Abstract
The aim of this study is to investigate the outcomes of bilateral same-day endoscopic myringoplasty using tragal cartilage from one ear in patients with bilateral chronic otitis media. In this retrospective study, medical records of 62 (84 ears) patients aged between 18 and 65 years who underwent endoscopic myringoplasty at our center between January 2015 and December 2017 were evaluated. Patients were classified into 2 groups according to surgical procedure they received: unilateral myringoplasty (group 1) and bilateral same-day myringoplasty (group 2). The comparisons were made between groups in terms of anatomical graft success and functional outcomes. There were 40 patients in the unilateral group (group 1) and 22 patients in the bilateral same-day group (group 2). The graft success rates were 92.5% and 93.2% for groups 1 and 2, respectively (P = .904). The mean preoperative air–bone gaps (ABGs) were 21.1 ± 7.1 and 20.5 ± 6.7 dB, respectively, whereas the mean postoperative ABGs were 8.1 ± 2.7 dB and 7.9 ± 3.0 dB, respectively. The difference between pre- and postoperative ABGs for the entire group was statistically significant (P < .001). Mean hearing gain was 12.5 ± 11.0 dB and 15.6 ± 10.1 dB in groups 1 and 2, respectively, (P = .183). Postoperative ABG was ≤10 dB in 33 (82.5%) and 36 (81.8%) ears in groups 1 and 2, respectively. The functional success rates were similar in both groups (P = .582). The average lengths of operation time were 61.6 ± 12.5 minutes and 110.1 ± 25.2 minutes for groups 1 and 2, respectively. Bilateral same-day endoscopic myringoplasty using tragal cartilage from one ear seems to be a safe and satisfactory procedure with a good satisfactory success rate.
Introduction
Myringoplasty, a common and well-established method for the repair of tympanic membrane (TM) perforations, is conventionally performed under the guidance of a surgical microscope via retroauricular, endaural, and transcanal approaches. Recently, the endoscopic transcanal approach has been preferred predominantly because it does not necessitate incision or canaloplasty, is less invasive than the microscopic approach, does not require transplantation of hair to the ear region, and reduces postoperative bleeding and pain. 1 Huang et al 2 reported that the endoscopic technique for tympanoplasty offered cosmetically improved outcomes and decreased operative time and exposure to anesthetic agents and associated complications.
Traditionally, each TM was obtained for grafting sequentially in 2 different settings, considerably increasing the cost, time, and patient discomfort. 3 The concept of bilateral same-day myringoplasty is debatable. Among otologic surgeons globally, the traditional approach to a patient with bilateral TM perforations is 2-staged, leading to a significant increase in cost and time along with greater patient discomfort to the patient. 3 This has primarily been attributed to the theoretical risk of iatrogenic sensorineural hearing loss (ISNHL), which is approximately 1.2% to 4.5%. 4 -6 However, it is essential to note the risk of ISNHL, which is encountered primarily in patients with cholesteatoma, congenital malformation, or granulation tissue or in cases where ossiculoplasty has been performed. Tos et al 6 reported no incidence of ISNHL in a series of 439 patients undergoing myringoplasty. Another argument against performing bilateral myringoplasty is the idea that bilateral ear packing postoperatively causes severe conductive hearing loss, resulting in transient social handicap for the patient. 7,8
In the present study, we investigated the outcomes of bilateral same-day endoscopic myringoplasty using tragal cartilage from one ear in 22 patients with bilateral chronic otitis media (COM) and analyzed the possible factors affecting the outcomes of this surgery.
Materials and Methods
We retrospectively reviewed 67 patients aged between 18 and 65 years with bilateral TM perforations who underwent endoscopic myringoplasty under general anesthesia from January 2015 to December 2017. Retrospectively collected data included patient age and sex, type (central/marginal) and site of perforation regarding its relation to the handle of the malleus (anterior/posterior/inferior), surgical procedure (unilateral/bilateral same day), preoperative and postoperative hearing levels, air–bone gaps (ABGs), graft take, and operation time. Our exclusion criteria were presenting with discharging ear, history of previous otologic surgery, ossicular defects, stapes or malleus fixation, tympanosclerosis, or cholesteatoma and being younger than 18 or older than 65 years old at the time of surgery.
The patients were categorized into 2 groups based on the surgical procedure: group 1 (44 patients) underwent unilateral endoscopic myringoplasty and group 2 (23 patients) underwent bilateral same-day endoscopic myringoplasty, both using the underlay technique. Four patients in group 1 and 1 patient in group 2 did not have follow-up data and thus were excluded from further analysis, leaving 40 patients for group 1 and 22 patients for group 2.
The joint institutional review board approved the study protocol (decree no: 2018/250), and the study was conducted in accordance with the ethical principles stated in the Declaration of Helsinki. Prior to surgery, written informed consent was obtained from all individual participants.
An endoscopic system (Karl Storz, Tuttlingen, Germany) and 0° rigid endoscopes (3.0 mm diameter, 14 cm long; Karl Storz) were used. Perforation edges were refreshed and a lateral circumferential incision was performed 4 to 6 mm laterally from the tympanic annulus. This incision was integrated with radial incisions at the 6-o’clock and 12-o’clock positions. The middle ear cavity was visualized after the tympanomeatal skin flap was elevated. Ossicular continuity was evaluated by eliciting the round window reflex. In group 1, an incision through the skin and cartilage was made on the medial side of the tragus, leaving 2 mm of cartilage in the dome of the tragus for cosmesis. Tragal cartilage was harvested with perichondrium on both sides and the tragal cartilage perichondrium at its convex side was peeled. An absorbable material was used to suture the incision. The cartilage graft was carefully thinned with a scalpel and shaped according to the size and shape of the perforation (Figure 1). The graft was placed via the underlay technique after placing an absorbable gelatin sponge (AGS) medial to the graft. After repositioning the tympanomeatal flap, the external ear canal was packed with AGS. In group 2, to harvest the tragal cartilage, perichondrium was used and kept intact on both sides. The tragal cartilage obtained from one ear was sliced into 2 pieces with the help of a #15 surgical scalpel (Figure 2), and 2 pieces of cartilage graft were obtained (Figure 3). One piece of cartilage graft was shaped according to the size of perforation of the first ear. After placing AGS in the middle ear cavity, the graft was placed using the underlay technique. The tympanomeatal flap was then repositioned and the external ear canal was packed with AGS. After surgery was performed on the first ear, the head was turned to the opposite side and a similar procedure was performed using the other piece of the tragal cartilage graft. Mastoid dressing was not necessary. The patients were discharged on the day of surgery. Each patient was prescribed systemic antibiotics (amoxicillin/clavulanate), analgesics, and cetirizine for 7 days postoperatively. Stitches and aural dressings were typically removed 1 week postoperatively, and AGS fragments were aspirated, thereby permitting visualization of the graft. Ear drops containing topical antibiotics (ofloxacin) were administered for 1 week postoperatively to prevent local infections twice daily for 2 to 4 weeks.
Photograph showing harvested tragal cartilage with intact perichondrium on both sides.
Photograph showing preparation of cartilage grafts for use in bilateral perforations. Tragal cartilage obtained from one ear was sliced into 2 pieces with the help of a #15 surgical scalpel.
Photograph showing 2 pieces of cartilage grafts obtained from tragal cartilage.
Pre- and postoperative air and bone conduction thresholds were measured at 500, 1000, 2000, and 3000 Hz using a clinical audiometer (Interacoustic AC-40, Assens, Denmark). A repeat audiogram was performed at the end of the sixth month. Air–bone gaps were calculated as the average difference between air and bone conductions at 4 frequencies (0.5, 1, 2, and 3 kHz). A successful functional result was defined as a postoperative ABG of ≤10 dB.
Postoperative follow-up controls were conducted at the hospital at the first, second, and third weeks; first, third, sixth, and 12th months; and annually thereafter. Anatomical success was defined as full, intact healing of the without perforation, retraction, or lateralization evaluated by microscopy at the last follow-up visit at 12 months. The operation time was recorded as the time taken from tragal local anesthesia to the closure of the incision after placement of the graft using the underlay technique.
Statistical analyses were performed using SPSS version 20 (SPSS Inc, IBM Company, Chicago, Illinois). The data were expressed as mean (standard deviation [SD]) and percentage (%). The χ2 test was used for the comparison of groups and recovery rates. Normality of data was examined with the Kolmogorov-Smirnov test. The Wilcoxon and Mann-Whitney U tests were used for nonparametric variables, while independent and paired samples t tests were employed for parametric variables. A P value of <.05 was accepted as statistically significant.
Results
A total of 62 patients (mean age, 37.3 [13.1] years) with 84 operated ears (35 left, 49 right) who met the aforementioned criteria were evaluated. The mean follow-up period was 21.2 ± 7.2 months (range, 12-36 months). Patient characteristics are given in Table 1. There were no statistically significant differences between the 2 groups in terms of age (36.7 [12.6] and 38.4 [14.1] years, respectively; P = .618), gender, operated side, and type and location of TM perforation.
Characteristics of patients and perforations in groups.
aSignificance level: P < .05.
The graft success rates were 92.9% (78 ears), 92.5% (37 ears), and 93.2% (41 ears) for overall, group 1, and group 2, respectively (not statistically significant, P = .904; Table 2). Additionally, the mean preoperative ABGs of groups 1 and 2 were 20.5 (6.9) dB, 21.1 (7.1) dB, and 20.5 (6.7) dB, respectively, whereas the mean postoperative ABGs were 10.9 (9.7) dB, 8.1 (2.7) dB, and 7.9 (3.0) dB, respectively. The difference between the pre- and postoperative ABGs for the entire group was statistically significant (P < .001). The functional success rate (ABG ≤ 10 dB) for the entire group was 82.1% (69 ears). The functional success rates were similar in both groups (P = .582; Table 3). The mean hearing gain was 12.5 (11.0) dB and 15.6 (10.1) dB in groups 1 and 2, respectively, and the postoperative ABG was ≤10 dB in 33 (82.5%) and 36 (81.8%) ears in groups 1 and 2, respectively. There were no statistically significant differences between the groups in terms of hearing gain (P = .183). Lastly, the average lengths of operation time were 61.6 (12.5) minutes and 110.1 (25.2) minutes for groups 1 and 2, respectively.
Comparison of anatomical success between groups.
aSignificance level: P < .05.
Comparisons of hearing outcomes and functional success between groups.
Abbreviation: ABG, air-bone gap.
aSignificance level: P < .05, functional success: ABG less than <10 dB.
Discussion
We documented the practicality of bilateral same-day myringoplasty in bilateral TM perforations caused by COM. The underlay technique was used to treat ears through a transcanal endoscopic approach using the tragal cartilage from one ear as graft material.
In the literature, the graft success rates of cartilage tympanoplasty vary from 92% to 100%. 9 -14 It is important to emphasize that these results relate to cases in which bilaterality of the disease is not taken into consideration. Tympanoplasty is less successful in patients with bilateral COM; thus, bilaterality of the disease represents a negative prognostic factor. 15 In the present study, we found success rates of 92.9%, 92.5%, and 93.2% for overall, unilateral, and bilateral same-day groups, respectively. The 81.8% hearing success rate for bilateral myringoplasty obtained from this study also corresponds well to the 82.5% hearing success rate for unilateral myringoplasty. Sakagami et al 16 reported an anatomic success rate of 72% (18 patients) and a postoperative ABG of <20 dB in 15 (60%) of 25 patients. Katsura et al 17 reported an 85% success rate for graft take with hearing improvement in 15 (88%) patients. Caye-Thomasen et al 7 found a 94% success rate for graft take in all patients, with a closure of ABG <10 and 20 dB postoperatively in 92% and 100% of 26 patients, respectively. Yu et al 18 recorded a 100% success rate, with an improvement in ABG from 15.8 to 8.4 dB. Rai et al 19 reported a 93% graft take rate and an ABG of <20 dB postoperatively in 27 (90%) patients who had undergone bilateral myringoplasty using temporalis fascia. The authors did not find a significant difference in graft take and hearing improvement between the results of unilateral and bilateral myringoplasty. Daneshi et al 20 calculated a 94.4% success rate, with an improvement in ABG from 13.8 to 9.6 dB in patients having undergone bilateral simultaneous endoscopic transcanal cartilage tympanoplasty. Karataş and Kaskalan 21 performed bilateral inlay cartilage tympanoplasty using tragal cartilage from one ear and reported an 86.3% success rate, with an ABG of <20 dB and 10 dB postoperatively in 98% (65 patients) and 56% (37 patients) of 66 patients, respectively. In our study, the 93.2% (41 ears) graft take rate in group 2 was also similar to the results of the above studies. Furthermore, no patient had bilaterally failed TM grafting; thus, at least one TM closure was achieved at the end of 12 months. Likewise, in this study, the ABG for group 2 was <10 dB in 36 (81.8%) ears, which is also within the average reported success rate of the previous studies in the literature.
Endoscopic transcanal middle ear surgery, which is minimally invasive, is a practical, time-saving, and conservative technique compared with conventional surgical techniques. 2,20,21 Apart from tragal incision, this technique does not require retroauricular skin incision, canal drilling, or hair shaving. In our study, the average length of operation time was 61.6 minutes for the unilateral group, which is consistent with existing studies on the cited subject. The less pain and decreased demand for analgesics are other advantages of this technique. Since postoperative pain is a significant factor for patient comfort after middle ear surgery, we prefer the endoscopic approach when performing bilateral same-day myringoplasty at our clinic. However, Rai et al indicated that the severity of pain did not cause any greater degree of disturbance to the patients after bilateral same-day myringoplasty performed via a retroauricular approach, and they found no statistically significant difference between the unilateral and bilateral same-day myringoplasty groups in terms of postoperative pain scores. 19
Adult TM measures 9 to 10 mm vertically and 8 to 9 mm horizontally. 22 The average tragal cartilage size was reported as 21.9 mm × 15.3 mm. 23 Consequently, only one tragus provides an adequate amount of graft even for bilateral large-sized TM perforations. The advantage of using tragal cartilage from one ear for both TM perforations is that it reduces the time required to obtain another tragal graft. Furthermore, using tragal cartilage from one ear preserves the contralateral tragal cartilage, which can subsequently be used as graft material in case of failure of graft take or revision surgery. Therefore, we harvested tragal cartilage from one ear and used the same graft to repair both TM perforations.
From the data collected on operation time, it is clear that by eliminating the need for a second procedure for graft harvesting, bilateral same-day surgery (110.1 minutes) becomes less time consuming compared to unilateral surgery (61.6 minutes) done twice. We believe that this technique will provide substantial cost savings by reducing the number of hospital admissions and bed occupancy. Moreover, it also eliminates hidden costs related to the patient taking time off work and away from home.
Some otologic surgeons are reluctant to perform bilateral tympanoplasty because of a theoretical risk of ISNHL during surgery. From a review of literature, it is essential to note that such incidents occurred in patients with congenital diseases, cholesteatoma, and granulation tissue or in cases undergoing ossicular chain reconstruction. 4-7,24 In our study, we did not observe any cases of postoperative ISNHL. Our findings are in agreement with those of previous studies. 7, 16 –18,24 Moreover, Daneshi et al 20 reported that they did not encounter any case of ISNHL, facial paralysis, or chorda tympani injury in their previous series of endoscopic stapedectomy, even though the theoretical risk for ISNHL was greater in cases of stapes surgery. Kim et al 25 reported that performing bilateral simultaneous middle ear surgery for COM provided favorable hearing results. They also reported reduced costs, operation time, and number of postoperative outpatient control visits, as well as a low incidence of complications. Therefore, the risk of developing ISNHL is negligible regardless of the nature of the graft or technique used unless the ossicular chain is manipulated as in myringoplasty because the homeostasis of the internal ear is not disturbed. It is essential to note that ISNHL has seldom been reported in patients undergoing exclusive myringoplasty. The primary disadvantage of bilateral myringoplasty is hearing impairment during the ear canal packing period. Caye-Thomasen et al 7 investigated the debatable issue of bilateral packing and concluded that hearing was impaired for a few days during postoperative bilateral packing, but thereafter no significant hearing problems were reported in everyday activities. The authors’ explanation for this was that the packing material dried over time, allowing passage of air, thereby gradually improving hearing. None of our patients who underwent bilateral same-day myringoplasty experienced deafness hindering their daily activities.
In case of bilateral surgery for TM perforations, due to the increased risk of ISNHL during surgery caused by the presence of middle ear granulation tissue or necessity of ossicular chain reconstruction, only nondischarging ears with no suspicion of additional pathology should be included. 6 Surgery should be initiated on the ear with the most severe pathology/largest perforation, and in case of unexpected events, which increase the risk of ISNHL during first ear surgery (eg, necessity for ossicular chain reconstruction), the second ear procedure should be abandoned.
In this study, there are 2 issues to be addressed. First, the sample was relatively small to reach a widely accepted conclusion. A more extensive survey of cases would be beneficial. Second, patients who underwent bilateral same-day surgery were exposed to general anesthesia for a longer time as the duration of this type of procedure is longer compared to unilateral surgery. Therefore, in cases where exposure to general anesthesia for an extended time poses a risk and in elderly patients, bilateral same-day surgery should be performed under local anesthesia.
Conclusion
Bilateral same-day endoscopic myringoplasty using tragal cartilage from one ear is a safe and satisfactory procedure with a good success rate. Harvesting of tragal cartilage from one ear allows the opposite ear tragal cartilage to be used during subsequent surgery in case of potential graft failure. The hearing impairment experienced during postoperative ear canal packing is modest and is therefore readily acceptable by patients.
Footnotes
Declaration of Conflicting Interests
The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.
Funding
The author(s) received no financial support for the research, authorship, and/or publication of this article.