OUTCOME OF TYPE 1 TYMPANOPLASTY WITH AND WITHOUT THE USE OF TOPICAL NASAL STEROID : A COMPARATIVE STUDY FROM EASTERN NEPAL

Introduc on Chronic suppura ve o s media (CSOM) is the infec on of the middle ear cle . It is an important cause of preventable hearing loss. Objec ves The primary objec ve of this study is to compare the surgery outcome in terms of gra uptake described as intact tympanic membrane or residual perfora on of tympanic membrane in pa ents with use of levoce rizine tablet 5 milligram only and levoce rizine tablet 5 milligram with topical flu casone 100 microgram nasal steroid spray. This study is also aimed to determine the hearing status before and a er the surgery and to find out its associa on with gra intake. Methodology This prospec ve cross sec onal study was conducted on pa ents diagnosed with chronic suppura ve o s media with medium to large central perfora on of tympanic membrane in Birat Medical College Teaching Hospital during the period from 14 April 2015 to 13 April 2017. All the pa ents underwent type 1 tympanoplasty with placement of temporalis fascia under general anesthesia. A er surgery, two equal groups were created with 40 pa ents in each group. One group received an bio cs, levoce rizine tablet and another group received an bio cs, levoce rizine tablet st along with topical intranasal steroid spray from 1 post opera ve day ll 6 wks. All the pa ents were followed up on th th nd nd 5 day, 7 day and 42 day. On 42 day, status of tympanic membrane gra , post opera ve hearing assessment was done and compared between the two groups. Data were entered and analysed using Sta s cal Package For Social Sciences (SPSS) v21. Result There were 40 pa ents who received levoce rizine only star ng from the first post opera ve day and 39 pa ents received levoce rizine and topical nasal steroid spray. Pa ents with intact tympanic membrane following surgery were 88.6% and remaining had residual perfora on of tympanic membrane. Of the study par cipants 87.3 % had improvement during post opera ve hearing assessment. 92.3% of the pa ents receiving levoce rizine and topical nasal steroid post surgery had intact tympanic membrane on otoscopic examina on and there was a significant associa on with p value of 0.04 Conclusion Combina on therapy with topical intranasal steroid spray, an histaminics and an bio cs is beneficial compared to an bio cs and an histaminics in type 1 tympanoplasty in terms of gra intake and improvement in hearing.


Objec ves
The primary objec ve of this study is to compare the surgery outcome in terms of gra uptake described as intact tympanic membrane or residual perfora on of tympanic membrane in pa ents with use of levoce rizine tablet 5 milligram only and levoce rizine tablet 5 milligram with topical flu casone 100 microgram nasal steroid spray.This study is also aimed to determine the hearing status before and a er the surgery and to find out its associa on with gra intake.

Methodology
This prospec ve cross sec onal study was conducted on pa ents diagnosed with chronic suppura ve o s media with medium to large central perfora on of tympanic membrane in Birat Medical College Teaching Hospital during the period from 14 April 2015 to 13 April 2017.All the pa ents underwent type 1 tympanoplasty with placement of temporalis fascia under general anesthesia.A er surgery, two equal groups were created with 40 pa ents in each group.One group received an bio cs, levoce rizine tablet and another group received an bio cs, levoce rizine tablet st along with topical intranasal steroid spray from 1 post opera ve day ll 6 wks.All the pa ents were followed up on th th nd nd 5 day, 7 day and 42 day.On 42 day, status of tympanic membrane gra , post opera ve hearing assessment was done and compared between the two groups.Data were entered and analysed using Sta s cal Package For Social Sciences (SPSS) v21.

Result
There were 40 pa ents who received levoce rizine only star ng from the first post opera ve day and 39 pa ents received levoce rizine and topical nasal steroid spray.Pa ents with intact tympanic membrane following surgery were 88.6% and remaining had residual perfora on of tympanic membrane.Of the study par cipants 87.3 % had improvement during post opera ve hearing assessment.92.3% of the pa ents receiving levoce rizine and topical nasal steroid post surgery had intact tympanic membrane on otoscopic examina on and there was a significant associa on with p value of 0.04

Conclusion
Combina on therapy with topical intranasal steroid spray, an histaminics and an bio cs is beneficial compared to an bio cs and an histaminics in type 1 tympanoplasty in terms of gra intake and improvement in hearing.

INTRODUCTION
Chronic suppura ve o s media (CSOM) is the infec on of the middle ear cle .This results as an ini al episode of acute o s media followed by a persistent discharge from the middle ear through a perfora on in tympanic membrane.It is an important cause of preventable hearing In this study, post aural approach underlay technique was used for gra placement and gra was taken from temporalis fascia.The most commonly used gra in primary tympanoplasty with well aerated middle ears is temporalis 5,6 fascia with success rate between 93% and 97 %.
The primary objec ve of the present study is to compare the surgery results in terms of gra uptake described as intact tympanic membrane or residual perfora on of tympanic membrane in pa ents with use of levoce rizine tablet 5 milligram only and levoce rizine tablet 5 milligram with topical flu casone 100 microgram nasal steroid spray.
Topical intranasal steroid spray helps to improve the Eustachian tube dysfunc on by reducing allergic and non allergic mucosal swelling with success rate ranging from 70 7 to 90 %.Combina on therapy with an bio cs and intranasal steroids spray is beneficial than use of an bioi cs 8 alone especially in children.
This study is also aimed to determine the hearing status before and a er the surgery and to find out its associa on with gra intake.
As CSOM is common in developing countries especially in marignalised popula on, early iden fica on of the disease and its mely treatment can reduce the unwanted sequale in the form of morbidity and hearing disability.

METHODOLOGY
This prospec ve cross sec onal study was conducted in ENT department of Birat Medical College and Teaching Hospital from 14 April 2015 ll 13 April 2017.Informed wri en consent was obtained from the par cipants and permission was obtained from the ins tute to carry out this study.
The inclusion criteria for the par cipants were (a) Age more than 10 years (b) Diagnosed case of chronic suppura ve o s media with medium sized central perfora on.The following par cipants were excluded from the study (a) Age less than 10 years (b) Diagnosed case of chronic suppura ve o s media with marginal perfora on, (c) Pa ent who had acute ear infec on (ac ve ear discharge, fever) and upper respiratory tract infec on, (d) Pa ent who had history of diabetes, ac ve tuberculosis, bleeding disorders and other immune suppressed condi on; and (e) those who didn't consent to par cipate.
Relevant history and examina on findings were noted with focus on dura on of ear discharge, hearing status and other co morbid condi on including diabetes, hypertension, and immune suppression.Otoscopic examina on was done in all the pa ents and status of ear drum was iden fied and noted.Preopera ve hearing assessment was done in all the pa ents by Pure Tone Audiometry.A er ruling out all the exclusion criteria, all the preopera ve inves ga on was sent and pa ents underwent underlay type 1 tympanoplasty.All the pa ents were operated by same surgeon, using same technique under general anesthesia.Temporalis fascia was used as a gra material in all the pa ents.During post opera ve period, star ng from first post opera ve day, One group of pa ents were given an bio cs, levoce rizine 5 milligram tablet and another group of pa ents were given an bio cs, levoce rizine 5 milligram tablet and flu casone nasal steroid spray 100 microgram 2 puff per nasal twice a th day for 6 weeks.All the pa ents were followed on 5 post opera ve day and status of wound was assessed.Again they nd nd were followed on 7th day and on 42 day.On 42 day, otoscopic examina on was performed on all the pa ents and intake of gra was assessed on the basis of intact tympanic membrane or residual perfora on of tympanic membrane.Post opera ve hearing assessment was also done in all the pa ents by Pure Tone Audiometry and categorized as improved, not improved or worsened hearing status when compared to pre-opera ve values.
All the findings were noted on semi standardized study proforma.The data thus obtained was entered into sta s cal so ware SPSS v21 and analyzed.For descrip ve sta s cs, percentage, mean and standard devia on was calculated along with graphical and tabular presenta on.Con nuous variables with normal distribu on were expressed as mean, standard devia on and were compared using t-test.

RESULT
Ini ally equal number of par cipants (n=40) were enrolled in both the groups.However one pa ent who was prescribed nasal steroid a er the surgery didn't turn up for follow up.Hence, total number of cases in the present study is 79 of which 46. 8% were male and 53.2 % female.Mean age of presenta on was 32.48+13.0years and mean hearing loss prior to surgery was 41.94+7.22decibel.(Table 1)  There were 40 pa ents who received levoce rizine only star ng from the first post opera ve day and 39 pa ents received levoce rizine and topical nasal steroid spray.This was con nued for 6 weeks.Frequency of male and female pa ents receiving levocetrizine only and levocetrizine with nasal steroid post opera vely is shown in Figure 1.There th were 68 pa ents who came for follow up on 5 day, 79 pa ents came on follow up on day 7 and 79 pa ents came on follow up on day 42.Pa ents with intact tympanic membrane following surgery were 88.6% and remaining had residual perfora on of tympanic membrane.Of the study par cipants 87.3 % had improvement during post opera ve hearing assessment.(Table 1) th On 6 week follow up, 48.5% of pa ents with intact tympanic membrane post surgery had improvement in post opera ve hearing assessment.Among them 33 pa ents received only levocetrizine and 35 pa ents received levocetrizine plus nasal steroid.(Table 2) 92.3% of the pa ents receiving levoce rizine and topical nasal steroid post surgery had intact tympanic membrane on otoscopic examina on and there was a significant associa on with p value of 0.04 (Table 2) 86.07% of the pa ents had improvement in hearing post surgery with intact tympanic membrane and there was a significant associa on with p value of 0.025.(Table 3)

DISCUSSION
The prevalence of o s media in the school children in Nepal was found to be ranging from 5.4 to 13.2% and those with hearing loss comprised 12.47%.Prevalence was much higher in children than adults, par cularly belonging to 9-12 lower economic strata.
Tympanoplasty is the opera ve procedure done in pa ents with chronic o s media to restore middle ear func on and 3 remove infec on.The technique and approach for this 13 procedure is chosen by the surgeon, however post auricular approach is much favored as it leaves less visible scar.
Studies have shown that use of intranasal topical steroid is beneficial than use of only an bio c in Eustachian tube 14,15 dysfunc on which was comparable to our study.
In the present study underlay technique was used as it is ideal technique in terms of visualiza on, less me consuming and easy to perform.The other advantage of this technique is the correct level of healing of the drum in 3 respect to the annulus and ossicles.
There was remarkable postopera ve hearing improvement and closure of perfora on in 81 of 100 dry eared pa ents

CONCLUSION
Combina on therapy with topical intranasal steroid spray, an histaminics and an bio cs during post opera ve period a er Type 1 tympanoplasty for medium to large central perfora on of tympanic membrane is beneficial compared to an bio cs and an histaminics only in terms of gra intake and improvement in hearing.

RECOMMENDATION
This study, about outcome of Type 1 Tympanoplasty, with and without the use of topical nasal steroid is one of its kind conducted in Nepal.RCT and mul centric study has to be conducted to know about the exact beneficial effect of the use of topical nasal steroid following tympanoplasty.

LIMITATIONS OF THE STUDY
The research was conducted only in a small group of popula on with medium to large sized central perfora on a ending the ENT OPD.Similar kind of study has to be conducted in all the cases of mucosal disease in a larger group of popula on to know the exact beneficial effect of topical nasal steroid post surgery.

Figure 1 :
Figure 1: Bar diagram showing frequency of male and female pa ents receiving levocetrizine only and levoce rizine with nasal steroid post opera vely.

Table 1 :
Descrip on of general characteris cs of pa ents

Table 2 :
Comparison of surgical outcome in both the groups

Table 3 :
Associa on between post opera ve gra intake with assessment of hearing a er surgery It has been observed that age, gender or size of the perfora on had no significant effect on the outcome of 16 surgery.The condi on of the ear whether dry or wet (suppura ve) also doesn't play a role in outcome of surgery as sa sfying results were noted in terms of gra uptake and post opera ve hearing improvement in both dry and wet 17cases.