Outcomes of Tympanoplasty Performed in Dry and Wet Ear Groups: A Comprehensive Comparative Study

Abstract

There are various factors which affect the success rate of tympanic membrane (perforation) closure, including age of the patient, size of the perforation, duration of the ear discharge, the presence or absence of infective discharge at the time of surgery. Our aim was to observe the effect of presence of discharge from the ear on the success (outcome) of tympanoplasty. This is prospective study which was conducted on 300 cases with 150 patients each in dry and wet ear group. The study was conducted on patients of age 12–65 years and of either sex presenting with chronic otitis media. Ear discharge for less than 10 years, 78% in dry ear group and 81% in wet ear group. Around 64% had complaint of decreased hearing for < 5 years in dry ear group and 60% in wet ear group. The size of perforation in dry ear group, moderate size perforation was found being predominant 46%, large in 42% and small in 12% patients. In wet ear group 46% patients had moderate, 16% patients had small and 38% patients had large perforation. Improvement in hearing was seen in 105 (70%) cases and worsening in 9 (6%) cases in dry ear group and 114 (76%) hearing improvement, 9 (6%) worsening in wet eargroup. Graft failure was 12 (8%) in dry ear and 15(10%) in wet ear. Worsening in the hearing was seen in 6% cases in both dry and wet ear groups. No other complications were noted in patients during follow up period.

Introduction

Chronic suppurative otitis media (CSOM) is an inflammatory process in the middle ear cavity. It can cause long term, more often permanent changes in the tympanic membrane that includes atelectasis, dimer formation, perforation, tympanosclerosis, retraction pocket development or cholesteatoma [1]. It is a common condition seen in patients coming to otorhinolaryngology clinic. The patient may present with ear discharge, a permanent perforation or impairment in hearing. A perforation in the tympanic membrane can result from either trauma or infective process; out of which the infective process is a more common cause. Lot of the perforation heals spontaneously, but this spontaneous healing is affected by chronicity of infection and certain permanent changes in the margin of perforation leading to a non-healing permanent perforation. This leads to a constant exposure of middle ear for re-infection and hearing disability [2].

CSOM is further sub-classified as inactive mucosal type, active mucosal type, inactive squamous type, active squamous type & healed type [1]. Tympanoplasty is the reconstruction of the tympanic membrane defect along with elimination of disease, if any, from the middle ear and reconstruction of ossicular chain if diseased [2]. Targets of tympanoplasty are to achieve a dry ear by eradicating middle ear disease and hearing improvement by closure of any tympanic membrane perforation by grafting and/or ossicular reconstruction.

There are many factors which influence the success rate of tympanic membrane closure, including age of the patient, size of the perforation, duration of the ear discharge, the presence or absence of infective discharge at the time of surgery [2]. The discharging ear presents to the surgeon whether to operate or not to operate. This is due to the widespread belief that the success rate while doing tympanoplasty on wet ear is decidedly and comparatively inferior. The main objective of this study is to observe the effect of this discharge from the ear on the success of tympanoplasty [3].

Objectives

This study has been conducted to compare the outcomes of tympanoplasty in patients with dry and wet ears on the ground of success of graft uptake in dry and wet ears and the post-operative hearing improvement.

Methods

Study Design and Setting

• Prospective study

• It was conducted in the department of Otorhinolaryngology (ENT) in our tertiary care hospital during the period of December 2017 to November 2020 after taking clearance from the institutional ethical committee.

Sample Size and Study Population

• This study was conducted on 300 cases with 150 patients each in dry and wet ear group. The study was conducted on patients of age 12–65 years and of either sex presenting with Chronic Suppurative Otitis Media. Due written informed consent was obtained from the patients before the recruitment. The consent was explained in vernacular language to the patients.

Inclusion Criteria

• Patients of age 12–65 years and of either sex with chronic otitis media having mucosal type of disease and willing to participate for the study and surgery. All patients were given oral and/or injectable antibiotics with/without local antibiotic ear drops in selective patients, alongside symptomatic therapy for an adequate duration before posting them for surgery.

Exclusion Criteria

• Patients of age less than 12 years and above 65 years, patients with chronic otitis media, squamous type of disease, patients with culture positive discharge to pathogen, patients with any active predisposing sinonasal pathology, patients with complicated COM, patients with eustachian tube dysfunction (assessed by impedance audiometry), totally deaf ear, patients with syndromal deafness, patients who refuse or unfit for surgery, patients with SNHL and mixed hearing loss and patients with revision surgery.

Study Procedure

The patients underwent thorough clinical, audiological, radiological and laboratory investigations according to set performa. Patients were admitted to the hospital one day before surgery. After ensuring pre-operative anaesthesia fitness, patients were taken for surgery. All cases were operated under general anesthesia. 2% lignocaine with adrenaline (1:200000) was used for local infiltration. Most patients were operated through the Wilde’s post-auricular incision while few cases were operated through endaural and transcanal approaches as well. Status of ossicles and condition of middle ear mucosa was noted. Patency of aditus was established by antrotomy and confirmed by seeing the flow of saline into middle ear from antrum. The temporalis fascia graft was placed by interlay technique in all cases medial to the handle of malleus. Periosteum, subcutaneous tissue and skin were sutured in layers and mastoid bandage dressing was applied.

Post-operatively patients were given antihistamines for 3 weeks and antibiotics, analgesics, topical nasal decongestants were used for 1 week. The mastoid bandage dressing was changed after 48 h of surgery and the sutures were removed after 1 week of surgery and regular follow-up took place at 4th week, 8th week and 12th week postoperatively. Graft uptake and complications were evaluated in each visit. Hearing improvement was evaluated with the help of pure tone audiometry at 3rd month and compared with pre-operative pure tone audiometry. The hearing improvement was evaluated on speech frequencies of 0.5, 1 and 2 KHz. The observations and results were tabulated and statistically analyzed to draw final conclusions.

Statistical Analysis

All the data were filled in Microsoft Excel, which was then transferred to SPSS version 21, for statistical analysis. Differences in the values of pre-operative and post-operative clinical and investigatory outcome variables in the study groups were eventually evaluated using Chi-square test. The confidence interval percentage for this study was 95 % and result was considered significant if the p-value was >0.05.

Results

In our study most of the patients belonged to the age group of 12–25 years amongst which 102 (68%) were in dry ear group and 87 (58%) were in wet ear group. It was observed that there was a female predominance—78 (52%) in dry ear group and 102(68%) in wet ear group. Most of the patients had a complaint of bilateral ear discharge—63(42%) in dry ear group and 66 (44%) in wet ear group. Amongst those having unilateral complaint, right ear involvement 51(34%) was more in dry ear group and left ear 45(30%) in wet ear group.

Majority of the patients had a complaint of ear discharge for less than 10 years—78% in dry ear group and 81% in wet ear group, while 96 (64%) had hearing impairment for less than 5 years in dry ear group and 90 (60%) in wet ear group.

Regarding the size of perforation in dry ear group, moderate sized perforation was found to be predominant i.e. 69 cases (46%), large in 63 cases (42%) and small in 18 cases (12%) patients. In wet ear group the distribution was found to be 69 cases (46%) had moderate, 24 cases (16%) small and 57 cases (38%) large perforation.

In our study, successful graft uptake was seen in 126 cases (92%) and failure in 12 cases (8%) in dry ear group while in wet ear group graft uptake was seen in 135 cases (90%) and failure in 15 cases (10%). Hearing improvement was seen in 105 cases (70%) while worsening was seen in 9 cases (6%) amongst the dry ear group. On the other hand, hearing improvement was seen in 114 cases (76%) and worsening in 9 cases (6%) amongst the wet ear group.

As seen in Table 1, the improvement in hearing seen in 48 (72.7%), 33 (64.7%), 12 (80%), 12 (66.7%) in patient with ear discharging from 0–5 years, 6–10 years, 11–15 years and more than 15 years respectively and graft uptake—63 (95.4%), 45 (88.2%), 15 (100%), 15 (83.3%)in patient with ear discharging from 0–5 years,6–10 years, 11–15 years and more than 15 years respectively in dry ear group.

Table 1.

Surgical outcome in relation to duration of dry ear discharge

Duration of onset of ear discharge (in years)	Total number of dry ears	Improvement in hearing			Graft uptake
		Improved	Not improved	Worsen	Taken	Not taken
0–5	66	48	15	3	63	3
6–10	51	33	15	3	45	6
11–15	15	12	0	3	15	0
> 15	18	12	6	0	15	3

As seen in the Table 2, wet ear group showed improvement in hearing in 57 (82.6%), 42 (73.7%), 6 (100%), 9 (50%) in patient with ear discharging from 0–5 years, 6- 10 years, 11–15 years and more than 15 years respectively and graft uptake—57 (82.6%), 57 (100%), 6 (100%), 15 (83.3%) in patient with ear discharging from 0–5 years,6–10 years, 11–15 years and more than 15 years respectively.

Table 2.

Surgical outcome in relation to duration of wet ear discharge

Duration of onset of ear discharge (in years)	Total number of dry ears	Improvement in hearing			Graft uptake
		Improved	Not improved	Worsen	Taken	Not taken
0–5	69	57	3	6	57	12
6–10	57	42	15	3	57	0
11–15	6	6	0	0	6	0
> 15	18	9	9	0	15	3

Table 3 shows that the improvement in hearing was observed in 69 (71.9%), 24 (66.6%), 9 (60%), 3 (100%) in patient with complaint of impaired hearing present for duration since 0–5 years,6–10 years, 11–15 years and more than 15 years respectively and graft uptake—90 (93.7%), 33 (91.6%), 15 (100%), 0 in patient with ear discharging from 0–5 years,6–10 years, 11–15 years and more than 15 years respectively in dry ear group.

Table 3.

Duration of hearing impairment after surgical outcome in dry ear

Duration of onset of ear discharge (in years)	Total number of dry ears	Improvement in hearing			Graft uptake
		Improved	Not improved	Worsen	Taken	Not taken
0–5	96	69	24	3	90	6
6–10	36	24	6	6	33	3
11–15	15	9	6	0	15	0
> 15	3	3	0	0	0	3

Table 4 shows that in wet ear group, hearing improvement was seen in 75 (83.3%), 30 (71.4%), 6 (50%), 3(50%) in patient with complaint of impaired hearing present for duration since 0–5 years,6–10 years, 11–15 years and more than 15 years respectively and graft uptake—78 (86.7%), 42 (100%), 9 (75%), 6 (100%) in patient with ear discharging from 0–5 years,6–10 years, 11–15 years and more than 15 years respectively.

Table 4.

Duration of hearing impairment after surgical outcome in wet ear

Duration of onset of ear discharge (in years)	Total number of dry ears	Improvement in hearing			Graft uptake
		Improved	Not improved	Worsen	Taken	Not taken
0–5	90	75	9	6	78	12
6–10	42	30	9	3	42	0
11–15	12	6	6	0	9	3
> 15	6	3	3	0	6	0

Figures 1 and 2 shows that—15 (83.3%), 57 (82.6%), 33 (52.3%) patients showed improvement in hearing and graft uptake was seen in 18 (100%), 69 (100%), 54 (85.7%) having small, moderate and large perforations respectively in dry ear group. In wet ear group, hearing improvement was observed in 21 (87.5%), 60 (86.9%), 33 (57.9%) and graft uptake was seen in 24 (100%), 63 (91.3%), 48 (84.2%) patient having small, moderate and large perforations respectively.

Fig. 1.

Distribution of cases based on size of perforation in dry and wet ear

Fig. 2.

Distribution of cases based on graft uptake in accordance to the size of perforation in dry and wet ear

Discussion

It was observed during our study period that most patients attended for surgical management in chronic otitis media belonged in the age group of 15–25-years. Increased awareness amongst people regarding health issues and the disease affecting their daily pursuits leading patients to seek early medical intervention might be the reason for this early presentation. The results are comparable to a similar study conducted by Varshney et al., where the number of cases in the 16–25-year age group were 51.3%, and this formed the most predominant group in their study [4]. Another similar study conducted by Lasini et al. showed that the majority of the patients were young aged between 21 and 34 years [5].

In our study there was a female predominance in both dry and wet ear group—52 and 68% respectively. The results were comparable to similar studies conducted by Kaur et al. [5], Varshney et al. [4] and Lasini et al. [5].

In our study, the observed incidence of bilateral ear discharge was found to be in 42% cases in dry ear group while in 44% cases in wet ear group. The incidence with unilateral ear discharge—right ear affected more in dry ear group and left ear in wet ear group. Findings were comparable with a similar study conducted by Kaur et al. where left sided ear was affected in 29 cases (58%) and right side was affected in 21 cases (42%) [6].

It was observed that most of the cases had a complaint of ear discharge for less than 10 years and decreased hearing for less than 5 years. A trivial number accounting for mere 12% were observed with ear discharge lasting for more than 15 years in both groups. In a similar study conducted by Lasini et al., it was documented that majority of the patients had the complaint of ear discharge as their major complaint and the duration was more than 10 years [5].

In our study, the duration of hearing impairment had no significant importance to the post-operative hearing improvement in both dry and wet ear groups. This could possibly be because the patients were not aware about the severity of hearing impairment in early stages of the disease. Uncertain and indefinite history regarding the duration of hearing loss may be another factor responsible.

According to the observations made in our study, the successful graft uptake following tympanoplasty was seen in 92% in dry ear and 90% in wet ear. There was no statistical significance (p = 0.72) between the two groups in respect to graft uptake. In a study conducted by Hosny et al., graft uptake rate for myringoplasty was 90.4% in dry ears and 87% in wet ears, and it also suggested that these differences were not statistically significant [7]. Rate of successful graft uptakes in studies conducted by Jain et al., Guo et al., Patil et al., Komune et al., Kawatra et al., and Hay and Blanshard were 96.6, 96, 96, 94.2, 93.3 and 91% respectively [8–13].

In our present study, there was a hearing improvement in 105 cases (70%) in the dry ear group and in 114 cases (76%) in wet ear group, while 57 (38%) and 54 (36%) cases showed a hearing improvement of more than 10 dB in wet ear groups and dry ear groups respectively. There was no statistical significance (p = 0.312) found on comparing the both groups in accordance to hearing improvement. Similar observations were seen in a study conducted by Hosny et al. where the hearing improvement seen was 91.3% in wet ear group and 92.3% in dry ear group, and these differences were not statistically significant [7]. Another study conducted by Hatice Emir et al. suggested that the post-operative hearing improvement was 47.3% in dry ear group while it was 40.7% in wet ear group [14]. In a study conducted by Benjamin et al., similar findings were seen and it was concluded that the post-operative hearing improvement for dry and wet ear groups were not statistically significant [15]. Observations made by Tos et al. in a similar study concluded that there was a hearing improvement of more than 10 dB in 87% of the dry ear cases and 66% of the wet ear cases. Raj et al. observed improvement in hearing ability in 68% of the patients undergone myringoplasty in wet ear [16].

In our study, it was seen that there was an inverse relationship between the size of perforation and the improvement of hearing and chances of graft uptake. This can be attributed to thin nature of the remnant tympanic membrane and reduced vascularity to the margins of perforation. In both dry and wet ear groups, there was a 100% graft uptake having small perforation pre-operatively. Similar outcomes where the success rate with small perforations being 87.5% and that with bigger perforations being 75.8% were made by Emir et al.[14]. The success rate observed by Benjamin et al. for small and large perforations were 93 and 85.1% [15]. These findings were comparable to our results.

Limitations

Like every study, our study too had its share of limitations. The findings cannot be generalized as—the study had limited sample size, the study was conducted in a limited geographical area, there was difficulty in achieving long term follow up with patients and since the failure rate might have increased due to poor hygiene of the patients as most of them were belonging to low socio-economic background. Also confounding factors like atopy, immunological factors etc. possibly must have interfered with the results.

Conclusion

Successful graft uptake obtained was 92 and 90% in the dry and wet ear groups respectively which statistically has a p-value of 0.72 (p > 0.05) which is not significant. The post-operative hearing improvement was between 0 and 5 dB in 24 patients with dry ear and 9 patients with wet ear; between 6 and 10 dB in 24 patients with dry ear and 48 patients with wet ear; of more than 10 dB in 57 patients with dry ear and 57 patients with wet ear where statistically p-value is 0.312 (p > 0.05) which is not significant. To summarise, the p-value was observed to be not significant in respect to both—the graft uptake rate and hearing improvement. This shows that the presence of discharge in the ear at the time of surgery does not interfere with the outcome of tympanoplasty. The rate of graft failure was 12 (8%) in dry ear group and 15(10%) in wet ear groups. A worsening in the hearing was observed in 6% cases belonging to the dry ear and wet ear groups. There were no other complications noted in cases during the follow up period.

Funding

The authors did not receive support from any organization for the submitted work. No funding was received to assist with the preparation of this manuscript. No funding was received for conducting this study. No funds, grants, or other support was received.

Declarations

Conflict of interest

The authors have no relevant financial or non-financial interests to disclose. The authors have no conflicts of interest to declare that are relevant to the content of this article. All authors certify that they have no affiliations with or involvement in any organization or entity with any financial interest or non-financial interest in the subject matter or materials discussed in this manuscript. The authors have no financial or proprietary interests in any material discussed in this article.

Ethical Approval

Ethical approval for the study was approved by the Institutional Ethics Committee of SMIMER, Surat, Gujarat (India).

Informed consent

Informed consents were taken from all patients participating in the study.