Hemorrhage risk after coblation tonsillectomy in Chinese pediatric: a multicenter, prospective, observational cohort study.

Abstract

Objectives: The study aimed to assess the incidence of post-coblation tonsillectomy hemorrhage (PCTH) and identify associated risk factors in a pediatric Chinese population.

Methods: 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.

Results: 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.

Conclusions: 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).