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 Table of Contents  
ORIGINAL ARTICLE
Year : 2016  |  Volume : 9  |  Issue : 3  |  Page : 303-307

Assessment of hearing in patients undergoing tympanoplasty with and without cortical mastoidectomy for chronic otitis media: A hospital-based, randomized controlled trial


Department of ENT and HNS, J.N. Medical College, KLE University, Belagavi, Karnataka, India

Date of Web Publication21-Dec-2016

Correspondence Address:
Dr. M K Vybhavi
No. 867, 8th Main, 12th Cross, Saraswathipuram, Mysore - 570 009, Karnataka
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/2349-5006.196323

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  Abstract 

Aims: To assess hearing in patients undergoing tympanoplasty with and without cortical mastoidectomy for chronic otitis media.
Settings and Design: A hospital-based, randomized controlled study.
Subjects and Methods: The study included sixty patients. Patients were randomly allocated into two groups of thirty each. In Group 1, patients underwent tympanoplasty alone. In Group 2, patients underwent tympanoplasty with cortical mastoidectomy. Hearing assessment was done by pure tone audiometry. Follow-up period was 3 months.
Statistical Analysis Used: Paired and unpaired t-tests were used for quantitative variables and Chi-square test was used for qualitative ones. P< 0.05 was considered statistically significant.
Results: The mean pre- and post-operative pure-tone average was 42.4 ± 10.53 dB and 32.8 ± 13.02 dB in Group 1, with a mean hearing gain of 9.5 ± 11.33 dB. The mean pre- and post-operative pure-tone average was 42 ± 10.43 dB and 34.9 ± 9.94 dB in Group 2, with a mean hearing gain of 7.1 ± 8.85 dB. The mean pre- and post-operative air-bone gap was 37.27 ± 9.51 dB and 24.21 ± 11.64 dB in Group 1, with improvement in air-bone gap of 13.07 ± 12.93 dB. The mean pre- and post-operative air-bone gap was 32.27 ± 11.53 dB and 23.75 ± 9.91 dB in Group 2, with improvement in air-bone gap of 8.52 ± 9.13 dB. No statistically significant difference was seen between the two groups.
Conclusions: Combining cortical mastoidectomy with tympanoplasty in the patients of chronic otitis media, mucosal disease, offers no additional benefit in terms of hearing improvement compared to tympanoplasty alone.

Keywords: Chronic otitis media, cortical mastoidectomy, tympanoplasty


How to cite this article:
Vybhavi M K, Mudhol R S. Assessment of hearing in patients undergoing tympanoplasty with and without cortical mastoidectomy for chronic otitis media: A hospital-based, randomized controlled trial. Indian J Health Sci Biomed Res 2016;9:303-7

How to cite this URL:
Vybhavi M K, Mudhol R S. Assessment of hearing in patients undergoing tympanoplasty with and without cortical mastoidectomy for chronic otitis media: A hospital-based, randomized controlled trial. Indian J Health Sci Biomed Res [serial online] 2016 [cited 2019 Dec 5];9:303-7. Available from: http://www.ijournalhs.org/text.asp?2016/9/3/303/196323


  Introduction Top


Chronic otitis media is an inflammatory process of the mucoperiosteal lining of the middle ear space and mastoid, characterized by chronic, intermittent, or persistent discharge through a perforated tympanic membrane. Chronic otitis media is a widespread disease of developing countries such as India, especially in rural areas, and the prevalence ranges from 2% to 15%.[1]

Surgery is the treatment modality of choice and tympanoplasty is a commonly performed surgical procedure to close perforations of the tympanic membrane in chronic otitis media. Tympanoplasty is performed to eradicate disease from the middle ear cleft and to reconstruct the hearing mechanism with or without tympanic membrane grafting.[2] It can be combined with cortical mastoidectomy.

There has always been a controversy regarding the role of coupling cortical mastoidectomy with tympanoplasty in chronic otitis media, mucosal type of disease. Mastoid pneumatic system acts as a buffer for pressure changes in the middle ear. As a precautionary measure, many surgeons perform both cortical mastoidectomy and tympanoplasty routinely and this has made the surgical procedure very elaborate and time-consuming. If a mastoidectomy could be avoided in at least some of the cases, where it was unnecessary, much time and effort could be saved.[3]

Previous research findings have provided evidence both for and against the use of mastoidectomy in chronic otitis media, mucosal type. Most of these studies were retrospective cohort studies and case series, and only a few randomized controlled trials (RCTs) had been undertaken to address this controversy. Hence, the present randomized controlled study was undertaken to assess hearing in patients undergoing tympanoplasty with and without cortical mastoidectomy for chronic otitis media.


  Subjects and Methods Top


This 1-year RCT was carried out from January 2014 to December 2014 in the Department of Otorhinolaryngology and Head and Neck Surgery, KLES Dr. Prabhakar Kore Hospital and Medical Research Centre, Belagavi. A total of sixty patients who fulfilled the eligibility criteria were included in the study and randomly allocated into the two groups of thirty each. Patients in Group 1 underwent tympanoplasty only whereas patients in Group 2 underwent tympanoplasty with cortical mastoidectomy.

The inclusion criteria comprised patients of chronic otitis media, mucosal type of disease in the age group of 10–60 years. The exclusion criteria comprised cases of cholesteatoma, patients with the history of mastoid surgery, and cases of complicated otitis media and mixed hearing loss. Ethical Committee Clearance was obtained before the commencement of the study. A written informed consent was obtained from all the patients to participate in the study.

A detailed pro forma was filled for each patient with regard to history, complete general, physical, systemic, and ENT examination. In all the patients, routine blood investigations, X-ray mastoid, otomicroscopy, and pure tone audiometry were done. Most of the patients were operated under local anesthesia. Patients aged <18 years were operated under general anesthesia. Postauricular approach was used for tympanoplasty. The temporalis fascia graft was used and underlay technique was employed. In cortical mastoidectomy, mastoid antrum was opened, and the patency of aditus was checked and established.

Patients were followed up in the ENT outpatient department at 15 days, 1 month, and 3 months. Patients underwent pure tone audiometry at the end of 3 months. Hearing improvement was assessed by calculating pure-tone average, hearing gain, and air-bone gap.

The data obtained were coded and entered into Microsoft Excel worksheet. Statistical analysis was done using paired and unpaired t-test for quantitative variables and Chi-square test for qualitative ones. P < 0.05 was considered statistically significant.


  Results Top


The study included sixty patients who were divided randomly into two groups of thirty each. In Group 1 (tympanoplasty only), there were 12 males and 18 females with a mean age of 24.5 years. In Group 2 (tympanoplasty with cortical mastoidectomy), there were 17 males and 13 females with a mean age of 26.1 years. Both the groups were comparable in terms of age and sex [Table 1].
Table 1: Age and sex distribution in the study

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Majority of the patients were from poor socioeconomic background in both the groups and were comparable. No statistically significant differences were seen in terms of mean duration of ear discharge and mean duration of hearing loss. Most of the patients had large central perforation in both the groups (50% in Group 1 and 56.66% in Group 2).

In this study, the mean pre- and post-operative pure-tone average was 42.4 ± 10.53 dB and 32.8 ± 13.02 dB in Group 1, with a mean hearing gain of 9.5 ± 11.33 dB. The mean pre- and post-operative pure-tone average was 42 ± 10.43 dB and 34.9 ± 9.94 dB in Group 2, with a mean hearing gain of 7.1 ± 8.85 dB. No statistically significant difference was seen between the two groups [Table 2].
Table 2: Pure tone average in both the groups

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In this study, the mean pre- and post-operative air-bone gap was 37.27 ± 9.51 dB and 24.21 ± 11.64 dB in Group 1, with improvement in air-bone gap of 13.07 ± 12.93 dB. The mean pre- and post-operative air-bone gap was 32.27 ± 11.53 dB and 23.75 ± 9.91 dB in Group 2, with improvement in air-bone gap of 8.52 ± 9.13 dB. No statistically significant difference was seen between the two groups.

Graft success rates were 93.33% in Group 1 and 86.66% in Group 2. No statistically significant difference was seen between the two groups [Graph 1].




  Discussion Top


Literature supports the contention that the mastoid pneumatic system acts primarily as a buffer to pressure changes in the middle ear.[4],[5],[6] The functional advantage of a large aerated mastoid was first suggested by Holmquist and Bergström [4] and Flisberg et al.[5] and later substantiated by Sadé[6] and Richards et al.[7]

The presence of a pneumatized mastoid greatly increases the volume of the middle ear/mastoid system, which, in accordance with Boyle's Law, can minimize the effect of pressure changes in the middle ear cleft. Poorly pneumatized mastoids, on the other hand, do not have this buffering capacity and are therefore more prone to tympanic membrane retraction and chronic inflammatory conditions.[8]

The advantages and disadvantages of adding mastoidectomy to tympanoplasty in noncholesteatomatous chronic otitis media have always been the focus of much controversy and debate.[3] When considering the addition of a mastoidectomy to a tympanoplasty, the performing surgeon should consider not only the potential added benefit but also the potential risks and costs to the patient. As such, the risk associated with the performance of a mastoidectomy varies greatly with each surgeon and cannot easily be generalized to all surgeons.[9]

As a precautionary measure, many surgeons perform both procedures routinely irrespective of the stage of the disease, fearing recurrence, and graft failure. This has made the surgical procedure very elaborate and time-consuming. If a mastoidectomy could be avoided in at least some of these cases, where it was unnecessary, much time and effort could be saved. Therefore, the question arises whether mastoidectomy is always routinely necessary in every case of tubotympanic chronic suppurative otitis media (CSOM).[3]

Several studies have retrospectively reviewed outcomes of tympanoplasty with or without mastoidectomy for the treatment of noncholesteatomatous CSOM. However, these retrospective studies have frequently been affected by selection bias including the presence of cholesteatoma, infection severity, and varying selection criteria for performing mastoidectomy.

Balyan et al.[10] in 1997 reviewed 323 patients with CSOM where the patients were separated into three groups: Group I consisted of patients with draining CSOM treated with tympanoplasty alone, Group II consisted of patients with draining CSOM treated with tympanoplasty with mastoidectomy, and Group III consisted of patients with nondraining CSOM treated with tympanoplasty alone. No statistically significant differences were found for graft success and mean residual gap differences between dry and draining ears. They concluded that mastoidectomy is an avoidable procedure in noncholesteatomatous CSOM.

Mishiro et al.[11] in 2001 compared tympanoplasty alone and tympanoplasty with mastoidectomy in a study of 251 patients with noncholesteatomatous CSOM. No statistically significant differences were noted between graft success rates and postoperative air-bone gap. They concluded that mastoidectomy is not helpful.

McGrew et al.[9] in 2004 reviewed 320 patients undergoing tympanoplasty alone and 144 patients undergoing tympanoplasty with mastoidectomy for tympanic membrane perforations related to noncholesteatomatous CSOM. No statistically significant differences were noted between perforation repair success and postoperative air-bone gap. They provided the most comprehensive analysis of long-term differences between tympanoplasty with and without mastoidectomy and found that patients with tympanoplasty alone were more likely to require subsequent otologic procedures compared with patients who underwent concomitant mastoidectomy. They recommended concurrent mastoidectomy.

In a similar study conducted by Toros et al.[12] in 2010 in an analysis of 46 patients undergoing tympanoplasty alone and 46 patients undergoing tympanomastoidectomy, no statistically significant differences were noted. They concluded that mastoidectomy might not be necessary.

A prospective comparative study was done by Krishnan et al.[13] in 2002 which included 120 patients of CSOM with 44 patients in Group 1 who underwent tympanoplasty alone and 76 patients in Group 2 who underwent tympanoplasty with cortical mastoidectomy. Significant inhomogeneity was seen between the study arms. They concluded that mastoidectomy did not seem to play a significant beneficial role as regards the postoperative hearing gain.

Bhat et al.[3] in 2009 conducted a randomized controlled study which included 68 patients of chronic otitis media, tubotympanic disease. Thirty-five patients underwent type one tympanoplasty along with cortical mastoidectomy. Thirty-three patients underwent type one tympanoplasty alone. No statistically significant differences in hearing improvement or graft uptake were seen. They concluded that mastoidotympanoplasty was not found to be superior to tympanoplasty alone over a short-term follow-up period.

A similar study was conducted by Ramakrishnan et al.[14] in 2011 which included 62 patients with 31 patients in each group. No statistically significant differences were seen between the two groups in terms of tympanic membrane closure and hearing outcomes.

Albu et al.[15] presented the largest RCT comparing results with and without mastoidectomy. They conducted RCT in 2012 where 282 patients of CSOM were included in the study. One hundred and forty patients underwent tympanoplasty alone and 142 patients underwent tympanoplasty with mastoidectomy. No statistically significant differences were seen between the two groups in terms of graft success rate and hearing outcomes. They concluded that mastoidectomy offered no additional benefit to tympanoplasty in CSOM.

A randomized controlled study was done by Kamath et al.[16] in 2013 which included 120 patients with sixty patients in each group. No statistically significant results were found indicating that tympanoplasty with mastoidectomy yields better results. They concluded that satisfactory hearing outcome could be achieved irrespective of cortical mastoidectomy in the surgical treatment of tubotympanic disease.

Similar prospective study was performed by Mohammed Abdel Tawab et al.[17] in 2014 which included forty patients with noncholesteatomatous CSOM with twenty patients in each group. They concluded that mastoidectomy performed in the study gives no statistically significant benefit over simple myringoplasty as regards graft success rate and dryness of the middle ear with comparable hearing outcome.


  Conclusion Top


In this study, it can be concluded that combining cortical mastoidectomy with tympanoplasty in the treatment of patients of chronic otitis media, mucosal disease, offers no additional benefit in terms of hearing improvement compared to tympanoplasty alone.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.

 
  References Top

1.
World Health Organization. Child and Adolescent Health and Development. Prevention of Blindness and Deafness [Press Release]. Geneva, Switzerland: World Health Organization; 2004.  Back to cited text no. 1
    
2.
Athanasiadis-Sismanis A. Tympanoplasty: Tympanic Membrane Repair. Glasscock Shambaugh Surgery of the Ear. 6th ed.. China: PMPH-USA; 2010. p. 465-85.  Back to cited text no. 2
    
3.
Bhat KV, Naseeruddin K, Nagalotimath US, Kumar PR, Hegde JS. Cortical mastoidectomy in quiescent, tubotympanic, chronic otitis media: Is it routinely necessary? J Laryngol Otol 2009;123:383-90.  Back to cited text no. 3
    
4.
Holmquist J, Bergström B. The mastoid air cell system in ear surgery. Arch Otolaryngol 1978;104:127-9.  Back to cited text no. 4
    
5.
Flisberg K, Ingelstedt S, Ortegren U. The relationship of middle ear disease to mastoid hypocellularity. A working hypothesis. Acta Otolaryngol Suppl 1963;182:69-72.  Back to cited text no. 5
    
6.
Sadé J. The correlation of middle ear aeration with mastoid pneumatization. The mastoid as a pressure buffer. Eur Arch Otorhinolaryngol 1992;249:301-4.  Back to cited text no. 6
    
7.
Richards SH, O'Neill G, Wilson F. Middle-ear pressure variations during general anaesthesia. J Laryngol Otol 1982;96:883-92.  Back to cited text no. 7
    
8.
Ruhl CM, Pensak ML. Role of aerating mastoidectomy in noncholesteatomatous chronic otitis media. Laryngoscope 1999;109:1924-7.  Back to cited text no. 8
    
9.
McGrew BM, Jackson CG, Glasscock ME 3rd. Impact of mastoidectomy on simple tympanic membrane perforation repair. Laryngoscope 2004;114:506-11.  Back to cited text no. 9
    
10.
Balyan FR, Celikkanat S, Aslan A, Taibah A, Russo A, Sanna M. Mastoidectomy in noncholesteatomatous chronic suppurative otitis media: Is it necessary? Otolaryngol Head Neck Surg 1997;117:592-5.  Back to cited text no. 10
    
11.
Mishiro Y, Sakagami M, Takahashi Y, Kitahara T, Kajikawa H, Kubo T. Tympanoplasty with and without mastoidectomy for non-cholesteatomatous chronic otitis media. Eur Arch Otorhinolaryngol 2001;258:13-5.  Back to cited text no. 11
    
12.
Toros SZ, Habesoglu TE, Habesoglu M, Bolukbasi S, Naiboglu B, Karaca CT, et al. Do patients with sclerotic mastoids require aeration to improve success of tympanoplasty? Acta Otolaryngol 2010;130:909-12.  Back to cited text no. 12
    
13.
Krishnan A, Reddy EK, Chandrakiran C, Nalinesha KM, Jagannath PM. Tympanoplasty with and without cortical mastoidectomy – A comparative study. Indian J Otolaryngol Head Neck Surg 2002;54:195-8.  Back to cited text no. 13
    
14.
Ramakrishnan A, Panda NK, Mohindra S, Munjal S. Cortical mastoidectomy in surgery of tubotympanic disease. Are we overdoing it? Surgeon 2011;9:22-6.  Back to cited text no. 14
    
15.
Albu S, Trabalzini F, Amadori M. Usefulness of cortical mastoidectomy in myringoplasty. Otol Neurotol 2012;33:604-9.  Back to cited text no. 15
    
16.
Kamath MP, Sreedharan S, Rao AR, Raj V, Raju K. Success of myringoplasty: Our experience. Indian J Otolaryngol Head Neck Surg 2013;65:358-62.  Back to cited text no. 16
    
17.
Mohammed Abdel Tawab H, Mahmoud Gharib F, Algarf TM, ElSharkawy LS. Myringoplasty with and without cortical mastoidectomy in treatment of non-cholesteatomatous chronic otitis media: A comparative study. Clin Med Insights Ear Nose Throat 2014;7:19-23.  Back to cited text no. 17
    



 
 
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