Department of Anesthesiology, People's Hospital, Peking University.
Department of Otorhinolaryngology, Head and Neck Surgery, People's Hospital, Peking University, Beijing, People's Republic of China.
Int J Surg. 2024 Jul 1;110(7):4170-4175. doi: 10.1097/JS9.0000000000001366.
The microscopic middle ear surgery involves a limited operating space and numerous important anatomical structures in which good visualization is crucial, as even a small amount of bleeding can greatly affect the clarity of surgical field. This study aims to investigate whether intravenous 1 g of tranexamic acid can improve surgical visualization and further shorten the operation time in microscopic middle ear surgery.
This study is a prospective, randomized, double-blind, controlled trial conducted from December 2021 to December 2022, enrolling patients who were scheduled for microscopic modified radical mastoidectomy due to chronic otitis media. In addition to standard techniques to optimize the surgical field, participants were randomized into the TXA (tranexamic acid) group (1 g diluted to 20 ml normal saline) and the control group (20 ml normal saline). The primary outcome was assessed based on the clarity of the surgical field using the Modena Bleeding Score. Secondary outcomes included operation time, the surgeon satisfaction with the visual clarity, postoperative 24 h coagulation parameters, and the incidence of adverse events. Student's t -test, χ2 test, and ANOVA of repeated measures were used for statistical analyses.
A total of 28 patients were enrolled in each group using a 1:1 randomized allocation with similar demographic characteristics, including 24 male and 32 female individuals, and the mean age is 45.6±11.9 years. The surgical visualization in the TXA group was significantly better than that of the control group (2.29±0.46 vs. 2.89±0.31, P <0.001) as assessed by the Modena Bleeding Score. Furthermore, the TXA group demonstrated a shorter operation time compared to the control group (88.61±10.9 vs. 105.2±15.9, P <0.001) and higher surgeon satisfaction with surgical field (7.82±0.55 vs. 6.50±0.64, P <0.001). No statistically significant differences were found in postoperative coagulation parameters in the two groups. No TXA-related adverse events or complications occurred during the 12-month follow-up.
Intravenous 1 g of TXA can further significantly improve the visual clarity in the microscopic middle ear surgery and shorten the operation time based on other standard measures implemented.
显微镜下中耳手术的操作空间有限，涉及众多重要解剖结构，因此良好的可视化效果至关重要，因为即使是少量出血也会极大地影响手术视野的清晰度。本研究旨在探讨静脉注射 1g 氨甲环酸是否可以改善手术可视化效果，并进一步缩短显微镜下中耳手术的时间。
这是一项前瞻性、随机、双盲、对照临床试验，于 2021 年 12 月至 2022 年 12 月期间入组因慢性中耳炎而行显微镜下改良乳突根治术的患者。除了采用标准技术优化手术视野外，参与者还被随机分为氨甲环酸（TXA）组（1g 氨甲环酸稀释至 20ml 生理盐水）和对照组（20ml 生理盐水）。主要结局是根据 Modena 出血评分评估手术视野的清晰度。次要结局包括手术时间、术者对视觉清晰度的满意度、术后 24 小时凝血参数以及不良事件的发生率。采用 Student's t 检验、χ2 检验和重复测量方差分析进行统计学分析。
每组各纳入 28 例患者，采用 1:1 随机分组，两组患者的人口统计学特征相似，包括 24 例男性和 32 例女性，平均年龄为 45.6±11.9 岁。TXA 组的手术可视化效果明显优于对照组（Modena 出血评分：2.29±0.46 vs. 2.89±0.31，P<0.001）。此外，TXA 组的手术时间明显短于对照组（88.61±10.9 vs. 105.2±15.9，P<0.001），术者对手术视野的满意度也更高（7.82±0.55 vs. 6.50±0.64，P<0.001）。两组患者术后凝血参数无统计学差异。在 12 个月的随访期间，未发生与 TXA 相关的不良事件或并发症。
在采用其他标准措施的基础上，静脉注射 1g 氨甲环酸可进一步显著提高显微镜下中耳手术的视觉清晰度，并缩短手术时间。
