Multicentre clinical study of haemorrhage after coblation tonsillectomy in children: a prospective study protocol.

Abstract

Post-tonsillectomy haemorrhage (PTH) is the most common and significant life-threatening complication following tonsillectomy, especially in children. Coblation tonsillectomy (CTE) at low temperature is extensively used in China and has gradually replaced conventional tonsil dissection. However, risk of late PTH has been shown to increase with the use of hot instruments. The aim of this study is to detect post-CTE haemorrhage (PCTH) rates and analyse risk factors of PCTH in China, through a nationwide multicentre prospective study. This investigator-initiated, prospective, multicentre clinical trial will involve children with tonsil disease who will undergo CTE from 22 research centres in different cities in China. All operations will be performed using the same technique of extracapsular tonsillectomy. Data will be collected for all patients enrolled in this study through a preoperative visit, intraoperative data and a postoperative visit. The measurement data conforming to a normal distribution will be expressed by means±SDs, and a Student's t-test will be used for comparison. The comparison among groups of counting data will be expressed by percentage or rate, and a χ² test will be used for comparison. Non-conditional logistic regression analysis will be used to analyse the preoperative, intraoperative and postoperative risk factors for haemorrhage rate after CTE. P<0.05 will be considered statistically significant. This study protocol was approved by the Ethics Committee of Shanghai Children's Hospital/Shanghai Jiao Tong University (reference number 2021R096-E01). All patients will provide written informed consent. Results of this study are to be published in respected, peer-reviewed journals and findings presented at scientific conferences in the field of paediatric otorhinolaryngology. NCT05206799.