Randomized Clinical Trial Comparing Bucket Handle and Cartilage Tympanoplasty Techniques for the Reconstruction of Subtotal or Anterior Tympanic Membrane Perforation

随机临床试验比较桶柄式鼓室成形术和软骨鼓室成形术治疗鼓膜次全穿孔或前部穿孔的疗效

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Abstract

OBJECTIVE: The purpose of the study is to compare the clinical outcome of the two techniques of Bucket Handle Tympanoplasty and Cartilage Tympanoplasty in achieving success in graft survival as well as acceptable auditory results. 60 patients who suffered chronic otitis media with anterior perforation of the tympanic membrane were chosen. The patients were randomly assigned using Block Randomization Method of two groups including patients who underwent Bucket Handle Tympanoplasty (n = 30) or those that underwent Cartilage Tympanoplasty (n = 30). The patients were followed up for 1, 3, 6, and 12 months postoperatively. RESULTS: The mean PTA was lower in Bucket Handle Tympanoplasty group as case group compared to Cartilage Tympanoplasty group as the control (P = 0.023). No significant statistical differences had identified passing through the time, in terms of PTA outcome (P Value = 0.547) and SRT outcome (P Value = 0.352), between Bucket Handle Tympanoplasty group and the Cartilage Tympanoplasty group. In total, postoperative tympanic membrane perforation was found in 10.0% of patients in Cartilage Tympanoplasty group and 13.3% in Bucket Handle Tympanoplasty group with no difference (P = 0.500). CONCLUSIONS: Hearing improvements in both methods were similar. REGISTRATION NUMBER: The trial is registered with IRCT2016022626773N1.

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