A Study on Outcome of Myringoplasty in Dry Ear (Quiescent/Inactive CSOM) Without Using Gelfoam in Middle Ear

Abstract

Myringoplasty is a common surgery done for patients with tympanic membrane perforation in our clinical practice. This study was done to know the outcome of myringoplasty done without using gelfoam as a scaffold material. Simultaneously other parameters influencing the outcome were analysed. In a total of 80 patients assessed over 25 months were divided into test and control group by quasi randomisation. All patients underwent endoscopic underlay myringoplasty. Control groups had gelfoam bed created with gelfoam, whereas the test group only middle ear air pocket created with a proper seal without using gelfoam. The study revealed that without using gelfoam and creating a good middle ear air pocket the results were comparable to the method of using middle ear gelfoam bed. Also few insights and understanding regarding the parameters we need to asses preoperatively were also observed. With comparable healing and hearing results without using gelfoam in the middle ear, the normal physiology is restored in the postoperative period much earlier. The result of the surgery also becomes evident in the second postoperative week when the use of gelfoam in the middle ear is avoided.

Introduction

From the seventeenth to the nineteenth century, many attempts at closing tympanic membrane perforations using various materials were made, resulting in the “paper patch” technique done by Blake in 1887. Now, Temporalis fascia is the material of choice for reconstruction of the tympanic membrane [1]. Myringoplasty, a technique for reconstructing a vibrating tympanic membrane [2] is a common procedure but has evolved over the years with the development of new concepts in dealing with simple perforations. As documented in the experimental animal studies, the proliferation of stratified squamous epithelium at the rim of the perforation begins within 12 h, and granulation begins at 36 h [1]. As long as there is a suitable flat surface, squamous epithelium grows at a rate of 1 mm a day. It is hypothesized that the use of gelfoam in the middle ear has lead to an increased incidence of postoperative discharge and intratympanic adhesions that can significantly hinder the outcome of the hearing of the patient. The aim of the study is to avoid using gelfoam in the middle ear and allow normal transmucosal gas exchange to be restored so that the tympanic cavity can be aerated earlier.

Materials and Methodology

The study was conducted in the Department of Otorhinolaryngology of our institution after obtaining Human ethics committee approval. The study was conducted as a prospective quasi-randomised method. All patients who were aged between 15 and 65 years either sex, patients with small, moderate and subtotal central perforation, patients with only mild to moderate conductive hearing loss, patients with no evidence of active infection in nose, para nasal sinuses and throat, patients with no evidence of allergy or related symptomatology, patients with no evidence of attic perforation, sensorineural hearing loss or active chronic suppurative otitis media (CSOM) were included in the study. Those patients with a total perforation or an attic perforation, a mixed or a pure sensorineural hearing loss, an active mucosal CSOM, an active infection in the nose, para nasal sinuses and throat, allergy related symptomatology, patients with Diabetes mellitus, Coronary artery disease were excluded from the study.

A total of 80 patients were enrolled in the study after screening for inclusion criterion. They were divided into a control group (odd) and a test group (even). The test group did not use the standard gelfoam bed in the middle ear after the placement of underlay graft in myringoplasty (Fig. 1).

Fig. 1.

Showing the details of the patients included in the study and divided into two groups

All the patients went through the following (1) examination under microscope (2) pure tone audiogram (pre-op and post-op) (3) X-ray both mastoid (4) routine laboratory investigation (complete blood counts, renal function tests) after enrolling for the study.

It was primarily a prospective quasi-randomised control study where all patients in the odd number were chosen for myringoplasty with gelfoam in the middle ear and all patients enrolled in the even number were chosen for no gelfoam technique. All the surgeries were done under local anaesthesia with prescribed weight titrated premedication. A 0 degree Hopkins rod nasal endoscope and Karl Storz camera unit was used for the transcanal myringoplasty. Temporalis fascia was used in all the patients as the graft material which was harvested by a separate supra-aural incision under local anaesthesia.

Local anaesthesia of 1:1,00,000 adrenaline given in the four quadrants of the external auditory canal as in any standard ear procedure. This was followed by asking the patient to do a Valsalva manoeuvre to test the patency of the Eustachian tube. Patency confirmed by noticing air bubbles coming out through the perforation of the tympanic membrane. Ear canal packed with cottonoids soaked in local anaesthetic (4% lidocaine) and adrenaline for local vasoconstriction.

The margins of the perforation were freshened by using a sickle knife and under surface of the remnant tympanic membrane was made raw with a round knife. Rosen incision from 6’o clock position to 1’o clock position anterior to the lateral process of malleus was made, tympanomeatal flap elevated, annulus elevated from the sulcus, middle ear entered, malleus skeletonised from the lateral process to tip. Ossicular continuity confirmed by demonstrating a round window reflex.

In patients who were in the control (gelfoam) group, after placing the graft lateral to handle of malleus. Dry gelfoam placed in the middle ear to prepare the bed for the graft and the tympanomeatal flap repositioned. Gelfoam placed along the approximating margins of canal incision (Fig. 2a–d).

Fig. 2.

Showing the endoscopic pictures, a central perforation, b Valsalvae method and visualising the air bubbles, c elevating TM flap and middle ear inspection, d underlay graft placement, e replacing the flap in position with gelfoam in external auditory canal, f postoperative image at the end of 6 weeks

In patients who were in the test (no gelfoam) group, placement of the graft was lateral to handle of malleus, which acts as a support and prevent graft medialisation. Tympanomeatal flap repositioned. An air pocket was created in the middle ear which was sealed by approximating the tympanomeatal flap with the canal and securing the margins of the incision with gelfoam in the external auditory canal (Fig. 2e).

Ear canal packed with medicated gauze wick. All patients were treated as inpatients for 4 days. They were given postoperative antibiotics (Inj.Cefotaxime 1gm i.v.) for 4 days. Ear canal pack and sutures were removed on the 7th post operative day (POD). Patients were reviewed on the 14th POD then on the 3rd, 6th, 9th week. A postoperative audiogram was taken at the end of the 6th week. The outcome of the surgery was termed successful by the presence of a healed, intact and a mobile tympanic membrane (Fig. 2f).

The statistics were calculated using SPSS version 16.0 was used for analysis. The mean, median, mode and standard deviation were calculated for all continuous variables. Distribution of the variables was assessed by Kolmogorov–Smirnov tests. For continuous variables not normally distributed median and the mid-quartile range were calculated. Pearson’s Chi square was applied to categorical variables including age, sex, symptomatology, clinical findings, audiological evaluation. Fischer’s Exact was applied wherever required. Chi square for trends was applied for ordinal data. A p value less than 0.05 was taken as significant.

Results

Demographic Profile of the Study Population

The mean age of the study population was 32 years (± 9.667). There was no significant difference between the two groups (p = 0.875). The sex distribution in the study population consisted of 52 female (65%) and 28 male (35%) patients (p = 0.639).

Comparison of Outcome in Relation to Clinical Profile

By comparing the size of the perforation in relation to the outcome of the study population, medium-sized perforation had maximum unsuccessful outcome 11 (78.6%) of the 14 failures and 36 (54.5%) of the 66 patients with successful closure at the end of 6 weeks. The influence of the perforation on the success of the surgery was statistically insignificant (p = 0.248). Among the 80 patients, 47 patients had a medium sized perforation. Medium sized perforations are those that had perforation involving either 2 or 3 quadrants of the tympanic membrane. Perforations involving the 4 quadrants were named as subtotal perforation. Perforations involving only a single quadrant were termed as a small perforation. 24 patients had subtotal perforation and 9 patients had small perforations (Table 1).

Table 1.

The distribution of the perforation sizes in the two groups

	Small	Medium	Subtotal
Control (gelfoam)	6 (15%)	23 (57.5%)	11 (27.5%)
Test (no gelfoam)	3 (7.5%)	24 (60%)	13 (32.5%)
Total	9	47	24

Comparison of Outcome in Relation to Middle Ear Status

In the test population, six patients had abnormal middle ear status and five patients had a successful outcome at the end of the study period. 85% of the test population had normal middle ear status and rest (15%) had abnormal middle ear status. The influence on the outcome of the study was insignificant though. (p = 0.745). The patient’s middle ear status was termed as normal (pink coloured mucosa) and abnormal (pale pink, red, polypoidal) were designated as 0 (normal) and 1 (abnormal) respectively. 69 Patients of the study population had a middle ear status score of 0 and 11 patients had a middle ear status score of 1. In the control group, 35 patients had a score of 0 and 5 patients had a score of 1. In the test population, 34 patients had a score of 0 and 6 patients had a score of 1 (Table 2).

Table 2.

The distribution of the middle ear status in the two groups

	Control (gelfoam)	Test (no gelfoam)
0 (normal middle ear)	35 (87.5%)	34 (85%)
1 (abnormal middle ear)	5 (12.5%)	6 (15%)

The above table shows the improvement in hearing in each group (Table 3, Fig. 3). The grading was done with improvement in the air–bone gap in the post-op pure tone audiogram. Excellent if the post-op ABG is < 10, good if < 20, fair if < 30 and rest were termed poor. The results were not statistically significant (p = 0.510).

Table 3.

The distribution of hearing improvement in the two groups

Air–bone–gap	Gelfoam	No Gelfoam	Total
Excellent	14	13	27
Good	14	16	30
Fair	3	4	7
Poor	2		2
Total	33	33	66

Fig. 3.

Showing the distribution of hearing results in both the groups

Comparison of Outcome in Relation to the Use of Gelfoam in the Middle Ear

In the study population, 14 patients had an unsuccessful outcome 7 were in the control group (50%) and 7 were in test population (50%). Out of the 66 patients with a successful outcome, 33 were in the control group (50%) and 33 were in the test group (50%). The difference was not significant (p = 1.000) (Fig. 4, Table 4).

Fig. 4.

Showing the comparable outcome of the test group with the control group

Table 4.

Showing the comparable outcome in myringoplasty without using gelfoam (test group)

	Unsuccessful	Successful
Control (gelfoam)	7 (50%)	33 (50%)
Test (no gelfoam)	7 (50%)	33 (50%)
Total	14	66 (82.5%)

Observatory Differences in Two Groups

In the control group, two patients developed new-onset myringosclerotic patches in the follow-up period. The neovascularization that appears in the postoperative period seemed to develop earlier in the test group but in the control group, this happens at least 4 weeks after surgery in the control group. In the test group, the unsuccessful outcome became evident in the 2nd post operative week. In the control group, the outcome could be decided only at the end of the 3rd or the 4th post operative week. The outcome of the surgery was better within less favourable middle ear status by avoiding the use of gelfoam in the middle ear. This was evident from the statistics that showed a higher percentage of success rate in the test group (15%) with abnormal middle ear status than in the control group (9%).

Discussion

The 80 patients were distributed in the control group (40) and the test group (40). The age group included in the study were from 15 to 65 years. The reason was to exclude the confounding factor of upper airway infection and Eustachian tube dysfunction that happens in younger children. This factor was considered taking into account the study of who found better success with advancing age [3]. The sex distribution in the control and test population showed maximum number were female population. 67.5% of the population in the control group and 62.5% in the test population were female and the rest were male. The ratio was 1:1.85. In one of the study 52.7% of the patients were male and 47.3% were female [4].

The duration of discharge was found to be 73 and 60 months in the control and test group respectively. The duration of the dry ear was 4.26 and 4.29 months in the control and test group respectively. The duration of hard of hearing was 23 months and 33 months in the control and test group respectively.

Medium sized perforation was the most common in our study (47/80) which was similar to a study [5]. The distribution of perforation in both groups was closely matching each other. The success rate with small size perforation was high which was comparable to a study [6] where the success rate was 100% with small sized perforations. The success rate with subtotal perforation was 91.66% in our study population which was higher compared to a study [6] where it was 75% and an another study [5] showed a success rate of 77.7%.

The closure of the air–bone gap was 11 dB both in the control and test group. The closure of the air–bone gap was comparable to a study [5, 7, 8] in which the closure was 11 dB. The improvement in the hearing was statistically significant (p = 0.0001) in both the groups and the study population as a whole.

The use of gelfoam was thought to provoke middle ear inflammation and result in postoperative adhesions by inciting local tissue reactions [9, 10]. There were predominant polynuclear cell invasion and reaction. Though the material is used as a compliment in ear surgery and is made as a scaffold or support, in other words acting as a graft bed for holding substances in place the reason it incited tissue inflammation provoked the thought of not using gelfoam in the middle ear and use the available structure such as the handle of malleus for scaffold and using the graft saline soaked so that the surface tension holds the graft in place tucked beneath the margins of the perforation [11–13]. The air pocket that is created is useful in the no gelfoam technique as stated by Takahashi [14] where middle ear cleft is akin to the alveoli with ventilation taking place by transmucosal gas exchange than by the Eustachian tube, especially in the postoperative period. This principle is extrapolated to the surgery of cholesteatoma where the normal middle ear mucosal status becomes very essential for normal ventilation and healing process after surgery.

Limitations

The influence of tympanosclerotic patches with the result could not be analysed. Long term results of the patients hearing could not be studied.

Conclusion

With comparable healing and hearing results without using gelfoam in the middle ear, it allows the normal physiology to be restored in the postoperative period much earlier. The result of the surgery also becomes evident in the second postoperative week when the use of gelfoam in the middle ear is avoided. With studies explaining that the use of gelfoam incites trauma to the middle ear structures and provokes new inflammatory tissue reaction, the newer technique of avoiding gelfoam in the middle ear holds its place better than the former. This would become the technique of preference while operating in the ear with unfavourable middle ear mucosal status. This study would lead the way for more elaborate research in the future which would highlight the surgical techniques that is much more anatomical and most important physiological.

Compliance with Ethical Standards

Conflict of interest

The authors declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: The authors certify that they have no affiliations with or involvement in any organisation or entity with any financial interest or non-financial interest in the subject matter or materials discussed in this manuscript.