Comparison of single-piece and multiple-piece cartilage grafts for the repair of large tympanic membrane perforations: a randomized controlled trial.

OBJECTIVE

We compared graft success rates, hearing outcomes, and operation times between single-piece cartilage grafts (SPCGs) and multiple-piece cartilage grafts (MPCGs) in patients with large tympanic membrane (TM) perforations.

STUDY DESIGN

Single-center blinded randomized controlled trial.

SETTING

Tertiary referral center.

MATERIALS AND METHODS

Patients with large TM perforations exceeding 50% of the TM area were recruited and randomly assigned to the SPCG or MPCG group. Graft success rates, hearing outcomes, operation times, and complications were evaluated at 12 months postoperatively.

RESULTS

In total, 61 patients with large TM perforations were included. The mean operation time was significantly longer in the MPCG group (47.2 ± 3.8 min) than in the SPCG group (32.6 ± 4.1 min). All patients completed a 12-month follow-up. Postoperatively, residual perforation was observed in one patient (3.3%) in the SPCG group and in two patients (6.5%) in the MPCG group. The graft success rates were 96.7% (29/30) and 93.5% (29/31) in the SPCG and MPCG groups, respectively. The postoperative air-bone gap (ABG) exhibited significant improvement compared to preoperative values in both groups. In addition, no significant inter-group differences were observed in preoperative or postoperative ABG values. Although the mean ABG gain did not differ significantly between the groups, the SPCG group demonstrated greater hearing improvement compared to the MPCG group. None of the patients developed postoperative otitis media with effusion or graft retraction.

CONCLUSIONS

Endoscopic myringoplasty using the SPCG and MPCG techniques demonstrated comparable graft outcomes. However, the operation time of the SPCG technique was significantlyshorter.

TRIAL REGISTRATION

Chinese Clinical Trial Registry (ChiCTR) ChiCTR2300078776 (registered on 18 December 2023).

STATISTICAL ANALYSES

Statistical analyses were performed using SPSS version 19 (IBM Corp.). Continuous variables are presented as means ± standard deviations, whereas categorical variables are presented as numbers or percentages. The chi-squared test was used to compare categorical variables. The Wilcoxon and Mann-Whitney U-tests were used to compare non-parametric variables between the two groups. Analyses of variance were used to compare preoperative and postoperative ABG and BC variables, with preoperative hearing status included as a covariate. P-values < 0.05 were considered statistically significant.