Background: The Otitis media is an important and a highly prevalent disease of the middle ear and poses serious health problem world-wide especially in developing countries where large percentage of the population lacks specialized medical care. With a large number of patients frequently undergoing tympanoplasty for chronic suppurative otitis media (CSOM), it is important to assess the severity of the disease and predict the outcome of the surgical management. Materials and Methods: This was a prospective study of 90 cases of chronic otitis media, carried out over one year, who underwent various types of tympanoplasty, carried out in the Department of Ear, Nose, and Throat (ENT), Tertiary Care Teaching Hospital. The selection of cases was by convenience sampling method. All the cases of Chronic Otitis Media (COM), mucosal and squamous, in the age group of 10–80 years, irrespective of gender were included. Patients above 80 years, sensorineural or mixed hearing loss, COM with complications, any co morbid medical condition and unwilling patients were excluded. Result: The clinical profile of cases in present study. Almost all patients (97.8%) have complaint of on and off ear discharge followed by 91.1% cases having complaint of HOH followed by tinnitus (in 24.4% cases). In this study, 11.1% of the patients had active discharge. Maximum patients (48.9%) had ear dry for less than 3 months, rest had dry ear for more than 3 months. Three patients had history of trauma and no history of ear discharge. Ossicular involvement was seen in only 18.9% cases while in 81.1% cases, there was no ossicular involvement. In majority of cases (80%) middle ear mucosa was dry followed by wet mucosa in 13.3% cases. Total number of patients with score 1-3 (mild score) were 64.2%, with score 4-6 (moderate disease) were 27.1% and with score 7-12 (severe disease) were 8.7%. Conclusion: This study concludes that the MERI can be a useful tool in the preoperative evaluation in order to assess the probability of success of tympanoplasty. |
There are many factors which influence the success rate of tympanoplasty. [1] These include age of the patient, size and site of the perforation, status of the ear (dry or discharging), and the surgical technique, but their real role is still unclear. [2] Therefore, the reported success rate of tympanoplasty is extremely variable, ranging from 35% to 92%. [3] Furthermore, Bluestone, considered the postoperative recurrence of negative middle ear pressure or serous effusion as a surgical failure. There is no agreement as to the timing of the procedure. [4]
Some authors prefer to perform surgery as soon as possible to prevent disease progression, ossicular chain erosion, and the formation of cholesteatoma, avoid hearing loss in the speech development period, and allow swimming activities. [5] Others prefer to delay the operation because of the high incidence of upper respiratory infections during childhood, unpredictable Eustachian tube function, immature immunity, possible spontaneous healing, and the possibility of preventing recurrent middle ear infection because of the adequate ventilation allowed by tympanic perforation during the period of Eustachian immaturity. [6-15]
Many previous studies in the literature have found good correlation between middle ear risk index (MERI) developed by Kartush and success of tympanoplasty. MERI scoring can be useful in predicting the outcome of tympanoplasty, with low MERI having a good surgical outcome. [16] Our study is different from previous studies in that we have used MERI in predicting the outcome of tympanoplasty in our cases.
This was a prospective study of 90 cases of chronic otitis media, carried out over one year, who underwent various types of tympanoplasty, carried out in the Department of Ear, Nose, and Throat (ENT), Tertiary Care Teaching Hospital. The selection of cases was by convenience sampling method.
Inclusion Criteria
All the cases of Chronic Otitis Media (COM), mucosal and squamous, in the age group of 10–80 years, irrespective of gender were included.
Exclusion Criteria
Patients above 80 years, sensorineural or mixed hearing loss, COM with complications, any co morbid medical condition and unwilling patients were excluded.
All the cases underwent detailed history taking, general physical examination and examination of ear, nose and throat including oto-microscopy. Audiological examination was done. Pure tune audiometry was done by Pure-tone audiometry (PTA) by MA 42, MAICO Audiometer, ASI standardized. Air and Bone conduction was measured for 250,500,1000,2000,4000 Hertz. And the results were expressed in dB (decibel) hearing loss. The degree of hearing was calculated according to WHO criteria. Masked PTA was done if the air bone gap (A-B gap) was more than 40 dB.
According to the MERI score, risk categorization was done. All the patients underwent tympanoplasty under same setup and by the same surgeon using postaural approach and the temporalis fascia as the graft material. Ossicular status was assessed at the time of tympanoplasty surgery. All the patients were followed up every 2 weeks for the 1st month. Thereafter, they were followed up monthly for 4 months during which the assessment of graft uptake was done. Repeat PTA was done. The results were tabulated and analyzed.
Statistical Analysis
Data was analyzed by using SPSS 26. The results were expressed in number and percentage. Mean and standard deviation with range were recorded. Significance level of association was assessed by calculating ‘p’ value using t-test and chi-square test, p-value less than 0.05 was considered significant.
Table 1 shows the demographic profile of cases in present study. Maximum number of patients (44.4%) belong to age group 21-30 years followed by 10-20 years age group (35.6%). The youngest of the case was 12 years old girl and oldest was 60 years old male patient. In present study, female outnumbered male showing 53.3% cases in comparison of 46.7% males.
Table 1: Distribution of Age Group
Age group |
No. of cases |
Percentage cases |
10-20 |
32 |
35.6 |
21-30 |
40 |
44.4 |
31-40 |
10 |
11.1 |
41-50 |
6 |
6.7 |
>50 |
2 |
2.2 |
Total |
90 |
100 |
Table 2: Distribution of Gender
Gender |
No. of cases |
Percentage cases |
Male |
42 |
46.7 |
Female |
48 |
53.3 |
Table 3: Distribution of Chief Complaint
Chief Complaint |
No. of cases |
Percentage cases |
Ear discharge(on/off) |
88 |
97.8 |
HOH |
82 |
91.1 |
Tinnitus |
22 |
24.4 |
Earache |
8 |
8.9 |
Ear itching |
0 |
0 |
Table 3 shows the clinical profile of cases in present study. Almost all patients (97.8%) have complaint of on and off ear discharge followed by 91.1% cases having complaint of HOH followed by tinnitus (in 24.4% cases).
Table 4: Distribution of Duration of discharge free period
Duration of discharge free period |
No. of cases |
Percentage cases |
Active ear |
10 |
11.1 |
<3 months |
44 |
48.9 |
4-6 months |
20 |
22.2 |
7-12 months |
7 |
7.8 |
>1 Year |
8 |
8.9 |
No History of Discharge |
1 |
1.1 |
In table 4, 11.1% of the patients had active discharge. Maximum patients (48.9%) had ear dry for less than 3 months, rest had dry ear for more than 3 months. Three patients had history of trauma and no history of ear discharge.
Table 5: Distribution of Ossicular involvement
Ossicular status |
No. of cases |
Percentage cases |
Ossicular chain intact and mobile |
73 |
81.1 |
Malleus necrosed |
9 |
10 |
Incus necrosed |
5 |
5.6 |
Stapes suprastructure |
2 |
2.2 |
Ossicular chain fixed |
1 |
1.1 |
In table 5, Ossicular involvement was seen in only 18.9% cases while in 81.1% cases, there was no ossicular involvement.
Table 6: Distribution of Middle ear mucosa status
Middle ear mucosa |
No. of cases |
Percentage cases |
Dry |
72 |
80 |
Wet |
12 |
13.3 |
Congested |
6 |
6.7 |
In table 6, in majority of cases (80%) middle ear mucosa was dry followed by wet mucosa in 13.3% cases.
Table 7: Profile of post-operative graft uptake during follow up
Parameter |
Observations |
||
|
Graft uptake |
No. of cases |
Percentage cases |
Graft uptake at 20 days |
Wet Graft |
7 |
7.8 |
Congested graft |
79 |
87.8 |
|
Pale graft |
4 |
4.4 |
|
Graft uptake at 6 weeks |
Graft uptake at 6wks |
No. of cases |
Percent |
Perforation |
9 |
10 |
|
Intact |
81 |
90 |
|
Graft uptake at 6 months |
Graft uptake at 6mths |
No. of cases |
Percent |
Perforation |
10 |
11.1 |
|
Intact |
80 |
88.9 |
Table 7 shows that 20 days after surgery, 11.1% cases had wet graft. Rest 88.9% cases had congested dry graft. After 6-week follow-up, 10% cases had perforation while 90% cases had intact graft. After 6 months follow-up, 11.1% cases had permanent perforation while 88.9% cases had intact graft.
Table-8: Comparison of hearing before and after surger
|
Mean±SD (N=90) |
p-value |
Pre-operative PTA |
36.64±11.594 |
<0.001 |
Post-operative PTA |
29.19±11.158 |
Table 9: Distribution of cases as per MERI Index
MERIs index |
Percentage |
Mild (1-3) |
64.2% |
Moderate (4-6) |
27.1% |
Severe (7-12) |
8.7% |
Table 9 shows that total number of patients with score 1-3 (mild score) were 64.2%, with score 4-6 (moderate disease) were 27.1% and with score 7-12 (severe disease) were 8.7%.
Risk factor |
Value-assigned risk |
Otorrhea (belluci) |
|
I)Dry |
0 |
II)Occasionally wet |
2 |
III)Persistently wet |
3 |
IV) Wet, cleft palate |
4 |
Perforation |
|
Absent |
0 |
Present |
2 |
Cholesteatoma |
|
Absent |
0 |
Present |
3 |
Ossicular status (Austin/Kartush) |
|
0) M+I+S+ |
0 |
A) M+S+ |
2 |
B) M+S- |
3 |
C) M-S+ |
4 |
D) M-S- |
5 |
E) Ossicle head fixation |
3 |
F) Stapes fixation |
4 |
Middle ear: granulations or effusion |
|
No |
0 |
Yes |
3 |
Previous surgery |
|
None |
0 |
Staged |
2 |
Revision |
3 |
Smoker |
|
No |
0 |
Yes |
3 |
*A value is assigned for each risk factor, and then the values are added to determine the MERI. (M-malleus, I-incus, S-stapes).
Tympanoplasty is a commonly performed procedure. Previously published studies have demonstrated its benefits in this age group and investigated the most important determinants of surgical success with the aim of selecting the best candidates for tympanoplasty. [17] In the present study, the rates of surgical anatomical and functional success with a minimum follow up period of 12 months, demonstrating that tympanoplasty is a safe and highly effective procedure in childhood. Our results are similar to those of other studies in which the same definitions of anatomical and functional success were used. Gonçalves et al. obtained anatomical and functional success, while Çayir, reported a functional success rate between 85.7% and 90.4%, depending on the type of graft used. [18] Similarly, Baklaci, showed an anatomical success rate of 86.3% and functional success rate of 74.5%.
Multiple factors have been shown to influence the surgical success of pediatric tympanoplasty, including the status of the contralateral ear, the type of tissue used as graft, and the surgical technique. In the present study, there were no statistically significant differences in these factors between the two groups (surgical success versus failure), which shows that in isolation, they may not play a major role in determining the outcomes, a finding that has also been confirmed by previous studies. [19]
The assessment of middle ear status is a crucial factor for surgical success. The MERI has been shown to be useful for the prediction of surgical outcomes, and some studies have shown a positive correlation between the MERI scores and recurrence of postoperative tympanic perforation. [20] In the present study, we demonstrated that a MERI score higher than 7 was significantly correlated with the likelihood of an unfavorable postoperative outcome, whereas scores lower than 3 (mild disease) were found to be protective against surgical failure. These findings are in line with those reported in the literature, emphasizing the reproducibility of the MERI in children. [21]
The present study demonstrates that the MERI is a useful tool during presurgical evaluation for predicting the success of tympanoplasty in patients. The MERI is a useful tool in clinical practice because it allows selection of the best candidates, identification of risk factors that may be optimized before the surgical intervention, and giving information to the patient about the probability of surgical success