereby epitympanum can be inspected, and 3 is done by detaching the drum and limbus so far backward, downward that the hypotympanum can be inspected . There are clear and distinct statements. There were 103 myringoplastics in the series in which postoperative hearing result was given; 32% reached the 15 db-line and 51% reached more than 30 db-lines. In all cases, full thickness skin graft was used. Wullestien H 8 (1957) reported a series of tympanoplasties of 1000 cases of which 23% were myringoplasties. Postoperative hearing results were given as bone air gap, and it was shown that in the first half of the series, 34% of the cases had a bone air gap of 0-15 db, while in second part this results was reached in 70% The number of cases in Group-2 was not given. Full thickness retro-auricular skin used as graft and supports the grafts the tympanic cavity was filled with reabsorbable substance. Beickert (1958) have shown post operative perforations may occur owing to sweat and sebaceous glands and hair follicle in grafted skin. In happens that a Lappencholesteatoma develops or microscopial perforation appear when glands and hair are served served by grafting, or retention cysts developed from the same parts of full
5

thickness grafts. Another difficulty, also emphasized, is that of effecting a complete adaption to the vascular bed; the elastic fibres of skin cause the graft roll and curl, thereby leaving a space between the graft and its bed, which prevents nutrition. Guilford FR, et al9 (1959) have published results of tympanoplasties with split- thickness skin grafts. The series contained 154 tymanoplasties of all categories which have been divided in two different types. They carefully discussed different types of skin grafts found thick split-skin preferable because of the structure of the vascularization of the skin. The importance of a traumatic grafting was emphasized, so was the danger of

infection of the vascular bed and importance of fixing the graft with the lowest possible pressure of the packing. There were 97 takes and 57 failures. Takes were observed for 348 months, while the follow up of the failures covered 1- 8 months. The authors also emphasized the necessity of a good tubal function for good results. The examination has been carried out by polarization and calibrated valsalva test. Urban Ortgren (1959) gave a preliminary report on a comparison between results with fascial and a similar series of skin graft used as control in myringoplasty. Out of 5 myringoplasties performed with fascia from temporalis muscle, there were 5 takes three months after operation, during the same period 5 failures out of 7 skin grafted myringoplasties. Heermann H10 (1960) made a through description of a method for fascial grafting used by him for 2year. Shea JJ11 (1960) described a method for closing central perforation of the drum by means of a vein graft. The graft was placed on the inner side of the drum, with the intima side inwards. Link R 12 (1960) showed that a (corium graft) a skin graft without epithelium takes much more easily. This was explained by the fact that skin grafts give autoimmunization because of antigen component bound to the nuclear substance of the epithelium cell. This might explain the allergically induced secretion observed for the Heermann and others. Literature on plastic surgery gives support for the use connective tissue graft in shape of fascia where great strains is expected and where nutrition is not so good during healing. Agazzi C
13

(1960) presented long term result of a series of 292 tymanoplasties

performed between 1955-1958 all of these cases were re-examined at least 1 year after
6

operation. The material contained 94 myringoplasties, which has not been stated, were performed with patriotism. Healing results were provided in the groups improved, unimproved, and worse.Hearing was improved in 48.8% and there were 18% perforation; but also 32.9% moist middle ear postoperatively. Wullstein H (1960) put a small acrylic tube through a perforation in the tympanic membrane maintenance of ventilation. Livingstone G, et al[14] (1961) described 26 myringoplasties with vein grafts re-examined 6 month postoperatively. There were 70% takes and 73% of the cases had reached the 30 db-line. Stoors LA15 (1961) recorded 6 fascial grafted myringoplasties re-examined 1-5months after treatment with 6 takes. Schlosser WD, et al16 (1961) obtained 2 takes out of 3 cases with the same technique. Sooy FA, et al
17

(1961) presented a comparison between

different grafting methods, full thickness skin graft from the ear canal skin, pedicle grafted from the ear canal skin and different types of vein graft. Skin grafts shows 12 takes out of 25 cases, pedicle grafts 11 takes out of 16 cases. Beasles (1958), Booth TE18 (1961) and Proctor B19 (1962) have published results of tympanoplasties performed with full thickness grafts with post operatively healing and hearing results which agree with Agazzis result. Howes EL20 (1943) observed that curling and rolling cause failures because of insufficient adaptation to the vascular bed. The relatively limited number of cells results in lower metabolism and thereby in stronger resistance to poor healing condition. Since, further connective tissue surface becomes epithelialized from the edge of vascular bed with a velocity which reduces the diameter of unepithelialized surface by 1mm/day, it is possible for the drum surface to be epithelialized in less than 10 days both in and outside. Austin DF21 (1963) in a series of 503 tympanoplasties performed 190 myringoplasties with vein graft.117 were re-examined 12 month later. There were 14 failures and 89% of these the cases was air- bone gap of 0-20 db. Jansen C22 (1963) used free tissue transplants of autogenous perichondrium of nasal septum or homoplastic septal perichondrium septal cartilage film, which have been
7

preserved and embedded in plastics materials to create new tympanic membranes the preserved canal skin supplies favorable nutrition to the transplant. The two types of perichondrium autogenous or preserved homoplastic heal up easily and quickly, so that a normal looking and functioning ear drum can be formed. During a period of 3 years, over 100 operations were done with above technique. With the exception of two cases all ears were dry within 3 weeks after the operation and required practically no postoperative treatment. As compared to other free tissue transplants, the perichondrium is a thin membrane and has yielded for better results with regard to mobility of new tympanic membrane. The obtainable perichondrium flap from the nasal septum is sufficient to cover even largest perforation. Zollner F23 (1963) mentioned that normal function of the Eustachian tube is fundamental condition for successful tympanoplasty and there is tendency to form adhesions in hypofunctioning or malfunctioning Eustachian tube. Farrior JB24 (1965) reported that tubal function impairment is one of the main causes for failure in tympanopasty and myringoplasty. He divided the tubal obstruction into central (nasopharyngeal) and peripheral (isthmus) obstruction. Goodhill V25 (1967) used tragal perichondrium and cartilage for myringoplasty and tympanoplastic reconstruction. He showed that perichondrium and cartilage obtained from tragus provide viable autograft materials for tympanoplastic reconstruction. Sheehy JL, et al26 (1967) noted that after tympanoplasty there will be an occasional thin graft which will thicken greatly in healing. One of the reasons for it is Eustachian tube dysfunction. A thick reconstructed membrane is seen more frequently in those cases, which are left with serous otitis due to persistent tubal insufficiency. Sengupta RP, et al27 (1974) showed the correlation between preoperative tubal function with hearing and healing perforation1-2 years after operation. Out of 104 myringoplasties , the follow up was complete for 1-2 years in 90 cases; complete closure of perforation was ultimately established in 73(81.2%) cases. The improvement in result meatal skin graft was thus given in favour of tragal perichondrium. Kacker SK (1975) used tragal perichondrium as a graft material in 650 cases. These myringoplasties were done from September 1969 to August 1975. They were done by permeatal technique under local anesthesia and tragal perichondrium graft was used.
8

Following conclusions were reached: 1. Delayed epitheliazation of grafted tympanic membrane is seen in rainy season with external otitis and wrong placement of graft. It is facilitated with meatal skin grafting. 2. Acute ear infection is easily controlled and the perichondrium graft offers good resistance. 3. Epithelial pearls occur most commonly round the handle of malleus and should be removed. Inlay graft in cases of large perfection is recommended. 4. Lateralization is often a displacement of graft rather than misplacement at surgery. 5. Thick opaque looking tympanic membrane may have fluid or cholesteatoma behind it and tympanotomy should be done in such cases. Kacker SK28(1976) while suggesting improvement in myringoplasty has retracted a preoperative check up with special reference to the importance of tubal function test. Packer P29(1982) in his comparative study of fascia and dura report a graft take rate of 88% of overlay fascia, 82% for underlay fascia and 93% for underlay dura. The average improvement in hearing in hearing at 6month in 8db for underlay fascia and 10.2 db of underlay dura. Gerrit JH30(1982) in his report on tympanic membrane grafting report the graft take rate of 92.3% in fascia,90.6% in perichondrium and 92.26% of vein. Ahad SA31 (1986) reports a success rate of 83.3% with homologous temporalis fascia, 76.4% success rate with autologous temporalis fascia .He used onlay technique in 88.8% of the cases. Isiah V32 (1986) reports his result in geriatric myringoplasty using tragal perichondrium by transcanal route. Graft uptake was seen in 94% of cases. Majority of his patients achieved socially adequate hearing. Kumaresean M33 (1986) claims 100% take up graft using temporalis fascia for his myringoplasty where graft was placed under vascular strip and pars flacida. His hearing results are means preoperative air conduction levels 28 db and postoperative air conduction levels of 24 db. Gordon HE34 (1986) in his review states that autologous fascia is one of the most commonly used tympanic membrane grafting material, having a success rate of about
9

95%. According to him devitalized grafts primarily provides scaffolding for the migration of epithelium which ultimately closes the tympanic membrane effects. Palva T35 (1987) reports a success rate of about 97% using underlay connective tissue for repair of tympanic membrane. The average postoperative air-bone gap was gap was 4.8 db in 88cases of myringotomy. Tos M35 (1987) finds no difference in results of myringoplasty using temporalis fascia glued with tissue seal and myringoplasty using temporalis fascia fixed with gel-foam balls. Terry RM37 (1988) claims a success rate of 70% using fat graft for myringoplasties at review at one year postoperatively. Gross CW38 (1989) describes adipose plug myringoplasty in managing small tymapanic membrane perforations in children reports. Kaddour HS39(1992) in his report of graft myringotomy under local anesthesia claims closure of 80% (8/10) of the perforations, with average improvement of 11 db. Pagnini P40 (1992) in his report on sandwich graft myringotomy using temporalis fascia claims 93.1% of complete closure of perforations. An average functional recovery of 14.1 db was observed compared to preoperative gap of 21.6.In 25% of the cases, average recovery was grater than25 db and in 5 patients a slight worsening of 3.3db was observed. On the whole, in 41 patients residual postoperative gap 10 db was achieved. Sitnikov VP41 (1992) reports a method of myringotomy using ultra thin allo-

cartilaginous plate (an internal layer), autofascia of temporalis muscle (as intermediate layer) and stored amnion (external layer) in patients with extensive defects. Hartwein J42 (1992) describe crown-clock tympanoplasty for complete reconstruction of tympanic membrane, using autologuos tragal composite graft. He claims 100% success rate. Verbist M43(1993) reports deterioration of mean high frequency thresholds up to db following middle ear surgeries including myringoplasties. Ajulo SO, et al44 (1993) presented a paper in which they repaired tympanic membrane perforation with periumbilical superficial fascia via a transtympanic route. They
10

conclude that the technique was cost effective and quick, making bilateral repairs possible under same anesthesia. MacDonalnd RR, et al45(1994) presented a retrospective study of 26 patients who undergone fasciaform myringoplasty surgeries. They concluded that fasciform myringoplasty has proven to be successful procedure for closing large tympanic membrane perforation and improving hearing acuity in the pediatric population. Quareshi MS, et al46 (1995) presented a study of myringoplasty, in which tragal perichondrium grafts were placed permeataly as a day case procedure in 32 patients. They compared with a control group, matched for age and for the size of their perforations, in which temporalis fascia was grafted via an end-aural or post-aural incision. The success rate was 94% in the perichondrial group as compared with 84% in the control group. Mitchell RB, et al47 (1997) presented a review of 342 children, who underwent fat myringoplasty. It is a safe and successful procedure, which result in a dry and safe ear in majority of the children. Albera R, et al48 (1998) asserted that myringoplasty can be considered a safe procedure to be used in children and it does not appear essential to wait until they have finished growing before performing this procedure. Guo M, et al49 (1999) stated that the interlay method of myringoplasty is an ideal method for healing perforation of tympani. Supiyaphun P, et al50 (1999) described a new myringoplasty technique requiring only a partial removal of skin on ear drum remnant followed by lateral placing of fascia and free skin graft. The overall cure rate in their series was 97%. Yu L, et al
51

(2001) studied the auricular cartilage palisade technique for repairing of

tympanic membrane. Sixty-six cases (Group1) of large tympanic membrane perforation were treated with auricular cartilage. Results were compared with that of temporalis fascia (Group 2) repairing in 60 ears. The closure rate is 92.4% in Group 1 and 80 % in group 2. There was no significant improvement difference in hearing result. They concluded that the auricular cartilage palisade technique is an ideal method for repairing tympanic perforation.
11

Jassar P, et al52 (2002) stated that flying at altitude in a pressurized environment within a week of myringoplasty does not adversely affect early operative success. Gierek T, al53 (2004) did a study to demonstrate the anatomical and functional results of tymanoplasty in comparison with the material used. The studies included a selected a group of 142 patients who were operated on because of tympanic membrane perforation. The analyzed group consisted of 112 patients when perichondrium and cartilage were used to reconstruct the tympanic membrane. The comparison group consists of 30 patients when temporalis fascia was used to close a defect of tympanic membrane. The comparison of operation result showed that there was no significant difference between the two groups. Indorewala S54 (2005) did a retrospective analysis of tympanoplasties performed for large perforation or granular myringitis using either a fascia lata (group I) or temporalis fascia (group II) as material. Ears in group I had lesser rate of recurrent perforation on long term follow-up than ears in group II. No significant difference was noted in improvement of hearing between the two groups. He concluded that shrinkage of graft during healing phase appears to have significant relevance in the clinical situation. Ears having large perforation have high chances of residual perforation caused by limited margin of remnant tympanic membrane overlapping that graft. It seems logical to use fascia lata as graft material for large perforations because it has better dimensional stability. Jyothi P Dabholkar55(2007) The perforations of the tympanic membrane maybe of traumatic origin or due to chronic suppurative otitis media. If the perforations fail to heal conservatively, they require surgical closure. Autologous graft materials have stood the test of time in repairing tympanic membrane perforations. In our tertiary care institution we conducted a prospective randomized control trial on 50 subjects to evaluate the comparative efficacy of temporalis fascia and tragal perichondrium as grafting material in underlay tympanoplasty. In this study surgical success was evaluated in terms of intact drum membrane during the follow up period and closure of AB gap within 10 dB. Temporalis fascia achieved a graft uptake of 84% and a satisfactory hearing improvement in 76% of the patients. Tragal perichondrium achieved a success rate of 80% graft uptake and 75% hearing gain. The rates are comparable with no statistical significance of the difference between them.
12

B.J. Singh, A. Sengupta56(2009) Two hundred twenty cases of unilateral chronic suppurative otitis media (CSOM) with dry central perforation were chosen for this study and myringoplasty were done. Age group ranged from 13 to 48 years. Four types of autogenous tissues were used as graft material. Grafting was done by underlay technique when temporalis fascia,tragal perichondrium, areolar tissue were used as graft material and when fat graft was used the ear lobule fat was placed directly into perforation through transcanal route. Postoperative follow-up was carried out up to 6 months. In this study, it was found that the younger age group has less impairment of hearing and better chance of tympanic membrane perforation closure than the older age group in CSOM with central perforation. An anterior perforation has less impairment of hearing and better result in successful closure of tympanic membrane than posterior perforation group. It was also observed that larger the size of perforation greater is the hearing impairment preoperatively and postoperative hearing gain is also less compared to small perforation. Best hearing improvement occurred using temporalis fascia. Failure occurred may be due to postoperative infection, respiratory tract infection, neglected post-operative advice etc. A.Sengupta, B. Basak57 (2011) Myringoplasty is a procedure which deals on repair of the tympanic membrane. This procedure can be done via postaural, endaural or endomeatal route. Various grafts such as temporalis fascia, vein graft, and perichondrium are used. The technique can be categorized as underlay, overlay, interlay or its combination depending on the placement of the graft material. This study was done to compare underlay, overlay and combined technique in terms of the closure of the membrane defect, postoperative complications and overall success rates. Apart from few complications, this study revealed overall success rate was best with combined technique but the difference was not significant statistically when the methods are comparable among them. Sunita Chhapola, Inita Matta58 (2011) Temporalis fascia has long been regarded as the ideal graft material for tympanic membrane repair. However it often does not seem to withstand negative middle ear pressure in the post operative period. Tragal cartilage with perichondrium would appear to be a better graft material with good hearing outcome. It can be obtained easily with cosmetically acceptable incision. In the present study, we have compared the graft properties of temporalis fascia verses tragal cartilage perichondrium with respect to healing, hearing and rate of post operative retraction or reperforation. 132 patients of chronic otitis media with pure conductive hearing loss were
13

posted for tympanoplasty.Temporalis fascia graft was used in 71 patients and cartilage perichondrium (composite graft) was used in 61 patients. Post operative healing, hearing and rate of retraction or reperforation were compared for both the graft materials. All the patients were followed up for 2 years. Patients where temporalis fascia graft was used, 60 (84.5%) showed a good neotympanum, 7(9.85%) had reperforation and 5(7.04%) had retraction pockets. Patients where tragal cartilage perichondrium was used, 60(98.36%) showed a healed tympanic membrane and only 1(1.63%) had reperforation. None of the patients showed retraction pocket or cholestetoma. Postoperative hearing was accessed 6 months after surgery. Patients with temporalis fascia graft showed an air bone gap of less than 10 dB in 49 (82%) patients and more than 10 dB in 11 (18%) patients. Air bone gap closure with tragal cartilage perichondrium was less than 10 dB in 45 (78%) patients and more than 10 dB in 13 patients (22%). Tragal cartilage perichondrium (0.5 mm) seems to be an ideal graft material for tympanic membrane in terms of postoperative healing and acoustic properties. It can easily withstand negative middle ear pressure which may have contributed to the development of otitis media and significantly affect healing outcomes in postoperative period. Tragal cartilage being composed of collagen type II is also physiologically similar to the nature of the tympanic membrane. P.K. Parida, S.K Nochikattil59(2012) To compare the surgical outcome of temporalis fascia graft (TFG) and vein graft (VG) in myringoplasty. This prospective study was carried out over 60 patients with inactive tubotympanic type of chronic suppurative otitis media, with small to moderate size central perforation in Jawaharlal Institute of Post Graduate Medical Education and Research, Puducherry from November 2009 to March 2011. Patients were equally randomized into two groups; TFG group and VG group according to the graft material used for myringoplasty. After routine investigations, Xray mastoid and paranasal sinuses and pure tone audiometry, all cases were operated under local anesthesia using underlay technique. Patients were followed at 2 week, 1 and 3 month postoperatively. Graft uptake, audiological improvement, degree of hearing improvement, and complications were studied during follow up. In TFG group, graft uptake rate was 80 % and hearing improvement was present in 66.7 % whereas in VG group graft uptake rate was 83.3 % and hearing improvement was present in 70 %. No patient had deterioration in hearing, sensory neural hearing loss or any other complications postoperatively. Difference between the preoperative and postoperative air bone (AB) gap was considered as degree of hearing improvement. Postoperative AB gap was 10 dB in 60 % and 66.7 % of patients of TFG group and VG group respectively. The
14

difference in graft uptake rate and hearing improvement between two groups was not statistically significant. Both TFG and VG are equally effective in terms of graft uptake and hearing improvement in myringoplasty.

15

ANATOMY
ANATOMY OF TYMPANIC MEMBRANE The tympanic membrane (Tony Wright and Peter Valentine)67 is a membrane partition separating the external ear from tympanic cavity. It is a semitransparent and elliptical, measuring 9-10 mm vertically and 8-9 mm horizontally. Its external aspect is concave, most depressed point being the umbo, which corresponding to the tip of the manubrium of the malleus. The manubrium itself extends from umbo to the malleal prominence, formed by the lateral process of the malleus. From the malleal prominence, the the anterior and posterior malleal fold extends to the edges of the tympanic notch (notch of rivinus) and separates pars flaccida (Sharpnells membrane) above from pars tensa below. The average thickness of the tympanic membrane is 0.074mm: it is thickest at antero-superior quadrant and inferiorly near the annulus (0.09mm). It is thinnest at posterosuperior quadrant (0.055mm). The pars tensa of the tympanic membrane is composed for three layers. The outer epitelial layer is continuous with the skin lining the external auditory meatus. Medial to this is a fibrous layer, or lamina propria. More medial is the mucous layer continuous with the tympanic cavity. The connective tissue fibers originate from the handle of malleus and inserts on the annular ring. Circular fibers originate from the short process of malleus more medially. Transverse and parabolic fibers intertwine between these two layers. Epithelial migration of the tympanic membrane has been demonstrated by the Litton (1963) who showed centrifugally from the umbo at about 0.05mm per day. The blood supply is provided by vessels from the epidermal mucosal surface that communicate within the lamina propria. The arterial supply laterally is from the tympanic branch of the deep auricular artery and medially from the anterior tympanic branch of the internal maxillary artery, the stylomastoid branch of the internal maxillary artery, and the stylomastoid branch of the posterior auricular artery.These three arteries join to form a peripheral vascular ring.(Rete arterisom marginlae).The venous drainage is to maxiallary + external juglar vein and pterygoid venous plexus. Innervation is via the auricular branch of the vagus, the tympanic branch of glosso-pharyngeus (of Jacobson), and auriculotemporal branch of the mandibular nerve.
16

17

ANATOMY OF TEMPORALIS FASCIA Ortegren described the use of temporalis in the repair of the tympanic membrane in 1959. Temporalis fascia (anatomy of temporails fascia by Wormald P.J68. is having two distinct layers: Superficial and deep temporal fascia. Superficial temporal fascia is thin highly vascular layer of moderately dense connective tissue, which is attached loosely to overlying subdermal tissues, above zygomatic arch. This layer has its own rich blood supply. Its arterial supply comes from superficial temporal artery. Deep temporal fascia closely covers the temporalis muscle and its aponeurosis follows the muscles anatomical boundaries. Blood supply of this is from middle temporal artery, which arises from superficial temporal artery. The total area of fascia on each side of the head is 260sq.cm. Importance of this is emphasized because temporal fascia (superficial or deep) should always be available for myringoplasties and tympanoplasties even in repeat operations. Access to the fascia is easily obtained by extending a post- auricular incision. The advantage of temporalis fascia graft. a) It is easy to harvest. b) It can be used as onlay,intermediate,or underlay graft. c) No size limitation. d) Low BMR-requires less nutrition- high survival. e) It can be used in more than one piece,each piece overlapping other, f) The only suitable autologous membrane for recostruction of tympanic cavity and ear canal. g) It can be used as sandwich technique as one of the double grafts with ear canal skin on the fascia.

18

AREA FOR HARVESTING TEMPORALIS FASCIA GRAFT

19

ANATOMY OF TRAGAL PERICHONDRIUM GoodHill V 25 in 1967, advocate the use of tragal perichondrium for myringoplasties and tympanoplasties surgeries. Based on the recipient area provide the most physiologically desirable autografts. The advantages to the tragal perichondrium are: 1. Easy accessibility in the operative field. 2. Availability in the adequate amount. 3. It is a mesodermal graft, 4. Excellent contour. 5. Excellent survival capacity, better dimensional stability. SURGICAL PRINCIPLE The perforations of tympanic membrane that tend to heal spontaneously rend to exclude the connective tissue layer (monomeric membrane). The tympanic membranes that do not heal tend to have ingrowth of outer squmous epithelium covering the edges of the perforation. The aim of the grafting is truly anatomic reconstruction (Marcos VG, 1989).69 The collagen layer placed as a graft reinstates the middle layer allows epithelial cells to migrate, re- establishes continuity, and membrane to recover its vibratory characterizes. TYMPANOPLASTY Tympanoplasty is final step in the surgical conquest of the conductive hearing loss is the culmination of cover 100 years of development of surgical procedures on the middle ear to improve the hearing. Tympanoplasty is a procedure to eradicate dieses in the middle ear and to reconstruct the hearing mechanism. Tympanoplasty implies reconstruction of the membrane but also deals with pathology within the middle ear cleft such as chronic infection, cholesteatoma, or problems with the ossicular chain. Zollner and Wullstein provided a classification of tympanoplasty that focuses on the type of ossicular chain reconstruction needed. This classification is of historical interest
20

because reconstruction of the ossicular chain was not undertaken at that time. It does provide a standardized method for analyzing pathology of the ossicular chain and for reporting outcomes of middle ear reconstruction. The five types of tympanoplasty that these authors described define the status of the ossicular chain as a result of pathologic changes from eustachain tube dysfunction and middle ear disease. Progression from type I to type V describes the status of the remaining ossicular chain. Type I have all ossicles intact and require reconstruction of only the tympanic membrane. Type V consists of no ossicles and connection to the inner ear through a fenestrated horizontal semicircular canal or the vestibule at the oval window. WULLSTEIN & ZOLLNERS CLASSIFICATION OF TYMPANOPLASTY (1952).

It is based on the type of damage caused and the method of reconstruction used.
Type I- Perforated tympanic membrane with normal ossicles. The procedure includes inspection of the middle ear cleft with closure of the perforation. Type II- Membrane perforation with erosion of malleus. Graft placed against malleus remnant or incus. The subtypes are as follows: Type IIa: Classical myringoincudopexy. Type IIb: Malleus Stapes assembly. Type IIc: Resconstruction independent of malleus. Type III- Membrane perforation with erosion of malleus and incus with presence of intact and mobile stapes .Graft placed over the stapes superstructure (Columella tympanoplasty or myringostapediopexy). Type IV- Membrane perforation with erosin of malleus,incus and stapes superstructure with presence of intact and mobile stapes footplate. Stapes footplate left exposed and graft is kept coveringEustachian tube orifice and the round window with an air pocket (cavum minor) providing sound protection to the round window (baffle effect).Skin graft placed over stapes footplate.

21

TypeV- Membrane perforation with erosion of malleus, incus and stapes suprastrutcure with presence of intact but fixed stapes footplate. Fenestration made over lateral semi circular canal. Graft placed over the fenestration and the middle ear space for sound protection of round window. Type VI- Membrane perforation with erosion of malleus, incus and stapes suprastructure with presence of intact and mobile stapes footplate.Round window left exposed and graft placed over the stapes footplate.(SONO INVERSION Garcia Ibanez)

22

HISTOPATHOLOGY OF HEALING AFTER MYRINGOPLASTY

Various grafts can be used in closure of perforation. According to MARQUET(1968), the graft interested during myringoplasty acts as a temporary scaffolding over which the external epithelium and the internal endothelium grow to completely seal the perforation. This scaffolding gets absorbed soon and is replaced by the newly formed fibrocytes of the host by the 10th day (PLESTER AND STEINBACH, 1977). The growth of epithelium occurs from the periphery to the centre of the graft necroses before the perforation gets sealed. This leaves a residual perforation. Placing the graft on the medial surface of the tympanic membrane does not interfere with the healing since the endothelial mucosa lateral to the graft undergoes atrophy. At the junction of the graft and the endothelium, a layer of flattened endothelium slowly advances to cover the medial surface of graft. On the external surface, keratinized epithelium migrates over the lateral surface of the graft. Within 6-8 weeks, the graft is covered on both sides (PLESTER AND STEINBACH, 1977). Most important of all the successful myringoplasty is an understanding of the manner in which the free skin graft becomes vascularized and survives. PADGETT (1942) and CONWAY (1951) studied the histopathology of survival of skin grafts and concluded that for the first 48 to 72 hours, the graft is nourished by a Plasmic circulation, with a continuity of blood vessels between the graft and its bed not taking over until 65 to 72 hours. This vascularization proceeds from the annulus and the mucosa. Wright (1956) points out that in the case of large or medium sized tympanic membrane perforation where a space of several millimeters or most must be bridged by the graft it could hardly be expected to survive for three days by means of Plasmic circulation alone. McLAUGHIN (1954) believes that tiny blood vessels of free skin grafts come in contact with open blood vessel of the bed, establishing a vascular circulation within first day or two. WRIGHT confirmed this conclusion by removing free split thickness grafts 4 hours and 24 hours they had been placed on their bed. At 4 hours microscopic section show an intense spasm of the grafts of blood vessels which had squeezed out all erythrocytes .At 24 hours of blood vessels of the grafts were relaxed and filled with erythrocytes, indicating that capillary continuity with the bed had been established. If, as seems probable this is mechanism of survival of free grafts bridging a perforation, the need is evident for a graft of sufficient thickness to include a capillary network, and for a good vascular bed on which place it. Moreover undue pressure on the grafts that might interface with capillary circulation must be avoided, while the drafts itself must be handled with a minimum of trauma. At least 3mm of vascular bed on all sides of the perforation should be provided.

23

MATERIALS AND METHODS

This prospective study was carried out from July 2010 to September 2012 on the patients attending the ENT Outpatient Department of our institution. All patients with the complaint of discharging ear and decreased hearing were screened. Those patients, in whom tubotympanic type of chronic suppurative Otitis Media was found, were taken for this prospective study with randomization. The necessary permission and approval from ethics committee and authority, prior to starting the study was taken. Informed written consents were obtained from the patients involved in the study according to the protocol approved by the Ethics Committee of our institution. This study comprises of patient who were subjected to tymapnoplasty for the treatment of chronic suppurative otits media. Each patient was subjected to a detail examination of nose, paranasal sinuses and throat to rule out any focus of infection, which could influence the result of tympanoplasty. Patients were subjected to tympanoplasty with temporalis fascia while the remaining underwent with tragal perichondrium.

24

CRITERIA FOR SELECTION

INCLUSION CRITERIA 1. Cases of safe type of chronic suppurative otitis media. 2. The ear should be dry minimum for 1 month with intact ossicular chain. 3. Patent Eustachian Tube.

EXCLUSION CRITERIA 1. Unsafe CSOM 2. Safe CSOM with sensorineural hearing loss. 3. Patient <15years >50years.

25

METHOD OF COLLECTION OF DATA

Cases selected for the study were subjected a detailed history taking and clinical examination of ear, nose and throat and special reference to the ear. The method of study was carried out under the following heading. History taking. 1. Clinical examination 2. Investigation 3. Operative procedures 4. Follow Up HISTORY A details history was taken in following parts: A. Complaints: Ear discharge hearing loss vertigo pain if any other B. History of present illness : Onset, duration, progress Blood stained discharge Aggravating and relieving factor noted Dry ear since Recurrent URTI C. Personal history: Any relevant points in relation to occupation and habits were noted. D. Past history: This was enquired in relation to discharge, otalgia, sore throat, cold throat, colds allergy, infectious disease like measles, chickenpox etc.

26

CLINICAL EXAMINATION GENERAL EXAMINATION EXAMINATION OF EAR: 1. 2. 3. 4. 5. 6. Examination of pre-auricular area Examination of post-auricular area Examination of pinna Examination of EAC Examination of Tympanic membrane Examination of under microscope

Assessment of hearing 1. 2. Tuning Fork testing with 256,512 and 1024 Hz. Pure Tone audiometry.

EXAMINATION OF NOSE EXAMINATION OF THROAT LABORATORY INVESTIGATION 1. Routine investigation TLC Hb% DLC 2. Blood Sugar (Fasting and PP if indicated) 3. Urine investigation 4. X-ray chest 5. X-ray mastoid 6. X-ray PNS(if indicated) 7. PTA (Pure Tone Audiometry)

27

OPERTAIVE TEQHNIQUE ANAESTHESIA Tympanoplasty for reconstruction of the tympanic membrane and correction of conductive hearing loss was typically performed through a postauricular approach, especially in patients with large or anterior perforations and revision operations. However, intravenous sedation with local anesthesia is prefer and typically well tolerated by the patients. Majority of patients underwent surgery under Local anaethesia with sedation after a xylociane sensitivity test. Local anesthesia was achieved by using 2% xylocaine with 1:2 00,000 adrenaline in the subcutaneous tissues of post-auricular region and external auditory canal.

SURGICAL APROACH POSITIONING AND PREPARATION The patient was positioned supine on the operating table. The head was turned toward the side away from the operated ear. While taking care to ensure that the contralateral auricle is not being compressed. A small amount of hair in the postauricular region was shaved to keep the operating field free of hair. The patients remaining hair was then secured with tape to keep it out of field. The post-auricular crease was cleaned with betadine and inject with lidocaine with epinehrine. The patient was secured to the table with straps because rotating the bed was sometimes necessary during the procedure. The operative field was then prepared with povidone-iodine (Betadine) and the ear canal was flooded with preparative solution. Suction and irrigation tubing was set up, the instrument table and operating microscope are brought into position. Before the start of the procedure, the surgeon should ensure that the microscope was properly balanced and that the correct lens (usually 200 or 250mm) was attached. The external auditory canal (EAC) and tympanic membrane (TM) are examined under the operating microscope. Cerumen o debris in the EAC was removed while taking care to not cause bleeding.

28

PLANNING THE POSTAURICULAR INCISION The microscope is moved aside and a post-auricular incision is made with a no. 15 blade. The incision extends from just superior and posterior to the root of the helix down to the mastoid tip. The incision was placed 5 millimeters behind the post-auricular sulcus. In young children without a well-developed mastoid tip, the inferior aspect of the incision is more posterior and is not carried down as far to avoid injuring the facial nerve. The incision is carried down to the level of the loose areolar tissue overlying the temporalis fascia. Identification of this plane is facilitated by pulling laterally on the auricle as the incision is made. Once the correct plane has been entered, the knife blade is turned flat and dissection is carried anteriorly toward the posterior EAC while taking care to not enter the EAC at this point. Temporalis fascia was now harvested. The inferior-most aspect of the fascia harvest site should be placed at least one centimeter above the linea temporalis. Preserving the fascia at the linea temporalis allowed more solid closure of the superior periosteal incision. GRAFT MATERIAL In 25 cases temporalis fascia and 25 cases tragal perichondrium were used as a graft materials for tympanoplasty. a. Tragal Perichondrium After injecting local anesthesia, an incision is made over tragal margin and skin flap along with subcutaneous tissue are elevated. Tragal cartilage is exposed and excised out with perichondrium attached to it. The perichondrium is separated from the cartilage using a flag knife. The perichondrium graft so obtained was used. b. Temporalis fascia After injecting local anesthesia, a post-aural incision is made to expose the temporalis muscle alone with its fascia. Fascia was taken out from the surface of the temporalis muscle. It was spread on a hard surface such as a graft plate and any fat or connective tissue was scrapped away with a sharp knife edge.
29

Majority of patients were operated by the post-aural route. Patients were operated by underlay technique. Integrity of ossicular chain was confirmed in all cases of tympanoplasty.

STEPS OF SURGERY After harvesting the appropriate graft following steps were followed1. Elevation of the periosteal flap 2. Meatotomy in cases of post- auricular approach. 3. Freshening of the edges of the perforation. 4. Elevation the tympanomeatal flap. 5. Assessing the ossicular continuity and freedom from the disease.
30

6. Placing the graft by underlay technique. 7. Reposing the tympanomeatal flap. 8. Packing the EAC with antibiotic soaked gel foam. 9. Suturing of periosteal flap and postauricular skin. Standard mastoid dressing was given in cases operated by post-aural route. Postoperative stay in wards was usually one week. In this period all patients were on the following medications: 1. Antibiotic as indicated. 2. Analgesia and anti-inflammatory. Patients were discharged with instruction to continue antibiotics and antihistaminic. Sutures were removed on 7th day. Steroid-antibiotic ear drops for local instillation were started after 7th day. Thereafter, patients were followed up in the OPD for: 1. Cleaning the ear 2. Otoscopy. Visit: 1st follow up (15 POD) 2nd follow up (21 OPD) 3rd follow up (After 45 days) Then monthly follow up. PTA done after 6 month of operation. Result evaluation by appropriate statistical test was done subsequently. Pure tone audiometry was repeated once the tympanic membrane healed usually after 6 months. Ear finding and audiometry reports were recorded. Any complication was treated as and when it arose.

31

Data Analysis Observations were tabulated on a spread sheet by using Microsoft excel. Statistical analysis of the patients was carried out with Studentt test and Z test. A P value<0.05 was considered statistically significant.

32

OBSERVATIONS AND RESULTS

33

 Total number of patients in this study Mean age of patients Range Male Female Sex ratio Type of graft material used: a) Temporalis fascia b) Tragal perichondrium

50 30.36 years 16 to50 years 22 28 1:1.27

25 25

Route of surgery: a) Post auricular b) Endaural Age distribution: a) Mean age

45 05

30.36years

Duration of illness / symptoms prior to surgery: a) Mean duration

15.78 months

TABLES
34

TABLE-1 : SEX DISTRIBUTION.

Sex Male Female Total

No. of Patients 22 28 50

Percentage 44% 56% 100%

The above table indicates that there were 22 (44%) males and 28 (56%) females. The male to female ratio is 1:1.27.

35

sex distribution

56% 44%

female male

TABLE-2 : AGE DISTRIBUTION.

Age in years < 20 21 - 30 31- 40 >40

No of Patients 09 17 16 08

Percentage 18% 34% 32% 16%

Total

50

100%

The above table indicates that maximum number of patients belonged between the age group of 21-40 years.

36

CHART SHOWING AGE WISE DISTRIBUTION

18 16 14 No of Patients 12 10 8 6 4 2 0 < 20 21 - 30 31 - 40 > 40 Age in Years 9 8 no of patients 17 16

37

TABLE-3 : PREOPERATIVE HEARING LEVELS.

Preoperative Air- Bone Gap

No.of Patients Temporalis Tragal Fascia Perichondrium 0 0 6 4 1 5 3 4 2 0 0 0 7 6 2 3 3 3 0 1

Percentage Total 0 0 13 10 3 8 6 7 2 1 0 0 26% 20% 06% 16% 12% 14% 04% 02%

0-5 5-10 10-15 15-20 20-25 25-30 30-35 35-40 40-45 45-50

Majority of the patients shows mild to moderate hearing loss. 46% of being in 0-20 db air- bone gap range. 38% of being in 20-40 db air- bone gap range. Only 6% of them had air- bone gap range above 40 db.

38

8 7 7 6 6 5 no of patients 5 4 4 3 3 2 2 1 1 0 0 0 0-5 5 - 10 10 - 15 15 - 20 20 - 25 25 - 30 hearing loss in db 0 0 temporalis fascia tragal perichondrium 6

39

TABLE-4 : POSTOPERATIVE HEARING LEVELS.

Postoperative Air- Bone Gap

No.of Patients Temporalis Tragal Fascia Perichondrium 10 9 3 0 0 2 0 0 1 0 14 7 1 1 0 1 0 1 0 0

Percentage Total 24 16 4 1 0 3 0 1 1 0 40% 32% 08% 02% 00% 06% 00% 02% 02% 00%

0-5 5-10 10-15 15-20 20-25 25-30 30-35 35-40 40-45 45-50

In the postoperative hearing analysis, 80% of the patients showed air- bone gap in the range of 8-10db 10% of the patients showed air- bone gap in the range of 11-20db 74% of the patients operated with temporalis fascia showed air bone gap in the range of 0-10db. 84% of the patients operated with tragal perichondrium showed air-bone gap up to 10db.

40

Bar diagram showing post operative hearing levels

16 14 14 12 10 no of patients 10 8 6 4 2 0 0 - 5 5 - 10 10 15 15 20 20 25 25 30 30 35 35 40 40 45 45 50 3 2 1 0 1 00 1 00 0 1 1 0 00 9 7 temporalis fascia tragal perichondrium

hearing loss in db

41

TABLE-5 : POSTOPERATIVE HEARING LEVELS WITH RESPECTIVE TO SEX.

Postoperative Air- Bone Gap

No. of Patients Male Female 12 6 1 0 0 2 0 0 1 0 12 10 2 2 0 1 0 1 0 0

Percentage Total 24 16 3 2 0 3 0 1 1 0 48% 32% 06% 04% 00% 06% 00% 02% 02% 00%

0-5 5-10 10-15 15-20 20-25 25-30 30-35 35-40 40-45 45-50

In the postoperative hearing analysis, 81.81% male showed air bone gap in the range of 0-10db 78.57% female patients showed 0-10db air-bone gap.

42

Bar diagram showing post operative hearing loss with respect to sex
14 1212 12 10 10 no of patients 8 6 6 4 2 2 0 0 - 5 5 - 10 10 - 15 15 - 20 20 - 25 25 - 30 30 - 35 35 - 40 40 - 45 45 - 50 hearing loss in db 1 0 00 2 2 1 00 0 1 1 0 00 male female

43

TABLE 6: POST OPERATIVE IN HEARING Mean change in hearing levels No change or worsen 05 5 10 10 15 15 20 20 25 25 30 30 35 No of patients Temporalis Tragal Total fascia perichondrium 3 1 4 6 3 2 3 3 3 0 4 8 2 4 2 2 6 1 5 14 6 7 7 4 Percentage

12% 2% 10 % 28 % 12 % 14 % 14 % 8%

Hearing at 3months 44 of 50 patients showed improvement in hearing between 0 to 35 db (88%). Out of these patients, 22 were operated using temporalis fascia i.e. 22 out of 25 patients (88%). 22 out of 25 using tragal perichondrium showed improvement in hearing i.e. (88%). There is no statistical significant difference in hearing improvement, using temporalis fascia or perichondrium for tympanoplasty.

44

Bar diagram showing post operative improvement in hearing

9 8 7 no of patients 6 5 4 3 2 1 0 <0 05 5 10 10 15 15 20 20 25 25 30 30 35 hearing loss in db 1 0 3 3 4 4 3 2 2 4 3 2 3 2 temporalis fascia tragal perichondrium 6 8

TABLE 7:

MEAN HEARING LEVEL IN TYMPANOPLASTY USING FASCIA AND PERICHONDRIUM Mean levels of hearing Preoperative Post hearing operative levels hearing levels 640/25 = 242.5/25 25.6 = 9.7 Post operative change in hearing 397.5/25 = 15.9

Type of graft

Temporalis fascia

Tragal 580/25 = perichondrium 23.2 Total 1220/50 = 24.4

193.75/25 383.75/25 = 7.75 = 15.35 436.25/50 781.25/50 = 8.725 = 15.625

45

 Mean improvement in hearing temporalis fascia is 15.90 db. Mean improvement in hearing using tragal perichondrium is 15.35 db. On applying Studentt test, t= 0.19, P>0.05, we found that there was no statistically difference in mean improvement in hearing using either temporalis fascia or tragal perichondrium.

Bar diagram showing mean hearing level in tympanoplasty using fascia and perichondrium
30 25.6 25 mean value 20 15 10 5 0 temporalis fascia tragal perichondrium Type of graft 9.7 post operative hearing levels 7.75 post operative change in hearing 15.9 23.2 pre operative hearing levels

15.35

TABLE NO 8: GRAFT UPTAKE RATE Type of graft Temporalis fascia Tragal perichondrium Overall Graft uptake 21/25 20/25 41/50 Percentage 84 % 80% 82 %

The above table indicates that 21 (84%) out of 25 ears operated using temporalis fascia graft healed completely at the end of 6months with well taken graft.20 (80%) out of 25 ears operated using tragal perichondrium
46

were dry with graft in place at the end of 6 months. No statistical significant association was found in graft uptake with respect to type of graft (P>0.05). Most revision patients were not included in the study as these patients were subjected to more extensive surgery including atticotomy and mastoidectomy to detect and treat hidden pathologies. Z=0.36, P>0.05

47

GRAFT TAKE RATE ACCORDING TO SITE AND SIZE OF PERFORATION

SUBTOTAL 10/12

POSTERO-SUPERIOR 2/4
ANTERO-SUPERIOR 1/2

POSTERIOR 5/6 ANTERIOR 3/3

POSTERO-INFERIOR 9/10

ANTERO-INFERIOR 7/9

INFERIOR 4/4

TABLE NO 9: TYPE OF PERFORATIONWISE GRAFT UPTAKE IN STUDY GROUP

S. NO 1 2 3 4 5 6 7 8 TOTAL

TYPES OF PERFORATION Subtotal Anterior Inferior Posterior Posterosuperior Posteroinferior Anteroinferior Anterosuperior

GRAFT UPTAKE + 10 2 3 0 4 0 5 1 2 2 9 1 7 2 1 1 41 9

TOTAL 12 3 4 6 4 10 9 2 50

48

10 out of 12 subtotal perforations were successful 5 out of 6 perforations in posterior half of ear drum were successful. 4 out of 4 perforations in inferior part of drum were successful. 3 out of 3 perforations in anterior half of drum were successful. 2 out of 4 perforations in posterosuperior quadrant of drum were successful. 9 out of 10 perforations in posteroinferior quadrant of drum were successful. 7out of 9 perforations in anteroinferior quadrant were successful. 1 out of 2 perforations in anterosuperior quadrant were successful.

Most of the smaller perforations here were taken for tympanoplasty when they failed to respond to medical treatment of weekly trichloro acetic acid cautery or when patient cannot come for repeated sittings.

49

FACTORS AFFECTING GRAFT TAKE RATE Age and sex of the patients were also compared with graft take rate:

TABLE 10: GRAFT UPTAKE RATE WITH RESPECT TO AGE OF THE PATIENTS (n = 50). Age in years 20 21 30 31 40 >40 No of patients 7/9 14/17 12/16 6/8 Percentage % 77.77 82.35 75 75

From the above table it is seen that maximum graft uptake rate observed in the age group 21-30 years (82.35%).

TABLE 11: GRAFT UPTAKE RATE WITH RESPECT TO SEX (n = 50). Sex Male Female Graft uptake 17/22 24/28 Percentage % 77.27 85.71

The above table shows that graft uptake rate was 77.27 %( 17 out of 22 ears) in males and 85.71 %( 24 out of 28 ears) in female. Z=0.77, P>0.005 There is no statistical significant difference seen in graft uptake rate in sex.

50

DISCUSSION
This is the prospective study of 50 Tympanoplasties on patients between the age of 16 to 50 years, who were admitted in the Department Of E.N.T and Head and Neck Surgery at Dr D.Y Patil medical college, Pimpri, between July 2010 to September 2012. This entire study group of patient suffered from Chronic Suppurative Otits Media. Patients in this study were from all socioeconomic groups, including patients referred from other practitioners also. Conservative measures were first tried in all cases, particularly for small to moderately sized perforations. These included systemic antibiotics, trichloro-acetic acid cautery, repeated aural toilet in ears with active infections. Cases with bilateral ear diseases with suspected central septic focus were operated with tonsillectomy, adenoidectomy, septoplasty, etc. as needed. 25 patients were subjected to tympanoplasty with temporalis fascia remaining 25 with tragal perichondrium. postoperative cases was for 6months. Follow up of

TECHNICAL ASPECTS
Tympanoplasty is technically more difficult in patients having a narrow canal, undergoing revision surgery, by transcanal approach and in anterior perforations. Only a few difficult cases were operated by seniors E.N.T surgeons. All other cases were operated by resident. Perhaps hearing result and graft uptake would have been better if more experienced surgeon would have taken over. Sade (1982) has expressed similar opinion.

51

Post-auricular approach is commonly used in our institution; end-aural route was used in some of the cases with wide external auditory canals and tragal perichondrium cases. It was technically easier in endaural cases to harvest the tragal perichondrium graft from same incision. The contour of tragus was found to be satisfactory in postoperative period without any cosmetic deformity.

GRAFT TAKE RATE

The graft take rate after 6 months was 82%. Long term studies were not possible due to patients noncompliance. Similar reports was given by Palva T et al (1995)60 with graft take rate was 97%. In our study, graft uptake rate for temporalis fascia was 84% as compared to tragal perichondrium (80%). Graft take-rate was slightly better for temporalis fascia than for tragal perichondrium (not significant p>>0.005). These result compare well with Jyoti P Dabholkar (2007)55 whose postoperative graft uptake rate with temporalis fascia 84% and tragal perichondrium showed 80%. Tragal perichondrium was used in revision tympanoplasty where temporalis fascia was initially used. There was good graft-take in these cases. These reports compare well with Jain CM (1968) 61 who reports 83.33% success rate with temporalis fascia, Ahad SA (1986)31, with 83.30% success with homologous temporalis fascia, Blanshard JD (1990)62, 78% take-rate with tempoarlis fascia in pediatric tympanoplasty. Tragal perichondrium graft take rate was 90.91% in cases of subtotal perforation which was significantly better than that of temporlis fascia. Wiegand (1978)63 also found good for closing large defects with satisfactory sound transmission. Most of graft failures seen in the follow-up period were due to infection probably transmitted either along Eustachian tube or along external auditory canal.

HEARING RESULT

52

88% of cases showed improvement in hearing, while 12% of them showed either deterioration or no improvement, at 6 month follow-up period. About 88% cases operated with temporalis fascia showed hearing improvement, while same percentage (88%) of cases who were operated using tragal perichondrium showed improvement in hearing (statistically not significant p>> 0.05) as shown in the Table-6. Mean improvement in hearing using temporalis fascia was 15.9 db and that with tragal perichondrium it is 15.35 db (statistically not significant p>>0.05) as shown in Table -7 These result compare well with Strauss et al(1975) who found that improvement in air bone gap was 15 db. These result also compare well with Ophir D (1987)64, Terry RM (1988)37, result with fat myringoplasty. Hartwein (1992)42 claims reduction of air bone gap of around 15 db with tragal perichondrium graft. This study compare well with Sunita Chhapola,Inita Matta (2011)58 whose postoperative hearing accessed after 6 months of surgery, with temporalis fascia graft showed air bone gap of less than 10dB in 82% of patients and more than 10dB in 18% patients. Air bone gap closure with tragal perichondrium was less than 10 dB in 78% patients more than 10dB in 22% of patients. The patient population attending our hospital was also from low socioeconomic status, many had poor personal hygiene and poor nutritional status. These were probably some of the factors which contribute to higher rate of graft rejection. FACTORS AFFECTING GRAFT TAKE-RATE Majority of perforations operated in our study were subtotal (24%) followed by posteroinferior (20%) and anteroinferior perforations (18%) Least number of perforations was seen in anterosuperior quadrant (4%). Take-Rate was maximum for perforation in inferior half of the drum where all 4 perforations have healed well, take rate was least for perforation involving superior half of tympanic membrane anterior quadrant or posterior quadrant. But the ears operated with perforation in these sites were small in number to be significant. Finally, then takerate is not influenced by size or site of perforation.

53

Similar opinion is expressed by Blanshard JD (1990)62 who opines that age at operation, size of perforation and prior adenoidectomy had no significant influence on the success rate or audiological outcomes. Factor such as duration of illness, age and sex of patients used, did not significantly affect graft uptake rate in our study. Vartiainen E (1993)65 also states that the preoperative factor like dryness or discharging ear, site of perforation of technique (onlay/underlay) do not affect the take rate. Berger G, et al (1997)66, stated that results of myringoplasty were independent of patients age, location and size of perforation and the seniority were not decisive factors in the result of myringoplasty. As the number of patients for tympanoplasty after 6 months were too less, hence were not taken into consideration.

54

SUMMARY

50 tympanoplasties were performed on indoor basis.

Age range from 16-50 years with mean age of patients 30.36 years. 22 (44%) males and 28 (56%) females with male to female ratio 1:1.27. Mean duration of illness was 15.78 months. Majority of the patients preoperatively showed mild to moderate hearing loss.70% patients showed upto 30 db air bone gap range, 24% patients being in 30-40db air-bone gap and only 6% patients is above 40db.

Surgeries were performed by post-aural or end-aural approach. In all surgeries grafts were placed as underlay technique. 25(50%) patients were operated using temporalis fascia and 25(50%) patients using tragal perichondrium. Graft take rate was overall 82%. Take-rate was 84% with temporalis fascia and 80% with tragal perichondrium. This might be because tragal perichondrium was used in large central perforation and revision tympanoplasties.

In postoperative hearing analysis, 80% patients showed air-bone gap around10db. Overall mean improvement in hearing was 15.625 db. Mean improvement in hearing for temporalis fascia was 15.90 db and for tragal perichondrium was 15.35 db. Take rate of graft was not influenced by the size of perforation.
55

 Improvement in hearing was also not significantly influenced by the type of graft used.

56

CONCLUSIONS

Tympanoplasty is the most effective method for control of the disease and hearing improvement.

Both temporalis fascia and tragal perichondrium are excellent graft materials for closure of perforation of tympanic membrane and hearing improvement.

Graft uptake rate is good for both with slightly better take rates for temporalis fascia, than tragal perichondrium.

Hearing improvement does not depend on type of graft (No statistically significant difference p>>0.5).

In our study, take rate of graft was neither influenced by the (p>>0.5) site or size of the perforation.

Improvement in hearing is not significantly influenced by duration of disease, age or sex of patients.

57

BIBLIOGRAPHY
1. Wullestein H : Method for split-skin covering of perforation of the drum by tympanoplasty operations in cases of chronic otitis. Arch.Ohr-Nas- u.Kehlk Helik.1952; 161:422. 2. Zollner F: Tymanoplasties intented to replace large drum defects combined with defects of ossicles.Panel on myringoplasty.Second workshop on reconstructive Middle Ear Surgery. Arch Otolaryng. 1953; 78:301. 3. Zollner F: Abandoned split skin graft because of its low resistance,preferring full thickness retro- auricular skin grafts.Proc 5 Int Congr Otolaryng.1953;119. 4. Frenckner P: Pedicle graft from ear canal skin for myringoplasty. Acta Otolaryng. 1955; 45: 19. 5. Zollner F: The principle of the plastic surgery of the sound conducting apparatus. J Laryng. 1955; 69: 637. 6. Wright WK: Repair of chronic central perforation membrane: by repeated acid cautery; by skin grafting. Laryngol. (St. Louis) 1956; 66: 1464. 7. Wullestein H: Theory and practice of tympanoplasty. Laryng. (St. Louis) 1956; 66: 1076 8. Wullestein H: Reported series tympanoplasties of 1000 cases. Arch Ohr-u.Kehlk-Heilk. 1957; 171: 84. 9. GuilfordFR, Wright WK and Draper WL: Tympanic skin grafting and reconstruction of the middle ear sound conducting mechanism. Arch. Otolaryng. 1959; 69: 70. 10. Heerman H: Thorough description of a method of fascial grafting. HNO. 1960; 9: 136 11. Shea JJ: Vein graft closure of ear drums perforations. J. Laryng. 1960; 74: 358. 12. Link R: Corium graft a skin graft without epithelium takes much more easily. Arch OhrNas-u.Kehlk-Heilk. 1960; 176: 462 13. Agazzi C: Long term of series of 292 tympanoplasties. Laryng Rhinol. 1960; 39: 351. 14. Livinstone G and Miller H: Results of tymanoplasties . J Laryng.1961; 75:668. 15. Stoors LA: Myringoplasty with the use of fascia grafts. Arch Otolaryng.1961; 74:45.

58

16. Schlosser WD Pratt LL: An evaluation of various tympanoplasty techniques.1961;74:429. 17. Soofy FA and Hambley WM: Myringoplasty techniques.Arch Otolaryng.1961; 71:429. 18. Booth TE: Restoration of hearing by tympanoplasty.Laryngoscope (St.Louis).1961; 74:45. 19. Proctor B: Tymanoplasty. Arch Otolaryng.1962; 76: 377. 20. Howes EL: the rate and nature of epithelialization in wounds with loss of substance. Surg Gynaec Obstet.1943;76 21. Austin DF: Vein graft tympanoplasty: two year report. Trans Amer Acad Ophthal Otolaryng. 1963; 67:198. 22. Jansen C: Use of free tissue transplants of autogenous nasal septal perichondrium.Laryngoscope.1963; 73:78:394. 23. Zollner F: Threapy of Eustachian tube patency in tympanoplasty. Arch Otolaryn.1963; 78:394. 24. Farrior JB: Total tympanoplasty type V. Eustachian tube patency in tympanoplasty. Arch Otolaryn.1965; 81:398-409. 25. Goodhill V: Tragal perichondrium and cartilage for myringoplasty. Arch Otolaryn.1967; 71:480-491. 26. Sheely JL, Glassocock ME: Tympanic membrane grafting with temporalis fascia. Arch Otolaryn.1967; 86:391-402. 27. Sengupta RP and Kacker SK: Study of Eustachian tube with particular reference to long term follow up in myringoplasty.Ind J Otol.1974; 26:132-137. 28. Kacker SK: Suggestions for improving result in myringoplasty. Ind J Otol.1976; 28:7375. 29. Packer P: What is best in myringoplasty; underlay or overlay dura or fascia? J Laryngology and otology.1982;96:25-41 30. Gerrit J Hordijk: Tympanic membrane grafting with fascia, pericardium and vein. J Laryngology and otology.1982;96:43-47.

59

31. Ahad SA: Myringoplasty using homologous temporalis fascia. . Ind J Otol.1986; 33:2829. 32. Isiah V: geriatric myringoplasty. Ind J Otolar. Suppl of Report of 38th Annual Conference of A.O.I., 1986. 33. Kumaresean M: Vascular myringoplasty. Ind J Otolar. 1986; 38(4) :127 34. Gordon H Epstein: Biologic and nonbiologic materials in otologic surgery. Otolaryngologic Clin of N Am. 1986; 20(1): 45-53. 35. Palva T: Surgical treatment of chronic ear disease 1. Myringoplasty and tympanoplasty. Acta Otolaryngol. (Stockh) 1987; 104(3-4): 279-284. 36. Tos M: Autologous tissue seal in myringoplasty. Laryngoscope. 1987; 97(3 pt 1): 370371. 37. Terry RM: Fat graft myringoplasty: Aprospective trial. Clin Otolaryngol. 1988; 13(3) : 227-229. 38. Gross CW: Adipose plug myringoplasty an alternative to formal myringoplasty technique in children. Otolaryngol Head & Neck Surg. 1989; 101(6): 427-434. 39. Kaddor HS: Myringoplasty under local anaesthesia: Day care surgery. Clin Otolaryngol. 1992; 17(6): 567-568. 40. Pagnini P: Sandwitch- graft myringoplasty: The authors personal technique and result. Acta Otorhinolaryngol Ital. 192; 153-163. 41. Sitnikov VP: A method of myringoplasty used in patient; with extensive defects of tympanic membrane. Vestn Otorhinolaryngol. 1992; 3: 31-33. 42. Hartwein J: Crown-cork tympanoplasty a method completes reconstruction of tympanic membrane. Laryngor-Hinoootogies. 1992; 71(2): 102-105. 43. Verbist M: High frequency thresholds prior to and following middle ear surgery. Acta Otorhinolaryngol Belg. 1993; 47(1): 17-21. 44. Ajula SO, Myatt HM, Alusi G: Peri-umbilicus superficial fascia graft myringoplasty a simple alternative. Clin Otolaryngol Allied Sci. 1993; 18(5): 433-435. 45. Macdonald RR, Lusk RP, Muntz HR: Fasciaform myringoplasty in children. Acta Otolaryngol Head Neck Surg. 1994; 120(2): 138-143.
60

46. Quareshi MS, Jones NS: Day care myringoplasty using tragal perichondrium. Clin Otolaryngol Allied Sci. 1995; 20(1): 12.

47. Mitchell RB, Pereira KD, Lazar RH: Fat graft myringoplasty in children a safe and successful day stay procedure. J Laryngol Otol. 1997; 111(2): 106-108. 48. Albera R, Milan F, Riotino E,Ferro VM: Myringoplasty in children : A comparision with adult population .Acta Otorhinolaryngol Ital.1998; 18(5): 295-299.

49. Guo M, Huang Y, Wang J: Report of myringoplasty with interlay method in 53 perforations of tympani. Acta Otolaryngol. 1999; 45: 19. 50. Supiyaphun P, Kerekhanjanarong V: Myringoplasty: is a simple procedure for outpatient. J Med Assoc Thai. 1999; 82(12): 1220-1225.

51. Yu L, Han C, Yu H, Yu D: Auricular cartilage palisade technique for repairing tympanic membrane perforation. Zhonghua Er Br Yan Hau Ke Za Zhi. 2001;36(3):166168 52. Jasser P, Homer JJ, Ram B, Murray D: Does flying after myringoplasty affect graft take rate? Clin Otolaryngol Allied Sci. 2002; 27(1): 48-49. 53. Gierek T, Slaska- Kaspera A, Majezel K, Klimczak- Gobal L: Results of myringoplasty and type-I tympanoplasty with use of fascia, cartilage and perichondrium graft. Otolaryngol Pol. 2004; 18(3): 529-533. 54. Indorewala S: Dimensional stability of free fascia graft: clinical application. Laryngoscope. 2005; 115(2): 278-282. 55. Jyoti P Dabholkar: 56. B.J Singh, A. Sengupta:A comparative study of different graft materials used in myringoplasty. Ind.Otolaryngol Head Neck Surg. 2009;131-134. 57. A. Sengupta, B.Basak:A study on outcome of underlay,overlay and combined technique of myringoplasty. Ind.Otolaryngol Head Neck Surg. 2011; 64(1): 63-66. 58. Sunita Chhaopla, I.Matta:Cartilage-Perichondrium :An ideal graft material? Ind.Otolaryngol Head Neck Surg. 2011; 0306-7. 59. P.K. Parida,S.K Nochikatil: Ind.Otolaryngol Head Neck Surg. 2011: 0543-4.
61

60. Palva T, Ramsay H: Myringoplasty and tympanoplasty- results related to training and experience. Clin Otolaryngology Allied Science. 1995; 20: 329-335. 61. Jain CM: Technique of myringoplasty using a fascial graft. Indian J Otolaryngol. 1968; 20(4) : 173. 62. Blandshard JD: A long term view of myringoplasty in children. J Laryngol. Otol. 1990; 104(10): 758-762. 63. Wiegand H: Tympanic membrane repair with cartilage and double tissue layered graft, HNO, 1978 Jul; 26(7): 233-6. 64. Ophir D: Myringoplasty in paediatric population. Arch Otolaryngol Head and Neck Surg. 1987; 113(2) : 1288-1290. 65. Vartiainer E: Findings in revision myringoplasty. Ear Nose and Throat J. 1993; 72(3): 201-204. 66. Berger G, Ophir D, Berco E, Sade J: Revision myringoplasty. J Laryngol. Otol. 1997; 111(6) : 517-520. 67. Tony Wright and Peter Valentine: Anatomy and embryology of external ear and middle ear, edited by Michael G. Scott- Brown Otorhinolaryngology, Head and Neck Surgery, 7th edition, 2008; 3108. 68. Wormald PJ: Anatomy of the temporalis fascia. J Laryngol. Otol. 1991; 105(7) : 522524. 69. Marcos V Goycoolea: Grafting of tympanic membrane. Atlas of Otologic Surgery, Edited by Goycoolea MV, WB Saunders Company, 1989; 220.

70. Francois M: Myringoplasty in children. Ann Otolaryngol Chir Cervicofac. 1985; 102(5): 321-327.

62

APPENDIX A ABBREVATION
db EAC U.R.T.I PNS DLC TLC Hb TF TP PTA desi-bel External Auditory Canal Upper Respiratory Tract Infection Para- Nasal Sinus Differential Leukocyte Count Total Leukocyte Count Haemoglobin Temporalis Fascia Tragal Perichondrium Pure Tone Audiometry

63

APPENDIX B PROFORMA

Serial Number Reg No. Name of patient Age / Sex Occupation Indoor Number Address DOA DOO DOD

: : : : : : : : : :

64

PRESENTING COMPLAINTS WITH DURATION

1. Ear discharge (Duration, Side, Character, Smell ,Amount ,Associated with cold or not, Bleeding, Responding to medicines 2. Decreased Hearing(Uni/bilateral, Rate of progression, Fluctuating or not) 3. Tinnitus 4. Vertigo 5. Otalgia 6. Recurrent URTI 7. Headache, vomiting, facial weakness 8. Nose complaints 9. Throat complaints

PAST HISTORY
1. H/o similar complaints int the past 2. H/o any significant medical illness 3. H/o trauma

PERSONAL HISTORY

FAMILY HISTORY

65

EXAMINATION Examination of Ear:

1. 2. 3. 4. 5. Examination of pre- auricular area Examination of post auricular area Examination of pinna Examination of EAC Examination of tympanic membrane

Rt.Ear

Lt.Ear

Assesement of hearing Acuity

1. 2. Qualitative Tuning fork testing with 256,512 and 1024Hz Pure Tone Audiometry Symptomatic

Examination of Nose:

Examination of Throat:

66

LABORATORY INVESTIGATION: 1) Routine investigationTLC DLC Hb% 2) Urine investigation 3) X-ray chest 4) X-ray mastoid ( Schullers view) 5) X- ray PNS (if indicated)

OPERATIVE DETAILS 1. 2. 3. 4. Date of operation. Graft used Approach Intraoperative complication

POST OPERATIVE CHECK UP 1. Graft takes up 2. Assessment of Hearing Acuity : (after 6 months) Qualitative

67

68