METHODS: This prospective randomized case-control study was conducted from February 2017 to March 2022. We included 320 patients with a medium-sized TM perforation with inactive mucosal otitis media. Transcanal FGM managed all patients under general or local anesthesia according to the patient preference. According to PRP, patients were divided into two groups: the first with PRP (170 patients) and the other without PRP (150 patients). We evaluated the closure rate of both groups one month, six months, and one year after the surgery. Also, we assessed the audiological performance before and one year after the operation for the patients with a successful closure.
RESULTS: The closure rate was 87.6 % in the first group and 72.7 % in the second group, with a statistically significant difference between both groups as the P-value, was 0.001. Successful closure of the ABG to <10 dB occurred in 95.3 % of group A and 90.8 % of group B without a statistically significant difference between both groups (P-value = 0.163).
CONCLUSIONS: This prospective comparative study on a relatively large number of patients revealed that FGM effectively closed medium-sized TM perforations. It also significantly improved postoperative audiological performance in both groups. Adding PRP during the FGM enhanced the closure success and the healing process without recorded complications. We recommend using the PRP in the routine FGM for closing medium-sized TM perforations.
方法:这项前瞻性随机病例对照研究于2017年2月至2022年3月进行。我们纳入了320例中型TM穿孔伴非活动性粘膜中耳炎的患者。经肛门FGM根据患者的喜好对所有患者进行全身或局部麻醉。根据PRP,患者分为两组:第一组有PRP(170例),另一组无PRP(150例).评估两组患者1个月的闭合率,六个月,手术后一年.此外,我们评估了成功闭合的患者手术前和手术后一年的听力学表现。
结果:第一组的闭合率为87.6%,第二组的闭合率为72.7%,两组之间的P值具有统计学上的显着差异,是0.001。A组为95.3%,B组为90.8%,两组间无统计学差异(P值=0.163)。
结论:这项针对相对大量患者的前瞻性比较研究表明,FGM可以有效地封闭中型TM穿孔。这也显著改善了两组的术后听力学表现。在FGM期间添加PRP可增强闭合成功率和愈合过程,而没有记录并发症。我们建议在常规FGM中使用PRP来关闭中型TM穿孔。