Efficacy of Tympanic Membrane Regeneration Therapy for Secondary Cholesteatoma With Tympanic Membrane Perforation

OBJECTIVE: To investigate the effectiveness of tympanic membrane (TM) regeneration therapy (TMRT) for secondary cholesteatoma (SC) with TM perforation (TMP). STUDY DESIGN: Retrospective case review. SETTING: General hospitals. PATIENTS: The study included 38 patients (41 ears) with SC (M/F: 21/17, aged 12 to 86 y) who underwent TMRT and 33 patients (33 ears) with SC (M/F: 15/18, aged 20 to 75 y) who underwent conventional tympanoplasty (CTP). INTERVENTIONS: During TMRT, an endoscope was used to remove all of the remaining TM, leaving the annulus intact, and then the cholesteatoma was removed completely. For TM repair, the edge of the TMP was disrupted mechanically, and a gelatin sponge immersed in basic fibroblast growth factor was placed inside and outside the tympanic cavity and covered with fibrin glue. The protocol was repeated up to 4 times until closure was complete. MAIN OUTCOME MEASURES: Operative time, TMP closure rate, and hearing improvement were evaluated. Adverse events, including cholesteatoma recurrence, were monitored for at least 3 years. RESULTS: The surgical time, TM closure rate, and cholesteatoma recurrence rate were 65 minutes, 100% (41/41 ears), and 2.4% (1/41) in the TMRT group and 125 minutes, 93.9% (31/33), and 9.1% (3/33) in the CTP group, respectively. The average hearing improvements were 12.2 and 7.5 dB in the TMRT and CTP groups, respectively. CONCLUSIONS: TMRT achieved excellent TM closure, favorable hearing outcomes, and acceptable cholesteatoma control during the short-to-mid-term follow-up period in patients with SC. TMRT may be expanded beyond simple TMPs to selected cases of SC.