Abstract
Chronic otitis media (COM) poses significant challenges globally, affecting millions with hearing impairment and associated morbidities. This prospective study aimed to compare the surgical outcomes of type I tympanoplasty with and without canaloplasty in adolescent patients with COM, focusing on hearing improvement and graft success rates. Sixty-eight patients aged 11–18 years, diagnosed with inactive mucosal disease and conductive hearing loss, were enrolled from 01 January 2022 to 01 July 2023. They were randomly assigned to Group A (type I tympanoplasty with canaloplasty, n = 34) or Group B (type I tympanoplasty alone, n = 34). Preoperative and postoperative audiometric evaluations were conducted to assess air-bone gap closure and hearing thresholds. Graft uptake was evaluated at three months post-surgery. Both groups showed significant improvement in hearing postoperatively (p < 0.01). Group A exhibited a higher rate of successful graft uptake (94.11%) compared to Group B (91.17%), though this difference was statistically significant (p = 0.01). Canaloplasty in Group A facilitated enhanced visualization of the tympanic membrane and improved graft placement, contributing to favorable outcomes. The study underscores the potential benefits of combining canaloplasty with type I tympanoplasty in adolescent patients with COM, emphasizing improved hearing outcomes and graft success rates. These findings support the incorporation of canaloplasty to optimize surgical outcomes and enhance patient outcomes in chronic otitis media management.
Keywords: Canaloplasty, Tymanoplasty, Chronic otitis media, Paediatric tympanoplasty
Introduction
The World Health Organization has estimated that approximately 65 to 330 million people have chronic otitis media (COM) worldwide with 50% having hearing impairment and approximately 28,000 deaths per annum due to complications [1]. In India prevalence rate is 7.8%. In Indian children with hearing loss from CSOM, 94% had moderate loss and the rest severe hearing loss [2]. COM usually begins with episodes of acute otitis media (AOM) or otitis media with effusion in childhood which results in long-term changes of the tympanic membrane [3]. Patients with TM perforations present with ear discharge and hearing loss. As the perforation size increases, transformer ratio diminishes leading to larger canceling effect of sound. Hearing loss almost reaches 40–45 decibel (dB) with total perforation even with intact ossicular chain [4].
Goals of tympanoplasty include closing the defect, restoring the anatomical and functional characteristics, producing acoustic characteristics comparable to those of a normal tympanic membrane. When the tympanic membrane is damaged without ossicular interruption, type-1 tympanoplasty is the treatment of choice [5].
Canaloplasty, is widening of bony EAC to visualize entire tympanic annulus in a single view field and create a good self-cleaning canal. There may be complete circumferential, partial or segmental enlargement of bony EAC. Canaloplasty improves the visualization of tympanic membrane, helps in anterior tympanomeatal flap elevation adequately and provide precise tucking of graft. All these factors improve the rate of graft uptake. Thus, canaloplasty should be done till the canal becomes an inverted truncated cone. The secret of the success of the procedure is in the preservation of the canal skin, and to do so, the canal is widened in parts [6].
The ear canal plays an important role in modulating the sound that is incident upon the tympanic membrane. A resonance-induced amplification of 20 dB sound pressure occurs in the normal ear canal at frequencies of 2800–3000 Hz owing to the length and diameter of the canal [7].
Materials and methods
The present study was conducted in the Department of Otorhinolaryngology at the Mahatma Gandhi Medical College and Hospital, Jaipur, from 01 JAN 2022.
to 01 JULY 2023. Institutional ethics committee approval was taken prior to the commencement of the study. It was a prospective study comparing the surgical outcome in type I tympanoplasty with or without canaloplasty.
Patients with chronic otitis media inactive mucosal disease and conductive hearing loss with bony hump in EAC in the age group of 11–18 years were included in the study. Patients with a history of previous ear surgery, Sensorineural hearing loss, Chronic Otitis Media with atticoantral (unsafe) type, ossicular erosion, tuberculosis, granulations, patients having recurrent infection of Chronic otitis media, patients with normal EAC, and on diagnostic nasal endoscopy gross septal deviation with turbinate hypertrophy, nasal mass or polyp, adenoid hypertrophy were excluded.
A complete ENT examination was done. Consent was taken from parents. All the patients were operated under general anesthesia. A preoperative audiometric evaluation was done using the Madsen Astra 2 audiometer. Air bone gap was calculated by averaging the values over 0.5 kHz, 1 kHz, 2 kHz, and 4 kHz frequencies.
68 patients were included in the study. They were randomly divided into two groups of 34 patients each. Randomization was done using a chit-and-box system. Group A patients underwent type I tympanoplasty with canaloplasty, while group B patients underwent type I tympanoplasty without canaloplasty.
Under general anesthesia, with all aseptic precaution, the post-auricular region and EAC up to annulus was infiltrated with 2% lignocaine with adrenaline. A post-auricular incision was given and the temporalis fascia was harvested for graft. The canal was opened and the margin of perforation were freshened. Tympanomeatal flap is elevated by 270 degrees. Integrity and mobility of ossicular chain checked.
Canaloplasty done by using cutting and diamond burrs to remove the canal wall bulge or hump till the annulus was reached. The shape of the EAC was made like an inverted cone. The canaloplasty aimed to expose and visualize the entire tympanic annulus in a single view field of the microscope. The graft placement was done medial to the handle of the malleus and gel-foam was placed in the middle ear cavity, medial to graft. The wound closed in layers and a mastoid bandage was applied.
Post-op antibiotics, anti-inflammatories, and antihistamines were given. In POD2 dressing changed and the patient was discharged. Follow-up was done after 1 week for stitch removal. After 3 months of operation, a successful outcome was assessed in the form of graft uptake and closure of the Air-Bone Gap.
Result
A total of 68 patients were included in the current study out of which 34 patients each were included in group A and group B. Out of 68 patients, 32 (47.05%) were females, and 36 (52.95%) were males. The mean age of the patients in group A was 15.91 ± 1.33, while in group B, it was 16.08 ± 1.42, with a p-value of 0.121 which was statistically insignificant.
Similarly, the chi-square value for the distribution of perforation size between the two groups showed a p-value of 0.786 as seen in Table 1. showing no significant difference between the two groups.
Table 1.
The distribution of perforation size between the two groups
| Size of perforation | Group A | Group B | Total |
|---|---|---|---|
| Small | 10(29.41%) | 9 (26.47%) | 19 (27.94%) |
| Medium | 17 (50%) | 18 (52.94%) | 35 (51.47%) |
| Large | 3 (8.82%) | 4 (11.76%) | 7 (10.29%) |
| Sub-total | 4(11.76%) | 3(8.82%) | 7(10.29%) |
| Total | 34 | 34 | 68 |
In group A, mean values of BC pre-operative (16.13 ± 3.82) and post-operative (15.91 ± 2.51) is not significant (P-value 0.679). The mean values of AC pre-operative (41.50 ± 8.94) and post-operative (29.45 ± 6.82) is significant (P-value < 0.01). The mean values of ABG pre-operative (25.16 ± 8.02) and post-operative (12.5 ± 3.21) is significant (P-value < 0.01). Table 2.
Table 2.
Group A, comparison of average hearing threshold (0.5 kHz, 1 kHz, 2 kHz, and 4 kHz) as evaluated by audiometry 6 months after the surgery
| Hearing Threshold | Pre-OP (In dB) | Post-OP (In dB) | p-value |
|---|---|---|---|
| Mean AC | 41.50 ± 8.94 | 29.45 ± 6.82 | < 0.01 |
| Mean BC | 16.13 ± 3.82 | 15.91 ± 2.51 | 0.679 |
| ABG | 25.16 ± 8.02 | 12.5 ± 3.21 | < 0.01 |
In group B, mean values of BC pre-operative (16.98 ± 4.28) and post-operative (16.04 ± 2.43) is not significant (P-value 0.140). The mean values of AC pre-operative (55.53 ± 8.83) and post-operative (47.99 ± 4.70) is significant (P-value < 0.01). The mean values of ABG pre-operative (38.55 ± 7.72) and post-operative (32.89 ± 4.02) is significant (P-value < 0.01). Table 3.
Table 3.
Group B, comparison of average hearing threshold (0.5 kHz, 1 kHz, 2 kHz, and 4 kHz) as evaluated by audiometry 6 month after the surgery
| Hearing Threshold | Pre-OP (In dB) | Post-OP (In dB) | p-value |
|---|---|---|---|
| Mean AC | 55.53 ± 8.83 | 47.99 ± 4.70 | < 0.01 |
| Mean BC | 16.98 ± 4.28 | 16.04 ± 2.43 | 0.140 |
| ABG | 38.55 ± 7.72 | 32.89 ± 4.02 | < 0.01 |
In group A, 32 patients out of 34 had improvement and in group B 31 patients out of 34 had improvement. The remaining patient did not improve because of graft failure, lateralization of graft, reduced middle ear space, and infection.
Postoperatively, at 3 months, in group A, 32 patients (94.11%) showed successful graft uptake, while in group B, 31 patients (91.17%) showed successful graft uptake. (Table 4).
Table 4.
Graft uptake at 3 months
| Graft Uptake At 3 Months | Group A | Group B |
|---|---|---|
| In percentage | 94.11% | 91.17% |
In the remaining, patient non-compliance, inadequate graft preparation, improper placement, insufficient tympanic membrane bed preparation, perioperative infection, poor vascular supply, and systemic health issues like diabetes or immunodeficiency disorders can impact healing.
The patients having graft uptake in percentage is higher in group A (tympanoplasty with canaloplasty) than in group B (tympanoplasty without canaloplasty) with a p-value of 0.01 showing a statistically significance difference between the two groups.
In terms of hearing outcomes, post-operatively mean AC and ABG were reduced in group A with a showing statistically significant and establishing overall improved hearing outcome. Same in group B mean AC and ABG reduced, showing statistical significance. The difference between the two groups was not significant.
Discussion
Canaloplasty is a surgical procedure that aims to widen the external auditory canal [6]. Canaloplasty leads to better view of surgical field, ease of graft placement and good results of graft uptake. The ear canal plays an important role in modulating sound. This study was conducted to determine the additional improvement in hearing by combining canaloplasty with type I tympanoplasty. In the present study, confounding factors were size of perforation (small, medium, large). Preoperative air-bone gap did not show any significant statistical difference between the two groups. There are very few studies that compared outcomes of tympanoplasty with or without canaloplasty when the graft is placed medial to the handle of the malleus.
After 12 weeks postoperatively, the success of graft uptake in group A (94.11%) was better than group B (91.17%) in the current study. This collaborates with the earlier studies done by Morrison et al. (2019) at the University of Alabama, who reported 91.6% graft uptake in patients with tympanoplasty and canaloplasty as compared to 69% in patients with tympanoplasty alone. The success rate of graft uptake was higher in the patients with tympanoplasty irrespective of canaloplasty, but the p-value was not significant in the present study. It was significant in the study conducted by Morrison et al. (2019) [8].
Twelve weeks postoperatively, hearing outcome in terms of air-bone gap closure was better in patients with tympanoplasty with canaloplasty. The air bone gap closure was 14.87 dB ± 5.99 in patients who underwent tympanoplasty alone. In the study conducted by Morrison et al. (2019), the air-bone gap was 8.7 dB ± 6.3 with tympanoplasty and canaloplasty as compared to 14.3 dB ± 11.1 in tympanoplasty alone, but the difference was statistically significant [8].
Similarly, Vijayendra H et al. (2008) in their study had a 9 dB improvement in hearing in cases with canaloplasty and tympanoplasty as compared to tympanoplasty alone [9]. Prakash et al. (2018) in the study achieved 13.48 dB of air-bone gap closure when canaloplasty was done with tympanoplasty 11.26 dB of air-bone gap closure was noted in cases without canaloplasty, and the difference was statistically significant too [10].
VN, Prasad KC (2023) in this study group A patients underwent type 1 tympanoplasty with canaloplasty, and group B comprises tympanoplasty alone. Graft uptake was 94.3% in group A and 88.57% un group B. Air bone gap closure was better in group A as compared to group B (15.76 dB ± 6.75 v/s 14.87 dB ± 5.99) at 12 weeks postoperatively [11]. This is similar to what we have seen in the current study; however, the difference was not statistically significant with a p-value of 0.606. There are a few studies available that assessed the impact of canaloplasty on hearing outcomes in patients undergoing type 1 tympanoplasty.
The limitations of this study are the small sample size and the patency of eustachian tube. In our study hearing is better in tympanoplasty with canaloplasty. The hump in the bony canal wall obstructs the complete view of tympanic membrane and middle ear. After canaloplasty, there is 360-degree visualization of the tympanic membrane remnants and the graft placement is more precise. Surgeon’s ease of doing the procedure is increased as frequent adjustment of microscope is not needed. Air-bone gap is much reduced in cases of tympanoplasty with canaloplasty as there is no hindrance in conduction of sound waves through external auditory canal.
Conclusion
Patients of chronic otitis media inactive mucosal disease with a bony hump in EAC undergoing type 1 tympanoplasty must undergo canaloplasty for good Air-Bone gap closure (hence improved hearing) and good graft uptake as proven in this study.
Funding
Not applicable.
Declarations
Conflict of Interest
The authors declare no conflict of interest.
Footnotes
Publisher’s Note
Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.
References
- 1.Monasta L, Ronfani L, Marchetti F et al (2012) Burden of disease caused by otitis media: a systematic review and global estimates. PLoS ONE 7:e36226 [DOI] [PMC free article] [PubMed] [Google Scholar]
- 2.Acuin J (2004) Chronic suppurative otitis media - burden of illness and management options. World Health Organisation, Geneva
- 3.Schilder AG (1999) Assessment of complications of the condition and the treatment of otitis media with effusion. Int J PediatrOtorhinolaryngol 49(Suppl 1):S247–S251 [DOI] [PubMed] [Google Scholar]
- 4.Lim DJ (1970) Human tympanic membrane. An ultrastructural observation. Acta Otolaryngol 70:176–186 [DOI] [PubMed] [Google Scholar]
- 5.Mudry A (2008) History of myringoplasty and tympanoplasty type I. Otolaryngol Head Neck Surg 139(5):613–614 [DOI] [PubMed] [Google Scholar]
- 6.Lavy J, Fagan P (2001) Canaloplasty: review of 100 cases. J Laryngol Otol 115(4):270–273 [DOI] [PubMed] [Google Scholar]
- 7.Huttenbrink KB (2010) Biomechanical aspects of middle ear reconstruction. In: Jahnke K (ed) Middle ear surgery, recent advances and future directions. Thieme, New York [Google Scholar]
- 8.Morrison DR, O’Connell B, Lambert PR (2019) The impact of canaloplasty on outcomes of medial graft tympanoplasty. Otol Neurotol 40(6):761–766 [DOI] [PubMed] [Google Scholar]
- 9.Vijayendra H, Ittop CJ, Sangeetha R (2008) Comparative study of hearing improvement in type 1 tympanoplasty with and without canaloplasty. Indian J Otolaryngol Head NeckSurg 60(4):341–344 [DOI] [PMC free article] [PubMed] [Google Scholar]
- 10.Prakash MD, Badkar P (2018) Efect of canaloplasty in tympanoplasty. Int J Otorhinolaryngol Head Neck Surg 4:1049–1052 [Google Scholar]
- 11.Prasad VN (2023) A comparative study to Determine hearing outcome in type 1 Tympanoplasty with and without Canaloplasty in Tubotympanic Type of Chronic Suppurative Otitis Media. Indian J Otolaryngol Head Neck Surg 75(4):3344–3348. 10.1007/s12070-023-03961-5Epub 2023 Jun 21. PMID: 37974802; PMCID: PMC10645666 [DOI] [PMC free article] [PubMed] [Google Scholar]