A, The 2.7-mm (60-cm) endoscope (Karl Storz) used throughout the operation. B, Central perforation in the tympanic membrane, showing all the boundaries of the perforation. C, Harvesting the tragal cartilage through a 1-cm incision posterior to the tragus and taking a graft slightly larger than the perforation size. D, Cartilage that fits accurately under the edges of the tympanic membrane perforation. E, Endoscopic view of a healed tympanic membrane at 6 months’ postoperative follow-up with complete healing.
Awad OGA, Hamid KA. Endoscopic Type 1 Tympanoplasty in Pediatric Patients Using Tragal Cartilage. JAMA Otolaryngol Head Neck Surg. 2015;141(6):532-538. doi:10.1001/jamaoto.2015.0601
The main objective in the treatment of chronic otitis media is to relieve drainage and to rehabilitate hearing. Various materials can be used to repair the tympanic membrane (TM) through different tympanoplasty techniques.
To assess the results of endoscopic type I tympanoplasty in pediatric patients using tragal cartilage as a grafting material.
Design, Setting, and Participants
In this prospective study, we studied 80 ears in 80 pediatric patients (ages, 5-17 years) who had undergone type I tympanoplasty from January 2011 to December 2013 at a tertiary referral hospital. We classified our patients into a younger group (≤10 years; n = 40) and an older group (>10 years; n = 40). Patients were followed for up to 6 months.
Endoscopic type I tympanoplasty using split-thickness tragal cartilage.
Main Outcomes and Measures
We identified the following criteria for success: (1) healing of the TM (anatomical success) and (2) improvement in hearing by assessing the change in the air-bone gap (ABG). We also assessed the mean operation duration and the different prognostic factors.
Healing of the TM healing occurred in 34 patients (85%) in the younger group vs 36 patients (90%) in the older group. Both groups had notable improvement compared with the preoperative measurements, with no significant differences between the 2 groups. Thirty patients (75%) in the younger group had improvement in their ABG vs 32 patients (80%) in the older group, with a mean ABG of 8.0 dB and 10.5 dB in the younger and older groups, respectively. Both groups had significant functional success with no significant differences between the 2 groups. Sixty patients (75%) displayed a type A tympanogram at their 6-month postoperative audiometric testing (28 patients in the younger group vs 32 patients in the older group). There were no statistically significant differences regarding the anatomical and functional success between the patients who had previously undergone adenotonsillectomy and the other patients. The mean (SD) operation duration was 55.03 (2.50) minutes.
Conclusions and Relevance
In pediatric patients undergoing type I tympanoplasty, the endoscopic approach using the tragal cartilage as a grafting material resulted in successful anatomical and functional outcomes that are in comparable to other techniques but with a shorter operation duration. Age of the patient, auditory tube dysfunction, and previous adenotonsillectomy were not prognostic factors for this procedure.
Tympanoplasty is a relatively common procedure in children. Most tympanic membrane (TM) perforations in children result from a otitis media–related complication. These children may have underlying eustachian tube dysfunction, which makes the decision to undertake TM grafting complicated.1 However, children may have the most to gain from an intact TM: water activity would not be restricted, and hearing may improve. Tympanoplasties performed in children are reported as being less successful compared with those performed in adults.2,3 Many factors may influence the surgical outcome of tympanoplasty in children, including age, the size and location of perforation, status of the operated and contralateral ear, presence of hypertrophic adenoids, function of the auditory tube, and the surgeons’ experience.3- 5
Since the introduction of the modern tympanoplasty by Zollner and Wullstein, clinicians have sought the ideal graft material for closure of TM perforations.6 The most commonly used techniques for graft placement on the TM are the “inlay” (underlay, medial) and “onlay” (lateral) techniques, and the most used types of graft are the temporal muscle fascia and the tragal perichondrium, with similar success rates.7,8
For pediatric myringoplasty, it has been suggested that a more robust graft material, such as cartilage, may lead to a more durable repair with hearing results equivalent to fascial repair. It has been shown in both experimental and clinical studies that cartilage is well tolerated by the middle ear and that it survives in the long term.9 Cartilage was first used to rebuild the ossicular chain in 1958 by Janse.10 Some years later, this material started to be used as a graft in tympanoplasty, especially in cases of advanced middle ear diseases.7 In 1998, Eavey11 described tympanoplasty in children using the tragal cartilage and bilateral perichondrium (cartilage plug) and graft placement without incisions in the external acoustic meatus (inlay approach).
The microscope revolutionized the surgical management of diseases of the ear, but the basic optical properties of microscopes have remained the same for the last 30 years. Meanwhile, endoscopes with better optics and magnification and with angled lenses have been used in numerous applications in ear surgery. It has been established that endoscopes make a positive difference in surgery of the ear, but the difference is not yet enough for the endoscope to gain worldwide popularity.12 The goal of this study was to assess the clinical and audiometric results of the endoscopic inlay approach of tragal cartilage to correct TM perforations in the pediatric population.
This prospective study was conducted at Otolaryngology, Head and Neck Surgery Department, Minia University, Minia, Egypt. The study was approved by the institutional review board at El-Minia University, and informed written consent was obtained from the parents of the patients after they received the explanation of the research.
We prospectively selected 80 patients (80 ears) with chronic otitis media (COM) who were younger than 18 years (range, 5-17 years) and who underwent a primary type 1 tympanoplasty in our department between January 2011 and December 2013. We selected our patients according to the following inclusion criteria: (1) patients younger than 18 years; (2) patients having central perforation with the possibility to visualize all its borders; (3) patients with dry perforation for 6 months or longer; (4) patients with an intact ossicular chain; and (5) patients completed at least 6 months’ follow-up after the surgery. We excluded from the study all patients with cholesteatoma, previous tympanoplasty, sensorineural hearing loss in the affected ear, tympanosclerosis, immune deficiency, metabolic diseases, malignancy, and/or mental retardation. Fifty patients who did not meet the inclusion criteria or had one of the exclusion criteria were excluded from the study.
Patient’s age at surgery, sex, size, side, location of perforation in the TM, status of the operated and contralateral ear, history of previous otolaryngology surgical procedures (namely, ventilation tube placement surgery and adenotonsillectomy), auditory tube function, preoperative and postoperative hearing levels, duration of the operation, and postoperative complications were recorded. All the patients were also assessed through a clinical history, general and thorough otorhinolaryngeal examination, temporal bone computed tomographic (CT) scans, and preoperative tests.
The location of perforations was classified as anterior or posterior to the long process of the malleus. If an anterior perforation extended posteriorly to the long process of the malleus, it was considered as central. Perforations were considered as inferior if they were inferior to the umbus of the malleus and were considered as marginal when concerning the annulus tympanicus. Regarding the status of the contralateral year, we recorded the presence of infection, otorrhea, effusion, tympanostomy tubes, or atelectasis.
We divided our population into 2 groups according to the expected eustachian tube maturity—a younger group (age ≤10 years; n = 40) and an older group (age >10 years; n = 40)—because the rate of upper airway infection is considered higher in the first group.2,4,13 All patients underwent preoperative and postoperative audiological evaluation, including hearing thresholds at 0.5, 1.0, 2.0, and 4.0 kHz, which allowed us to assess functional success. We report the air-bone gap (ABG) as the 4 pure-tone average for air conduction minus the same average for bone conduction determined at the same time. The mean (SD) of the postoperative ABG and the number of decibels of closure of the gap are reported according to the recommendations of the committee on hearing and equilibrium guidelines for the evaluation of results of treatment of conductive hearing loss.14 Patients also underwent tympanometry and nonintact TM auditory tube function tests, including (1) force response test, (2) pressure equilibration test, and (3) 9-step inflation and deflation test.15
The senior author (O.G.A) performed all the operations. With the patient under general anesthesia and with the use of a 0° 2.7-mm endoscope (Karl Storz; Figure, A), we examined the TM perforation (Figure, B). The perforation border was removed with a straight-tip stylet, and a curved-tip stylet was used next to scratch the mucosal face of the TM. The perforation’s size and shape were measured with the help of a hook-type stylet, drawing its shape on a piece of sterile paper. The paper was cut, and the perforation size was checked against the paper mold created. Cartilage was harvested from the tragus by making a 1-cm incision in the posterior aspect of the tragus, and the incision continued deep enough to incise through the tragal cartilage and perichondrium by using delicate scissors, leaving the dome of the tragal cartilage to maintain the normal shape of the tragus. We removed a fragment slightly larger than the mold we had previously created (Figure, C). The full-thickness graft obtained was dissected of its perichondrium on one side and was split with a sharp knife to obtain a partial-thickness graft. The graft was accurately placed and fitted using an underlay technique medial to the handle of the malleus and immediately adjacent to the incus to reconstruct the entire TM (Figure, D). On top of the graft, we placed a thin gel-foam layer with antibiotic ointment and a cotton ball to seal the external acoustic meatus. The duration of the operation was taken as being from the moment the surgeon started receiving instruments from the nurse until the procedure was concluded when the nurse received the tool from the surgeon.
All the patients were prescribed systemic antibiotics (amoxicillin-clavulanic acid) for 7 to 10 days postoperatively, and the patients were instructed to avoid vigorous blowing of the nose and sneezing. On the first postoperative visit after 1 week, the stitches and aural packs were usually removed, and the gel-foam fragments were aspirated allowing the graft to be seen and its viability determined. All patients had regular follow-up visits every 2 weeks for 6 months, and each patient had the postoperative audiogram and tympanogram after 6 months. Anatomical success was defined as the presence of an intact graft evaluated by a 0° endoscope and tympanometry without perforation, atelectasis, or lateralization at the last follow-up visit with a minimum of 6 months (Figure, E). Functional success was defined as a postoperative ABG (0.5–3.0 kHz) less than 20 dB.
Statistical analyses were performed using SPSS v.16 software (IBM Corp). Results are expressed as the mean (SD) for continuous variables and as percentages for categorical variables. Data were compared with the t test or a Mann-Whitney and a χ2 test as appropriate. P ≤ .05 was considered statistically significant.
We report complete data in 80 ears of 80 patients who met the criteria for inclusion in the study. Patients characteristics are presented in Table 1. Regarding the previous otorhinolaryngeal surgery, 15 patients (19%) were submitted to ventilation tube placement surgery. Five of these patients had persistent perforation after the tube removal, which was the indication of the tympanoplasty. The cause of other perforations was acute otitis media with repeated or persistent perforation. Forty-five patients (56%) had undergone adenotonsillectomy. The contralateral ear was identified as normal in 56 patients (70%), and 24 (30%) contralateral ears had perforations, with only 3 ears having active otorrhea. Among the 24 patients with contralateral perforations, 5 had undergone previous ventilation tubes and had posttympanostomy tube perforations. Perforation sizes are presented in Table 2.
In the initial audiological evaluation, we observed a minimum ABG of 10 dB and a maximum of 40 dB in the younger group (mean, 30.5 dB), and in the final postoperative evaluation, a minimum difference of 5 dB and maximum of 25 dB (mean, 8 dB). In the 1 to 10 years age group, 30 patients (75%) had significant improvement in their ABG compared with their preoperative ABG scores (8.0 [range, 5-25] dB vs 30.5 [range, 10-40] dB, respectively; P = .01). In the older group, the preoperative values varied between 8 dB and 45 dB (mean value of 35.5 dB). In the postoperative evaluation, there was a variation of 0 to 30 dB (mean, 10.5 dB), and 32 patients (80%) had significant improvement in their ABG compared with their preoperative ABG scores (P = .03). The change in the ABG in the 2 groups is presented in Table 2. There were no significant differences in the postoperative gain at any frequency between the younger and older groups.
Sixty patients (75%) displayed a type A tympanogram at their 6-month postoperative audiometric testing (28 patients in the younger group vs 32 patients in the older group). Five patients had transient otitis media with effusion that resolved in less than 3 weeks, and 5 patients had persistent middle ear negative pressure (type C tympanogram).
Thirty-five patients (44%) had normal auditory tube function preoperatively, and 45 patients (56%) had impaired auditory tube function. Patients with normal auditory tube function had 80% functional success vs 75% of patients with impaired auditory tube function (P = .06).
There was a total perforation closure in 70 patients (88%), 34 (85%) of whom were in the younger group vs 36 (90%) in the older group. We observed residual perforation in 10 patients (13%) during the follow-up period (6 patients in the younger group and 4 patients in the older group). There was no statistically significant difference between the 2 groups regarding the anatomical success (P = .41). We present the anatomical and functional success results regarding the size, location, and size of preoperative perforations in the total patient population in Table 3.
We observed 8 cases that achieved anatomical success without functional success (4 patients in the younger group and 4 patients in the older group). Patients with normal auditory tube function had 91% anatomical success vs 84% in patients with impaired auditory tube function (P = .06).
The mean (SD) operation duration was 55.03 (2.50) minutes. Sixty-five percent of our population had undergone a previous adenotonsillectomy. There were no statistically significant differences between the group previously submitted to adenotonsillectomy and other patients regarding the anatomical and functional success (Table 4).
Among our study patients, 3 developed postoperative complications. Of these, 2 patients developed otitis externa, which resolved with local treatment, and 1 patient developed transient vertigo, which resolved conservatively with office-based procedures.
The main objective in the treatment of COM is to achieve symptomatic relief, relieve drainage, rehabilitate hearing, and minimize complications. Meeting these goals is particularly important in children with COM because patients in this age group may develop hearing loss, especially in patients in whom both ears are affected in early childhood.5,13 The approach to COM in childhood is trending toward the application of minimally invasive surgical procedures under appropriate conditions.15
In recent years, the use of cartilage grafts has been widespread and is frequently applied in pediatric patients with COM.16,17 Cartilage is a more robust material than other grafting materials, easier to fit on the eardrum perforation site, thicker, and less prone to resorption and retraction.7,18,19 However, the cartilage acoustic transfer characteristics are theoretically worse because of its thickness.7,19,20 Zahnert et al21 carried out an experimental study and concluded that 500-μm-thick cartilage has acceptable acoustic transfer capacity with good mechanical stability.
Many surgeons perform tympanoplasty using an operating microscope. However, despite providing direct exposure, microscopy may be insufficient for the viewing of certain areas during surgery. There may be exposure problems caused by the anterior wall prominence, and hidden areas that cannot be seen under a microscope can be better observed via thin and rigid endoscopes with different angles. In the endoscopic tympanoplasty, endoscope allows for functional reconstruction, as well as the performance of minimally invasive procedures.22 The aim of our study was to assess the value of using the endoscopic approach in pediatric tympanoplasty.
The disparity of surgical outcome in pediatric tympanoplasty is partly explained by differences in the inclusion and exclusion criteria, as well as the definitions of success. Most studies used the anatomical criteria of success. However, a normally functioning middle ear after tympanoplasty clearly requires more than an intact graft. In our study, we used a stricter definition of success according to the American Academy of Otolaryngology Head and Neck Surgery guidelines.14 In general, investigators who use the strictest criteria usually report lower success rates.4,5,13 We found anatomical and functional success rates similar to others in the literature (85.7% and 76.9%, respectively).5,23- 25 The evidence of good audiological results in anatomically successful cases is associated with a highly probable return to normal function and lifestyle at any age.
Age is often cited as a key prognostic factor in evaluation for tympanoplasty in children.2,26,27 Some authors observed that older age was associated with better results.3,27 Other authors have reported no significant correlation between age and surgical outcome.28- 30 In our study, younger and older children had similar success rates, and the age was not a prognostic variable (P > .05).
Success rates of TM perforation closure with cartilage plugs in adults are high. Testa et al20 reported a closure success rate of 96.8%, with hearing improvement in all the cases. These are the goals to be reached in children; however, low immunity, high rate of upper airway infection, and eustachian tube dysfunction are factors responsible for reducing the success rates of tympanoplasties in the pediatric population. The use of tragal cartilage in perforation closure gives success rates similar to those achieved with other materials, such as the temporal fascia.31
Because TM must heal by secondary intention, the size of the perforation may influence the results.32- 34 Anterior perforations were reported to have a poorer surgical access to the anterior border, and because of that, they were considered an important factor for successful surgery.35 In our study, we achieved 95% anatomical success for the anterior perforations due to the endoscopic visibility of the anterior perforation borders. Marginal perforations were also reported with lower success rates because they are less vascularized,35 and that was also evident in our results with only 60% anatomical success. We reported a tendency of larger, posterior, and marginal perforations to have worse results than other perforations, however, with no statistically significant differences. For large and marginal perforations, Schraff et al36 described the “window shade technique,” which combines aspects of both the traditional underlay and the overlay tympanoplasty techniques with success rates of up to 95%.
Adenotonsillectomy can lessen the incidence of otitis media with effusion and therefore may be associated with a lower incidence of recurrent TM perforation.29 We found higher tympanoplasty success rates in patients who had previously been treated with adenotonsillectomy, but without statistical significance, which is in line with results published by others.23- 25
The use of endoscopic approach in ear surgery fulfills the requirements of minimally invasive surgery, and the least trauma to the normal tissues can be achieved in this way.37,38 However, the endoscopic approach still has several disadvantages, including a lack of sufficient microscopic magnification and instrument crowding within the surgical area.39 Complications of this approach in our study were rare and easily managed.37,38
The duration of the operation is an important parameter in terms of the duration of anesthesia, the surgeon’s concentration, and the increased risk of iatrogenic complications. In a study by Ghaffar et al,40 the mean operation duration was 62.85 minutes among 34 patients who underwent microscopic tympanoplasty. In our study, the operation duration was less than 60 minutes. The reason for these differences may be related to the fact that neither suturing nor extra time to view hidden areas is needed during endoscopic procedures.
The existing guidelines clearly support not using antibiotics for uncomplicated tympanoplasty. In another study, Govaerts et al41 concluded that antibiotic prophylaxis may not be mandatory in clean ear surgery; however, they advocated its use for the sake of patient and surgeon comfort. Operations in developing countries, especially in children, carry a higher risk of developing postoperative infection, so surgeons in our locality tend to use antibiotics after ear surgery.
In pediatric patients undergoing type I tympanoplasty, the endoscopic approach using tragal cartilage gives statistically significant success that is comparable to other techniques.
Submitted for Publication: October 12, 2014; final revision received February 13, 2015; accepted March 12, 2015.
Corresponding Author: Osama G. Abdel-Naby Awad, MD, Otolaryngology–Head and Neck Department, Minia University Hospital, 122 Kornish El-Neel St, Minia City, Minia, Egypt (email@example.com).
Published Online: April 30, 2015. doi:10.1001/jamaoto.2015.0601.
Author Contributions: Dr Awad had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.
Study concept and design: Awad, Hamid.
Acquisition, analysis, or interpretation of data: Awad.
Drafting of the manuscript: Awad, Hamid.
Critical revision of the manuscript for important intellectual content: Awad.
Statistical analysis: Awad, Hamid.
Conflict of Interest Disclosures: None reported.