Is It Wise to Wait for Ear to Become Dry in Indian Scenario?

Abstract

Tympanoplasty is the standard and well-established procedure for closure of tympanic membrane perforations. Tympanoplasty in wet ear is still a topic of debate among ENT surgeons. This study discusses the balance between wait and watch policy and early intervention in wet ear. It also compares the rate of graft uptake and hearing improvement in Type I tympanoplasty in dry and wet ears. This is a hospital based, observational, descriptive and comparative study. Total 246 patients enrolled in the study. Two groups were created with 123 patients in each group. One included dry ears and another included wet ears. All patients had mucosal type of chronic otitis media. They all underwent Type I tympanoplasty. Graft uptake rate and hearing was compared between both groups. The overall success rate (graft uptake) was 91.06% (224). The success rate in dry ear group was 93.50% (115) and in wet ear group it was 88.62% (109). This study concluded that there is no added advantage of drying the ear rather the delay in treatment increases morbidity and drop outs in Indian scenario.

Introduction

Chronic otitis media (COM) is chronic inflammation of the middle ear-cleft, i.e. eustachian tube, middle ear and mastoid air cell system. In COM a permanent tympanic membrane perforation and chronic otorrhea of greater than six weeks duration unresponsive to oral and ototopical medications are present. It is a major cause of deafness in India [1].

It causes serious lifelong consequences when treatment is delayed. Early detection and effective treatment results in a good outcome and possible complications are thus avoided. Surgery is its definitive treatment. Tympanoplasty is one of its surgical treatment modalities (‘‘Tympanoplasty is an operation to eradicate disease in the middle ear and to reconstruct the hearing mechanism, with or without tympanic membrane grafting’’) [2].

Repairing the tympanic membrane perforation provides many benefits in terms of hearing improvement, achieve dry ear, cure of recurrent ear infections and elimination of need to take water precautions. Although being the most common surgical procedure in treating COM, there is always a dilemma in the mind of otologists in performing tympanoplasty on patients with active ear discharge, due to widespread misbelief that the success rate of ear surgeries on wet ears is comparatively inferior [3]. This study was intended to evaluate and compare the outcome of tympanoplasty in dry and wet ears in form of graft uptake and hearing improvement.

Materials and Methods

This study was conducted in the Department of Otolaryngology and Head & Neck surgery, S.M.S Medical College and Attached Hospitals, Jaipur, between January 2013 to June 2015. Patients of Chronic Suppurative Otitis Media (CSOM) fulfilling inclusion and exclusion criteria were included in the study after written and informed consent. Total 246 patients enrolled in the study and divided into two groups which included 123 patients in each.

• Group A—Patients of tubotympanic CSOM, whose ear was dry for at least last 6 weeks.

• Group B—Patients who had mucoid middle ear discharge with no microorganisms on culture.

The patients were selected on the basis of following criteria:

Inclusion Criteria

• Tubotympanic CSOM

• Age 15 to 50 years (both sexes)

• Patients with only mild to moderate conductive hearing loss

• Patient having good general physical condition

• All wet ear patients in whom the aural discharge culture and sensitivity showed no microorganisms

Exclusion Criteria

• Presence of cholesteatoma/granulation tissue/ossicular chain discontinuity/immobile ossicular chain/attic retraction

• Sensorineural hearing loss

• Prior attempts at tympanic membrane repair and any history of trauma to tympanic membrane

• Patient having any evidence of active infection in nose, throat and paranasal sinuses

• Any major systemic illness contraindicating surgery

• Patients who required surgery other than tympanoplasty

All the patients included in the study were subjected to detailed history, otorhinolaryngological examination and investigations, including pure tone audiometry, X-ray of mastoid (law’s view) for pneumatization of mastoid air cells and routine hematological and biochemical investigations to assess fitness. After the examination and appropriate investigations, informed consent was taken for participation in the trial. The air and bone conduction threshold averages were calculated by taking the average of 500, 1000, 2000 and 4000 Hz frequencies. The Air–Bone–Gap (ABG) was calculated by taking difference between air conduction and bone conduction thresholds. The air and bone conduction thresholds were recorded both pre and post operatively (at 3 months). The post-operative Air–Bone–Gap (ABG) closure was calculated by taking difference between pre-operative ABG and post-operative ABG of average frequencies of 500, 1000, 2000 and 4000 Hz. Hearing improvement after surgery was said to be significant when Air–Bone–Gap Closure (ABGC) was more than 10 dB.

Most of the surgeries were performed under local anesthesia by standard post auricular approach using underlay technique taking temporalis fascia as a graft material. Postoperatively, all the patients were put on injectable antibiotics for 1 day followed by oral antibiotics, analgesics and antihistaminics for 7 days. Sutures were removed on 7th day. All patients were followed up at 4 weeks and 3 months after surgery.

Otoscopy was done to assess the graft status and presence of any discharge at every follow-up and pure tone audiometry was done at 3 months during follow up. The successful graft uptake was assumed as healed and clinically intact tympanic membrane. Graft failure included residual perforation, recurrent perforation, displacement of graft, and complete graft failure. All the results were analyzed statistically using MSTAT software. The data between the two groups were compared using Chi square test and significance was ascertained using p value.

Results

In this study, 246 patients were enrolled, 123 patients were included in the dry ear group (A) and 123 patients in the wet ear group (B). Out of 246, 119 (48%) were male and 127 (52%) were female. Group A had 57(46%) males and 66(54%) females while group B had 62(51%) males and 61(49%) females.

Size of perforation was divided into four groups based on the tympanic membrane area involvement i.e. small (< 25%), medium (25-50%), large (> 50%) and Sub-total (> 75%). Amongst the 246 patients involved in the study, 20 had small (A-9, B-11) perforations, 123 had medium (A-63, B-60) perforations, 87 had large (A-42, B-45) perforations and 16 had subtotal perforation (A-9, B-7).

Among wet ear group 86 patients had mucoid discharge, 32 patients had mucopurulent discharge and purulent discharge was present in only 5 patients.

The overall success rate (graft uptake) was 91.06% (224). The success rate in dry ear group(A) was 93.50% (115) and in wet ear group(B) it was 88.62% (109). The total failure rate of our study was 8.94% (22). Failure among dry ear group(A) was 6.50% (8) and in wet ear group(B) it was 11.38% (14) (Table 1).

Table 1.

Success of graft

Graft uptake	Dry ear	Wet ear	Total
Yes	115	109	224
No	8	14	22

p = 0.362 (not significant)

Success rate of graft uptake was slightly higher in mucoid discharge (p = <0.01 significant) as compared to mucopurulent and purulent. We had 100% success rate in small perforation group, 89.43% among medium size perforation group and 93.10% successful in large perforation group and only 81.25% success rate was observed in subtotal perforation. Even though we had slightly significant success rate among small perforation group (20 patients), the overall success rate (91.06%) was not statistically influenced by the size of perforation.

Pure tone audiometry was done at follow up at 3 months and there were 185(75%) patients who had improvement in hearing and 61(25%) patients didn’t show any improvement (Table 2).

Table 2.

Post-operative status of hearing at 3 months

PTA	Frequency	Percent
Improved	185	75
Not improved	61	25

Discussion

Chronic otitis media is the result of an initial episode of acute otitis media and is characterized by a persistent discharge from the middle ear through a tympanic perforation. It is an important cause of preventable hearing loss particularly in the developing world [4].

Tympanoplasty is an established procedure, yet several factors influencing the short-term and long-term results, have been a subject of controversies. Various factors influencing its success rate reported in the literature are patient’s age, site of perforation, condition of the ears (dry or wet), grafting material and surgical techniques.

Tympanoplasty can be performed on dry perforation or wet perforation. As far as literature goes, controversies still surround the subject of performing it in wet ears. While performing dry and wet tympanoplasties, some authors are of the opinion that results of dry myringoplasty are better while others believe that the results of wet myringoplasty are also good.

Dry central perforations means that the ear should be dry for at least 6 weeks, tympanic membrane remnant should be of normal color, middle ear mucosa and tympanic plexus should be normal while wet perforations mean congestion of drum remnant, congestion of middle ear mucosa, presence of discharge in middle ear, polypoidal or mucosal hypertrophy of middle ear mucosa obscuring the view of tympanic plexus [5].

According to proponents of dry ear, we have to wait to get an ear dry before surgery and meanwhile patient needs to visit hospital several times for taking medications, which is not so easy in Indian scenario due to low awareness coupled with financial constraints. Many studies show that patients with COM belong to a lower socioeconomic status. In such conditions, patients stop to get follow ups which lead to treatment delay and it may progress towards complications of COM. So, in Indian scenario it is essential to operate as soon as possible if surgery is indicated, without waiting to get a dry ear.

In this study we have included inactive (dry) and active (wet) mucosal COM. However, there is debate in the literatures over whether discharging ear is predictive of surgical success. The current study was designed prospectively to analyze the success rate among dry and wet ears.

The overall success rate (graft uptake) was 91.06%. The success rate in dry ear was 93.50% and in wet ear group it was 88.62%. These results were statistically insignificant. Our study results were comparable with other studies. Vartiainen et al. [6] compared results of 404 patients of which 394 had dry ear and 10 patients had wet ear at the time of surgery. Their success rate was 87.5% and 70% respectively. Another prospective audit study done by Kotecha et al. [7] reviewed 1070 individual patients that were operated by 73 surgeons. Their results showed that patients with dry ear, mucoid, serous and purulent discharge had failure rates of 17.7%,17.1%,11.8%,17.2%, respectively [7, 8]. Gersdosff et al. [8] analyzed long term results of myringoplasty performed with formalized temporalis fascia auto graft. They studied the effect of influencing factors such as age of the patient and presence of infection at the time of surgery. They compared 53 dry ear patients with 20 wet ear patients. Success rate was 79.2% and 50% respectively, concluding that wet ear patients have increased risk of perforation, retraction pocket and myringitis [8]. A study conducted by Raj et al. [8] on patients with wet ears undergoing myringoplasty showed primary closure of perforation in 84% of patients [9]. Another study by Onal et al. [9] showed 44.4% success rate in wet ear and 71% in dry ear [10]. On the other end, improved results were seen in the study of Naderpour et al. [10] who noted that 28 cases out of 30 patients with wet ears (93.3%) and 29 out of 30 patients with dry ears (96.7%) had successful operations in terms of graft uptake which was statistically insignificant [11]. In the study done by Deosthale et al. [3] graft uptake was seen in 86.95% cases of dry ear group and 80% of wet ear group, the difference was statistically insignificant, these data concur with our results.

Shankar et al. [11] reported a success rate of 88.6 per cent for dry ears and 80 per cent for wet ears. Neither the type (p = 0.526) nor the presence (p = 0.324) of discharge influenced the success rate [12]. A similar data was attained by Shreyash et al. [12], in a series of 60 patients who underwent tympanoplasty with success rate of 90% graft uptake in dry ears and 86.7% in wet ears [13]. In a series of 103 patients, with wet ear in 67 and dry ear in 36 patients of CSOM, Yojana Sharma et al. [13] reported that the success rate was 94% in wet ear and 100% in dry ear in terms of graft uptake and p value was 0.2 i.e. no statistically significant difference found between the two groups [14].

Various literature reviews show conflicting results on this issue. Nagle et al. [14], who did a comparative study of the outcome of type I tympanoplasty in dry and wet ear patients with scanty, mucoid discharge. They compared graft uptake and hearing improvement in both groups and quoted that in dry ear primary closure rate was 88% while in wet ear primary closure rate of was 74% which was statistically insignificant (p > 0.05) [15]. Some other authors have also found that attempts to repair perforation fail significantly more often in moist ear than in dry ear [16–18] (Table 3).

Table 3.

Graft uptake rate in various studies

Author	Study year	Success in dry ear (%)	Success in wet ear (%)
Vartiainen et al.	1985	87.5	70
Gersdosff et al.	1995	79.2	50
Onal et al.	2005	71	44.4
Nagle et al.	2009	88	74
Naderpour et al.	2016	96.7	93.3
Deosthale et al.	2017	86.95	80
R Shankar et al.	2017	88.6	80
Shreyash et al.	2017	90	86.7
Yojana Sharma et al.	2017	100	94
Present study	2020	93.5	88.62

Conclusion

The inference of this study is that the success rate of graft uptake and hearing gain is not influenced by presence of ear discharge at the time of surgery. Thus, there is no added advantage of dry ear rather than delay in treatment, increased morbidity and drop outs. So, it is not wise to wait for ear to become dry in Indian scenario.

Limitations

1. The study couldn’t be randomized due to ethical reasons of violation of standard treatment guidelines which state to wait till the ear gets dry before surgery.

2. Patient selection bias: Patients selected their own group because of time loss and financial loss in poor patients.

3. Berkson’s bias: Patient coming to SMS hospital may not be true representative of universe as study site is a government hospital and a particular section of population visiting there for treatment.

Authors’ Contribution

All authors contributed in the conceptualization, in the preparation and final disposition of this manuscript.

Compliance with ethical standards

Conflict of interest

There has been no financial support and no conflicts of interest in this study.

Ethical Approval

The study was approved by the ethics committee of SMS Medical College, Jaipur.

Informed Consent

An informed consent was taken from all patients as well as first hand relatives.