Xu Hongming, Qiu Shuyao, Wang Jinxia, Han Fugen, Xia Zhongfang, Ni Liyan, Ma Jing, Chen Chunguang, Gao Xingqiang, Zhang Junmei, Liu Haixia, Liu Haibing, Yao Hongbing, Zhuang Qianger, Song Wei, Zhao Sijun, Liu Dabo, Li Xiaoyan
Department of Otorhinolaryngology Head and Neck Surgery, School of Medicine, Shanghai Children's Hospital, Shanghai Jiao Tong University, No.355, Luding Road, Shanghai, 200062, China.
Department of Pediatric Otorhinolaryngology, Shenzhen Hospital, Southern Medical University, Shenzhen, China.
Eur Arch Otorhinolaryngol. 2025 Apr;282(4):1901-1909. doi: 10.1007/s00405-024-09140-8. Epub 2024 Dec 23.
The study aimed to assess the incidence of post-coblation tonsillectomy hemorrhage (PCTH) and identify associated risk factors in a pediatric Chinese population.
This prospective, multicenter cohort study, conducted over 17 months, included 8854 pediatric patients who underwent coblation tonsillectomy across 15 research centers in China. Patient data were collected through an Electronic Data Capture (EDC) system. The primary outcome was the incidence of PCTH within 21 days post-surgery. Secondary outcomes involved analyzing risk factors for PCTH using multivariable logistic regression.
The incidence of PCTH was 1.99%, with 176 patients experiencing hemorrhage. Significant risk factors included abnormal coagulation indicators (OR 10.56), longer surgery duration (OR 1.02), simultaneous adenoidectomy (OR 0.35), semi-liquid diet (OR 0.13), postoperative cough (OR 1.76), and the use of hemostatic agents (OR 1.58), intravenous antibiotics (OR 2.34), and painkillers (OR 2.33). Regional variations showed lower hemorrhage rates in East, Southwest, Central, and South China compared to North China.
The study found that the hemorrhage rate after coblation tonsillectomy is comparable to traditional tonsillectomy. Risk factors include coagulation status, surgical duration, and postoperative care. Regional differences in hemorrhage rates suggest the need for tailored approaches based on location. Coblation tonsillectomy is a safe and effective procedure for pediatric patients. TRIAL REGISTRATION NUMBER AND DATE OF REGISTRATION FOR PROSPECTIVELY REGISTERED TRIALS: This study was registered on Clinical trials.gov (NCT05206799), and approved by the Ethics Committee of Shanghai Children's Hospital, Shanghai Jiaotong University (2021R096-E01).
本研究旨在评估小儿扁桃体等离子消融术后出血（PCTH）的发生率，并确定中国小儿人群中的相关危险因素。
这项前瞻性、多中心队列研究历时17个月，纳入了中国15个研究中心的8854例接受扁桃体等离子消融术的小儿患者。通过电子数据采集（EDC）系统收集患者数据。主要结局是术后21天内PCTH的发生率。次要结局包括使用多变量逻辑回归分析PCTH的危险因素。
PCTH的发生率为1.99%，有176例患者发生出血。显著的危险因素包括凝血指标异常（比值比[OR] 10.56）、手术时间较长（OR 1.02）、同期行腺样体切除术（OR 0.35）、半流质饮食（OR 0.13）、术后咳嗽（OR 1.76），以及使用止血剂（OR 1.58）、静脉用抗生素（OR 2.34）和止痛药（OR 2.33）。区域差异显示，与华北地区相比，华东、西南、华中及华南地区的出血率较低。
该研究发现，扁桃体等离子消融术后的出血率与传统扁桃体切除术相当。危险因素包括凝血状态、手术时长和术后护理。出血率的区域差异表明需要根据地点采取针对性方法。扁桃体等离子消融术对小儿患者是一种安全有效的手术。前瞻性注册试验的注册号和注册日期：本研究在Clinical trials.gov（NCT05206799）上注册，并获得上海交通大学附属上海儿童医学中心伦理委员会批准（2021R096-E01）。
