title: The effect of radiofrequency and mitomycin C on the closure rate of human tympanostomy.
abstract: OBJECTIVE
  To conduct a prospective, randomized, controlled trial determining the feasibility of radiofrequency with or without topical mitomycin C application in delaying the closure time of human tympanostomy and screening its efficacy in management of recurrent acute otitis media and otitis media with effusion.
  
  
  METHODS
  From November 2002 to January 2004, 96 patients (180 ears) who were to undergo surgical intervention for recurrent acute otitis media or otitis media with effusion were included in this study. Sixty ears with a diagnosis of recurrent acute otitis media were equally randomized to three procedures: cold knife myringotomy (Group A), radiofrequency tympanostomy (Group B), and radiofrequency tympanostomy with topical mitomycin C application (Group C). One hundred twenty ears diagnosed as having otitis media with effusion were equally randomized to the last two procedures only. Patients were followed-up every week in the first month, every 2 weeks in the second month, and monthly after that until closure of the tympanostomy. A special follow-up setting was designed 3 months after tympanostomy closure where tympanograms and pure-tone audiograms were obtained.
  
  
  RESULTS
  Groups B and C showed a significantly slower rate of closure than Group A. At the same time, Group C demonstrated a slower rate when compared with Group B. The mean closure time of Group B was 3.5 weeks, with no difference between recurrent acute otitis media and otitis media with effusion. In contrast, the mean closure times for Group C were 5.3 and 7 weeks in cases of otitis media with effusion and recurrent acute otitis media, respectively, with the latter demonstrating a significantly slower closure rate. No recurrence of acute otitis media was reported in 10, 45, and 80% of Groups A, B, and C, respectively. Fifty-nine percent of Group C showed no clinical or tympanometric signs of otitis media with effusion 3 months after closure of tympanostomy. In contrast, Group B reported a lower cure rate (28%), with a statistically significant difference between both groups. Absence of recurrence and improvement in tympanometry signs correlated significantly with the duration of patency of tympanostomy (p < 0.01). The success rate was higher in patients who underwent adenoidectomy, but this did not reach statistical significance except in Group C (p < 0.01).
  
  
  CONCLUSIONS
  Radiofrequency and mitomycin C delay the closure rate of human tympanostomy. The efficacy of mitomycin C seems to be amplified in the presence of an inflamed tympanic membrane. Radiofrequency-assisted mitomycin-enhanced tympanostomy is a precise, safe, and cost-effective procedure that provides a viable approach in the management of recurrent acute otitis media and otitis media with effusion, especially when used in conjunction with adenoidectomy.
authors.affiliation: Tanta Faculty of Medicine and University Hospitals, Tanta, Egypt. sragab@doctors.org.uk
authors.forename: Sameh M
authors.initials: SM
authors.lastname: Ragab
mesh_terms: D000208:Acute Disease; D017115:Catheter Ablation; D002648:Child; D002675:Child, Preschool; D004867:Equipment Design; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D007223:Infant; D008297:Male; D008876:Middle Ear Ventilation / Q000009:adverse effects / Q000295:instrumentation; D016685:Mitomycin / Q000627:therapeutic use*; D019384:Nucleic Acid Synthesis Inhibitors / Q000627:therapeutic use*; D010033:Otitis Media / Q000188:drug therapy / Q000503:physiopathology / Q000601:surgery*; D010034:Otitis Media with Effusion / Q000188:drug therapy / Q000503:physiopathology / Q000601:surgery*; D011446:Prospective Studies; D012008:Recurrence; D013997:Time Factors; D014945:Wound Healing / Q000187:drug effects*
chemical_list: D019384:Nucleic Acid Synthesis Inhibitors; D016685:Mitomycin