Abstract
Chronic Otitis Media (COM) is a major cause of acquired hearing impairment especially in developing countries. Persistent perforations occur either due to improper treatment of recurrent otitis media or infected traumatic perforation. Myringoplasty, repair of the Tympanic membrane using autologous temporalis fascia, is the standard procedure for COM. Other graft materials commonly used include tragal perichondrium, tragal cartilage and adipose tissue. This prospective study aims to compare the surgical and audiological outcome of fat plug myringoplasty [FPM] and conventional myringoplasty using temporalis fascia [CM-TF] in COM with small dry central perforation. A total of 60 patients of COM with small dry central perforation, aged 16–60 years, during the study period of October 2013 to August 2015 were divided into two groups of 30 cases each. The first group underwent FPM while the second group underwent CM-TF. The graft uptake and hearing outcome [pre operative and 3 months post operative PTA] were assessed. The surgical outcome of FPM with graft uptake of 86.7% was comparable to CM-TF with a graft uptake of 90%. The mean post operative hearing gain in FPM was 3.43 ± 2.81 dB which correlated well with that of CM-TF with 3.85 ± 3.05 dB. The duration of hospital stay and operative time was significantly lower in FPM group. FPM can be safely performed in cases with dry, small central perforations of the tympanic membrane with outcomes comparable to CM-TF.
Keywords: Chronic Otitis Media, Fat plug myringoplasty, Conventional myringoplasty, Temporalis fascia
Introduction
Chronic Otitis Media (COM) is a major cause of acquired hearing impairment especially in developing countries [1]. It also gives rise to various extra and intra cranial complications which can be fatal if untreated. In the early centuries, ear infection with complication was a life threatening condition. The introduction of antibiotics and the use of operative microscope in surgical field were revolutionary advances in the control of disease.COM however still remains a major problem in our country.
Tympanic membrane (TM) perforations lead to recurrent ear infections and hearing loss. If the perforations are bilateral, hearing handicap becomes more evident. Persistent perforations occur either due to improper treatment of recurrent otitis media or infected traumatic perforation.
An ear with small TM perforation may lead to recurrent infections of middle ear because of contaminants from ear canal and also leads to low frequency conductive hearing loss. Both these complications can be prevented by repair of tympanic membrane [2].
Myringoplasty is one of the most commonly performed procedures in otolaryngology [3]. It is an operation, in which the reconstructive procedure is limited to repair of TM perforation [4] assuming that middle ear ossicular chain is intact, Eustachian tube is patent and patient has a good cochlear reserve whereas Tympanoplasty is an operation which includes inspection and repair, if any, of middle ear sound conductive apparatus with reconstruction of TM in view of achieving an intact neo tympanum with normal hearing acuity [5].
Various graft materials are successfully used for the closure of tympanic membrane perforations. Commonly used graft materials include autologous temporalis fascia, tragal perichondrium, tragal cartilage and adipose tissue [2, 3].
Myringoplasty using autologous temporalis fascia is the standard procedure for COM [2, 3]. In COM with small perforations, FPM can also be done with lesser morbidity. It can be done as an office procedure and patients are sent home on the same day of procedure.
With advanced microsurgical techniques and equipment, the state of art facility has now developed to the extent that graft success rates of 90–97% are to be expected [6].
This prospective study aims to study the usefulness of adipose tissue/fat for the closure of dry, small central perforations and to compare the efficacy of FPM with that of CM-TF in dry, small central perforations of tympanic membrane using surgical and audiological outcomes.
Materials and Methods
Study Design
Prospective Interventional study.
Study Period
October 2013 to August 2015.
Place of Study
Tertiary referral hospital.
Sample Size and Method
60 patients with inactive mucosal type of COM with small, dry central perforation were evaluated. Patients were randomised into 2 groups, each group consisting of 30 patients. Patients of group 1 underwent fat plug myringoplasty [FPM] while patients of group 2 underwent conventional myringoplasty using temporalis fascia graft [CM-TF].
Methods of Collection of Data
In this study 60 patients of both sexes, aged more than 15 years who presented with inactive mucosal COM with small central perforation were included. These patients were diagnosed by detailed history taking and thorough clinical examination. The hearing status was assessed by Pure Tone Audiometry. The patients were randomized into 2 groups, each group consisting of 30 patients. The first group comprised of patients who underwent FPM while the second group underwent CM-TF. Both the groups were matched by the distribution of age, sex, socioeconomic status, duration and stage of disease. Prior to surgery written informed consent was obtained. Three months after surgery, the surgical outcome was assessed in terms of graft uptake. The closure of the perforation was considered as the criteria for success audiological outcome was assessed by Pure Tone Audiometry.
The results obtained during the study were statistically analyzed using OpenEpi software version 3.03 and SPSS Version 20.0.
Results
A slight female preponderance was observed in both groups. Majority of patients were in the age group of 15–30 years. Majority of our patients had, onset of disease in 2nd and 3rd decade of life, hearing loss for 2–5 years duration and last episode of ear discharge 4–6 months prior to surgery but none of the parameters had statistically significant effect on the outcome (p > 0.05) (Table 1).
Table 1.
Demographic data and clinical presentation in both groups
| Group 1 | Group 2 | |
|---|---|---|
| Gender | ||
| Female | 18 (60%) | 16 (53.3%) |
| Male | 12 (40%) | 14 (46.7%) |
| Age | ||
| 15–30 years | 16 (53.3%) | 17 (56.6%) |
| 31–45 years | 12 (40%) | 12 (40%) |
| 46–60 years | 2 (6.6%) | 1 (3.3%) |
| Age at disease onset | ||
| 11–20 years | 8 (13.3%) | 12 (20%) |
| 21–30 years | 17 (28.3%) | 15 (25%) |
| 31–40 years | 4 (6.7%) | 3 (5%) |
| 41–50 years | 1 (1.7%) | 0 |
| Duration of hearing loss | ||
| < 2 years | 10 (16.7%) | 1 (1.7%) |
| 2–5 years | 16 (26.7%) | 19 (31.7%) |
| > 5 years | 4 (6.7%) | 10 (16.7%) |
| Last episode of ear discharge | ||
| < 3 months | 1 (1.7%) | 1 (1.7%) |
| 4–6 months | 16 (26.7%) | 15 (25%) |
| 7–9 months | 11 (18.3%) | 12(20%) |
| 10–12 months | 2 (3.3%) | 2 (3.3%) |
| Laterality | ||
| Right | 14 (46.7%) | 16 (53.3%) |
| Left | 14 (46.7%) | 14 (46.7%) |
| Bilateral | 2 (3.3%) | 0 |
| Presentation | ||
| Primary | 27 (90%) | 30 (100%) |
| Revision | 3 (10%) | 0 |
| Antero inferior | 12 (40%) | 18 (60%) |
| Postero superior | 4 (13.3%) | 3 (10%) |
| Postero inferior | 5 (16.7%) | 6 (20%) |
| Type of hearing loss | ||
| Normal | 7 (23.3%) | 2 (6.7%) |
| Conductive hearing loss | 23 (76.7%) | 28 (93.3%) |
| Sensorineural hearing loss | 0 | 0 |
| Degree of pre op hearing loss | ||
| 0–15 dB | 9 (15%) | 3 (5%) |
| 15.1–25 dB | 15 (25%) | 12(20%) |
| 25.1–40 dB | 6 (10%) | 15 (20%) |
There was no predominance of right or left ear disease in our study, both being equally affected. 2 (3.3%) patients in Group 1 had bilateral COM. 3 patients in Group 1 accounted for revision myringoplasty cases. Majority of the patients in our study had Antero inferior perforation in both the groups. No patients in the study had SNHL. 23(76.7%) patients in Group 1 and 28(93.3%) patients in Group 2 had conductive hearing loss. Majority of the patients in Group 1(15 patients) had hearing loss in the range of 15.1–25 dB whereas Group 2 patients (15 patients) predominantly had hearing loss in the range of 25.1–40 dB. Table 2 shows the pre operative hearing loss based on the perforation site. There was no statistical (ANOVA Test) correlation between site of perforation and the degree of hearing loss in our study.
Table 2.
Hearing gain based on site of perforation
| Perforation site | Mean hearing loss (dB) | No of patients |
|---|---|---|
| Antero inferior quadrant | 22.29 ± 6.89 | 30 (50%) |
| Antero superior quadrant | 21.53 ± 8.25 | 12 (20%) |
| Postero superior quadrant | 20.74 ± 3.69 | 7 (12%) |
| Postero inferior quadrant | 24.28 ± 5.92 | 11 (18%) |
Group 1 had success rate (in terms of graft uptake) of 86.7% which is comparable to success rate of 90% in group 2 (p > 0.05). There was significant hearing improvement post operatively in both the groups which was statistically significant (p < 0.05) (Table 3). When hearing improvement was compared between the two groups, there was no significant statistical difference (independent sample test). All patients in Group I got discharged on the day of surgery whereas 5 patients in Group 2 stayed for 2 days. Duration of hospital stay was less in Group 1 and was statistically significant (p < 0.05 ).
Table 3.
Outcome in both groups
| Group 1 | Group 2 | |
|---|---|---|
| Pre-op PTA (dB mean ± SD) | 19.89 ± 6.01 | 24.75 ± 6.49 |
| Post-op PTA (dB mean ± SD) | 16.46 ± 4.94 | 20.90 ± 5.69 |
| Hearing gain (dB mean ± SD) | 3.43 ± 2.81 | 3.85 ± 3.05 |
| Graft uptake | 26 (86.7%) | 27 (90%) |
Discussion
Majority of the patients were between 15 and 30 years of age in both the groups. Group 1 with 53.3% and Group 2 with 56.6%. Patients below 16 years were excluded from our study. Children are considered to be poor candidates for myringoplasty as they are more prone to recurrent respiratory tract infections, immaturity of immune system and Eustachian tube physiology [7]. In a study be Emir et al. [8] though children had a worse success rate of tympanoplasty of 85.7% as compared to older patients as it was not statistically significant they concluded that age may not affect the success rate of tympanoplasty. Similarly there was no effect of age of the patient on the pre operative hearing loss or the hearing gain following surgery in our study. In a study conducted by Debnath and Khanna [9], the average age of the study group was 35 years which is comparable with our study.
The average operative time taken for FPM was much lesser (20.8 min) compared to that taken for CM-TF (47.3 min) which was statistically significant (p value 0.00). In a study by Bertoli et al. [10], the duration of surgery in FPM did not exceed 30 min and in 57 patients (78.1%), the duration of surgery was between 15 and 30 min which is comparable with our study.
When the site of perforation was compared with the degree of hearing loss, there was no significant correlation statistically (ANOVA test).
In all 30 cases of FPM, fat was harvested from ear lobule. Rao et al. [11] did microscopic comparison of fat from 3 sources (ear lobule, abdomen, buttocks) which showed that fat cells from ear lobule were more compact and contains fibrous tissue. Garem et al. [12] in their study of FPM using different types of fat noted the success rate for ear lobule fat was 80% and for abdominal fat was 73.3%.
When surgical outcome in terms of graft uptake was compared between the groups, there was no statistical significance (p > 0.05). Hence surgical success of FPM is comparable with CM-TF. Graft uptake in both the groups was comparable to other studies. In literature, success rate of 80–95.2% has been reported for FPM by various authors from different parts of the world [13, 14].
In Group 1, 3 out of 4 patients who had graft failure had Antero inferior perforation and 1 patient had Postero inferior perforation. In Group 2, 2 of 3 patients who had graft failure had Antero inferior perforation and remaining 1 patient had Postero inferior perforation. Patients who had graft failure had episodes of upper respiratory tract infection which lead to graft failure. Halik et al. [15] in their study found higher risk of failure of graft in Anterior perforations. Bertoli et al. [10] in their study noted a low closure of Anterior perforations (67.7%) compared to that of posterior perforations(90.5%).
Graft failure may be due to infection, detached graft or dehiscence due to undersized grafts. Fiorio and Barbieri [14] described various causes of failure- Immediate failures due to technical difficulties such as Anterior perforations, inadequate graft support, infection or poor vascular supply and delayed failures due to atrophic TM, infections or Eustachian tube dysfunction with change in the TM structure. Hegazy et al. [16] described technical operative points during fat grafting that is, graft size in relation with the perforation, moistening of the lateral side of the graft and degree of lateral bulge in the fat plug as important factors for its success.
When audiological outcome(post op hearing gain) between Group 1 and 2 was compared by independent samples test, there was no statistical significance and hence hearing gain with FPM is comparable with CM-TF. In a study by Rao et al. [11], preoperatively the mean pre-operative hearing threshold was 31.67 ± 3.21 dB. The post operative PTA was done after 6 months of surgery, which showed post operative mean hearing threshold of 21.09 ± 2.72 dB and a mean gain in hearing of 10.58 ± 4.81 dB. Caye-Thomsasen et al. [17] in their study of 26 bilateral cases, the mean preoperative pure tone average was 20.1 dB, the mean post operative pure tone average was 11.5 dB and thus a hearing gain of 8.6 dB and Perforation closure was 94%, comparable to our study. In a study by Brown et al. [18] the mean pre-operative hearing threshold (dB) was 35 ± 3.07 and after procedure the mean hearing threshold (dB) was 25.67 ± 5.32 and there was a mean gain of about 9.33 ± 5.11 higher in comparison with our study.
In a study by Gun et al. [19] where fat myringoplasty, conventional temporalis fascia myringoplasty and hyaluronic acid fat myringoplasty techniques were compared, none of them provided a significantly better success rate in terms of perforation location (p > 0.05) or perforation size (p > 0.05). They proposed for large perforations Hyaluronic acid fat myringoplasty and for small perforations fat myringoplasty alone. They suggested temporalis fascia myringoplasty to be a secondary choice in small central perforations in view of its associated surgical technical difficulties.
In this study, 3 were revision cases with small residual perforations with previous history of ear surgery. All 3 underwent FPM of which 1 patient had graft failure due to repeated upper respiratory tract infections.
In this study 2 patients had bilateral COM. Both patients underwent bilateral FPM and had good graft uptake. However in one patient there was no post-operative hearing improvement.
Conclusion
FPM can be safely performed in cases with dry, small central perforations of tympanic membrane with surgical and audiological outcomes comparable to CM-TF. FPM is a simple, easy and cost effective technique which can be performed as an outpatient procedure by harvesting fat from ear lobule with no visible scar and negligible morbidity. Bilateral procedures can be done quite safely with minimal post operative care.
Abbreviations
- COM
Chronic Otitis Media
- FPM
Fat plug myringoplasty
- CM-TF
Conventional myringoplasty using temporalis fascia
- TM
Tympanic membrane
Compliance with Ethical Standards
Conflict of interest
The authors declare that they have no competing interests.
References
- 1.Parida PK, Nochikattil SK, Surianarayanan G, Saxena SK, Ganesan S. A comparative study of temporalis fascia graft and vein graft in myringoplasty. Indian J Otolaryngol Head Neck Surg. 2013;65(Suppl 3):S569–S574. doi: 10.1007/s12070-012-0543-4. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 2.Wasson JD, Papadimitriou CE, Pau H. Myringoplasty: impact of perforation size on closure and audiological improvement. J Laryngol Otol. 2009;123(9):973–977. doi: 10.1017/s0022215109004368. [DOI] [PubMed] [Google Scholar]
- 3.Sharma C, Singh J, Kakkar V, Yadav S, Malik P, Bishnoi S. Fat graft myringoplasty in small central perforations. Indian J Otol. 2014;20:211–215. doi: 10.4103/0971-7749.146942. [DOI] [Google Scholar]
- 4.Arindam D, Bhavika S, Debashish G, Arunabha S. Myringoplasty: impact of size and site of perforation on the success rate. Indian J Otolaryngol Head Neck Surg. 2015;67(2):185–189. doi: 10.1007/s12070-014-0810-7. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 5.Ajay M, Vijay B, Ravi R. Effect of canalplasty on outcome of results in type I tympanoplasty. Bengal J Otolaryngol Head Neck Surg. 2016;24(1):15–20. [Google Scholar]
- 6.Jackson CG, Kaylie DM, Glasscock ME, Strasnick B. Tympanoplasty-undersurface graft technique. In: Brackmann DE, Sheiton C, Arriaga MA, editors. Otologic surgery. 3. Amsterdam: Elsevier; 2010. pp. 149–160. [Google Scholar]
- 7.Telian SA, Schmalbach CE. Chronic Otitis Media. In: Snow JB, Ballenger JJ, editors. Ballenger’s otorhinolaryngology head and neck surgery. 16. Hamilton: BC Decker; 2003. pp. 271–272. [Google Scholar]
- 8.Emir H, Ceylan K, Kizilkaya Z, Gocmen H, Uzunkulaoglu H, Samim E. Success is a matter of experience: type 1 tympanoplasty. Eur Arch Otorhinolaryngol. 2007;264:595–599. doi: 10.1007/s00405-006-0240-6. [DOI] [PubMed] [Google Scholar]
- 9.Debnath M, Khanna S. A comparative study of closure of tympanic membrane perforation between chemical cauterization and fat plug myringoplasty. Int J Otolaryngol Head Neck Surg. 2013;2:248–252. doi: 10.4236/ijohns.2013.26052. [DOI] [Google Scholar]
- 10.Bertoli GA, Barbaro M, Giangande V, Bava G, Seta ED, Filipo R. Fat graft myringoplasty: an office procedure for the repair of small perforations of the tympanic membrane. Mediterr J Otol. 2007;3:120–125. [Google Scholar]
- 11.Rao SM, Chandra PR, Pallapati G, Pradeep KJ, Gudepu P. A comprehensive study of fat myringoplasty. ORL. 2015;5(1):8–13. [Google Scholar]
- 12.El Garem HF. Fat myringoplasty: better patient selection for better results. Otolaryngol Head Neck Surg. 2014;151(1 suppl):206–207. doi: 10.1177/0194599814541629a219. [DOI] [Google Scholar]
- 13.Mitchell RBI, Pereira KD, Lazar RH. Fat graft myringoplasty in children-a safe and successful day-stay procedure. J Laryngol Otol. 1997;111(2):106–108. doi: 10.1017/S002221510013659X. [DOI] [PubMed] [Google Scholar]
- 14.Fiorino F, Barbieri F. Fat graft myringoplasty after unsuccessful tympanic membrane repair. Eur Arch Otolaryngol. 2007;264:1125–1128. doi: 10.1007/s00405-007-0323-z. [DOI] [PubMed] [Google Scholar]
- 15.Halik JJ, Smyth GDL. Longterm results of tympanic membrane repair. Otolaryngol Head Neck Surg. 1988;98(2):162–169. doi: 10.1177/019459988809800211. [DOI] [PubMed] [Google Scholar]
- 16.Hegazy HM. Fat graft myringoplasty—a prospective clinical study. Egypt J Ear Nose Throat Allied Sci. 2013;14:91–95. doi: 10.1016/j.ejenta.2012.11.006. [DOI] [Google Scholar]
- 17.Caye-Thomasen P, Nielsen TR, Tos M. Bilateral myringoplasty in chronic otitis media. Laryngoscope. 2007;117(5):903–906. doi: 10.1097/MLG.0b013e318038168a. [DOI] [PubMed] [Google Scholar]
- 18.Brown C, Yi Q, McCarty DJ, Briggs RJS. The success rate following myringoplasty at the Royal Victorian Eye and Ear Hospital. Aust J Otolaryngol. 2002;5(1):21–25. [Google Scholar]
- 19.Gün T, Boztepe OF, Atan D, İkincioğulları A, Dere H. Comparison of hyaluronic acid fat graft myringoplasty, fat graft myringoplasty and temporal fascia techniques for the closure of different sizes and sites of tympanic membrane perforations. J Int Adv Otol. 2016;12(2):137–141. doi: 10.5152/iao.2016.1938. [DOI] [PubMed] [Google Scholar]