Abstract：
OBJECTIVE: The objective of this study was to compare the graft outcomes and complications of two endoscopic perichondrium-cartilage graft techniques for repairing large perforations.
METHODS: Single center blinded randomized controlled trial.
METHODS: 61 large perforations more than 50% of TM area were prospectively randomized to undergo the free perichondrium and free cartilage graft group (FPFC, n = 31) or perichondrium partial attachment the cartilage graft group (PPAC, n = 30). The primary outcome measures were the operation time; secondary outcome measures were the graft success rate and hearing gain at 12 months postoperatively and postoperative complications.
RESULTS: All patients completed follow-up of 12 months. The mean operation time was 38.2 ± 2.3 min in the FPFC group and 37.4 ± 5.6 min in the PPAC group (P = 0.658). At postoperative 3 months, the graft success rates were 96.7% in the FPFC group and 93.3% in the PPAC group (P = 0.976). At postoperative 12 months, the graft success rates were 96.7% in the FPFC group and 83.3% in the PPAC group (P = 0.182). However, the residual and re-perforation rate with no infection was 0.0% (0/31) in the FPFC group and 16.7% (5/30) in the PPAC group (P = 0.056). No significant between-group differences were observed pre- (P = 0.842) or post- (P = 0.759) operative air bone gap (ABG) values or mean ABG gain (P = 0.886). However, granular myringitis has been noted in 6.5% in the FPFC group and in 3.3% in the PPAC group.
CONCLUSIONS: This study suggested that 12-month graft success and hearing gain were comparable between the perichondrium free and partial attachment the cartilage graft techniques, nevertheless, partial attachment technique could increase residual and re-perforations.
METHODS: Single center blinded randomized controlled trial.
METHODS: 61 large perforations more than 50% of TM area were prospectively randomized to undergo the free perichondrium and free cartilage graft group (FPFC, n = 31) or perichondrium partial attachment the cartilage graft group (PPAC, n = 30). The primary outcome measures were the operation time; secondary outcome measures were the graft success rate and hearing gain at 12 months postoperatively and postoperative complications.
RESULTS: All patients completed follow-up of 12 months. The mean operation time was 38.2 ± 2.3 min in the FPFC group and 37.4 ± 5.6 min in the PPAC group (P = 0.658). At postoperative 3 months, the graft success rates were 96.7% in the FPFC group and 93.3% in the PPAC group (P = 0.976). At postoperative 12 months, the graft success rates were 96.7% in the FPFC group and 83.3% in the PPAC group (P = 0.182). However, the residual and re-perforation rate with no infection was 0.0% (0/31) in the FPFC group and 16.7% (5/30) in the PPAC group (P = 0.056). No significant between-group differences were observed pre- (P = 0.842) or post- (P = 0.759) operative air bone gap (ABG) values or mean ABG gain (P = 0.886). However, granular myringitis has been noted in 6.5% in the FPFC group and in 3.3% in the PPAC group.
CONCLUSIONS: This study suggested that 12-month graft success and hearing gain were comparable between the perichondrium free and partial attachment the cartilage graft techniques, nevertheless, partial attachment technique could increase residual and re-perforations.
摘要：
目的：本研究的目的是比较两种内窥镜软骨膜-软骨移植技术修复大穿孔的移植效果和并发症。
方法：单中心盲法随机对照试验。
方法：前瞻性随机将61个TM面积超过50％的大穿孔随机分为游离软骨膜和游离软骨移植组（FPFC，n=31)或软骨膜部分附着软骨移植组(PPAC，n=30)。主要结局指标是手术时间；次要结局指标是移植成功率和术后12个月的听力增益以及术后并发症。
结果：所有患者均完成12个月的随访。FPFC组平均手术时间为38.2±2.3min,PPAC组为37.4±5.6min(P=0.658)。术后3个月，FPFC组和PPAC组的移植成功率分别为96.7%和93.3%(P=0.976).术后12个月，移植成功率FPFC组为96.7%,PPAC组为83.3%(P=0.182).然而,FPFC组和PPAC组的残留和无感染的再穿孔率为0.0％（0/31），PPAC组为16.7％（5/30）（P=0.056）。术前（P=0.842）或术后（P=0.759）未观察到组间差异（P=0.886）。然而,在FPFC组和PPAC组中,分别有6.5%和3.3%的患者出现了颗粒性心肌炎.
结论：这项研究表明，12个月的移植成功率和听力增益在软骨游离和部分附着软骨移植技术之间具有可比性，然而，部分附着技术可能会增加残余和重新穿孔。
方法：单中心盲法随机对照试验。
方法：前瞻性随机将61个TM面积超过50％的大穿孔随机分为游离软骨膜和游离软骨移植组（FPFC，n=31)或软骨膜部分附着软骨移植组(PPAC，n=30)。主要结局指标是手术时间；次要结局指标是移植成功率和术后12个月的听力增益以及术后并发症。
结果：所有患者均完成12个月的随访。FPFC组平均手术时间为38.2±2.3min,PPAC组为37.4±5.6min(P=0.658)。术后3个月，FPFC组和PPAC组的移植成功率分别为96.7%和93.3%(P=0.976).术后12个月，移植成功率FPFC组为96.7%,PPAC组为83.3%(P=0.182).然而,FPFC组和PPAC组的残留和无感染的再穿孔率为0.0％（0/31），PPAC组为16.7％（5/30）（P=0.056）。术前（P=0.842）或术后（P=0.759）未观察到组间差异（P=0.886）。然而,在FPFC组和PPAC组中,分别有6.5%和3.3%的患者出现了颗粒性心肌炎.
结论：这项研究表明，12个月的移植成功率和听力增益在软骨游离和部分附着软骨移植技术之间具有可比性，然而，部分附着技术可能会增加残余和重新穿孔。
