Abstract
Objective
This study was performed to analyze the clinical effect of tragus perichondrium in endoscopic myringoplasty with underlay and overlay techniques for the repair of chronic tympanic membrane (TM) perforation.
Subjects and Methods
A total of 120 patients with chronic otitis media who underwent endoscopic TM repair with tragus perichondrium were analyzed. The cases were randomly divided into an overlay group (n=60) and an underlay group (n=60). The intraoperative duration, intraoperative blood loss, graft uptake rate, postoperative TM morphology, hearing outcomes and postoperative complications were compared between the two groups.
Results
Operative time and mean estimated blood loss were significantly lower in the underlay group than in the overlay group (χ2=4.82, p=0.0475)). At 12 months postoperatively, the overall graft uptake rate was significantly higher in the overlay group (98.4%) than in the underlay group (89.3%) (χ2=3.914, p=0.0281. 2 cases were found to have the formation of epithelial cholesteatoma bead in the overlay group, In addition, there were no significant differences between the two groups in the pre- or postoperative mean air-bone gap (postoperative air-bone gap: 11.25±2.71dB for underlay vs. 10.92±3.89dB for overlay, p=0.652). CT examination revealed no cholesteatoma in the middle ear.
Conclusions
In the treatment of chronic TM perforation, endoscopic tragus perichondrium overlay myringoplasty improves the graft success rate compared to the underlay technique. However, the probability of the formation of epithelial cholesteatoma bead will increase, and it requires a higher level of surgical precision. The underlay method is less invasive,takes less surgical time, and is easier to master than the overlay method.
Introduction
Perforation of the tympanic membrane (TM) is the most common result of chronic middle ear infection.
1
As shown in the available literature, the result of
In underlay
Materials and Methods
Study Setting and Patients
We conducted a prospective randomized controlled trial of 120 patients with chronic suppurative otitis media (CSOM) from July 2019 to July 2021 in our department. The inclusion criteria called for patients who were being treated surgically for unilateral medium or large perforations with residual TM around the perforation margin. All procedures were performed by a single experienced surgeon. The study was approved by the hospital’s medical ethics committee. Convenience sampling was used for recruitment. The inclusion criteria were as follows: 1. Medium or large TM perforation caused by chronic otitis media or trauma that did not heal for more than 3 months under conditions of dry ear; 2. No history of otological surgery; 3. No ossicular chain deformity, adhesive otitis media, cholesteatoma otitis media, sensorineural hearing loss, tympanosclerosis or otosclerosis; and 4. No serious systemic diseases, such as cardiovascular or cerebrovascular diseases, liver or kidney insufficiency, hematopoietic system diseases or advanced tumors. Dry ear was defined as the absence of obvious congestion or thickening of the tympanic mucosa, mucus or pus in the tympanic cavity, and granulation. Specifically, consecutive subjects who met the inclusion criteria and signed the consent form were assigned random numbers generated by the SPSS for Windows software package (ver. 20.0; SPSS, Inc., Chicago, IL, USA), which assigned them to either the overlay group or the underlay group. Written informed consent was obtained from each patient. Using the study form, preoperative data was collected, including information on demography, clinical details and postoperative data. A total of 120 patients underwent ET using tragus perichondrium: 60 with the underlay method and 60 patients with the overlay method.
Comparison of Demographic Data for Patients and Postoperative Outcomes Between the Two Groups
aChi-square test.
bIndependent-samples t test.
Methods
A German STORZ endoscopic imaging system and an otoscope (3.0 mm diameter at 0 ° and 30°) were used, and surgical videos were recorded in all cases to ensure consistency of surgical methods and procedures. Adequate communication was conducted with the anesthesiologist prior to the start of the procedure and intraoperative hypotension was applied to maintain blood pressure at 90/50 mmHg. Then a 1% ropivacaine solution with epinephrine was subcutaneously injected into the external auditory canal and tragus (graft area) so that the skin became white and slightly elevated, indicating complete infiltration and thus reducing intraoperative bleeding. The tragus skin was incised along the medial free edge of the tragus for approximately 2 mm and the subcutaneous tissue was separated. The tragus cartilage with perichondrium was excised according to the size of the perforation. The perichondrium has two layers, with a convex side and a concave side. We preserved the convex surface of the perichondrium near the parotid gland, as this surface is thicker and easier to remove from cartilage tissue. Then, the tragus incision was sutured. The otoendoscope was introduced to remove the epithelium approximately 1 mm from the edge of the perforated TM to form a fresh wound and the incision for a skin flap was placed 5 mm to 10 mm away from the tympanic ring. From 0:00 to 6:00 clockwise (taking the right ear as an example), the skin of the posterior wall of the external auditory canal was incised with a circumferential meatal flap knife on the surface of the external auditory canal bone. The flap was then carefully peeled forward and its integrity was ensured. Small cotton balls soaked with adrenaline were used if necessary to stop bleeding on the wound surface.
A1 The overall morphology of the left ear perforated TM before surgery. B1 Lift the entire TM to expose the middle ear cavity. C1 The perichondrial graft is placed under the TM. D1 The TM and external auditory canal flaps are repositioned. E1 The morphology of the repaired TM 12 months after surgery
A2 The overall morphology of the left ear perforated tympanic membrane before surgery. B2 Lift the entire epithelial layer of the TM to expose the fibrous layer of TM. C2 Place the perichondrial graft on the surface of the fibrous layer to cover the edge of the perforation. D2 Replace the epithelial layer of the TM and the external auditory canal flap. E2 The morphology of the repaired TM 12 months after surgery
In both groups, the surgical cavities of the external auditory canal were meticulously packed with gelatin sponges. The concha cavity was packed with dry cotton balls to prevent tragus hematoma. The patients were discharged from the hospital after 3 days, during which time they received intravenous antibiotics. The patients were also treated with oral antibiotics for 1 week, and the tragus incision suture was removed 1 week after the operation. Part of the external auditory canal packing was removed 2 weeks after the operation. Levofloxacin ear drops were used once a day for one month after the operation, with 5 drops each time. Patients were advised to avoid blowing and sniffing as much as possible after surgery and to avoid frequent coughing or sneezing to avoid graft displacement caused by sudden changes in positive and negative pressure in the middle ear.
Observation Indexes
All patients were followed up with otoendoscopy 1 month and 12 months after the operation to evaluate graft uptake and identify any complications. Six months after surgery, pure-tone audiometry was performed at 0.5/1/2/4 kHz. Hearing results were assessed by comparing preoperative and postoperative pure-tone averages as well as closure of the air-bone gap. Computed tomography (CT) was performed to assess pneumatization in the middle ear and mastoid air cells 12 months after surgery.
Statistical Analysis
SPSS 21.0 software was used for the statistical analysis of all data. Mean values were compared between groups by t test, and count data was compared by chi-square test. p<0.05 was considered to indicate a statistically significant difference.
Results
Operative Indexes in the Two Groups
The operative indexes in the underlay and overlay groups were quite different. The operative time was significantly shorter in the underlay group (31.8±4.6 min) than in the overlay group (50.1±7.9 min) (p<0.001). The volume of mean estimated blood losswas significantly lower in the underlay group (5.6±2.1 ml) than in the overlay group (8.4±3.2 ml) (p<0.001) (Table 1).
Postoperative Morphology
Otoendoscopy one month after the operation showed a preliminary establishment of the new TM morphology in the underlay(Figure 3 A and E) and overlay group (Figure 3 C and G). A prominent boundary was observed between the lateral perichondrium and the TM remnant, and the perichondrium could be clearly identified. Plentiful red capillary networks were observed on the surface of the both underlay and overlay groupsTM (Figure 3A and C and E and G), indicating the establishment of a good blood supply between the new TM and the residual TM. Through this blood supply nutrients could be continuously transported from the residual TM to the graft. By 12 months after the operation, the shape of the underlay groups TM(Figure 3B and F) and overlay groups TM had essentially been finalized. Most of the grafts were still stable, and no obvious reduction or absorption was observed. Graft medialization was observed in 7 cases in the underlay group (Figure 3A and B); these 7/60 (11.6%) grafts gradually migrated in toward the tympanic cavity under the effect of its negative pressure. A Moderate perforation in the underlay group 1 month after surgery. B Moderate perforation in the underlay group 12 months after surgery. C Moderate perforation in the overlay group 1 month after surgery. D Moderate perforation in the overlay group 12 months after surgery. E Large perforation in the underlay group 1 month after surgery. F Large perforation in the underlay group 12 months after surgery. G Large perforation in the overlay group 1 month after surgery. H Large perforation in the overlay group 12 months after surgery
Perforation Healing Rate in the Two Groups
The graft status (accepted or rejected) in 120 cases was statistically analyzed. At 1-month follow-up, graft failure was observed in 8 and 2 cases in the underlay and overlay groups, respectively. The success rates were 85.7% (52/60) and 96.9% (58/60) in the underlay and overlay groups, respectively (χ2=3.73, p=0.0475). At 12 months of follow-up, reperforation was observed in 7 cases and 1 case in the underlay and overlay groups, for success rates of 89.3% (53/60) and 98.4% (59/60), respectively (χ2=4.82, p=0.0281) (Table 1). In addition, of the 7 reperforations in the underlay group, 2 were in the anterosuperior quadrants and 5 were in the anteroinferior quadrant. The single reperforation in the overlay group occurred in the anteroinferior quadrant(Figure 4). Figures A and B illustrate cases of tympanic membrane perforation repaired using the underlay technique. In both instances, the perforation sites are situated in the anterior region of the tympanic membrane, proximal to the annulus tympanicus. Figure C presents a case of infection-induced perforation that was addressed using the overlay method
Postoperative Hearing Improvement
Comparison of Healing Gain and Air-Bone Gap Between the Two Groups (n=120)
Intragroup comparisons of preoperative and postoperative air conduction and air-bone gap (paired-samples t test).
Postoperative Complications
CT examination revealed well-pneumatized middle ears 12 months after surgery in both groups, and no middle ear cholesteatoma was observed. We observed that the reconstructed tympanic membrane was thin and uniform, without granulation, secretion, or formation of cholesteatoma in the tympanic cavity. The postoperative morphology of the TM was similar to that of the normal TM (Figure 5). In the patients who underwent the overlay method, 2 cases were found to have the formation of epithelial cholesteatoma bead during the reexamination 1 year after the operation, and they were removed after the revision surgery,The positions of the two epithelial cholesteatoma bead were both located at the junction of the tympanic membrane near the posterior wall of the external auditory canal. (Figure 6). Among the 120 patients who completed postoperative follow-up, 2 patients had transient tinnitus and 1 patient had vertigo. The symptoms of the above patients improved when re-examined one month after the operation. No serious complications such as dysgeusia, sensorineural hearing loss, facial paralysis, or secondary cholesteatoma, were found in any patient 12 months after the operation. CT examination of the overlay groups. A Right preoperative perforation on horizontal CT. B, C, D Reconstructed TM at 12 months postoperatively. e Right preoperative perforation on coronal CT. F, G, H Reconstructed TM at 12 months postoperatively Figures A and B show two cases of white pearl-like cholesteatoma epithelial pearls found during the otoscopic examination one year after the surgery

Discussion
Myringoplasty is the operative procedure performed to repair TM perforation and improve hearing. 11 The graft success rate depends on various factors, such as the size of the perforation, the functioning of the eustachian tube, the graft placement technique, and the experience of the operating surgeon. 12 There are many mature techniques that can be applied to repair small TM perforations and achieve good postoperative results; therefore, the comparability of small perforations is insufficient. Therefore, all small perforations cases were excluded from this study. Repair of medium or large perforations using the conventional underlay technique has often been reported to be less successful than repair of small perforations because it is technically more difficult. 6 Furthermore, the incidence of postoperative complications in cases of moderate or larger perforation size will increase. 13
In the past, the temporal fascia was the material most widely used and classically for TM repair under microscopy. According to reports, there is no significant difference between the perichondrium and temporal fascia in terms of postoperative efficacy, and both are considered suitable transplantation materials for
In our study, the average surgery time required was 31.8±4.6 min in the underlay group and 50.1±7.9 min in the overlay group, with a significant difference (p<0.001). Shorter operation caused less surgical trauma and blood loss, leading to faster postoperative recovery (Table 1). Extra time was required for overlay surgery, mainly to separate the epithelial layer from the fibrous layer of the residual TM, which requires surgical proficiency with a one-handed otoscope. Another study by N. Ahilasamy et al. showed that the time required for surgery with endoscopic techniques was 30–45 min for most patients (70%); in the remaining patients (30%), surgery was completed after approximately 60 min, without procedures that required more than 1 hour 10 min. We also found that more bleeding requiring hemostasis in the external ear canal, larger perforations, and a more anterior perforation location resulted in more surgical procedures and a longer operation.
In terms of graft uptake with tragal perichondrium as material, the graft success rate differed between the two groups. At one month after surgery, the graft success rate was 96.9% in the overlay group and 85.7% in the underlay group; the difference was significant (p=0.0475). At 12 months after surgery, the overlay group still had a significantly higher success rate than the underlay group (98.4% vs. 89.3%, p=0.028). The same conclusion also occurs with the use of temporal fascia to repair the TM with overlay and underlay techniques. Sinha M et al. reported graft success rates of 90.0% using endoscopic temporal fascia with the underlay technique.
18
In another study, 470 patients who underwent temporal fascia overlay
Regarding the placement of the tragus perichondrium in our study, why is the closure rate better for the overlay technique than for the underlay technique? It is well-known that the material of the perichondrium is relatively soft and lacks rigidity. In the underlay method, the perichondrium is supported only by the malleus bone and gelatin in the early stages. After the absorption of gelatin, the newborn TM is more dependent on the adhesion and gradual epithelial growth between the perichondrium and the residual TM. The supporting structure is not firm; When the negative pressure of the tympanic cavity is too high or the TM is subjected to severe impact, the TM may medialize, increasing the incidence of reperforation. In the present study, 11.6% of the grafts in the underlay group resulted in medialization and reduction of the space in the middle ear. Another important reason is that in the underlay technique with elevation of the tympanomeatal flap, the loosening and lifting of the fibrous layer of the TM can affect the blood supply to the graft leaving an inadequate area of contact between the graft and the remnant of the TM.
In contrast, the overlay technique can preserve the original shape of the eardrum, and the graft can establish a rich blood supply from the residual eardrum and maintain a stable structure, resulting in an excellent postoperative closure rate. The graft is stably embedded between the fibrous layer and the epithelial layer, which offers the advantages of firm structural fixation to improve the rate of successful uptake of the graft. 20 This unique “sandwich structure” allows the graft to establish a more easily a blood supply with the residual TM and to become more firmly fixed, which in turn better maintains the original shape of the TM. Therefore, the overlay method can result in better graft uptake than the underlay method by applying tragus perichondrium under otoendoscopy.
In terms of postoperative TM healing morphology, there was no difference in the healing speed of the perichondrium between the two groups (Figure 3). At 1-month follow-up, the successfully repaired TM was found to be flat and smooth, with a rich blood supply; the sharp angle of the anterior TM was not blunted; and a clear and visible capillary network covered the surface of the graft to provide nutrition (Figure 3 a, c, e, g). At 12 months of follow-up, the postoperative TM morphology was basically unchanged in the two groups. The capillary network had subsided and all grafts in the overlay group and the majority of grafts in the underlay group were still stable (Figure 3 d, f, h). Furthermore, there were some cases of perichondrial detachment in the underlay group (Figure 3 a, b). These findings verified from another perspective that the overlay technique could provide a more stable graft structure than the underlay technique.
Regarding hearing improvement, the postoperative ACT was 23.21±5.25 dB HL in the underlay group and 22.78±6.21 dB HL in the overlay group, compared to the preoperative values of 41.51±5.26 dB HL and 43.81±3.81 dB HL, respectively, with a statistically significant difference between the preoperative and postoperative values (Table 2). Because the mobility of the ossicular chain was intact in all cases, the slightly higher preoperative ACT can be solely attributed to the medium or large size of the perforations, as no other problems were found. This finding also demonstrates a postoperative improvement in hearing regardless of the method applied and confirms that TM repair with the tragus perichondrium can produce good mechanical stability and sound conduction. Tragus perichondrium, with its thinness and smooth surface, can be easily applied with either the underlay or the overlay method, with no significant differences between the two groups (Table 2).
In theory, there is a risk of iatrogenic middle ear cholesteatomawhen the superficial squamous epithelium of the TM is lifted up in the overlay group. However, CT revealed well-pneumatized middle ears 12 months after surgery, and no iatrogenic cholesteatoma was observed in the overlay groups (Figure 5). No local curling or thickening of the TM was found and the tympanic cavity was also very clean. The key point is that during the operation we removed a circle of epithelium around the residual eardrum and ensured that the entire epithelium layer was lifted. The surface of the tympanic mucosa was also checked to ensure that there was no epithelial detachment. Furthermore, some authors suggested that the development of middle ear cholesteatoma was more likely to be based on the environment of the middle ear. The wet environment will result in the proliferation of granulation tissue and will block drainage and ventilation in the middle ear, thus inducing the development of cholesteatoma. The formation of cholesteatoma could depend on the change of the drainage and ventilation systems in the middle ear rather than the buried epithelium. 21
Two cases of cholesteatoma epithelial bead formation were indeed observed in the overlay method (Figure 6). This outcome can be attributed to the fact that the overlay method necessitates lifting a complete circular segment of the epithelial tympanic membrane, during which local tearing or damage is prone to occur. When re-covering the epithelial tympanic membrane, there may be instances where the local epithelium becomes inverted, curled, or wrinkled. These complications place higher demands on the operator’s technical proficiency. Furthermore, in a minority of patients with thin tympanic membranes, such risks are likely to increase correspondingly. Therefore, surgeons must conduct a more thorough preoperative evaluation of the tympanic membrane conditions to mitigate potential complications. 12 months is relatively short to determine graft medialization and cholesteatoma formation,so the long-term efficacy and complications still require continuous observation.
Conclusion
Endoscopic
Footnotes
Ethical Considerations
Study protocol was reviewed and approved by local Ethics Committee, approval number (KY2022SL284-01).
Consent to Participate
Each participant (or their parent/legal guardian/next of kin) provided written consent to participate in the study.
Author Contributions
Xiang Cui and Jian Zhang were essentially involved in the implementation and conceptualization of the study. Ruixia Hou and WenJuan Hao were responsible for the enrollment of patients and data collection. Juntao Huang was responsible for data analysis and scientific writing. Zhisen Shen was contributed significantly to the success of the study by providing the appropriate human and diagnostic resources and support in data interpretation. Xiang Cui was major contributors to writing the manuscript. All authors read and approved the final manuscript.
Funding
This study was supported by Ningbo Top Medical and Health Research Program(No.2023030514);Ningbo Clinical Research Center for Otolaryngology Head and Neck Disease (No.2022L005);Zhejiang Medical and Health Technology Project(No.2023KY241).
Declaration of Conflicting Interests
The authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.
Data Availability Statement
All data generated or analyzed during this study are included in this article and its supplementary material files. Further inquiries can be directed to the corresponding author.
